2 

### Chlorfenapyr Proposed Interim Decision

- Table of Contents

Contents I. INTRODUCTION

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A. Public Comments

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II. USE AND USAGE

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III. SCIENTIFIC ASSESSMENTS

... ... ... ... ... ... ... ...................................................... 6

A. Human Health

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1. Risk Conclusions

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . 7 Dietary Assessment

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . 7

Residential Assessment

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 7 Aggregate Assessment

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Cumulative Assessment

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2. Human Incidents

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3. Tolerances

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1. Risk Conclusions

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2. Pollin ator Studies and Assessments

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... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 12 D. Endocrine Disruptor Screening Program

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 12

IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION

... ... ... ... ... ... ... 13 A. Risk Mitigation and Regulatory Rationale

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... . 13

B. Tolerance Amendmen ts

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. 17 C. Proposed Interim Registration Review Decision

... ... ... ... ... ... ... ... ... ... ... ... ... ... 17

V. NEXT STEPS AND TIMELINE

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 18 A. Interim Registration Review Decision

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. 18 B. Implementation of Mitigation Measures

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 183 References:

This Preliminary Interim Decision summarizes the Environmental Protection Agency's current position based on the following documents:

1. Registration Review: Preliminary Ecological Risk Assessment and Endangered Species Effects Determination for Chlorfenapyr

. Stephen P. Wente. June 12, 2014

.

2. Chlorfenapyr

- Preliminary Human Health Risk Assessment for Registration Review

. Monique M. Perron, William D. Wassell, and Lata V enkateshwara

. May 22, 2014

.

3. Chlorfenapyr. Revised Occupational and Residential Exposure Registration Review Assessment

. Lata Venkateshwara

. June, 18 2014.

4. Chlorfenapyr. Addendum to Registration Review Preliminary Risk Assessment to Update Occupational Post

- application Assessment based on Submitted Dislodgeable Foliar Residue (DFR) Data

. Kelly M. Lowe. March 10, 2015.

5. Chlorfenapyr: Review of Human Incident s. Khin Oo and Shanna Recore

. February 25, 2010.

These and other supporting documents for the chlorfenapyr registration review case may be found in the docket EPA

- HQ

- OPP

- 2010

- 0467 at http://www.regulations.gov

.4 

### I. INTRODUCTION

This document is the Environmental Protection Agency’s (EPA or the Agency) Proposed Interim Registration Review Decision (PID) for chlorfenapyr (case 7419 , PC 129093 ) and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A registration review decision is the Agency's determination whether a pesticide meets, or does n ot meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, a n I nterim R egistration R eview D ecision before completing a registration review. Among other things, the I nterim R egistration R eview D ecision may : 1) require new risk mitigation measures ; 2) impose interim risk mitigation measures ; 3) identify data or information required to complete the review ; and 4) include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. For further information on chlorfenapyr , additional documents can be found in EPA’s public docket ( EPA

- HQ

- OPP

- 2010

- 0467 ) at www.regulations.gov

. FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the continuous review of existing pesticides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the abi lity to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur ove r time. Through the registration review program, the Agency periodically re

- evaluates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided as www.epa.gov/oppsrrd1/registration_review/

. In 2006, the Agency implemented the registration review program pursuant to FIFRA section 3(g) and will review each registered pesticide every 15 years to deter mine whether it continues to meet the FIFRA standard for registration.

Chlorfenapyr is a member of the pyrroles class of insecticide/miticides. It acts by disrupting adenosine triphosphate (ATP) production

, leading to cell dysfunction in the target organism. Chlorfenapyr is registered for application to fruiting vegetables and ornamentals in greenhouses only and crack/crevice/spot treatment on indoor and outdoor residential sites (including as a bed bug treat ment), food/feed handling areas, indoor and outdoor commercial sites (including sewers) , and indoor medical sites. It is not registered for use on outdoor agricultural crops

. C hlorfenapyr is used to controls mites, caterpillar pests, thrips, fungus gnats, cockroaches, ants, and termites. Since chlorfenapyr was first registered in 2001 , it was not subject to reregistration.

Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for c hlorfenapyr (case 7419 )

. The following summary high lights significant events that have occurred during the registration review of c hlorfenapyr and can be found in EPA’s public docket

, EPA

- HQ

- OPP

2010

- 0467 , accessed at www.regulations.gov :

• Jun e 23, 2010

– Publication of chlorfenapyr p reliminary w ork p lan (PWP) , entitled Chlorfenapyr Summary Document Registration Review: Initial Docket June 2010

, f or a5 60

- day public comment period . The PWP was accompanied by the scoping document and problem formulation.

• J anuary 6, 2011

– A final work p lan (FWP) for chlorfenapyr , entitled Chlorfenapyr Final Work Plan (FWP) for Registration Review: November 2010

, was issued . Three public comments were received during the 60

- day comment period for the chlorfenapyr PWP. C omments and label changes submitted by the chlorfenapyr technical registrant resulted in a change of the data needs iden tified in the PWP.

o EPA’s consideration of public comments on the chlorfenapyr FWP are detailed in the following two response to comment s documents:

 Chlorfenapyr. Public Comments Regarding the Health Effects Division's (HED's) Human

- Health Assessment Scoping Document in Support of Registration Review of 26

- MAY

- 2010. HED's Response to Public Comments. Anwar Y Dunbar

. November 4

, 2010

.

 Response to Comments on the Preliminary Problem Formulation for Chlorfenapyr

. Robert A. Miller and Steve Wente October 28, 2010.

o T he FWP modified the PWP in concluding that there is no significant outdoor environmental exposure from the use of chlorfenapy r, and that EPA would therefore not conduct a comprehensive ecological risk assessment during registration review

.

 Compost Concerns Resolved : Certain ch lorfenapyr product labeling previously allowed chlorfenapyr

- treated plant material to be composted, raising concerns about possible environmental exposure from treated plant matter. After the chlorfenapyr PWP was issued, t he labe l language allowing composting w as removed and the following prohibition was added : “DO NOT compost any discarded plant mater ials that have been treated with this product.”

 Termiticide Use: EPA initially identified potential environmental exposure from the use of c hlorfenapyr in construction as a termi ti cide applied to the soil underlying a concrete slab prior to the slab being poured. However, at this time E PA does not believe this exposure route is sufficient to warrant the collection of additional fate and effects data or the development of an ecological risk assessment.

• October 12, 2011

– Generic Data Call

- In (GDCI

- 129093

- 10 34 ) for chlorfenapyr was issued.

• July 1, 2014

– The Agency published the Registration Review: Preliminary Ecological Risk Assessment and Endangered Species Effects Determination for Chlorfenapyr and the Chlorfenapyr

- Preliminary Human Health Risk Assessment for Registration Review for a 60

- day public comment period. Two comments were received during the comment period , and a discussion of these comments follows in section I.A. of this PID.

• July 2015

– The Agency is now publishing the C hlorfenapyr Proposed Interim Registration Review Decision , in docket number EPA

- HQ

- OPP

- 2010

- 0467 for a 60

- day6 public comment period. In addition to this document, the Agency is also publishing the following supporting documents:

o Chlorfenapyr. Addendum to Registrati on Review Preliminary Risk Assessment to Update Occupational Post

- application Assessment based on Submitted Dislodgeable Foliar Residue (DFR) Data

. Kelly M. Lowe. March 10, 2015.

A. Public Comments

Two comments were received during the comment period for the chlorfenapyr pr eliminary ecological risk assessment and draft human health risk assessment. To address these two comments on the pr eliminary ecological risk assessment , EPA d rafted an October 28, 2014 memo entitled Response to Public Comments on the Registration Review: Preliminary Ecological Risk Assessment and Endangered Species Effects

- Determination for Chlorfenapyr

. This document was posted to the chlorfenapyr docket on November 7, 2014. One comment (EPA

- HQ

- OPP

- 2010

- 0467

- 0022) was an anonymous p ublic comment disputing the Agency’s finding of no ecological risks of concern for chlorfenapyr due to an incomplete exposure pathway. The second was a comment (EPA

- HQ

- OPP

- 2010

- 0467

- 0023) from the Center for Biological Diversity supporting EPA’s No Effect finding for chlorfenapyr under the Endangered Species Act (ESA). EPA thanks the Center for Biological Diversity for their comment and reiterates the Agency’s finding of a “ No Effect ” (NE) determination for all listed species as well as a No Habitat Modifi cation determination for all designated critical habitats for the currently registered uses of chlorfenapyr.



### II

. USE AND USAGE

Chlorfenapyr is a member of the pyrroles class of insecticide/miticides, which works by disrupting ATP production in the target pests, leading to cell dysfunction. Chlorfenapyr is registered for application to fruiting vegetables and ornamentals in greenhouses only and crack/crevice/spot treatment on indoor and outdoor residential sites (including as a bed bug treatment), fo od/feed handling areas, indoor and outdoor commercial sites, and indoor medical sites. It is not registered for use on outdoor agricultural crops. Outdoor uses are limited to crack/crevice/spot treatments and use as a termiticide applied to soil prior to t he pouring of concrete slabs in construction.



### III. SCIENTIFIC ASSESSMENTS

A. Human Health

A summary of the Agency’s human health risk assessment is presented below. The Agency used the most recent Agency science policies and risk assess ment methodologies to prepare a
qua nti tative risk assessment in support of the registration review of c hlorfenapyr

. For a detailed discussion of the human health assessment for chlorfenapyr , see Chlorfenapyr

- Preliminary Human Health Risk Assessment for R egistration Review dated May 22, 2014 and Chlorfenapyr.7 Addendum to Registration Review Preliminary Risk Assessment to Update Occupational Post

application Assessment based on Submitted Dislodgeable Foliar Residue (DFR) Data dated March 10, 2015. Both documents are available i n the public docket EPA

- HQ

- OPP

- 2010

- 0467

, which can be accessed at http://www.regulations.gov/

.
1. Risk Conclusions

Dietary Assessment :
There are no dietary risk estimates of concern for chlorfenapyr from either acute or chronic
exposure. In addition, there are no existing or proposed uses of chlorfenapyr expected to result in co ntamination of drinking water. A cute and chronic dietary an alyses were conducted using tolerance

- level residues and 100% crop treated (CT).

Dietary risk incorporates both exposure to and toxicity of a given pesticide , and is expressed as a percentage of a level of concern. The level of concern is the dose predict ed to result in no unreasonable adverse health effects to any human population subgroup, including sensitive members of such population subgroups. This level of concern is referred to as the population adjusted dose (PAD), which reflects the reference dos e (RfD), either acute or chronic, adjusted to

accou nt for the FQPA safety factor.

The acute dietary exposure for chlorfenapyr is estimated at 14% of the acute population

- adjusted dose (aPAD) for the general U.S. population and 35% of the aPAD for children 3 to 5 years old, the population subgroup with the highest estimated acute dietary exposure to chlorfenapyr. The chronic dietary exposure for chlorfenapyr is estimated at 3.8% of the chronic population

- adjusted dose (cPAD) for the general U.S. population and 9.4% of the cPAD for children 1 to 2 years old, the population subgroup with the highest estimated chronic dietary exposure to chlorfenapyr. Estimated risks that are less than 100% of the PAD are belo w EPA’s level of concern.

Residential Assessment :
Because there are no registered or proposed residential handler uses of chlorfenapyr, a residential handler exposure assessment was not conducted. Although certain chlorfenapyr products are approved for use in residential settings, these products are inte nded for use by homeowners themselves . This distinction is made on chlorfenapyr product labelling. All four chlorfenapyr registrations currently approved for use in household/domestic dwellings feature label language stating that the product is “For sale to, use and storage only by individuals/firms licensed or registered by the state to apply termiticide and/or general pest

- control products.”

There is , however, potential for residential post

- application exposure from chlorfenapyr. The residential post

- application exposure assessment calculated that there was one residential chlorfenapyr exposure scenario with risk s of concern: combined risk from post

- application incidental oral, dermal, and inhalation ex posure for children (1 to < 2 years old) with coarse

stream applications for indoor bed bug treatment

. This scenario resulted in a potential risk of

concern with a margin of exposure (MOE) of 62 , based on the assumption of a dermal absorption factor (DAF) of 13%

. For chlorfenapyr, EPA’s Level of Concern (LOC) is ≥ 100. This means that EPA considers MOE values lower than 100 to be a potential risk of concern for chlorfenapyr . MO Es at or above the LOC are not of concern.8 Aggregate Assessment :

Non

- Cancer Risks : Short

- and intermediate

- term aggregate risks for chlorfenapyr are based on a combination of d ietary a nd residential assessment data , while a cute and chronic aggregate risk estimates for chlorfenapyr are based solely on dietary sources of exposure. Because there are no dietary risk estimates of concern for chlorfenapyr, there are no acute and chronic aggregate exposures of concern.

There was, however, one scenario of potential concern for s hort

- and intermediate

- term exposure to chlorfenapyr. Short and int ermediate

- term aggregate risk assessments were performed because there is potential for post

- application exposure from the uses of chlorfenapyr in residential settings. Since the short

- and intermediate

- term endpoints and points of departure (PODs) are the same, the short

- term aggregate assessment is protective of intermediate

- term exposure. EPA found that t he short

- term aggregate MOE for adults is greater than EPA’s LOC ( MOEs ≥ 100), and is therefore not a risk of concern. The same safety finding was not made for risks to young children exposed to chlorfenapyr. For children (1 to <2 years old), the short

- term aggregate exposure with coarse

- stream applications yields an aggregate MOE of 60. This value of 60 is less than the LOC of 100 and therefore a risk of potential concern.

Cancer Risks : Chlorfenapyr is classified as “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential.” Therefore, a quantitative cancer aggregate risk assessment was not performed.

Cumulative Assessment :
Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to chlorfenapyr and any other substances. Chlorfenapyr does not appear to produce a toxic metabolite produced by other substances, so a cumulative risk assessment has not been

con ducted

. Occupational Assessment :
For chlorfenapyr, based on the currently existing labeled use patterns, short and intermediate

term occupat ional exposures are expected. An occupational assessment for chlorfenapyr was part of the Chlorfenapyr

- Preliminary Human Health Risk Assessment for Registration Review

, dated May 22, 2014

. Both handler and post

- applicati on assessments were conducted.

• Handler Risk: Most occupational handler risk estimates resulted in MOEs greater than the LOC at baseline or label specified levels of personal protective equipment (PPE), and therefore, are not of concern 1 . However, several exposure scenarios required addi tional

1 Note on Termiticide

– Crack and C revice Treatment: For this use scenario, there was an oversight in table 9.1.1 of the 2014 human health risk assessment. It was not noted that the values presented were for single layer with gloves rather than for a baseline level of PPE. For applicators using ready

- to

- use aerosol cans for application as a termiticide crack and crevice treatment, combined MOEs were below the LOC of 100 at baseline levels of PPE (MOE of 56). Current PPE, which includes a sin gle layer of clothing ( i.e. a long

- sleeved shirt , long pants, and shoes plus socks, but no gloves or respirator), yields this total MOE value of 5 6. If gloves are added, a total MOE of 130 will be reached and the use scenario will no longer be of concern.9 PPE to reach total MOEs greater than the LOC . For the use scenario of mixers/loaders/applicators of liquids using a mechanically

- pressurized handgun for greenhouse applications, there are ri sks of concern (MOE = 26) even with maximum PPE (i.e., dou ble layer, gloves and PF10 respirator).

• Post

- Application Risk: An occupational post

- application assessment was conducted for workers entering greenhouses after treatment of crops and/or ornamentals. Using a default Dislodgeable Foliar Residue (DFR) value of 0.56, r isk estimates for all post

application scenarios we re not of concern.

Since the default DFR value yielded dermal MOEs less than two times the LOC (i.e., < 200) based on default values for the fraction of application rate available for transfer after a foliar application , the 2014 human health risk assessment for chlorfenapyr called for the submission of a DFR study. The chlorfenapyr registrant provided a DFR study, which was revi e wed and found acceptable for use in registration review by the Agency. On the basis of this new DFR data, EPA revised its occupational post

- application assessment for chlorfenapyr in the March 10, 2015

memo Chlorfenapyr. Addendum to Registration Review Preliminary Risk Assessment to Update Occupational Post

- ap plication Assessment based on Submitted Dislodgeable Foliar Residue (DFR) Data

. Updated short

- and intermediate

- term occupational post

- application exposure scenarios were calculated for currently registered uses of chlorfenapyr :

• Post

- Application Risk: A ll use scenarios resulted in MOEs greater than the LOC of 100 (ranging from 880 to 28,000) on day 0 (12 hours after application) and are therefore not of concern to E PA

. MOEs for all occupational post

- application non

- cancer exposure scenarios increased from those calculated in the 2014 human health risk assessment, indicating that risks were even lower than previously believed

.

• Handler Risk: Occupation h andler risk was not discussed in the 2015 memo. The Agency’s characterization for this risk category re main s unchanged from the 2014 chlorfenapyr as sessment.

2. Human Incidents Human incidents involving chlorfenapyr are described in the February 25, 2010 memo Chlorfenapyr: Review of Human Incident s

. An analysis of the OPP Incident Data System (IDS) database from 2002 to 2010 found two incidents, and an analysis of the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notificat ion System for Occupational Risk

- Pesticides (SENSOR) database found six incidents from the time range of 1998

- 2006 . Based on the low severity and low number of incident cases, there does not appear to be a concern at this time that would warrant further in vestigation. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in a future risk assessment.

3. Tolerances Permanent tolerances (40 CFR §180.513) are established for res idues of chlorfenapyr in/on the vegetables, fruiting, group 8 at 1.0 ppm and in/on all food commodities at 0.01 ppm. Due to10 updates in crop grouping, existing tolerances for vegetable, fruiting group 8 (1.0 ppm) needs to be revised to vegetable, fruiting, group 8

- 10.

There are no Codex or Canadian maximum residue limits (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. There is a n MRL of 0.5 ppm for cotton seed in Mexico, which has no U.S. equivalent tolerance. Harmonizati on with Codex and Canada is not an issue.

B. Ecological

A summary of the Agency’s ecological risk assessment is presented below. The Agency used the most updated Agency science policies and risk assessment methodologies to prepare a qualitative risk assessment in support of the registration review of chlorfenapyr . For a detailed discussion of t he ecological assessment for chlorfenapyr , see Registration Review: Preliminary Ecological Risk Assessment and Endangered Species Effects Determination for Chlorfenapyr

, dated June 12, 2014, available i n the public docket EPA

- HQ

- OPP

- 2010

- 0467

, which can be accessed at http://www.regulations.gov/

. The Agency also completed an endangered species assessment for chlorfenapyr. Based on incomplete exposure pathways for all chlorfenapyr uses, the Agency made a No Effects (NE) determination for all listed species as well as a No Habitat Modification determination for all designated critical habitats for the currently registered uses of chlorfenapyr

.

1. Risk Conclusions

As described in the Introduction (Section 1) of t his Proposed Interim Decision, potential concerns regarding environmental exposure from (1) chlorfenapyr’s termi ti cide use in construction settings and (2) from the formerly permitted composting of chlorfenapyr

- treated plant materials were addressed in the 2011 chlorfenapyr Final Work Plan. Aside from chlorfenapyr’s termiticide use, al l other chlorfenapyr use sites are indoors and result in no complete environmental exposure pathways, or are crack and crevice treatments with little potential for outdoor re lease. EPA therefore concluded that there were incomplete environmental exposure pathways for all chlorfenapyr uses.

As noted in EPA’s 2014 memo Response to Public Comments on the Registration Review: Preliminary Ecological Risk Assessment and Endangered Species Effects

- Determination for Chlorfenapyr

, the Agency’s use of the phrase “incomplete exposure pathway” should not be mistaken for the idea of no (zero) exposure. The Agency uses the phrase “incomplete exposure pathway” to indicate that any potential exposure to an ecological receptor (non

- target organism) through registered (legal) uses of a pesticide would be far below the level necessa ry to cause harm to that receptor. Based on incomplete exposure pathways for all chlorfenapyr uses, the Agency made a No Effects (NE) determination for all listed species as well as a No Habitat11 Modification determination for all designated critical habit ats for the currently registered uses of chlorfenapyr. In addition, risks of concern are unexpected for non

- listed species.

Because no complete exposure pathway was identified for chlorfenapyr , ecological risks from chlorfenapyr were not assessed quanti tatively in the chlorfenapyr preliminary ecological risk assessment. If in the future chlorfenapyr is considered for additional uses that could result in environmental releases, further analysis will need to be undertaken to determine potential effects
to non

- target organisms, including listed species and their designated critical habitat.

2. Pollinator Studies and Assessment

When initially scoping the registration review for chlorfenapyr, EPA did not identify the need for any additional studies to evaluate potential effects on pollinators. However, since the issuance of the June 2014 Guidance for Assessing Pesticide Risks to Bees [1] , EPA has begun to require these data where applicable. EPA is currently determining whether additional pollinator data are needed for active ingredients in registration review whose dockets opened prior to June 2014. For those active ingredients where EPA determines that additional pollinator exposure and effects data are necessary to help make a final registration review decision, EPA intends to issue a DCI to obtain these data. In the near future, EPA will provide further information and guidan ce on this effort. The pollinator studies that could be required are included in Table 1 below. The Agency will require data it believes are needed to help inform the pollinator risk
assessment.

Table 1. Potential Pollinator Data Requirements

Guideline # Study
850.3020* Acute contact toxicity study with adult honey bees
850.3030* Honey bee toxicity of residues on foliage
850.3040** Field testing for pollinators
Non

- Guideline* (OECD 213) Honey bee adult acute oral toxicity

Non

- Guideline* (OECD 237) Honey bee larvae acute oral toxicity

Non

- Guideline* Honey bee adult chronic oral toxicity
Non

- Guideline* Honey bee larvae chronic oral toxicity
Non

Guideline** Residues in pollen and nectar/field residue analysis

Non

Guideline** (OECD 75) Semi

- field testing for pollinators (tunnel or colony feeding studies)

*Tier 1 (Laboratory

- based studies) **Tier 2 and 3 (Semi

- field and full field colony

- level studies) The need for a higher tier test for pollinators will be determined based upon lower

- tiered tests and/or other lines of data and the need for a refined pollinator risk assessment.

[1] http://www2.epa.gov/sites/production/files/2014

- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf12 C

. Endangered Species Assessment

There is no reasonable expectation for registered uses of chlorfenapyr to cause direct or indirect adverse effects to threatened and endan gered species. No adverse modification of critical habitat is expected from the use of chlorfenapyr . EPA has made a “no effect” determination under the Endangered Species Act (ESA) for all listed species as well as a “no habitat modification” determination for all designated critical habitats for the currently registered uses of chlorfenapyr

. The Agency has therefore concluded that consultation with the Fish and Wildlife Service and the National Marine Fisheries Service under ESA section 7(a)(2) is not requ ired. EPA anticipates conducting no further analysis of potential risks to endangered or threatened species, unless data or information are obtained during the Registration Review process that would indicate such an assessment would be needed to inform the Agency’s decision.

D

. Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic t oxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ hi stopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmenta l and reproductive effects in different taxonomic groups. As part of its most recent registration decision for chlorfenapyr , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), chlorfenapyr is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the 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 Tie r 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 dose

- response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. 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 and 9 inert ingred ients. A second list of13 chemicals identified for EDSP screening was published on June 14, 2013 2 and includes some pesticides scheduled for Registration Review and chemicals found in water. Neither of these lists should be construed as a list of known or likely endocrine disruptors. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 3

In this proposed interim decision , EPA is making no human health or environmental safety findings associated with the EDSP screening of chlorfenapyr . Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.



### I V

. PROPOSED INTER IM REGISTRATION REVIEW DECISION

A. Risk Mitigation and Regulatory Rationale

Ecological Risks : The Agency has made a No Effects (NE) determination for c hlorfenapyr under ESA section 7 for all listed species as well as a No Habitat Modification determination for all designated critical habitats for the currently registered uses. Also, no effects are expected for non

- listed species. Therefore, no ecological risk mitigat ion for chlorfenapyr is being p r oposed by th e Agency at this time.

Human Health Risks : Non

- cancer r isks of concern from chlorfenapyr were identified for residential post

- application
exposure and occupational handler exposure . Risk mitigation for chlorfenapyr focuse s on these two areas of concern.

Mitigation for Residential Post

- Applicati on Risks of C oncern

R esidential post

- application exposure assessment s and aggregate exposure assessments calculated that there was one residential chlorfenapyr use scenario with risk s of concern: combined ( post

- application incidental oral, dermal, and inhalation) residential exposure for children (1 to <2 years old) from residential applications of chlorfenapyr using a coarse

- stream application of product . The combined residenti al risk scenario for children 1 to <2 years old yielded an MOE of 62. When dietary exposure is added in to calculate aggregate risk, the MOE is 60

.
In the human health risk assessment, EPA noted that i f this use pattern was amended so that the chlorfenapyr product is applied using a pin

- stream nozzle rather than a c oarse

- stream application, this scenario would no longer be a risk concern (MOE of 110)

. However, the chlorfenapyr registrant has proposed an alternative mitigation strategy. T he registrant has proposed removing applications of chlorfenapyr to mattresses from all product labels. The Agency supports this action and is proposing the r emoval of chlorfenapyr mattress uses

.

2 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of chemicals.

3 http://www.epa.gov/end o/14 With the removal of the mattress application, the combined residential risk estimate for indoor perimeter/spot/bed bug use for children (1 to <2 years old) increase s from an MOE of 62 to 100

a nd would no longer be of concern. The corresponding aggregate risk MOE will increase from 60 to 92 after the removal of m attress uses . This MOE remain s of concern since it is less than EPA’s LOC of 100.

To refine the aggregate risk assessment , the registrant proposed refining EPA’s dietary assessment for chlorfenapyr

. EPA ’s h uman health risk assessment for chlorfenapyr as sum es tolerance

- level residues and a crop treatment factor of 100% for tomatoes , but chlorfenapyr is approved for tomato use only in greenhouses , not field

- grown tomatoes. Based on USDA
acreage data for field

- and greenhouse

- grown tomato, the registrant suggested that the percentage of US

- grown tomatoes with the potential to be treated with chlorfenapyr is significantly less than 100%.

However, tomato production per acre can be higher for green house

- grown tomatoes than for outdoor field

- grown tomatoes. EPA found that i n 2009, the most recent year for which production

- based greenhouse tomato data were available, USDA’s Census of Horticulture Special ties report ed that 3,207,177 hundredweights ( cw t .) of tomato production occurred “ under protection ,” or in greenhouses. That value can be compared to 32,781,000 cwt. reported as the production of fresh market tomatoes “ in the open ” (grown in outdoor fields) in USDA ’s National Agricultural Statistics S ervice ( NASS ) Vegetables Final Estimates 2008

- 2012

. Assuming all greenhouse tomato production goes into the fresh market, about 8.9% of US fresh tomato production by weight is from greenhouses. Making the further assumption that all greenhouse

grown toma toes are treated with chlorfenapy r, an upper bound value for the percentage of tomatoes that are treated with chlorfenapyr can therefore conservatively be expected to be 8. 9%

, more than 11x lower than the 100% PCT value used in EPA’s dietary risk assessment for chlorfenapyr

. Although considering dietary risks is an important part of EPA’s risk assessment process for chlorfenapyr, the main exposure pathway driving risks of concern for chlorfenapyr is dermal. As stated above, with a 1 00 % crop treat ment factor for tomato and the cancellation of mattress uses for chlorfenapyr , the resulting aggregate risk MOE for children (1 to <2 years old) is 92

. In addition to being influenced by the conservativeness of EPA’s dietary assessment for chlorfenapyr, t his MOE value of 92 is also likely to be conservative g iven the nature of the dermal data currently available for chlorfenapyr.

T he 13% dermal penetration f actor used to calculate human health risk estimates for chlorfenapyr is derived from an in vivo rat dermal penetration study (MRID 49 315901) that did not include tape stripping. Without tape stripping, all test material measured at the application site is included in the DAF calculation, potentially overestimating the amount of chemical that is bioavailable. T he 13% DAF val ue used for chlorfenapyr does not incorporate either in vitro rat

or in vitro human dermal absorption data , as these data are currently unavailable . DAF values derived solely from rat data tend to be more conservative tha n DAF values which incorporate data from dermal absorption studies conducted using human tissue. This is due to the higher permeability of rat skin relative to human skin.15 Taking into consideration these factors characterizing the nature of chlorfenapyr’s dermal and dietary risk s of concern

, and after the remov al of all mattress uses from chlorfenapyr labels, EPA is not proposing additional mitigation at this time to address residential risks from chlorfenapyr

use.

However, the Agency notes that this safety finding for residential uses of chlorfenapyr (after th e removal of mattress uses) is sensitive to small changes in EPA’s understan d ing of risks from this chemical

. Because aggregate exposure to chlorfen a pyr is right at the acceptable limit, EPA’s saf ety finding could be affected by minor changes to estimates of dietary consumption or post

application residential exposure. Furthermore, the finding that ch l orfenapyr’s current use pattern already reaches the maximum acceptable level of residential exposure at which EPA doses not expect unre asonable risks of adverse health effects from chlorfenapyr’s use (i.e. th e re is essentially a full “risk cup” for chlo r fenapyr ) means that no additional exposure scenarios ( new

uses ) will be allowed for this chemical.

Should the chlorfenapyr registrant wish to refine the residential risk estimate , the Agency advises that they s elect one or all of the following options :

1) The DAF used for calculating risk estimates for chlorfenapyr (13%) is currently based on

a n in vivo dermal penetration study conducted in rats with no tape stripping. As a result, all test material measured at the application site is included in the DAF calculation. A new study in rats could be conducted with tape stripping. Tape strips 1 and 2 are n ot included in current DAF calculations for chlorfenapyr since the material on these strips are considered non

- penetrating . T herefore, a new study with tape strips could potentially reduce the DAF depending on the amount of test material found in tape str ips 1 and 2. 2) The registrant could also consider submitting a dermal triple pack to refine the DAF, which consists of in vivo rat, in vitro rat, and in vitro human dermal absorption studies. The triple pack offers greater precision in estimating human derm al absorption by accounting for differences between in vitro and in vivo absorption rates, as well as for species differences between rats and humans. Should the registrant choose to conduct a dermal triple pack, a ll three studies in the triple pack shoul d be conducted using identical protocols, test material, and doses. The registrants have already submitted an in vivo rat study, one of the three components of a dermal triple pack. This dermal penetration study (MRID 49315901) was used to calculate the 13% DAF used in EPA’s human health risk assessment for chlorfenapyr. Though EPA notes the tape stripping issue mentioned in the previous bullet point , MRID 49315901 was fo und to be an acceptable study for use in risk assessment. 3) The indoor surface residue s used in the chlorfenapyr assessment represent default values taken from the Residential SOPs. The registrant could consider producing an indoor surface residue study that is representative of how chlorfenapyr will be used in a home. Such a study should be conducted so that it assesses indoor surface residues for multiple days after a chlorfenapyr application so that degradation/dissipation could be captured.

In all cases, the Agency recommends the registrant consult the Agency in their attempts to refi ne the chlorfenapyr risks, including submission of study protocols for review prior to conducting any study.16 Mitigation for Occupational Handler Risks of Concern

As described in the Chlorfenapyr

- Preliminary Human Health Risk Assessment for Registration Review , risks of concern are expected for certain short and intermediate

- term occupational
exposures for handlers.

For the use scenario of termiticide

- crack and crevice treatment ( EPA Reg. No. 499

- 548 ) using ready

- to

- use aerosol cans , gloves must be added to the PPE to reach a total MOE above EPA ’s level of concern. Gloves are currently included as a PPE requirement all other chlorfenapyr end

use products except EPA Reg. No. 499

- 548. Current PPE on EPA Reg. No. 499

- 548, which include s a single layer of clothing (i.e. a long

- sleeved shirt, long pants, and shoes plus socks, but no gloves or respirator), yields a total MOE of 56. If gloves are added, a total MOE of 130 will be reached and the use scenario will no longer be of concern.

• M itigation Action: Gloves are proposed to be added to chlorfenapyr label ling permitting this use scenario.

For several handler risk exposure scenarios

, additional PPE is needed on the Phantom® label ( EPA Reg. No. 241

- 392 ) to reach MOEs greater than the LOC of 100

. The submission of additional dermal data may impact the Agency’s future risk conclusions. Based on EPA’s current understanding of occupational risk from chlorfenapyr, the following PPE mitigation for chlorfenapyr ( listed by use scenario ) is proposed :

• Termiticide

– Structural Treatment :

o For mixers/loaders/applicators (MLAs) of liquids using a mechanically

pressurized handgun for termiticide applications to structures , c urrent levels of PPE yield combined MOEs below EPA’s level of concern 4 . Th is risk must be mitigated (to a total MOE of 120) by changing PPE for this labeled use scenario to include a double layer of clothing and gloves. The label currently requires gloves and a single layer of clothing.

 Mitigation Action: A double layer of clothing is proposed to be added to chlorfenapyr labels permitting this use scenario.

• General Crack and Crevice Treatment:

o For MLAs of liquids using a manually

- pressurized handwand for applications to indoor environments such as residential living space s, food handling establishments, and warehouses, the total MOE fail s to exceed the LOC of 100 at baseline levels of PPE. The total MOE rises to 150 w hen PPE is amended to include a single layer of clothing, gloves and a PF5 respirator

. The label currentl y requires gloves a nd a single layer of clothing.

 Mitigation Action: A PF5 respirator is proposed to be added to chlorfenapyr labels permitting this use scenario

. The Agency notes that label language for EPA Reg. No. 241

- 392 already includes a requirement that all termiticide handlers must wear a PF5 respirator when working in a

non

- ventilated space. This labelling amendment w ould expand that

4 Note that for this use scenario, table 9.1.1 in the 2014 human health risk assessment correctly presents the new MOE values with updated PPE, but the text in the bullet on pg. 35 incorrectly states single layer with gloves and PF5 respirator when it s hould say double layer with gloves and no respirator.17 requirement to all crack and crevice treatment uses of the product, occurring in bo th ventilated or non

- ventilated spaces.

Furthermore, for the use scenario of mixers/loaders/applicators of liquids using a mechanically

pressurized handgun for greenhouse applications to fruiting vegetables , there are risks of

concern s ( total MOE = 26) eve n with maximum PPE (i.e., double layer, gloves and PF10 respirator). The registrant proposed mitigating this risk by increasing applicator PPE to a double layer of clothing with glo ves plus a PF5 respirator, and by modifying application param et ers to increase the spray dilution from 0.04 lb. ai/gallon to 0.013 lb. ai/gal. However, applying these

measures would result in a combined MOE (dermal + inhalation) of 82, which still falls below the Agency’s LOC of 100. EPA is therefore proposing the removal of this use scenario from chlorfenapyr labels.

• Mitigation Action: The Agency proposes that a ll use scenarios of mixers/loaders/applicators of liquids using a mechanically

- pressurized handgun for greenhouse applications to fruiting vegetables be removed fro m chlorfenapyr labels

. Applicators wishing to perform greenhouse applications should substitute either a backpack or manually

- pressurized handwand for a mechanically

- pressurized handgun.

Comments are welcome from the public on all mitigation measures proposed for chlorfenapyr in this Proposed Interim Decision during the 60

- day public comment period following the publication of this document . Comments are especially welcome from gr eenhouse production stakeholders

. Again, these mitigation action s are based on EPA’s current understanding of risk s from chlorfenapyr. The submission of additional dermal data on this chemical may lead the Agency to reconsider its mitigation strategy

.

B. Tolerance Amendments

Although EPA has determined that there are no adverse human health effects from all food uses of chlorfenapyr, the Agency will pursue changes to the tolerance classification s for chlorfenapyr due to updates in crop grouping

. EPA will pursue the following changes to the tolerances of chlorfenapyr in 40 CFR § 180.513:

• The existing tolerances for vegetable, fruiting group 8 (1.0 ppm) will be revised to vegetable, fruiting, group 8

- 10.

EPA will conduct rulemaking to implement these tolerance changes, in accordance with FFDCA

.

C. Proposed Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this P roposed I nterim R egistration R eview D ecision. Except for the EDSP and pollinator components of this case, the Agency has made t he following Proposed Interim Registration Review Decision: (1) no additional data are required at this time (though dermal data is recommended) ; and (2) changes to the affected registrations and their labeling are needed at this time.18 In this proposed in terim registration review decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of chlorfenapyr

. The Agency’s final registration review decision for chlorfenapyr will depend upon the result s of an EDSP FFDCA section 408(p) determination.



### V. NEXT STEPS AND TIMELINE

A. Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Proposed Interim Registration Review Decision, and placing it in the chlorfenapyr registration review docket ( EPA

- HQ

- OPP

- 2010

- 0467 ) for public comment for 60 days. A Federal Register Notice will announce the availability of this P roposed I nterim R egistration R eview D ecision for chlorfenapyr and initiate a 60

- day comment period. If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its proposed interim decision, EPA will issue an I nterim R egistration R eview D ecision for chlorfenapyr (case 7419 ).

B. Implementation of Mitigation Measures

R egistrants are to submit amended labels that include the label changes summarized in Section IV of this Proposed Interim D ecision to the Agency within 60 days following issuance of the Interim Registration Review Decision in final form

.