2 

### Propoxur Proposed Interim Decision
Table of Contents

Contents

I. INTRODUCTION...................................................................................3 A. Summary of Propoxur Registration Review..................................................4

II. USE AND USAGE ...................................................................................5
III. SCIENTIFIC ASSE SSMENTS....................................................................5
A. Human Health..............................................................................

...... 6 1. Risk Concl usions...........................................................................6 2. Human Inci dents............................................................................7 3. Tolerances

................................................................................. ...8
B. Ecological

......................................................................................... 8 1. Risk Conclu sions............................................................................8 2. Ecological Incid ents................................................

.................. ....... .9 3. Characterization of Ecological Risk...................................................... ..9 C. Endangered Species A s sessm e nt.............................................................10
D. Endocrine Disruptor Scre en ing Program....................................................11

IV. PROPOSED INTERIM REGISTRAT ION REVIEW DECISION...........................12
A. Risk Mitigation and Regulato ry Rationale..................................................12

B. Proposed Interim Registration Review Decision......

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

V. NEXT STEPS AND TIMELINE..................................................................1 2 A. Interim Registration Revie w Decision........................................................1 3
B. Implementation of Mitigation Measures...........................

.. .........................13 Appendix A: Summary of Actions Taken for Propoxur

................................. ............. ...14 Appendix B: Propoxur Lab el Table.....................................................

............. ... ... 153 

### I. INTRODUCTION

This document is the Environmental Protection Agency’s (EPA or the Agency) Proposed Interim Registration Review Decision for propoxur ( case 2555 , PC code 047802 ) 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 not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodentic ide 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 propoxur , additional documents can be found in EPA’s public docket (EPA

- HQ

- OPP

- 2009

- 0806 ) at www.regulations.gov

.

FIFRA, as amended by the Food Quality Protec tion 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 ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides co ntinue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over 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. Informatio n on this program is provided at http://www.epa.gov/pesticide

- reev aluation/registration

- review

- process

.

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 determine whether it continues to meet the FIFRA standard for registration.

EPA is issuing a proposed interim registration review decision for propoxu r so that it can (1) move forward with aspects of the registration review that are complete and (2) impl ement interim risk mitigation. T he Agency will complete endocrine screening for propoxur, pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(p), before completing this registration review. Due to low usage and negligible exposure , the Agency does not expect propoxur to have direct or indir ect adverse effects to non

- listed and listed species or to designated critical habitat. As such, EPA has made a “No Effect” determination under the Endangered Species Act (ESA) for all listed species and designated critical habitat for such species. In add ition, a pollinator risk assessment will not be required for propoxur due to negligible exposure pathways to terrestrial invertebrates (honeybees). For further information,

see the Preliminary Environmental Fate and Ecological Risk Assessment for Registrat ion Review of Propoxur , dated August 6, 2014 and the Addendum Memorandum Clarifying the Preliminary Environmental Fate and Ecological Risk Assessment Conclusions for the Registration Review of4 Propoxur

. These documents are available in the public docket E PA

- HQ

- OPP

- 2009

- 0806, which can be accessed at http://www.regulations.gov/.

Propoxur is a residual N

- methyl carbamate insecticide registered to control ants, roaches, hornets, and other pests in and around commercial, industrial, and institutional buildings, and outside residences

. Ther e are 22 FIFRA Section 3 registrations

. A Rer egistration Eligibility Decision (RED) for propoxur was issued in August 1997

.

A. Summary of Propoxur Registration Review

Pursuant to 40 CFR S ection 155.50, EPA formally initiated registration review for propoxur (case 2555 ) in December 2009 . The following timeline highlights significant events that have occurred during the registration review of propoxur and can be found in EPA’s public docket, EPA

- HQ

- OPP

- 2009

- 0806 , accessed at www.regulations.gov :

• December 1 4 , 2009

– Publication of Summary Document for a 6 0

- day public comment period. The Summary Document included the Preliminary W ork P lan (PWP) and was accompanied by the scoping document and problem formulation. Comments were submitted by the registrant McLaughlin Gormley King Company (MGK) and by the Natural Resources Defense Council (NRDC). MGK commented that loose granular baits were no longer r egistered for outdoor use, that there is low usage of propoxur, and therefore, no significant environmental exposure. Subsequent to the publication of the FWP, EPA confirmed that all products formulated as loose granules for outdoor application were cance lled and therefore , that use pattern was not assessed as part of the
most recent ecological risk assessment. NRDC commented that they had petitioned the USEPA to cancel the pet collar uses of propoxur on November 26, 2007 and supplemented that petition on April 29, 2009. In 2014, EPA and the propoxur pet

- collar manufacturers reached an agreement to cancel all propoxur pet collar products. All propoxur pet collar products were ca ncelled effective April 1, 2015 and

, therefore

, were not considered in the most recent human health risk assessment for propoxur. The product cancellation order for all propoxur pet collar products can be accessed at www.regulations.gov , Docket ID EPA

- HQ

- OPP

- 2009

- 0207

- 0193.

• June 17 , 2010

- Final Work Plan (FWP) for propoxur was issued

.

• March 30, 2011

– Generic Data Call

- In (GDCI) for propoxur wa s issued. All required data were submitted and reviewed.

• July 8, 2015

– The Agency published the Preliminary Ecological Risk Assessment for the Registration Review of Propoxur and the Registration Review Draft Human Health Risk Assessment for Propoxur for a 60

- day public comment period. No comments were received.5 • September 22, 2015

– Final Cancellation Order for all indoor aerosol, spray and liquid formulations, food handling establishments

, and indoor crack and crevice uses was published. See Section II. for additional information concerning the cancellation. These uses are currently cancel led for all technical products containing propoxur. The Agency is completing the cancellation process to cancel or amend end

- use products that were registered for these

uses. The use cancellation order can be accessed at www.regulations.gov , Docket ID EPA

HQ

- OPP

- 2015

- 0296

- 0003

.

• March 2016

– The Agency is now publishing the following documents in docket number EPA

- HQ

- OPP

- 2009

- 0806 for a 60

- day public comment period :

o Propoxur Proposed Interim Registration Review Decision

o Characterization of Propoxur Spot Treatments

o Addendum Memorandum Clarifying the Preliminary Environmental Fate and Ecological Risk Assessment Conclusions for the Registration Review of Propoxur



### II. USE AND USAGE

Propoxur is a residual N

- methyl carbamate insecticide registered for use to control synanthropic arthropods

. Propoxur is an acetylcholinesterase inhibitor that is effective against a wide range of insects, arachnids, and other terrestrial arthropod s. Propoxur products are currently registered for limited indoor and outdoor use

. Registered use sites include outdoor structural perimeter applications and outdoor spot treatment s , bait in bait stations (indoor and outdoor)

, pastes (indoor and outdoor)

, impregnated shelf paper (indoor and outdoor) , and impregnated insect tape (indoor and outdoor)

. When the most recent propoxur registration review risk assessments were completed, propoxur was also registered for indoor use in institutional and industrial settings as aerosol , spray and liquid formulations for crack s and crevice a nd food

- handling establishment use. These uses were considered in the risk assessments but since then have been cancelled in order to mitigate dietary and residential post

- applicat ion risks of concern. These uses were cancelled effective September 22, 2015. These uses are currently cancelled for all technical products containing propoxur. The Agency is completing the cancellation process to cancel or amend end

- use products that wer e registered for these uses. Th e use cancellation order is available in the public docket EPA

- HQ

- OPP

- 2015

- 0296, which can be accessed at http://www.regulations.gov/

.

The current usage data available for propoxu r are very limited. Propoxur is a minor chemical used in the professional pest management sector. Between 2001 and 2003, the reported annual pounds active ingredient (a.i.) used were 8,000

- 9,000 lbs, accounting for less than 1% of the total reported chem icals applied each year in the pest management sector (See Use and Usage Information for Propoxur , dated October 7, 2009). In 2012, reported usage had decreased to 261 lbs in the Pest Control Operator (PCO) market (Non

- agricultural Market Research Data, 2012).6 

### 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 assessment methodologies to prepare a
qua nti tative risk assessment in support of the registration review of propoxur

. For a detailed discussion of the hu man health assessment for propoxur , see Propoxur : Human Health Draft Risk Assessment

, dated Ma y 2 2

, 201 5. This document is available i n the public docket EPA

- HQ

OPP

- 2009

- 0806

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

.
1. Risk Conclusions

When the draft human health risk assessment was c onducted propoxur was registered , amongst other things, for indoor crack and crevice applications (liquid and aerosol formulations) in food handling establishments (FHE) and institutional settings (i.e., hospitals, dormitories) and these uses were considered in the human health risk assessment. After the risk assessment was completed

, the technical registrant voluntarily canceled these uses to mitiga te identified dietary and residential post

- application risks of concern.

Dietary Assessment

An acute dietary (food only) assessment was conducted for the food handling establishment uses of propoxur. E xposure from drinking water is not expected and the refore a drinking water assessment was not conducted.

Acute dietary (food only) risks exceed the Agency’s level of concern for the U.S. general population and all population subgroups. The acute dietary exposure for propoxur is estimated at 550% of the acute population adjusted dose (aPAD) for the U.S. general population and 1400% of the aPAD for child ren 1

- 2 years old

. To mitigate these risks ( a fter the human healt h risk assessment was completed ) the technical registrant voluntarily cancelled all FHE, indoor liquid and aerosol formulations, and indoor crack and crevice use s. The remaining registered uses ( bait stations , pastes, impregnated shelf paper and strips, and outdoor spot treatments ) do not result in dietary exposure.

Resid ential Assessment

Residential handler exposure to enclosed/containerized bait stations and impregnated shelf paper products is considered to be negligible and therefore, a quantitative residential handler assessment for these uses was not conducted. Resi dential handler inhalation ( non

- cancer ) and cancer (dermal and inhalation ) exposure and risks were estimated for outdoor crack and crevice, spot, and perimeter treatment s using ready to use (RTU) aerosol cans. No risks of concern were identified for residential handlers.

Reside n tial post

- application exposure and risks were assessed for use of propoxur to treat for bedbugs in institutional setting s (military barracks, dormitories, etc.), and crack and crevice use in institutional settings (hospital waiting rooms). For residential post

- application exposure,7 incidental oral risks were identified for children resulting from crack and crevice treatment (of carpets) in institutional settings. The incidental oral m argin of exposure ( MOE ) for children coming in contact with treated carpet surfaces in institutional settings (hospital waiting rooms) is 60 ( target incidental oral MOE = 100 ). To mitigate these risks ( after the human health risk assessment was completed ) the technical registrant voluntarily cancelled all FHE, indoor liquid and aerosol formulations, and indoor crack and crevice use s. The remaining registered uses ( bait stations , pastes, impregnated shelf paper and strips, and outdoor spot treatments ) do not result in residential post

- application risks of concern.

Aggregate Assessment

A short

- term aggregate exposure and risk assessment was conducted for (background) dietary, inhalation residential, and incidental oral residential exposure. Since the l evel of concern for the dietary, inhalation, and incidental oral routes are different, an aggregate risk index ( ARI ) was used to calculate aggregate risk estimates. An ARI of less than 1 results in risk estimates of

concern. Short

- term aggregate risks of concern were identified for children (1

- 2) (ARI = 0.8). To mitigate these risks ( after the human health risk assessment was completed ) the technical registrant voluntarily cancelled all FHE, indoor liquid and aerosol formulations, and indoor crack and cre vice use s. The remaining registered uses ( bait stations , pastes, impregnated shelf paper and strips, and outdoor spot treatments ) do not result in aggregate risks exceeding level s of

concern.

Cumulative Assessment

Propoxur is a member of the N

- methyl carbamate (NMC) common mechanism group and was included in the 2007 NMC risk assessment

. The Agency will conduct an updated cumulative assessment for the NMC upon the completion of all individual assessments. This document is available i n the public docket EPA

- HQ

- OPP

- 2007

- 0935

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

. Occupational Assessment

An occupational handler exposure and risk assessment was conducted and no risks of concern were identified. Occupational post

- application exposure and risk assessments were not conducted because dermal post

- application exposure is not expected, and inhala tion post

application exposure is unlikely to occur.

2. Human Incident s

As part of the 2015 human health risk assessment , EPA completed a review of propoxur incidents in the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention /National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk

- Pesticides (SENSOR) databases. Based on the low frequency and low severity of incident cases reported for propoxur in both IDS and NIOSH SENSOR, and that many of the products implicated in the reported incidents were cancelled either in 2007 (indoor residential products) or 2015 (pet collars), there does not appear to be a concern at this time that would warrant furth er investigation. The Agency will continue to8 monitor the incident information and if a concern is triggered, additional analysis will be conducted.

3. Tolerances

There are c urrently no tolerances established for propoxur

. The Agency does not recommend the establishment of tolerances because all indoor crack and crevice uses in food handling establishment s have been voluntarily cancelled

.

B. Ecological

On August 6, 2014

, the Agency published the Preliminary Environmental Fate and Ecological Risk Assessment for the Registration Review of Propoxur

. Since the draft ecological risk assessment was posted to the docket , the risk assessment has been amended by the Addendum Memorandum Clarifying the Preli minary Environmental Fate and Ecological Risk Assessment Conclusions for the Registration Review of Propoxur

. As a result of this addendum, the Agency has changed the risk determination for listed freshwater aquatic invertebrates from “ M ay E ffect”
to “No Effect”

. 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 propoxur. For a detailed discussion of the ecological assessment for propoxur, see the Preliminary Environmental Fate and Ecological Risk Assessment for Registration Review of Propoxur and the Addendum Memorandum Clarifying the Preliminary Environmental Fate and Ecological Risk Assessment Conclusions for the Registration Review of Propoxur

. These documents are available i n the public docket EPA

- HQ

- OPP

- 2009

- 0806

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

.

1. Risk Conclusions

Terrestrial Assessment

Terre str ial exposure is not expected because outdoor use is limited (bait stations ; outdoor crack and crevice spot treatments ); registered uses are not expected to serve as attractive food sources to birds, mammals, or terrestrial i nvertebrates; and data indicate very low volume of propoxur use outdoors

. Therefore, there are no risk s of concern for non

- target non

- listed and listed terrestrial organisms and plants based on the lack of a complete exposure pathway and limited exposure due to low use

. A pollinator risk assessment will not be required for propoxur. Pollinator exposure and effects data are not necessary to make a final registration review decision for propoxur due to neglig ible exposure pathways to terrestrial invertebrates (honeybees) based on currently registered uses

. For further information, see the Preliminary Environmental Fate and Ecological Risk Assessment for9 Registration Review of Propoxur , dated August 6, 2014. This document is available in the public docket EPA

- HQ

- OPP

- 2009

- 0806, which can be accessed at http://www.regulations.gov/

.
Aquatic Assessment

Based on currently registered uses, aquati c exposure is expected to be limited. The only use scenario that could result in potential aquatic exposure is outdoor handheld spray spot treatments that occur close to streams and other waterbodies. Although exposure is expected to be minimal,
propoxur has high mobility and persistence in the environment and there is potential for runoff of propoxur to water where applications occur close to water bodies. The only potential aquatic risk identified in the preliminary ecological risk assessment was acute risk to listed aquatic invertebrates resulting from spot treatment use occurring close to streams or water bodies. A threshold analysis relating the exposure necessary to induce adverse impacts was conducted to describe potential exposure for aq uatic organisms and it was determined that acute effects to listed aquatic invertebrate s may occur when greater than or equal to 2.75 gallons of product are applied per use site per year

. While this potential for exposure exists, the potential is low beca use product usage at 2.75 gallons per spot treatment represents higher application tha n is expected given the available usage data. Since the preliminary ecological risk assessment was posted to the docket

, the Biological and Economic Analysis Division (BE AD) has provided additional information on propoxur outdoor spot treatment use , which support that propoxur is
not likely to be used at quantities near 2.75 gallons per use site per year

. T he preliminary propoxur ecological risk assessment has been amended to reflect this use information and indicates that there is no reasonable expectation for any registered use of propoxur to cause direct or indirect adverse effects to threatened or endangered species. Therefore , EPA has made a “No E ffect” determination for all listed taxa including listed freshwater aquatic invertebrates

. This determination supersedes the “May E ffect” risk determination for listed freshwater aquatic invertebrates presented in the risk assessment.

No other acute risks of concern were identified for all other listed and non

- listed aquatic organisms (freshwater fish, estuarine/marine fish, estuarine/marine invertebrates, aquatic plants). For further information see, the Addendum Memorandum Clarifying the Preliminary Environmental Fate and Ecological Risk Assessment Conclusions for the Registration Review of Propoxur

. This document is available in the public docket EPA

- HQ

- OPP

- 2009

- 0806

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

.

2. Ecological Incidents

A review of all available information in the following incident databases was completed in April 2014 covering incidents occurring from 1992 to 2014 : Ecological Incident Information System (EIIS) and the Avian Monitoring Information System (AIMS). Based on a search of EIIS, the Agency has received three reports of adverse field effects to non

- target plants linked to propoxur. A query of AIMS resulte d in 13 reports of incidents associated with propoxur. Most of the incidents were minor plant incidents, while three incidents involved birds and additional chemicals used in conjunction with propoxur. For a detailed discussion of the ecological incident s for propoxur, see the Preliminary Environmental Fate and Ecological Risk Assessment for Registration Review of Propoxur

, dated August 6, 2014

.10 3. Characterization of Ecological Risk

The preliminary risk assessment for propoxur initially identified potenti al risks of concern for listed aquatic invertebrates only. However, s ince the preliminary ecological risk assessment was posted to the docket, additional information on propoxur outdoor spot treatments was provided by the Biological and Economic Analysis Division (BEAD). An addendum to the preliminary ecological risk assessmen t was completed to reflect this usage information and to am end the preliminary risk assessment. The amended ecological risk assessment indicates that there is no reasonable expectation for any registered use of propoxur to cause direct or indirect adverse effects to threatened or endangered species. This risk characterization section is intended to provide context and describe the lines of evidence used to identify risk.

Aquatic Species

The only propoxur use that could result in aquatic exposure is outdoor handheld spray spot treatment application that occurs close to streams and other water bodies. Although there is the potential for runoff of propoxur to aquatic environments from outdoor handheld spray spot
treatment s occurring near water bodies, aquatic exposur e is likely minimal because spot treatment applications are non

- broadcast. Furthermore, the current use volume of propoxur is relatively limited based on nationwide data.

A quantitative ecological risk asses sment was not conducted and estimated environmental concentrations (EECs) and risk quotients (RQs) were not calculated because standard exposure scenarios have not been developed to calculate exposure for outdoor handheld spray spot
treatments , and the max imum application rate is not specified on labels. Instead, a threshold analysis relating the exposure necessary to induce adverse impacts was conducted to describe potential exposure for aquatic organisms based on its expected use as an outdoor spot treat ment. It was determined that acute effects to listed aquatic invertebrate s may occur, resulting from hand

- held spray applications , when greater than or equal to 2.75 gallons of product are applied per use site per year

. While th e potential for exposure e xists, the potential is low because product usage at 2.75 gallons per spot treatment would represent an application volume much
g reater tha n is expected given the available usage data. In addition, the limited use of propoxur also suggests that it is not widely used in an organized fashion within communities. Therefore, the amount of material used in outdoor spot treatments is not likely to be in copious amounts and not likely to be distributed widespread among different regions.

Since the preliminary ecological risk assessment was posted to the docket , additional information
on propoxur outdoor spot treatments w as provided by the Biological and Economic Analysis Division (BEAD) . An addendum to the preliminary ecological risk assessment was completed t o reflect this usage information and to amend the preliminary risk assessment . BEAD estimates that outdoor spot treatments of propoxur would not exceed one gallon of formulated product per property per year. This usage information is further evidence tha t propoxur is not used at quantities approaching 2.75 gallons per spot treatment

. The amended ecological risk assessment indicates that there is no reasonable expectation for any registered use of propoxur to cause direct or indirect adverse effects to thr eatened or endangered species. A “ No Effect ”11 determination was made for all federally listed species and designated critical habitat. For further information, see Characterization of Propoxur Spot Treatments and the Addendum Memorandum Clarifying the Preliminary Environmental Fate and Ecological Risk Assessment Conclusions for the Registration Review of Propoxur

. This document is available in the public docket EPA

- HQ

- OPP

- 2009

- 0806, which can be accessed at http://www.regulations.gov/.

C. Endangered Species Assessment
There is no reasonable expectation for any propoxur product to cause direct or indirect adverse effects to threatened or endangered s pecies. No adverse modification of critical habitat is expected to occur from use of propoxur

. This is b ecause the type and limited extent of outdoor

use is not likely to result in exposure that will result in risks exceeding levels of concern for non

listed and listed species . EPA has made a “No E ffect” determination under the Endangered Species Act (ESA) f or all listed species and designated c ritical habitat for such species and has therefore concluded that consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service under ESA section 7(a)(2) is not required. For de tails see, the Preliminary Environmental Fate and Ecological Risk Assessment for Registration Review of Propoxur and the Addendum Memorandum Clarifying the Preliminary Environmental Fate and Ecological Risk Assessment Conclusions for the Registration Review of P ropoxur . These documents are available in the public docket EPA

- HQ

- OPP

- 2009

- 0806, which can be accessed
at http://www.regulations.gov/

.

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, sub

- chronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, a nd general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, re productive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registrati on decision for propoxur , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as re quired by FFDCA section 408(p), propoxur is subject to the endocrine screen ing 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 identif y the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will pro ceed 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 212 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 che micals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 1 and includes some pesticides scheduled for Registration Review and chemicals found in w ater. Propoxur was not included on either of the first two list s for EDSP screening

. 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 procedur es, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 2

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



### I V

. PROPOSED INTERIM REGISTRATION REVIEW DECISION

A. Risk Mitigation and Regulatory Rationale

Human Health Risk
Non

- cancer risks of concern from propoxur were identified for dietary (food only) exposure and residential post

- application exposure. The technical registrant voluntarily cancelled all indoor aerosol, spray and liquid formulations, indoor crack and crevic e and food

- handling establishment (FHE) uses to mitigate the identified dietary and post

- application risks. These uses were canceled effective September 22, 2015. These uses are currently cancelled for all technical products containing propoxur. All techni cal and manufacturing use product labels must be amended to include formulation restriction language

. The Agency is completing the cancellation process to cancel or amend end

- use products that were registered for these uses

. The remaining registered

uses , which are bait sta t ions , pastes, impregnated shelf paper and strips, and outdoor spot
treatments
, do not result in dietary (no dietary exposure) and residential post

- application risk

. The use cancellation order is available in the public docket EPA

- HQ

- OP P

- 2015

- 0296

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

.

B. 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 components of the propoxur registration review case , the Agency has made the following Proposed Interim Registration Review Decision: (1) no additional data are required at this time; and (2) change s to the affected registrations and their labeling are needed at this time. A pollinator risk assessment will not be required for propoxur due to negligible exposure pathways to terrestrial invertebrates (honeybees). In addition, the Agency does not expec t propoxur to have direct or indirect adverse

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of chemicals.

2 http://www.epa.gov/endo/13 effects to non

- listed and listed species or to designated critical habitat. As such, EPA has made a “No E ffect” determination under the Endangered Species Act (ESA) for all listed species and designated critica l habitat for such species.



### 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 propoxur registration review docket (EPA

- HQ

- OPP

- 2009

- 0806). A Federal Register Notice will announce the a vailability of this Proposed Interim Registration Review Decision and initiate a 60

- day public 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 decision , EPA will issue an Interim Registration Review Decision for propoxur (case 2555).

B. Implementation of Mitigation Measures

The technical registrant voluntarily cancelled all indoor aerosol, spray and liquid formulations, indoor crac k and crevice and food

- handling establishment (FHE) uses to mitigate the identified dietary and post

- application risks. These uses were canceled effective September 22, 2015. These uses are currently cancelled for all technical products containing propoxur . All technical and manufacturing use product labels must be amended to include formulation restriction language. The Agency is completing the cancellation process to cancel or amend end

- use products that were registered for these uses. T he mitigation meas ures which have already been taken to cancel certain uses and associated label amendments to address the human health risks of concern are described in Appendices A and B below

.14 Appendix A: Summary of Actions Taken for Propoxur

Registration Review Case#: 2555 PC Code: 047802 Propoxur Type: Insecticide Propoxur Family: N

- methyl Carbamate Mode of Action: Acetylcholinesterase inhibitor Affected Population(s) Source of Exposure Route of Exposure Duration of Exposure Risk of Concern Proposed and/or Taken Action(s) Comment

Human Health  U.S. General

Population  Children (1

- 2) Human Health (food handling establishment, indoor aerosol, spray and liquid formulations, and indoor crack and crevice uses)  Dietary

(food)  Incidental

oral (hand

- to

mouth

, children ) Human Health  Dietary  Post

application Residential  Short and intermediate  Acute Human Health  Acute

Dietary aPAD = 550% (General Population); 1400% (Children (1

- 2))  Incidental

Oral MOE = 60 Human Health: Dietary & Incidental Oral Risk Mitigation  Voluntary

cancellation (action taken) : All indoor aerosol

, spray and liquid formulations, indoor crack and crevice use and

use in food

handling establishments

.  HH RA identified dietary and post

application residential risks exceeding levels of

concern. These risks were fully mi tigated by voluntary cancellations of certain

uses . There

are no remaining food uses; there are no tolerances for
propoxur.15 Appendix B: Propoxur Label Table

Summary of Proposed Labeling Changes for Propoxur Uses Description Amended Labeling Language for Propoxur Use Products Placement on Label
For Technical and all Manufacturing Use Products “ Not for formulation into aerosol or liquid products for indoor use.” First line in the

“ Directions for Use ”