Page 2 of 22 there are two uses that coul d potentially result in envi ronmental exposures: (1) distribution of composted ma terial from greenhouses that use chlorfenapyr; and (2) application of chlorfenapyr to soil underlyi ng a concrete slab prio r to the slab being poured (during construction). All other uses occur indoors, underground (termiticide), or involve small quantities (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.

The following is a discussion of the current use patterns and potential exposure pathways for currently registered uses of chlorfenapyr.

Greenhouse Uses: The chlorfenapyr label (EPA Reg. No. 000241-00374) for fruiting vegetables grown in a greenhouse states, “Compo st any discarded plant material that has been treated.” EFED concludes exposure is possible because the la bel does not preclude the distribution of chlorfenapyr treated com post material outside of the greenhouse. To assess this potential risk, additional data will be required (as specified in section 7) and a subsequent risk assessment will be performed.

Construction: C hlorfenapyr may be applied to soil underlying a concrete slab prior to the slab being poured (during constructio n) (EPA 000241-00392). In the event that a major rain event occurs after treatment and prio r to pouring of the concrete slab, there is a potential for exposure to chlorfenapyr in adjacent areas via runoff from the use site. EFED concludes that such exposure is possibl e because the label does not specify that the amount of time between applica tion of chlorfenapyr and the pouring of the concrete slab be minimized. To assess this potential risk, additional data will be required (as specified in section 7) and a subsequent risk assessment will be performed.

2. Current Chlorfenapyr Uses

The currently registered crop/sites, use groups , and registration numb ers for chlorfenapyr are listed in Table 1 . These uses are taken from the LUIS report (dated: July 23, 2009) prepared by the Biological a nd Economic Analysis Division (BEAD) of the U.S. EPA Office of Pesticide Programs.

Table 1. Complete List of Chlorfenap yr Uses by Registration Number. Crop/Site Use Group Reg.No

Commercial Storages/Warehouses Premises Indoor Non-Food 000241-00392 007969-00285 MS02002300

Commercial/Institutional/Indus trial Premises/Equip. (Indoor) Indoor Non-Food 000241-00392 007969-00285 MS02002300
Dairies/Cheese Processing Plant Equipment (Food Contact) Indoor Food 000241-00392 007969-00285 MS02002300

Eating Establishments Indoor Food 000241-00392 007969-00285 MS02002300Page 3 of 22 Table 1. Complete List of Chlorfenap yr Uses by Registration Number. Crop/Site Use Group Reg.No

Egg Packing Plants (Commercial) Indoor Food 000241-00392 007969-00285 MS02002300 Eggplant Greenhouse Food Crop 000241-00374

Feed Mills/Feed Processing Plants Indoor Food 000241-00392 007969-00285 MS02002300
Food Processing Plant Equipment (Food Contact) Indoor Food 000241-00392 MS02002300 Food Processing Plant Premises (Nonfood Contact) Indoor Food 007969-00285
Food Stores/Markets/Supermarkets Premises Indoor Food 000241-00392 MS02002300
Food/Grocery/Marketing/Storage/Distribution Facility Premise Indoor Food 000241-00392 007969-00285 MS02002300 Fruiting Vegetables Greenhouse Food Crop 000241-00374 Greenhouses-In Use Greenhouse Food Crop 000241-00374 Groundcherry (Strawberry Tomato/Toma tillo) Greenhouse Food Crop 000241-00374
Hospitals/Medical Institutions Premises (Human/Veterinary) Indoor Medical 000241-00392 007969-00285 MS02002300

Household/Domestic Dwellings Indoor Residential 000241-00392 007969-00285 MS02002300

Household/Domestic Dwellings Indoor Premises Indoor Residential 000241-00392 007969-00285 MS02002300

Household/Domestic Dwellings Outdoor Premises Outdoor Residential 000241-00392 007969-00285 MS02002300

Meat Processing Plant Premises (Nonfood Contact) Indoor Non-Food 000241-00392 007969-00285 MS02002300
Nonagricultural Outdoor Buildings/Structures Terrestrial Non-Food Crop* 000241-00392 MS02002300 Ornamental and/or Shade Trees Greenhouse Non-Food Crop 000241-00374 Ornamental Herbaceous Plants Greenhouse Non-Food Crop 000241-00374 Ornamental Non-flowering Plants Greenhouse Non-Food Crop 000241-00374 Ornamental Woody Shrubs And Vines Greenhouse Non-Food Crop 000241-00374 Pepino (Melon Pear) Greenhouse Food Crop 000241-00374 Pepper Greenhouse Food Crop 000241-00374

Pets (Unspecified) Indoor Non-Food 000241-00392 007969-00285 MS02002300

Poultry Processing Plant Premises (Nonfood Contact) Indoor Food 000241-00392 007969-00285 MS02002300

Sewage Systems Aquatic Non-Food Industrial 000241-00392 007969-00285 MS02002300 Tomatillo Greenhouse Food Crop 000241-00374 Tomato Greenhouse Food Crop 000241-00374Page 4 of 22 Table 1. Complete List of Chlorfenap yr Uses by Registration Number. Crop/Site Use Group Reg.No

Zoos Indoor Non-Food 000241-00392 007969-00285 MS02002300 * The Use Group designation, Terrestrial Non-Food Crop, is confusing because it refers to use on building and structures below concrete slabs, within the soil around foundations, and in and around cracks and crevices. It is probably meant to in dicate “some terrestrial application that is not to a food crop.” However, a literal interpretation would be “application to some crop other than food.”

The majority of these uses occurs in enclos ed indoor environments; and therefore, is assumed by EFED to have no complete exposur e pathways to ecologi cal receptors and, therefore, pose no risk to these recepto rs. However, several of the uses in Table 1 merit further explanation because these use group names may appear to result in outdoor exposures to ecological receptors:

• Household/Domestic Dwellings Outdoor Premises (Outdoor Residential) and Nonagricultural Outdoor Buildings/Structures (Terrestrial Non-Food Crop) – refers to uses that form a zone or ba rrier in the soil su rrounding a building or structure (under concrete slab floorin g and adjacent to basement walls) during construction and crack and cr evice treatments that are used on existing buildings and structures. Pre-construction uses of chlorfenapyr result in the pesticide sequestered by soils under th e floor of, or adjacent to the basement walls of, a building. Post-construction and crack and crevice treatments are limited to a 9.4 x 10 -5 lbs ai per 2 sq. feet every four week s. Therefore, assuming 4 sides of a building are treated with side s 10’ high by 100’ long (4000 ft 2 ) would result in a maximum treatment of 0.18 lbs ai to the building. However, EFED believes such applications would be unlikely to crea te a significant exposure pathway to ecological receptors because: most stru cturally sound buildings have far fewer cracks and crevices than the maximum a pplication rate allows; much of the applied pesticide would be retained inside the crevice or crack; and much of the pesticide that was dislodged from its applic ation site would be retained in any soil and/or landscaping at the ba se of the treated wall.

• Sewage Systems (Aquatic Non-Food Industrial) – is a crack and crevice treatment that is used in cracks in the concrete slab flooring around floor drains. The intent is not to discharge the chemi cal to the sewer system but, rather, to prevent ground-dwelling insects from en tering a building through cracks in the flooring around the drain. The label specifies that the drain must lead to a sewage system (and thus presumably, would be gr eatly diluted if some of the pesticide went down the drain) to prevent the use of the chemical arou nd drains that may discharge to the outside of the building (where relatively little dilution might occur).

• Zoos (Indoor Non-Food) – is also a crack and crevice use that is used on buildings enclosing zoo animals.

3. Chlorfenapyr Persistence Chlorfenapyr and its degradates have been show n to be highly persis tent. Chlorfenapyr'sPage 5 of 22 persistence is typified by a laboratory aer obic soil metabolism half -life of 1.4 years and its observed comparable field dissipa tion "half-life" of 1.3 years (MRID 44452621, 43492850). Chlorfenapyr is essentially stable to laboratory hydrolys is and anaerobic soil metabolism. Chlorfenapyr also has an organic carbon partition coefficient (K oc ) of 11,500 L/kg and thus binds to organic particulates and is generally immobile in soil. Sediment would be its principle latent reservoir in aquatic systems where it would remain available for extended periods.

Because of the persistence of parent and relatively short study durations, only small amounts of structurally similar metabolites or de gradates were identified in soil in field or lab studies. However, AC 312,094 has been de tected at 10% to 16% of parent in the radiolabeled North Carolina study (MRID 44452623). This metabolite has intermediate mobility characteristics (median K oc around 2200). Coupled with its persistence, this means that it has high potential for runoff into surface water with comparable amounts in solution and eroding soil if chlorfena pyr 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.

4. Chlorfenapyr Toxicity Available toxicity data are summarized below and are further discussed in Appendix A

. These data were obtained from previous assessments (EFED 1998, DP Barcode: 241963). In general, chlorfenapyr has demonstrated hi gh acute toxicity to terrestrial and aquatic organisms, and has demonstrated chronic toxi city at concentrations in the low μg/L
range.

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, respectively (MRIDs 43887004, 42770227, and 42770228). It is also very highly t oxic to waterfowl and passerine species and highly toxic to upland gamebirds on an acute dietary basis (MRID 42770229, 42770230, and 44452613). Chlorfenapyr has also re sulted 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 weight, serves as the chronic toxicity endpoint for avian long-term exposur e risk calculations (MRID 434928-13).

Chlrofenapyr has been shown to be less toxi c to mammals compared with birds. Acute LD 50 values in mammals range from appr oximately 45 mg/kg-bw to 1152 mg/kg-bw (MRIDs 43492828, 42770201, 42770207). A 2-generation mammalian study (MRID 43492836) produced a NOAEC value of 60 mg/kg-diet (5 mg/kg-bw).

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.Page 6 of 22 In aquatic organisms, acute LC 50 values for chlorfenapyr range from 7 μg/L to 12 μg/L in freshwater fish (MRIDs 42770231 and 42807801), 60 μg/L in saltwater fish (MRID 43492816), 6 μg/L to 18 μg/L in freshw ater invertebrates (MRIDs 42770232, 43887009), 2 μg/L in saltwater invertebrates (MRI D 43492818), and 0.2 mg/kg to 20 mg/kg sediment in benthic organisms (MRIDs 44452619, 44560002). Therefore, on an acute exposure basis, chlorfenapyr is very highly toxic to freshwater a nd estuarine/marine fish and invertebrates. Also, a degradate (CL 357,806) has shown to be more toxic than the parent chemical. However, the study on which th is conclusion is based is invalid.

Chronic NOAEC values range from 0.2 μg/L in estuarine/marine inverterbrates (MRID 43492821) to 4 μg/L (freshwater fish and invertebrates; MRIDs 43492819 and 43492822). Additional information from the 1998 EFED assessment is presented in Appendix A

. 5. Composting Concerns There is a concern for potential environm ental exposure through composting and land application of treated material after compos ting. The chlorfenapyr label (EPA Reg. No. 000241-00374) for fruiting vegetables grown in a greenhouse states “Compost any discarded plant material that has been trea ted.” Given chlorfenapyr’s persistence in aerobic soils and very high toxicity to avia n species, there is a concern that outdoor composting of treated plant material may provi de a potential route of exposure for avian species as well as othe r ecological receptors ( Figure 1 ).Page 7 of 22 Figure 1. Potential exposure pathways from chlorfenapyr-treated compost.

Persistence in compost is a concern because th e degradation of chlorfenapyr is likely to be slower than the degradation of the plant ma terial. Therefore, the potential exists for chlorfenapyr residues to increase in compost over time. Soils enriched with chlorfenapyrtreated compost may also have the potential to result in exposure to birds, mammals, and honey bees or other pollinators possibly re sulting in impaired survival, reproduction, and/or growth.

6. Treatment Prior to Pouring Concrete Slabs Based on EFED’s review of the label for use of chlorfenapyr as a termiticide, chlorfenapyr may be applied to soil underlyi ng a concrete slab prio r to the slab being poured (during construction). In the event that a major rain event occurs after treatment and prior to pouring of the conc rete slab, there is a potential for exposure to chlorfenapyr in adjacent areas via runoff from the use site.

7. Data Requirements

Justification for additional data needed to perform an ecological risk assessment for chlorfenapyr is presented below. EFED is currently requesting a composting study as part of this problem formulation. The study protocol must be submitted and reviewed by the Agency prior to conducting this study.

Chlorfenapyr applied to plants grown in greenhouse. Edible portion harvested from plants (Health Effects Division assessment).

Treated plant material discarded into outdoor compost pile

Compost material possibly degrading more rapidly than persistent parent and degradates resulting in higher concentrations in compost.

Birds and other animals exposed to, or feed on, discarded plant material/compost and organisms

ex p osed to chlorfena py r. Chlorfenapyr contaminated compost spread in field or yard. Run-off to water bodies exposes aquatic receptors.

Plants and animals exposed to compost contaminated soils.Page 8 of 22 Also, 40 CFR Part 158 criteria requires chroni c sediment data if the aerobic soil or aquatic metabolism half-life > 10 days and any one of the following conditions exist: 1) Kd > 50; 2) log Kow > 3; or 3) Koc > 1000. Chlorfenapyr meet s these criteria. In addition, several studies were id entified previously as data gaps in the RED (DP 241963). These studies remain data gaps.

Study Title: Evaluation of Chlo rfenapyr Degradation in Compost Non-Guideline Rationale for Requiring the Data The current labels recommend composting plant mate rials treated with chlorfenapyr. The composted material may then be distributed into the environment outside of the greenhouse environment resulting in potential exposures to non-target organisms. Therefore, understanding the fate of chlorfenapyr in compost is necessary to allow for an assessment of potential exposures to non-target organisms resulting from distribution of the compost material. Practical Utility of the Data How will the data be used? The data would be used to derive exposure concentrations to be used in the risk assessment for terrestrial and aquatic organisms and to evaluate the time needed to result in suffi cient degradation of chlorfenapyr such that the concern for potential effects is mitigated.

How could the data change the Agency’s decision or impact the Agency’s future decision-making? These data would serve as the basis for risk assessments resulting from distribution of composted material outside of the greenhouse. If future enda ngered species risk assessments are performed without these data, the Agency would have to assume that chlorfenapyr “may affect” listed species and use of chlorfenapyr may need to be restrict ed in areas where listed species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and could result in use re strictions for chlorfenap yr which are unnecessary.

Guideline Number: 850.4100, 4150, 4400, 5400 Study Title: Aquatic and Terrestrial Plant Toxicity Rationale for Requiring the Data Data regarding the toxicity of chlorfenapyr to aquatic and terrestrial plants have not been submitted to the Agency. These data are required under the 40 CF R Part 158 (2008) data requirements for pesticides with outdoor uses. These data are necessary to determine whether the outdoor use of chlorfenapyr could adversely affect aquatic and terrestrial plants. Practical Utility of the Data How will the data be used? These data will be used to determine the potential for chlorfenapyr to affect non-target plant species in the aquatic and terrestrial environments. In the ab sence of data specific for these plants, risk to terrestrial and aquatic plants will be assumed. Because plants are primar y producers, providing the foundation of food sources for all an imal species and habitat for most, th e lack of these data would result in the Agency presuming indi rect affects to all species.

How could the data impact the Ag ency’s future decision-making? If endangered species risk assessments are performe d without these data, the Agency would have to presume direct risk to non-target pl ants and indirect risk to all animal species from use of chlorfenapyr. Therefore, use of chlorfenapyr an d its formulated products may need to be restricted in areas where listed species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and could result in use restrictions for chlorfenapyr th at are unnecessarily severe.Page 9 of 22 Guideline Numbers: 850.1735 & 850.1740; EPA 600/R-99/064 Method 100.5 Study Title: Whole sediment: Fr eshwater and Marine Invertebrates Rationale for Requiring the Data No sediment toxicity tests for freshwater or marine invertebrates have been submitted to satisfy the Agency’s updated data requirements for outdoor uses in 40 CFR Part 158 (October 26, 2007).

o Benthic organisms inhabit sediment environments that may be exposed to run-off or spray drift from chlorfenapyr applications used in agricu ltural, forest, and residential settings

o Previous studies have identified a potential adve rse effect for freshwater and estuarine/marine aquatic organisms based on water column toxicity va lues. Therefore, there is uncertainty associated with that estimate that can be reduced using data from a toxicity test with benthic organisms.

o There is the potential for persistent exposure from chlorfenapyr in sediment indicated by the fate properties. Practical Utility of the Data How will the data be used? Data from sediment toxicity studies will be used to estimate potential risks to benthic organisms associated with uses of chlorfenapyr. The data w ill reduce uncertainties associated with the current risk assessment for benthic species and will improve our understanding of the potential effects of chlorfenapyr.

How could the data impact the Ag ency’s future decision-making? Acceptable data for benthic organisms will reduce the un certainty from the previous assessment. If the data indicates that registered chlorfenapyr usage may pose a risk of adverse effects to non-target benthic organisms above the Agency Level of Concern, the Agency may explore decision options to mitigate this risk. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endanger ed Species Act, and could result in us e restrictions for chlorfenapyr which may otherwise be avoided, or which are unnecessarily severe.

In addition to the new data requirements presented above, several data requirements listed in the RED (1998; DP241963) have not ye t been fulfilled, and remain data gaps. These studies are listed below.

Guideline Number: 850.1075 Test Substance: Photolysis degradate CL 357,806) Study Title: Fish Acute LC50 (Rainbow Trout) Rationale for Requiring the Data

This degradate has been shown to be more toxic than chlorfenapyr to fish. However, the studies on which this conclusion was based are invalid. An accept able study is needed to allow for an evaluation of the potential risks to fish from exposure to this degradate. Practical Utility of the Data

How will the data be used? These data would allow for a quantitative assessment of potential risk to freshwater fish, providing a basis for viable mitigation options to reduce potential exposure and effects (if needed).

How could the data impact the Ag ency’s future decision-making? If future endangered species risk assessments ar e performed without these data, the Agency would assume that this degradate "may affect" endangered fish directly (and endangered species from other taxa which feed on them indirectly), and use of chlo rfenapyr might need to be restricted in areas wherePage 10 of 22 endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and could result in use restrictions that are unnecessa ry or unnecessarily severe.

Guideline Number: 850.1025 Study Title: Estuarine/Marine Acute Invertebrate LC50 (Eastern Oyster) Rationale for Requiring the Data

Chlorfenapyr is classified as very highly toxic to mysid shrimp. Therefore it is likely that there will be some toxicity to mollusks as well. The submitted study in Eastern oysters (MRID 43492817) was invalid. Therefore, no reliable data exists to allow for an evaluation of potential risks to mollusks.

Since the RED was signed, the Agency has worked to finalize its update to data requirements in 40 CFR part 158, which were promulgated on October 26, 2007. Now estuarine/marine invertebrate acute toxicity studies are required using the TGAI for all outdoor end-use product uses. Chlorfenapyr end use products are currently assumed to be registered for outdoor uses. Practical Utility of the Data

How will the data be used? These data would allow for a quantitative assessment of potential risk to estuarine/marine invertebrates, providing a basis for viable mitigation options to reduce potential exposure and effects to these taxa.

How could the data impact the Ag ency’s future decision-making? If future endangered species risk assessments are pe rformed without these data, the Agency would have to assume that chlolrenapyr “may affect” endangered mollusks dir ectly (and endangered species from other taxa which feed on them), and use of chlofenapyr might need to be restricted in areas where endangered species could be exposed. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act and could result in use restrictions that are unnecessa ry or unnecessarily severe.

Guideline Number: 850.1400 Study Title: Fish Early-life Stage Toxicity Test Rationale for Requiring the Data

The fish early-life stage toxicity test provides the lethal and sublethal effects of the test compound on early life stages of fish species. These data are re quired for all outdoor uses, and some current uses of chlorfenapyr are considered outdoor uses, and the available environmental fate data suggests that chlofenapyr is persistent in the environment. No valid early life stage studie s are available. Without these data, the Agency is unable to evaluate the po tential risks to freshwater fish and aquatic-phase amphibians (for which fish serve as surr ogates) to early life stages of fish. Practical Utility of the Data

How will the data be used? The data from the fish early life stage test will be used to estimate the chronic risks to freshwater fish and amphibians associated with ch ronic exposures to chlorfenapyr.

How could the data impact the Ag ency’s future decision-making? The data from the fish early life stage test will be used to estimate potential risks to freshwater fish/amphibians associated with chronic exposures to chlorfenapyr. The da ta will reduce uncertainties associated with potential risks to freshwater fi sh/amphibians thereby facilitating sound environmental management of natural resources, particularly, freshwater fisheries.Page 11 of 22 Lastly, this data will allow the Agency to assess the chronic risk to freshwater fish, and should result in decisions that are protectiv e of these organisms, including endangered species.

Guideline Number: 830.6100 Data requirement: Analytical method Rationale for Requiring the Data

The registrant is required to submit soil and water methods of analysis that are suitable for detecting about one-tenth of the concentrations with observed ecological effects for EPA laboratory validation. Using this criterion, present procedures for water need to be improved by a factor of ten for sensitive species. Validation data for both accuracy and pr ecision should be subm itted for all methods. Practical Utility of the Data

This is basic information to characterize and identify the compound and is used to ensure that the chemical can be detected at concen trations that may cause adverse e ffects in the environment. This information is usually provided when a product is registered, but the existing data are inadequate.

References USEPA. August 31, 1998. Chlorfenapyr (PIRATE TM , ALERT TM , AC 303,630) Insecticide-Miticide Environmental Fate and Ecological Effects Assessment and Characterization for a Section 3 fo r Use on Cotton. DP Barcode: D241963, D240108, D243556, D245813, D246459, D246093, D246661. 140pp.Page 12 of 22 Appendix A. Guideline Toxicity Data as Presented in Previo us Assessments (DP 241963)Page 13 of 22Page 14 of 22Page 15 of 22Page 16 of 22Page 17 of 22Page 18 of 22Page 19 of 22Page 20 of 22Page 21 of 22Page 22 of 22