Docket Number: EPA-HQ-OPP-2010-0915 

www.regulations.gov 

Tau-fluvalinate Summary Document 

Registration Review: Initial Docket 

 December 2010 
2
3

TABLE OF CONTENTS 

 Page # 

I. Preliminary Work Plan (PWP) 4 

II. Fact Sheet 11 

III. Summary of Data Gaps 16 

________________________________________ 

Please Note 

This document summarizes the Environmental Protection Agency's current position on taufluvalinate based on the following documents: 

1. Registration Review: Preliminary Problem Formulation for Environmental Fate, 

Ecological Risk, and Endangered Species Assessments for Tau-fluvalinate. December 

15, 2010. 

2. Tau-fluvalinate. Human Health Assessment Scoping Document in Support of 

Registration Review. November 8, 2010. 

3. Tau-fluvalinate Reregistration Eligibility Decision. September 2005. (Available from 

http://www.epa.gov/oppsrrd1/REDs/taufluvalinate_red.pdf) 

4. Updated Review of Tau-fluvalinate Incident Reports. August 19, 2010. 

5. Screening Level Use Analysis (SLUA) for Tau-fluvalinate. January 21, 2010. 

6. Appendix A for Tau-fluvalinate. January 13, 2010. 

Additional supporting documents for tau-fluvalinate may be found in the docket located on the 

internet at www.regulations.gov.
4

I. Preliminary Work Plan – Tau-fluvalinate 

Introduction:

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides sold or distributed in the United States (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 review program is intended to make sure that, as the ability 

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided at: http://www.epa.gov/oppsrrd1/registration_review/. 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the 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 what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration 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 tau-fluvalinate. 

Tau-fluvalinate is a broad-spectrum insecticide/miticide in the pyrethroid class of pesticides. It 

is registered for a single food use (beehives/honey) and several non-food uses, including 

ornamentals (outdoor and container-grown, greenhouse, interior plantscapes, dip for cuttings), 

building surfaces/perimeters, ant mounds and certain crops (carrots and brassica/cole crops) 

grown for seed. It is registered for use on residential outdoor sites such as ornamental plants, 

ground cover, and shrubs. Tau-fluvalinate was first registered in one of its earlier forms, racemic 

fluvalinate, in 1983. Tau-fluvalinate was the subject of a Reregistration Eligibility Decision 

(RED), which was completed on September 28, 2005. 

Anticipated Risk Assessment and Data Needs:

The Agency intends to require data needed to update and revise the ecological risk assessment 

for tau-fluvalinate (including an endangered species risk assessment). The Agency also intends 

to require data needed to update and revise the human health risk assessment. Below is a 

summary of the issues relevant to the registration review of tau-fluvalinate and the data the 

Agency plans to require. 
5

Ecological Risk: 

• The most recent ecological risk assessment was completed in 2005 to support the taufluvalinate RED. 

• The Agency has not conducted a risk assessment that supports a complete endangered 

species determination. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of tau-fluvalinate 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 the 

U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), 

as appropriate. 

• An updated ecological assessment is planned to be conducted to incorporate new data and 

any relevant changes to risk assessment methodologies. 

• The Agency intends to require the following data in order to conduct a complete 

ecological risk assessment, including an endangered species assessment, for all uses: 

o Guideline (GLN) 850.4100 – Seedling emergence Tier II1

o GLN 850.4150 – Vegetative vigor, Tier II1

o GLN 850.4400 – Aquatic plant growth (vascular plant toxicity), Tier II1

o GLN 850.5400 – Aquatic plant growth (algal plant toxicity), Tier II1

o GLN 835.4300 – Aerobic aquatic metabolism 

o GLN 834.4400 – Anaerobic aquatic metabolism 

o GLN 835.6100 – Terrestrial field dissipation 

o GLN 850.1025 – Acute toxicity to estuarine/marine invertebrate for the oyster 

o GLN 850.1350 – Aquatic invertebrate life-cycle for mysid shrimp 

o GLN 850.2100 – Avian oral toxicity test for passerine species 

 

1 The Agency anticipates requiring a Tier II study. A Tier I study may be conducted in lieu of a Tier II 

study with the understanding that adverse effects (even if <25%) would necessitate a Tier II study as well. 

The purpose of a Tier II study is to establish either a No Observed Adverse Effect Concentration 

(NOAEC) or a concentration at which there is a 5% observed effect (EC05) to be used in an endangered 

species risk assessment for nontarget plants. If neither an NOAEC nor an EC05 value is available, then 

the Agency may have to presume that tau-fluvalinate "may affect" listed nontarget plant species in the 

registration review endangered species risk assessment. 
6

o Non-guideline – Test for Measuring the Effects of Sediment Associated 

Contaminants on Survival, Growth, and Reproduction on Hyalella azteca in 

USEPA 2000 Methods for Measuring the Toxicity and Bioaccumulation of 

Sediment-associated Contaminants with Freshwater Invertebrates (EPA 600/R99/064). 

o Non-guideline – Life-cycle Test for Measuring the Effects of Sediment-associated 

Contaminants on Chironomus dilutus or C. tentans in USEPA 2000 Methods for 

Measuring the Toxicity and Bioaccumulation of Sediment-associated 

Contaminants with Freshwater Invertebrates (EPA 600/R-99/064). 

o Non-guideline – Leptocheirus plumulosus in USEPA 2001 Method for Assessing 

the Chronic Toxicity of Marine and Estuarine Sediment-associated Contaminants 

with the Amphipod Leptocheirus plumulosus (EPA 600/R-01/020). 

• Please refer to the Registration Review: Preliminary Problem Formulation for 

Environmental Fate, Ecological Risk, and Endangered Species Assessments for Taufluvalinate located in the docket, for a detailed discussion of the anticipated risk 

assessment needs. 

Human Health Risk: 

• The most recent comprehensive human health assessment was completed in September 

2005 in support of the tau-fluvalinate RED. Subsequent to the last risk assessment, the 

Agency has identified age-dependent pharmacokinetic factors associated with all 

pyrethroid insecticides that may lead to uncertainty regarding effects in children. 

• Tau-fluvalinate residential use was restricted to commercial applicators in 2005. 

Therefore, a residential handler (homeowner) assessment was not conducted. However, 

since the 2005 assessment, two new homeowner end-use products have been registered 

for use on outdoor residential areas. During registration review, the Agency plans to 

assess potential residential handler exposure. A post-application exposure assessment of 

the current residential uses of tau-fluvalinate is not necessary as it is the Agency’s 

standard practice not to assess post-application residential exposures from treated 

ornamentals or from perimeter, spot, and crack and crevice treatments to patios and other 

outside surfaces. 

• During registration review, a new drinking water assessment will likely be conducted to 

take into account any new, relevant data submitted to the Agency or published in the 

literature. Input parameters to the drinking water model will also be updated to reflect 

current input parameter guidance. 

• During registration review, the Agency foresees conducting a full reassessment of dietary 

(food and water), occupational, residential, and aggregate risk, taking into account any 

changes to toxicological endpoints, safety factors, exposure values, and applicable 

standard operating procedures. 
7

• The Agency is in the process of examining its policies and processes regarding inhalation 

risk assessment and anticipates evaluating the need for a bystander inhalation risk 

assessment for tau-fluvalinate residential use during registration review. 

• The developmental neurotoxicity study (DNT) was previously not requested for taufluvalinate. However, the Agency has new information regarding the potential for 

increased susceptibility in juveniles from pyrethroid exposures, and therefore, the DNT 

study is currently required for all pyrethroids, including tau-fluvalinate. Despite the 

existing DNT requirement, the Agency has determined that conducting additional DNT 

studies on any pyrethroids is not likely to contribute new information relevant for risk 

assessment. EPA believes the existing DNTs on six pyrethroids (bifenthrin, cyfluthrin, 

cyhalothrin, cypermethrin, fenpropathrin and deltamethrin) provide sufficient information 

to determine that the conclusions drawn from the DNTs, as combined, are applicable to 

all pyrethroids. Thus, EPA is hopeful that the registrants with DNT requirements will 

elect to cite the existing database to satisfy the DNT requirement rather than devoting 

new substantial resources associated with performing and evaluating new DNT studies. 

Detailed considerations supporting this conclusion can be found in “Pyrethroids: 

Evaluation of Data from DNTs & Consideration of Comparative Sensitivity”, available at

http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html. 

• The Agency intends to require the following data in the registration review DCI for taufluvalinate in order to conduct a complete human health assessment: 

o GLN 870.7800 – Immunotoxicity 

o GLN 870.1300 – Acute inhalation 

o GLN 870.3465 – 90-day inhalation toxicity2

o GLN 870.6200 – Acute neurotoxicity 

o GLN 870.6300 – Developmental neurotoxicity 

o GLN 870.3250 – 90-day dermal toxicity 

• The Agency will make a decision regarding the need for an FQPA or other database 

uncertainty/safety factors for tau-fluvalinate following receipt of 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. 

• Tau-fluvalinate is a member of the pyrethroid class of insecticides. This class also 

includes permethrin, cypermethrin, cyfluthrin, tau-fluvalinate, bifenthrin, fenpropathrin, 

and lambda-cyhalothrin, among others. EPA developed a draft science policy document 

 

2 While the inhalation guideline calls for a 90-day study duration, a 28-day study duration will satisfy the 

Agency’s inhalation exposure data needs, and this will be noted in the data call-in that the Agency intends 

to issue. 
8

on the proposed common mechanism of toxicity for naturally-occurring pyrethrins and 

synthetic pyrethroids (Proposed common mechanism grouping for the pyrethrins and 

pyrethroids, draft, May 19, 2009; 

http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809a6

2df ). This document was supported by the FIFRA Scientific Advisory Panel (SAP) and 

is available in the docket 

(http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a1f

8d7). EPA will finalize the policy document on the pyrethroid common mechanism of 

toxicity taking into account the SAP comments. Pesticides with a common mechanism of 

toxicity are subject to cumulative risk assessment under the FQPA. Research is on-going 

by EPA’s Office of Research and Development (ORD) to make improvements to the 

Stochastic Human Exposure and Dose Simulation (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 was reviewed by the FIFRA SAP in 

July, 2010 and meeting materials are available in the docket

(http://www.regulations.gov/search/Regs/home.html#docketDetail?R=EPA-HQ-OPP2010-0378). For information regarding EPA’s efforts to evaluate the risk to pyrethroids, 

see http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html. 

• Please refer to Tau-fluvalinate. Human Health Assessment Scoping Document in Support 

of Registration Review, located in the docket, for a detailed discussion of the anticipated 

risk assessment needs for human health. 

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (including pesticide active 

and other ingredients) may have an effect in humans or wildlife similar to an effect produced by 

a “naturally occurring estrogen, or other such endocrine effects as the Administrator may 

designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if 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 

establish 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 (ais) and 9 inert 

ingredients. This list of chemicals was selected based on the potential for human exposure 

through pathways such as food and water, residential activity, and certain post-application 
9

agricultural scenarios. This list should not be construed as a list of known or likely endocrine 

disruptors. 

Tau-fluvalinate is not among the group of 58 pesticide ais 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 issuing 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 

pesticide ai. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.

Timeline:

EPA has created the following estimated timeline for the completion of tau-fluvalinate 

registration review. 

Registration Review for Tau-fluvalinate – Projected Registration Review Timeline

Activities Estimated Date 

Opening the Docket 

Open Docket and Public Comment Period 2010 – December 

Close Public Comment 2011 – February 

Case Development 

Final Work Plan 2011 – May 

Issue DCI 2012 – Jan. – March 

Data Submission1 2016 – Jan. – March 

Open Public Comment Period for Draft Risk Assessments 2017 – July – Sept. 

Close Public Comment Period 2017 – Oct. – Dec. 

Registration Review Decision 

Open Public Comment Period for Proposed Registration Review 

Decision2

 

 2018 – Jan. – March 

Close Public Comment Period 2018 – April – June 

Registration Review Decision and Begin Post-Decision Follow-up 2018 

Total (years) 8 

1. If the registrants choose to cite the 6 previously submitted DNT studies as explained above, then this time 

estimate will likely be shortened by approximately 2 years. 

2. An assessment of the potential cumulative risk from the pyrethroid class of insecticides may impact this 

time estimate.

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary registration review work plan and 

rationale. The Agency will carefully consider all comments as well as any additional 
10

information or data provided in a timely manner prior to issuing a final work plan (FWP) for taufluvalinate. 

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key 

export markets, providing as much specificity as possible regarding the nature of the concern. 

Water Quality:

Tau-fluvalinate 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 second Ingram Creek Site (confluence with San Joaquin 

River to confluence with Hospital Creek). 

Nonetheless, no Total Maximum Daily Loads (TMDL) have been developed for tau-fluvalinate, 

based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?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 extent possible, data should conform to the quality 

standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process (see: 

http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm) in order to ensure they 

can be used quantitatively or qualitatively in pesticide risk assessments. 

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental 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 their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to tau-fluvalinate, 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

Other Information:

Stakeholders are also specifically asked to provide information and data that will assist the 

Agency in refining the 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 in units related to mass per unit area of treatment 

zone 

e. frequency of application, application intervals and maximum number of 

applications per season 

f. geographic limitations on use 

2. use or potential use distribution use history 

3. application timing (date of first application and application intervals) 

4. typical interval (days) 

5. state or local use restrictions 

6. ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian 

and mammalian mortalities) not already reported to the Agency 

7. monitoring data, including existing or ongoing Publically Owned Treatment Works 

 effluent monitoring data for the pyrethroids. 

Next Steps:

After the 60-day comment period closes, the Agency will review and respond to any comments 

received in a timely manner, and then issue a FWP for tau-fluvalinate. 

II. FACT SHEET

• Pesticide Chemical (PC) code: 109302 

• Chemical Abstract Service (CAS) number: 102851-06-9 

• Registration review case number: 2295 

• Technical registrant: Wellmark International 

• First registered for use in the U.S. in 1983. 

• The RED for tau-fluvalinate was completed on September 28, 2005. 

• There are currently 4 end-use products and 1 technical product registered. 

• There are two Special Local Need (SLN) registrations for California for use on carrots, 

brassica vegetables, and cole crops (non-food uses; crops are grown for seed). 

• Impregnated plastic strips used to treat varroa mites in beehives is the only food use, and 

the only tolerance is for tau-fluvalinate residues in honey. 

• Pesticide Re-evaluation Division Chemical Review Manager: Molly Clayton, 

clayton.molly@epa.gov 
12

• Registration Division Contact: Richard Gebken, gebken.richard@epa.gov 

Use & Usage Information: (For additional details, please refer to the Appendix A and SLUA 

documents in the tau-fluvalinate docket.) 

• Tau-fluvalinate is a broad-spectrum insecticide/miticide in the pyrethroid class of 

pesticides used to control a variety of post-emergent insects. It is registered for a single 

food use (beehives/honey) and several non-food uses, including commercial and 

residential ornamentals (outdoor and container-grown, greenhouse, interior plantscapes, 

dip for cuttings), building surfaces/perimeters, ant mounds and certain crops (carrots and 

brassica/cole crops) grown for seed. 

• Formulation types include: ready-to-use liquids, flowable concentrate, and impregnated 

strips (bee hives). 

• Tau-fluvalinate application methods include aerial (in California for the SLN), dipping, 

spray, fogger outdoor perimeter treatments, and impregnated plastic strips. Spoon or 

mound drench methods are used for ant mound treatments. 

• The maximum concentration in residential outdoor use products is 0.61% ai. Taufluvalinate is labeled for use on greenhouse (non-food) plants, outdoor and interior 

ornamentals, Eugenia and pepper trees, and mound drenches at 0.34 lb ai/A. It is labeled 

for use on brassica/cole and carrot crops grown for seed in California at 0.15 lb ai/A; on 

flower and foliage cuttings at 5.0 fl oz ai/100 gal (as a dip); and on building perimeters at 

3 tsp ai/5 gal/1000 sq ft. Use in beehives is labeled as one strip for each, of five combs or 

less in each bee chamber. 

• Based on the 2010 SLUA, less than 500 pounds of tau-fluvalinate ai is used per year for 

agricultural proposes. It is primarily used on carrots grown for seed in California. The 

extent of current non-agricultural uses is unknown. 

Recent and Pending Actions: 

• The tau-fluvalinate labels have been amended to incorporate mitigation measures 

specified in the 2005 RED. 

• In November, 2006 two new end-use products (EPA registration numbers 72155-71 and 

72155-73) were registered for outdoor residential (homeowner) use, on sites such as 

flowers, ground covers, ornamentals, and shrubs. 

Ecological Risk Assessment Status: 

The following are key findings of the most recent ecological risk assessments for tau-fluvalinate. 

Please refer to the Registration Review: Preliminary Problem Formulation for Ecological Risk, 
13

Environmental Fate, Endangered Species, and Drinking Water Assessment for Tau-fluvalinate, 

located in the docket, for a detailed discussion of previous ecological risk assessments. 

• The most recent ecological assessment, completed in July 2005, identified potential acute 

and chronic risks to aquatic organisms and mammals. There was also a concern for nontarget terrestrial invertebrates. 

• In 2005, there were significant ecological data gaps, which limited the Agency’s ability 

to assess acute risk to aquatic organisms, aquatic plants, and terrestrial plants and chronic 

risk to marine/estuarine invertebrates. The risk assessment did not indicate a concern for 

birds, based on data available at the time 

• The use pattern for tau-fluvalinate suggested that the potential risks would likely be 

limited to those geographic areas where the chemical is most widely used, including use 

on ornamentals in California, Oregon, Michigan, Florida, Pennsylvania, and Texas. 

Human Health Risk Assessment Status:

The following are key findings of the most recent human health risk assessments for taufluvalinate. Please refer to Tau-fluvalinate: Human Health Assessment Scoping Document in 

Support of Registration Review, located in the docket, for a detailed discussion of previous 

human health risk assessments. 

• The most recent comprehensive human health risk assessment was completed September 

2005 in support of reregistration. 

Hazard Characterization: 

• Tau-fluvalinate, like other pyrethroid insecticides, causes neurotoxicity in insects and 

mammals by the modulation of nerve axon sodium channels. Pyrethroids interfere with 

the ability of the nervous system to relay nerve transmissions resulting in effects such as 

tremors, excessive grooming, and salivation. Similar signs of neurotoxicity were 

observed in the guideline studies conducted with tau-fluvalinate. 

 

• Data indicate no evidence of carcinogenicity in mice or rats, and there is no concern for 

mutagenicity. 

• At the time of reregistration, A 100X uncertainty factor was used to account for 

interspecies extrapolation and intraspecies variability (10X and 10X, respectively). 

Based on a review of both hazard and exposure data, the Agency reduced the special 

FQPA safety factor to 1X. 

Dietary (Food and Drinking Water): 
14

 

• In 2005, exposure from drinking water was incorporated in the acute and chronic risk 

assessments using the 1-in-10 year annual peak and average concentrations of surface 

water, respectively. Nearly all the estimated dietary exposure to tau-fluvalinate was from 

drinking water. 

• The acute and chronic dietary (food + drinking water) risk estimates were below the 

Agency’s level-of-concern for the general population and all population subgroups. 

Residential: 

• In 2005, since there were no registered homeowner uses, a residential handler risk 

assessment was not performed. The commercial applications to residential settings were 

limited to spot treatments or building perimeters, resulting in minimal potential postapplication exposure. In accordance with the Agency’s standard residential assessment 

practices, post-application risk was not assessed.

Aggregate: 

• The 2005 aggregate risk assessment considered only combined food and drinking water 

exposures. The aggregate risk estimates were below the Agency’s level-of-concern.

Occupational: 

• The 2005 occupational risk assessment considered inhalation exposure only; risk from 

potential occupational dermal exposures was not assessed quantitatively. No toxicity 

endpoint was selected for dermal exposure in available toxicology studies, and dermal 

exposures to products containing tau-fluvalinate were expected to be largely self-limiting 

due to the irritation that occurs as a result of the “pyrethroid reaction”, characterized by 

tingling sensations and/or itching, often severe, upon contact with the chemical. Potential 

dermal risk was addressed by labeling instructing the user to avoid contact with skin and 

instructions to wash the affected area immediately following contact. 

• At the time of the RED, the Agency did not have data with which to estimate possible 

tau-fluvalinate exposures from the greenhouse fogger use. To address this area of 

uncertainty, the Agency required an occupational post-application exposure study for 

greenhouse exposure scenarios (OPPTS Guideline 875.2500). These data were submitted 

and confirmed that the 12-hour restricted entry interval specified in the 2005 was 

adequately protective of post-application greenhouse inhalation risk. 

• All occupational handler and post-application inhalation risk estimates were below the 

Agency’s level-of-concern. 

Cumulative: 
15

• Tau-fluvalinate is a member of the pyrethroid class of insecticides. This class also 

includes permethrin, cypermethrin, cyfluthrin, tau-fluvalinate, bifenthrin, fenpropathrin, 

and lambda-cyhalothrin, among others. EPA developed a draft science policy document 

on the proposed common mechanism of toxicity for naturally-occurring pyrethrins and 

synthetic pyrethroids (Proposed common mechanism grouping for the pyrethrins and 

pyrethroids, draft, May 19, 2009; 

http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809a6

2df ). This document was supported by the FIFRA Scientific Advisory Panel (SAP) and 

is available in the docket 

(http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a1f

8d7). EPA will finalize the policy document on the pyrethroid common mechanism of 

toxicity taking into account the SAP comments. Pesticides with a common mechanism of 

toxicity are subject to cumulative risk assessment under the FQPA. Research is on-going 

by EPA’s Office of Research and Development (ORD) to make improvements to the 

Stochastic Human Exposure and Dose Simulation (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 was reviewed by the FIFRA SAP in 

July, 2010 and meeting materials are available in the docket 

(http://www.regulations.gov/search/Regs/home.html#docketDetail?R=EPA-HQ-OPP2010-0378). For information regarding EPA’s efforts to evaluate the risk to pyrethroids, 

see http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html. 

Incidents:

Ecological:

• The Agency consulted the Ecological Incident Information System database for reports of 

ecological incidents, and no incidences have been reported for tau-fluvalinate. 

Human Health: 

• The OPP Incident Data System (IDS) and the Sentinel Event Notification System for 

Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident 

data on the active ingredient tau-fluvalinate. 

o For IDS, from 2000 to May 25, 2010 there are 90 cases reported for taufluvalinate of minor, unknown, or no effects. For these minor incidents, there are 

no individual reports available that would provide details about the incidents, and 

single chemical incidents are not distinguished from multiple chemical incidents. 

There was one case reported for tau-fluvalinate in the database with moderate 

severity. In this case, an unknown age female reported dermal effects. 
16

o For NIOSH SENSOR from 1998 to 2007, seven cases of low to moderate severity 

were reported that involved the active ingredient tau-fluvalinate. The health 

effects reported included: gastrointestinal, respiratory, ocular, neurological, and 

dermal. 

Tolerances and International Harmonization: 

The only U.S. tolerance is established for tau-fluvalinate residues in honey. Currently, Codex, 

Canada, and Mexico do not have MRLs established for the use of tau-fluvalinate. The Agency 

will work to harmonize tolerances/MRLs during registration review as appropriate. 

DCIs:

A generic DCI (GDCI-109302-26155) was issued for tau-fluvalinate in March 2007. All data 

requirements identified in the DCI have been fulfilled. 

Labels: 

 

Active Section 3 registrations can be obtained from the Pesticide Product Label System (PPLS) 

website at http://oaspub.epa.gov/pestlabl/ppls.home. 

III. Summary of Data Gaps – Tau-fluvalinate 

The table below summarizes all anticipated data needs for tau-fluvalinate. 

Guideline 

Number Anticipated Data Requirement 

Test Material Estimated Timeframe 

850.4100 Seedling emergence Tier II1 TGAI 12 

850.4150 Vegetative vigor, Tier II1 TGAI 12 

850.4400 Aquatic plant growth (vascular plant toxicity), Tier II1 TGAI 12 

850.5400 Aquatic plant growth (algal plant toxicity), Tier II1 TGAI 12 

835.4300 Aerobic aquatic metabolism TGAI 24 

835.4400 Anaerobic aquatic metabolism TGAI 24 

835.6100 Terrestrial field dissipation TGAI 24 

850.1500 Fish full life cycle for one freshwater species TGAI 24 

850.1400 Fish early-life stage toxicity test for one freshwater species TGAI 12 

850.1350 Aquatic invertebrate life-cycle for mysid shrimp TGAI 12 

850.2100 Avian oral toxicity test for passerine species TGAI 12 

850.1025 Acute toxicity to estuarine/marine invertebrate for the oyster TGAI 12 

Nonguideline Test for Measuring the Effects of Sediment Associated 

Contaminants on Survival, Growth, and Reproduction on TGAI 24 
17

Guideline 

Number Anticipated Data Requirement 

Test Material Estimated Timeframe 

Hyalella azteca in USEPA 2000 Methods for Measuring the 

Toxicity and Bioaccumulation of Sediment-associated 

Contaminants with Freshwater Invertebrates. EPA 600/R99/064 

Nonguideline Life-cycle Test for Measuring the Effects of Sedimentassociated Contaminants on Chironomus dilutus or C. tentans

in USEPA 2000 Methods for Measuring the Toxicity and 

Bioaccumulation of Sediment-associated Contaminants with 

Freshwater Invertebrates. EPA 600/R-99/064 

TGAI 24 

Nonguideline Leptocheirus plumulosus in USEPA 2001 Method for 

Assessing the Chronic Toxicity of Marine and Estuarine 

Sediment-associated Contaminants with the Amphipod 

Leptocheirus plumulosus. EPA 600/R-01/020 

TGAI 24 

870.7800 Immunotoxicity TGAI 12 

870.1300 Acute inhalation toxicity study TGAI 8 

870.3465 90-day inhalation toxicity study2 TGAI 24 

870.6200 Acute neurotoxicity TGAI 24 

870.6300 Developmental neurotoxicity3 TGAI 48 

870.3250 90-day dermal toxicity study TGAI 24 

1

The Agency anticipates requiring a Tier II study. A Tier I study may be conducted in lieu of a Tier II 

study with the understanding that adverse effects (even if <25%) would necessitate a Tier II study as well. 

The purpose of a Tier II study is to establish either a No Observed Adverse Effect Concentration 

(NOAEC) or a concentration at which there is a 5% observed effect (EC05) to be used in an endangered 

species risk assessment for nontarget plants. If neither an NOAEC nor an EC05 value is available, then 

the Agency may have to presume that tau-fluvalinate "may affect" listed nontarget plant species in the 

registration review endangered species risk assessment. 

2

While the inhalation guideline calls for a 90-day study duration, a 28-day study duration will satisfy the 

Agency’s inhalation exposure data needs, and this will be noted in the data call-in that the Agency intends 

to issue. 

3

EPA believes the existing DNTs on six pyrethroids (bifenthrin, cyfluthrin, cyhalothrin, cypermethrin, 

fenpropathrin and deltamethrin) provide sufficient information to determine that the conclusions drawn 

from the DNTs, as combined, are applicable to all pyrethroids. Thus, EPA is hopeful that the registrant 

will cite the existing database to satisfy the DNT requirement rather than devoting new substantial 

resources to performing and evaluating a new DNT study for tau-fluvalinate.