Docket Number: EPA-HQ-OPP-2010-0467 www.regulations.gov



# Chlorfenapyr Summary Document Registration Review: Initial Docket

June 20103 TABLE OF CONTENTS

Page #



### I. Preliminary Work Plan 4

II. Fact Sheet 10

______________________ __________________

Please Note

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

1. Registration Review—Preliminary Problem Formulation for the Ecological Risk, Environmental Fate, and Endangered Species Assessments for Chlorfenapyr (PC Code 129093; DP Barcode 373109). May 11, 2010.

2. Chlorfenapyr. Human-Health Assessment Scoping Document in S upport of Registration Review. May 26, 2010.

3. Appendix A: Food/Feed & Non-Food/Non-F eed Uses Considered in Registration Review Work Planning. Chlo rfenapyr (129093). June 8, 2009

4. Chlorfenapyr (129093) California Department of Pesticide Regulation (DPR) Usage Data. June 30, 2009

5. Chlorfenapyr: Review of Human Incidents. February 25, 2010

The supporting documents for chlorfenapyr may be found in the docket EPA-HQ-OPP-2010- 0467, located on the internet at <www.regulations.gov>.4 I. Preliminary Work Plan - Chlorfenapyr
Introduction:

The Food Quality Protection Act of 1996 mandated a pesticide registration review program. All pesticides distributed or sold in the United Stat es generally must be registered by EPA, based on scientific data showing that th ey will not cause unreasonable risks to human health or the environment when used as directed on produc t labeling. The registrati on 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 environm ent. Changes in scien ce, 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. Inform ation on this program is provided at http://www.epa.gov/oppsrrd1/ registration_review/.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The Agency will consid er 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 other information it be lieves are needed to make a registration review decision. After reviewing and responding to co mments and data received in the docket during this initial comment period, the Agency will de velop and commit to a final work plan and schedule for the registration review of chlorfenapyr.

Chlorfenapyr (case number 7419) is a pyrrole ins ecticide and miticide used in greenhouses and other structures to control mites, termites, spiders, and insects. Use of chlorfenapyr is allowed in residential settings, but applic ations can only be made by certif ied professional applicators. Chlorfenapyr is a pro-insecticide (i.e., the biol ogical activity depends on it s activation to another chemical). The parent compound is converted to the N-dealkylated metabolite, which functions as an uncoupler of oxidative phosph orylation in mitochondria. Chlo rfenapyr was first registered in 2001 and therefore was not subject to the reregistration process under FIFRA.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates conducting comprehe nsive human health and ecological risk assessments, including an endangered species asse ssment, for all uses of chlorfenapyr and its metabolites of concern. Below is a summary of th e issues relevant to the registration review process for chlorfenapyr.

Ecological Risk:

The most recent ecological risk assessment was conducted in 1998 to support the initial registration of chlorfenapyr in 2001. There are two uses of chlorf enapyr that could potentially result in environmental exposures: (1) distribu tion of composted material from greenhouses that use chlorfenapyr; and (2) applicatio n of chlorfenapyr to soil unde rlying a concrete slab prior to the slab being poured (during construction). All other uses occur indoors, underground5 (termiticide), or involve small quantitie s (crack and crevice treatment) and are not expected to result in significant ecological exposure because greenhouse/indoor and underground uses have limited opportunity for outdoor residues, drift, runoff, and wildlife exposure. To assess the potential
risk from the two abovementioned uses of chlorf enapyr (crack and crevic e), additional data are anticipated to be required and a subsequent risk assessment will be performed. The Agency will also complete an endangered species assessmen t for all pesticide uses of chlorfenapyr. A summary of the anticipated needs for the ecological assessment follows:

• The Agency anticipates needing the followi ng data in order to conduct a complete ecological risk assessment for chlorfenapyr, including an endangered species assessment:

o Guideline 850.4100, 4150, 4400, 5400 - Aquatic a nd Terrestrial Plant Toxicity. (Tier II, chlorfenapyr). Registrants ma y opt to conduct a Tier I study, with the understanding that any adverse effects (even if less than 25 percent) will necessitate a Tier II study. A Tier II st udy will enable the Agency to conduct an endangered species assessment for nontarget plants.

o Guideline 850.1735 and 850.1740 - Whole Sediment: Freshwater and Marine Invertebrates. (chlorfenapyr)

o Guideline 850.1075 - Fish Acute LC50 (Rai nbow Trout). (photolysis degradate CL 357,806)

o Guideline 850.1025 - Estuarine/Marine Acute Invertebrate LC50 (Eastern Oyster). (chlorfenapyr)

o Guideline 850.1400 - Fish Early-life St age Toxicity Test. (chlorfenapyr)

o Guideline 835.6100 (Footnote 7) – Environm ental Chemistry Analytical Method. (soil)

o Guideline 835.6200 (Footnote 7) - Environm ental Chemistry Analytical Method. (water)

o Special Study - Evaluation of Chlo rfenapyr Degradation in Compost. (chlorfenapyr)

• The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for chlorfenapyr. Th e ecological risk assessment planned during registration review will allow the Agency to determine whether chlorfenapyr’s use has “no effect” or “may affect” federally liste d threatened or endangered species (listed species) or their designated cr itical habitat. 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 Service (the Services ), as appropriate.

• Refer to the document, Registration Review - Preliminary Problem Formulation for Ecological Risk, Environmental Fate, and Endangered Species Assessments for Chlorfenapyr (PC Code 129093; DP Barcode 373109) , for a detailed discussion of the anticipated ecological risk assessment needs.6 Human Health Risk:

The most recent risk assessment was conducted in 2003 to support the initial registration of greenhouse food crops and establishment of tolera nces for fruiting vegetables (crop group 8). A summary of the anticipated needs for the human health assessment follows:

• The Agency anticipates needi ng the following data in order to conduct a complete human
health risk assessmen t for chlorfenapyr:

o Guideline 870.3200 - 28-day Dermal Toxicity (rat) (chlorfenapyr)

o Guideline 870.3465 - 90-day Inhalation Toxicity (rat) (chlorfenapyr)

o Guideline 870.7800 - Immunotoxicity (chlorfenapyr)

• As part of registration review, the Agency anticipates conducting a new dietary risk
assessment which utilizes the most current version of DEEM-FCID TM (2.03), does not
include DEEM TM default processing factors (whi ch are not appropriate for a food handling establishment (FHE) use as residues would be expected to be incurred after processing) or citrus proce ssing factors, and includes tolerances for the currently registered uses on greenhouse-grown fru iting vegetable crop group 8 commodities and FHE only. The new dietary exposure assessmen t should also evaluate potential secondary residues of chlorfenapyr and its metabo lites in/on livestock commodities due to consumption of feed items with chlorfena pyr residues resulting from the established food/feed handling area use. If any proposed us es of chlorfenapyr are deemed to result in contamination of drinking water, estimated drinking water concentrations (EDWCs) will need to be incorporated into future dietary assessments.

• Livestock dietary burdens should be reassessed to evaluate potential secondary residues of chlorfenapyr and its metabolites in/on livestock commodities due to consumption of feed items with chlorfenapyr residues resulting fr om the established food/feed handling area

use.

• As part of registration review, the Agency expects to conduct a revised residential postapplication and occupational handler and postapplication assessment. The revised
residential assessment would need to include dermal and incident al oral routes of exposure. Two occupational handler scenar ios would need to be assessed during registration review and, in addi tion, several occupational handle r scenarios may need to be reassessed in accordance with changes to the hazard assessment. The occupational post application exposure assessment would need to reassessed base d on current labeled application rates and updated transfer coeffici ents and may also need to be reassessed in accordance with changes to the hazard assessment.

• The tolerance expression in 40 CFR Part 180.513 will be reviewed during registration review to ensure that it appropriately covers the metabolites and degradates of chlorfenapyr and that it specifies the re sidues to be measured for each commodity.

• In future risk assessments for chlorfenapyr, the FQPA factor will need to be updated based upon the changes in policy, the submitted deve lopmental neurotoxicity study (DNT), along with the immunotoxicity, 28-dermal a nd 90-day inhalation studies when submitted, may lead to revision of the current e ndpoints for future risk assessments.7 • Please refer to the document, Chlorfenapyr - Human Health Assessment Scoping Document in Support of Registration Review , for a detailed discussion of the anticipated
risk assessment and data needs for human health.

Other anticipated data needs:

• Guideline 830.7050 - UV/Visible Light Abso rption. This study is a new data requirement under 40 CFR Part 158 for regi stration of a pesticide (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 photochemical degradation.

Endocrine Disruptor Screening Program:

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered ap proach to making the statutorily required
determinations. Tier 1 consists of a battery of 11 scr eening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine related eff ects caused by the substance, and 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-app lication agricultural scenarios.
This list should not be construed as a lis t of known or likely endocrine disruptors.

Chlorfenapyr is not among the gr oup of 58 pesticide activ e ingredients on the initial list to be
screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticipates issuin g EDSP orders/data call-ins for all Registration Review cases, including those for which EPA ha s already opened a Registration Review docket for a pesticide active ingredient.

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

Timeline:

EPA has created the following estimated time line for the completion of the chlorfenapyr registration review.8 Registration Review for Chlorfenapyr – Projected Registration Review Timeline

Activities Estimated Date Opening the docket Open Docket and Public Comment Period 2010 – June Close Public Comment 2010 – August Case Development

Final Work Plan 2010 – November Issue DCI 2011 – July – Sept. Data Submission 2013 – July – Sept. Open Public Comment Period for Preliminary Risk Assessments 2015 – Jan. – March Close Public Comment Period 2015 – April - June Registration Review Decision Open Public Comment Period for Proposed Registration Review Decision 2015 – July - Sept.

Close Public Comment Period 2015 – Oct. – Dec. Final Registration Review Decision a nd Begin Post-Decision Follow-up 2016 Total (years) 6

Guidance for Commenters:

The public is invited to comme nt on EPA’s preliminary regist ration review work plan and rationale. The Agency will carefully consid er all comments as well as any additional information or data provided in a timely manne r prior to issuing a fi nal work plan for the chlorfenapyr 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:

Chlorfenapyr 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. In addition, no Total Maximum Daily Loads (T MDL) have been developed for chlorfenapyr, 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/tm dl/. 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 qualitati vely in pesticide risk assessments.9 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 thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to chlorfenap yr compared to the general population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure compared to the general population.

Additional Information:

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining the risk assessments, incl uding any species-specific ecological effects determinations. The Agency is interested in obtaining the following information regarding the use of chlorfenapyr:

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 f. geographic limitations on use

2. use or potential use distribution

3. use history

4. state or local use restrictions

5. ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not alr eady reported to the Agency

6. monitoring data

Next Steps:

After the 60-day comment period closes, the Ag ency will consider and respond to any comments received in a timely manner, and then issue a Final Work Plan for this pesticide in the fall of

2010.10 II. FACT SHEET: Chlorfenap yr Registration Review

Background Information:

• Chlorfenapyr registration review case number: 7419

• Chlorfenapyr Pesticide Chemical (PC) Code: 129093

• Chlorfenapyr Chemical Abstracts Service (CAS) number: 122453-73-0

• Chlorfenapyr was first registered in the United States in 2001 as a foliar spray for ornamental crops grown in greenhouses (non-food use).

• BASF Corporation is the only techni cal registrant for chlorfenapyr.

• There are four chlorfenapyr products register ed under FIFRA Section 3. There is also one Special Local Need (SLN) registration in Mississippi.

• Pesticide Re-Evaluation Divi sion (PRD), Chemical Revi ew Manager (CRM): Susan Bartow: bartow.susan@epa.gov

• Registration Division (RD) contact:

Richard Gebken: gebken.richard@epa.gov.

Use & Usage Information: (For additional details, please re fer to the Biological and Economic Analysis Division (BEAD) Appendix A document in the chlorfenapyr docket.)

• Chlorfenapyr is an insecticide registered for use to control a variety of insects on terrestrial non-food crops, aquatic non-food industrial sites, greenhouse food and nonfood crops, outdoor residential, indoor f ood and non-food uses, indoor medical, and
indoor residential.

• Target pests include mites, caterpillars, centipedes, thrips, fungus gnats, ants, cockroaches, beetles, bed bugs, silv erfish, spiders, and termites.

• Chlorfenapyr is sold in emulsifiable concentrate and pressurized liquid forms.

• Use is allowed in residentia l settings, but applications can only be made by certified professional applicators.

• Chlorfenapyr is applied via aerosol can, low pr essure sprayer, foam applicator, injection equipment, hand pressure sprayer, low volum e sprayer, power sprayer, and pump spray
bottle.

Recent Actions:

• In 2003, chlorfenapyr was first registered fo r greenhouse food crops and tolerances were established for fruiting ve getables (crop group 8).

• In 2006, chlorfenapyr was first registered for indoor and outdoor resi dential uses, indoor non-food, terrestrial non-food crops, a nd aquatic non-food industrial uses.11 • In 2009, additional use sites were register ed for chlorfenapyr (e.g., zoos, windows, furniture, sewers, drains).

Ecological Risk Assessment Status :

The following are key findings of the most recen t chlorfenapyr ecological risk assessment, conducted in support of the initial registra tion of chlorfenapyr. Please refer to Registration Review – Preliminary Problem Formulation for the Ecological Risk, Environmental Fate, and Endangered Species Assessments of Chlorfenapyr for a detailed discussion of the ecological risk

assessment.

Sediment Persistence:

• Chlorfenapyr and its degradates have been show n to be highly persis tent. Chlorfenapyr’s persistence is typified by a laboratory aer obic soil metabolism half -life of 1.4 years and its observed comparable field dissipation “h alf-life” of 1.3 years. Chlorfenapyr is essentially stable to laboratory hydrolysis and anaerobic soil metabolism. Chlorfenapyr also has an organic carb on partition coefficient (K
oc ) of 11,500 L/kg and thus binds to organic particulates and is ge nerally immobile in soil. Sedi ment would be its principal latent reservoir in aquatic systems where it would remain available for extended periods.

Because of the persistence of the parent and relatively short study durations, only small amounts of structurally similar metabolites or de gradates were identified in soil in field or laboratory studies. However, the degradat e AC 312,094 has been detected at 10 percent to 16 percent of parent in the radiolabeled North Carolina study. This metabolite has intermediate mobility characteristics (median K
oc around 2200). Coupled with its persistence, this means that it has high pot ential for runoff into surface water with comparable amounts in solution and eroding so il if chlorfenapyr is used in outdoor
environments.

In general, transformation products appear to approximate or exceed the persistence of the parent. Structurally similar metabo lites or degradates (AC 312,094, AC 303,267, AC 303,268, AC 322,118, AC 322,250, AC 325,195, some of which exhibit ecotoxicity)
were identified in soil in fiel d or lab studies. Concentrations of these, when detected were typically a few percent each or less of the applied chlorfenapyr.

Terrestrial Animal Toxicity (Birds, Mammals, and Invertebrates):

• Chlorfenapyr is very highly toxic to birds on an acute basis. The LD 50 values for redwinged blackbird ( Agelaius phoneiceus ), mallard ( Anas platyrhynchus ), and bobwhite quail ( Colinus virginianus ) are 2.2, 8.3, and 34 mg/kg, respectivel y. It is also very highly toxic to waterfowl and passerine species a nd highly toxic to upland gamebirds on an acute dietary basis. Chlorfenapyr has also resulted in reproductive and growth effects to birds at low concentrations of 1.5 mg/kg- diet. The mallard duck NOAEC value of 0.5 mg/kg-diet, which is based on reduced body we ight, serves as the chronic toxicity endpoint for avian long-term exposure risk calculations.

• Chlorfenapyr has been shown to be less toxic to mammals as compared with birds. Acute

LD 50 values in mammals range from approxi mately 45 mg/kg-bw to 1152 mg/kg-bw. A 2-generation mammalian study produced a No Observed Adverse Effect Concentration (NOAEC) value of 60 mg/kg-diet (5 mg/kg-bw).12 • Chlorfenapyr is highly toxic to honey bees ( Apis mellifera ) on an acute contact exposure basis with a corresponding LD 50 value of 0.12 μg/bee.

Aquatic Animal Toxicity (Fish and Aquatic Invertebrates):

• In aquatic organisms, acute LC 50 values for chlorfenapyr range from 7 μg/L to 12 μg/L in freshwater fish, 60 μg/L in saltwater fish, 6 μg /L to 18 μg/L in freshwater invertebrates, 2 μg/L in saltwater invertebrates, and 0.2 mg/kg to 20 mg/kg sediment in benthic organisms. Therefore, on an acute exposure basis, chlorfenapyr is very highly toxic to
freshwater and estuarine/marine fish and i nvertebrates. Also, based on an unacceptable study, one of the degradates (CL 357,806) appears to be more toxic than the parent
chemical.

• Chronic NOAEC values range from 0.2 μg/L in estuarine/marine inve rtebrates to 4 μg/L
in freshwater fish and invertebrates.

Human Health Risk Assessment Status:

The following are key findings of the most recent chlorfenapyr human health risk assessment.
Please refer to Chlorfenapyr - Human Health Assessment Scoping Document in Support of Registration Review for chlorfenapyr for a detailed di scussion of the human health risk

assessment.

Hazard Characterization:

• Chlorfenapyr has moderate acute toxicity vi a the oral route (Cate gory II) and low acute toxicity via the dermal (Category III) and inha lation routes (Category III). It is a mild eye irritant, but it is not a de rmal irritant or sensitizer.

• The central nervous system is the primary ta rget of chlorfenapyr in rats and mice.

Dietary (Food and Water) :

• For acute and non-cancer chroni c exposures, the Agency is concerned when estimated dietary risk exceeds 100 percent of the populat ion-adjusted dose (PAD). The acute and chronic dietary (food only) exposures to chlorf enapyr were below the Agency’s level of concern for the general U.S. population and all population subgroups examined.

• The most recent risk assessment stated that there are no existing or proposed uses of chlorfenapyr which would result in contamin ation of drinking water. Accordingly, no estimated drinking water concentrations (EDW Cs) were incorporated into the 2004 acute and chronic dietary exposure assessments.

Residential :

• Chlorfenapyr is registered for residentia l (indoor and outdoor) and medical (indoor) uses. There are currently no registered residential uses that permit residential handlers, they are only allowed for application by cer tified professional applicators.

• The Agency has determined that there is poten tial for post-application exposure to adults
and children/toddlers from the residential termiticide and crack and crevice/mattress applications of chlorfenapyr. Based on a review of the register ed labels, there is potential for dermal, incidental oral, (for young children) and inhala tions exposure resulting from13 this use. In the October 2001 occupational/res idential exposure assessment, a residential post-application exposure assessment was conducted; however, onl y post-application inhalation exposure was assessed. Because hi ghly conservative, worst case assumptions resulted in margins of exposure (MOEs) ≥ levels of concern (LOC = 100), risks did not exceed the Agency’s level of concern a nd are considered to be negligible.

Occupational :

• The Agency has determined that occupationa l handlers are likely to be exposed to chlorfenapyr residues from the registered uses . In most cases, no chemical-specific data were available with which to assess potential exposure to pesticide handlers. Therefore, occupational handler assessments were base d primarily on surrogate unit exposures from the Pesticide Handler’s Exposure Database (P HED) as presented in the PHED Surrogate Exposure Guide. The risk calculations were based on the maximum application rates and assuming maximum area treated per day or ga llons handled. Handle r’s exposure and risk
were calculated at two levels of mitigation: baseline (long pants, a long-sleeved shirt, no chemical-resistant gloves, and no respirator) and personal protective equipment (baseline clothing with chemical-resista nt gloves when necessary).

• The most recent exposure assessment for pesticide handlers for the registered greenhouse use (fruiting vegetables) was conducted in March of 2003. Provided that commercial pesticide handlers used label prescribed personal protective equipment (PPE), all assessed MOEs were not of concern to the Agency (i.e., MOEs were ≥ LOC = 100) at the
maximum label rate of 0.2 lb ai /A (or 13 fl oz/100 gallons).

• A 1999 assessment was conducted for chlorfenapyr use on ornamental plantings in greenhouses, at a maximum application rate of 0.64 lb ai/A. No occupational handlers MOEs were of concern to the Agency at this rate. The current label for this use lists the maximum application rate as 0.32 lb ai/100 gallons.

• Exposures and risks to handler s applying chlorfenapyr at a rate of 0.0469 lb ai/gal as a soil termiticide and crack and crevice spray were below the Agency’s level of concern (MOEs ≥ LOC = 100).

• Occupational handler assessments have not b een assessed for the following scenarios:

o mixer/loader/applicator scenarios for aeros ol can applications for all use sites

o mixer/loader/applicator scenarios for high pressure spray application on non-edible greenhouse ornamentals at the current maxi mum label rate of 0.32 lb ai/100 gal.

In addition to those scenarios that have not been assessed previously, several occupational handler scenarios may need to be reassessed if changes are made to the
hazard assessment.

• Occupational post-application expo sure is expected from the foliar uses of chlorfenapyr in greenhouses. Occupational post-applica tion exposure is not expected from the
termiticide and crack and crevice use in resi dential sites, indoor medical, indoor outdoor commercial sites, or food/f eed handling establishments.

• The most recent occupational post-applicati on exposure assessment of chlorfenapyr was
conducted in March of 2003 for activities associ ated with fruiting vegetables. In that assessment, the following post-application activities for fruiting vegetables were14 assessed: hand harvest, pruning, staking, thin ning, training, tying, scouting, and weeding. MOEs were not of concern to the Agency (i.e., MOEs were ≥ LOC = 100).

• Past chlorfenapyr risk assessmen ts rely 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, invo lving exposure to many different pesticides, comprise generic pesticide exposure database s such as the Pestic ide Handlers Exposure Database (PHED) and the Agricultural Reen try Task Force (ARTF) Database. EPA has reviewed all the studies supporting 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 significantly deficient relativ e to the ethical standards prevailing at the time the research was conducte d. All applicable re quirements of EPA’s
Rule for the Protection of Hu man Subjects of Research ( 40 CFR Part 26) have been satisfied, and there is no re gulatory barrier to continue d reliance on these studies.

Aggregate :

• The 2003 risk assessment determined that because none of the use patterns for chlorfenapyr would result in contamination of drinking water or resi dential exposures, an aggregate risk assessment was not necessary. An aggregate risk assessment will need to be conducted once a revised residential pos t application assessment is available.

Incident Reports:

Ecological Incidents:

• Approved uses of chlorfenapyr are largely limited to indoor envir onments with little potential for outdoor releases. There are no reported ecological incidents from the currently registered uses of chlorfenapyr.

Human Incidents:

• The Incident Data System (IDS) identified tw o human health case repor ts attributable to chlorfenapyr reported to the IDS between 2002 and present. One incident involved a person who experienced occupational exposure to his eyes while at work. The patient immediately flushed his eyes and the itchiness went away within few hours. The other case involved a patient with a history of brain surgery who de veloped seizures after being at home for 20-30 minutes while the produc t (Phantom Termiticide) was applied.

Six cases were reported in the NIOSH SE NSOR database that involved the active ingredient chlorfenapyr (from 1998-2006). One incident involved a 52 year old female who experienced an asthma attack after a nearby office was sprayed with Phantom Termiticide. The only symptoms reported were respiratory effects. This case was ranked as low severity.

Tolerances:

• There are no Codex or Canadian MRLs established for chlorfenapyr.

• The U.S. and Mexican tolerance definitions are harmonized for residues of chlorfenapyr in/on commodities in fruiting vegetable crop group 8.15 • There is an MRL of 0.5 ppm for cotton seed in Mexico which has no U.S. equivalent
tolerance.

• Mexico adopts U.S. tolerances a nd/or Codex MRLs for export purposes.

Data Call-In Status:

• To date, no DCIs have been issued for chlorfenapyr.

Labels :

Product registration numbers are listed below a nd labels can be obtained from the Pesticide Product Label System (PPLS) website (<ht tp://oaspub.epa.gov/pestlabl/ppls.home>).

Active Chlorfenapyr Registrations

Registration

Number Name Company Name Percent
Active Ingredient

241-366 Chlorfenapyr Technical 241 – BASF Corporation 97.1

241-374 Pylon Miticide-Insectici de 241 – BASF Corporation 21.4

241-392 Phantom Termiticide-Insectic ide 241 – BASF Corporation 21.45

7969-285 Prescription Treatment Brand
Phantom Pressurized Insecticide 7969 – BASF Corp oration 0.5

MS020023 Phantom Termiticide-Insect icide 241 – BASF Corporation 21.45