2 Morpel® Repellent 326

– Table of Contents

I. Introduction 3

II. Statutory and Regulatory Authority 3

III. Morpel® Repellent 326 Chemical Facts 4

IV. Use and Usage Information 4

V. Recent Actions 5

VI. Scientific Assessments 5

VII. Combined Work Plan, Summary Document, an d Proposed Interim Registration

Review Decision 9

VIII. Next Steps and Timeline 9

Appendix A

– Additional Areas Considered in the Morpel® Repellent 326 Registration Review 11

References:

This document 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 Dipropyl isocinchomeronate (aka Morpel® Repellent 326, forme rly MGK ® Repellent 326)

. Melanie Biscoe, Katherine Stebbins, Melissa Panger

. October 20 , 2014

.

2. Dipropyl

- isocinchomeronate (Di

- N

- propyl isocinchomeronate): Scoping and Preliminary Risk Assessment for Registration Review. Thurston G. Morton, Kelly O’Rourke, Abdallah Khasawinah

. May 19 , 2015

.

3. BEAD Chemical Profile for Registration Review: Dipropyl isocinchomeronate (PC Code 047201)

. David Brassard, Sepehr Haddad, Michelle Ranville

. April 28 , 201 4

.

4. Dipropyl Isocinchomeronate (MGK

- 326): Tier I Review of Human Incidents. Shanna Recore. April 9,

2014.

These and other supporting documents for the Morpel® Repellent 326 registration review case ma y be found in the docket EPA

- HQ

- OPP

- 2014

- 0578 at http://www.regulations.gov

.3 I. INTRODUCTION

The docket for dipropyl isocinc h omeronate ( referred to within as Morpel® Repellent 326

and Morpel®; formerly MGK 326 ) is now open ( EPA

- HQ

- OPP

- 2014

- 0578 ) , initiating the first public comment perio d for this registration review. T his document is the Environmental Protection Agency’s (EPA or the Agency herein ) combined Work Plan

, Summary Document, and Proposed Interim Registration Review Decision for Morpel® Repellent 326

. It is being issued pursuant to 40 CFR Sections 155.50, 155.56, and 155.58. This document explains what EPA’s Office of Pesticide Programs

knows about Morpel® Repellent 326 , highlighting anticipated data and assessment needs and providing an anticipated ti meline for completing the Morpel® Repellent 326 Registration R eview. It also includes the Agency’s Proposed Interim Registration Review Decision for Morpel® Repellent

326

. In addition to general areas on which the public may wish to comment, the Appendix highlights topics of special interest to the Agency where additional information could be of particular use.

A registration review decision is the Agency’s determination whether a pesticide meets, or does not meet, the standard for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, a proposed interim registration rev iew decision before completing registration review. Among other things, the proposed interim regi stration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assess ment and completing registration review.

Morpel® Repellent 326 is a n insect repellent registered for use as a human and companion

animal (dog, cat , and horse) insect repellent. Morpel® is never the sole active ingredient; it is always

coformulated with other insecticides/repellents

, such as DEET, piperonyl buxtoxide, and pyrethrins

, to
broaden the ir spectrum of repellency. Morpel® 326 is registered for use to repel flies, gnats, and other flying and biting insects. Morpel® 326 is only registered fo r indoor non

- food and residential use.

The Reregistration Eligibility Decision document (RED) for dipropyl isocinchomeronate was completed on March 1 1, 2005

. For further information about Morpel® Repellent 326 , additional

documents can be found in EPA’s public docket ( EPA

- HQ

- OPP

- 2014

- 0578 ) at www.regulations.gov

.

II. STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the U.S. generally must be registered by EPA, based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides

continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically re e valuates pest icides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at www.epa.gov/oppsrrd1/registration_review/

.4 The Agency is implementing the registration review program pursuant to Section 3(g) of FIFRA, and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing registration review begin at 40

CFR 155.40

. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review decision

.

III. MORPEL® R EPELLENT 326 CHEMICAL FACTS

PC code 047201

Case Number 2215

CAS Number 136

- 45

- 8, 3737

- 22

- 2 Year first registered 19 57 Pesticide Type Conventional Chemical

Chemical class Insecticide Reregistration Eligibility Decision (RED) Mar ch 2005

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative Group Not applicable; The Agency has not determined that dipropyl isocinchomeronate shares a common mechanism of toxicity with

other chemical substances.

40 CFR Citation Not applicable; There are no food /feed tolerances established for dipropyl isocinchomeronate in 40 CFR.

Dual

- u se Not applicable

Non

- pesticidal uses Not applicable

Pesticide Re

- evaluation
Division, Chemical Review Manager Marianne Mannix

, mannix.marianne@epa.gov, 703

- 347

- 0275

Registration Division, Product Manager Jennifer Urbanski

, urbanski.jennifer@epa.gov

, 703

- 347

- 0156

IV. USE AND USAGE INFORMATION

Morpel® Repellent 326 is an ingredient contained in insect repellent products registered for application to humans (personal use) and pets (health care products)

. Morpel® Repellent 326 is never used as the sole active ingredient; it is used to expand the repellency of other insecticides

. Below is a summary of the use/usage of Morpel® Repellent 326 . For more details please see BEAD Chemical Profile for Registration Review: Dipropyl isocinchomeronate (PC Code 047201) (April 28, 2014).

Summary of Use Morpel® Repellent 326 is formulated with a number of other insecticide active ingredients to extend the spectrum and period of repellency.

Use Sites Indoor non

- food and residential use5 Summary of Usage Annual average of 6,800 pounds/year; 4,800 for insect repellent use
on humans, 2,000 for animal

- only insect repellent uses Formulation Type(s) Aerosol, impregnated material (towelette) , pet dip Technical Registrant(s) Vertellus Specialties

, Inc. No. of Registrations 39

Restricted Use No

V. RECENT ACTIONS

While use of Morpel® 326 on dairy cattle is mentioned in supporting documents, there are no active registrations which include this use site on any technical or end use label.

VI. SCIENTIFIC ASSESSMEN TS

A. Human Health Assessment

The human health exposure and toxicological database is adequate for registration review of Morpel® 326 . The Agency does not need additional studies in order to characterize the human

health exposure, hazard and risk from Morpel® 326 . Because no additional human health or toxicity

data are needed for the registration review of Morpel® 326 , the Agency has determined that it is appropriate to conduct a preliminary human health risk assessment fo r Morpel® 326 . A summary of the Agency's preliminary human health risk assessment is presented below. For detailed information

see: Dipropyl

- isocinchomeronate (Di

- N

- propyl isocinchomeronate): Scoping and Preliminary Risk Assessment for Registration Review dated May 19, 2015 dated in the public docket (EPA

- HQ

- OPP

- 2014

- 0578 ) which

can be accessed at www .regulations.go v

.

A summary of the Agency’s human health and environmental fate and ecological risk

assessments

, and Registration Review

– Preliminary Ecological Risk Assessment and Endangered Species Effects Determination for Dipropyl isocinchomeronate (aka Morpel® Repellent 326, formerly MGK ® Repellent 326) ( October 20

, 201 5 ) is presented below. For the detailed risk a ssessments, see the Morpel® Repellent

326 public docket ( EPA

- HQ

- OPP

- 2014

- 0578 ) at www.regulations.gov

.

1. Risk Conclusions

Hazard Characterization The toxicological database is considered adequate for characterizing hazard and assessing

risk from Morpel® Repellent 326

. The Agency does not anticipate requiring any additional studies for registration review.

Dietary Assessment There are no registered food uses for Morpel® Repellent 326 and it is not likely to occur in drinking water ; therefore there is no concern for dietary risk.

Residential Assessment Residential exposure is expected based on the registered residential use s of Morpel® 326. However, based on a conservative quantitative assessment, no risks of concern were identified.6 Occupational Assessment Based on a screening

- level assessment, it was determined that there are no risks of concern associated with exposure during occupational treatment of companion animals. Occupational post application exposure is expected to be minimal because it is assumed that treated animals would be returned to their residential settings after treatment.

Aggregate Assessment

Since th ere is no concern for dietary risk, an aggregate risk assessment for Morpel® 326 was not completed.

2. Human Health Incidents

The Office of Pesticide Programs (OPP) Incident Data System (IDS) was used to retrieve pesticide incident data on Morpel® 326. The IDS records incidents in one of two modules: Main IDS and Aggregate IDS. Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. Aggregate IDS contains incidents resulting in less

severe hum an incidents (minor, unknown, or no effects outcomes). In the Main IDS, from January 1, 2009 to March 5, 2014, there were no incidents involving the single chemical; Morpel® 326 reported in the database. There were 26 incidents reported involving more tha n one chemical. Twenty five of these incidents were classified as moderate severity, not life threatening and the person returned to his/her pre

- exposure state of health with no additional residual disability. In the Aggregate IDS, from January 1, 2009 to March 5, 2014, there were 449 reported incidents involving Morpel® 326. One hundred seventy nine incidents were classified as unknown or no effects and 270 incidents were classified as minor severity.

The Centers for Disease Control and Prevention/Nation al Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk

- Pesticides (SENSOR) databases were also queried. The NIOSH SENSOR

- Pesticides 1998

- 2010 data identified

73 cases involving Morpel® 326

, all involving multiple active ingredients. Of the 73 cases involving the single active ingredient, 68 cases were low in severity, three case s w ere moderate in severity, and two cases were high severity.

Reports of adverse health effects allegedly due to a specific pesticide exposure (i.e., an "incident") are largely self

- reported and therefore, generally speaking, neither exposure to a pesticide or reported symptom (or the connection between the two) is v alidated or otherwise confirmed. Typically, causation cannot be determined based on incident data. For detailed information, see Dipropyl Isocinchomeronate (MGK

- 326): Tier I Review of Human Incidents dated April 9, 2014 in the public docket ( EPA

- HQ

- OPP

- 2014

- 0578 ) at www.regulations.gov

.

3. Food Tolerances

There are no existing food tolerances for Morpel® Repellent 326 because it is not established for any food or feed uses

.

B. E cological Assessment

Based on the low use pattern, diffusion over a large treatment area, and the low probability

of non

- target organism exposure to Morpel® Repellent 326, the Agency has determined that it is7 appropriate to conduct an abbreviated preliminary ecological risk as sessment for Morpel® 326. A summary of the Agency's preliminary ecological risk assessment is presented below. For detailed

discussions see Registration Review

– Preliminary Ecological Risk Assessment and Endangered Species Effects Determination for Diprop yl isocinchomeronate (aka Morpel® Repellent 326, formerly MGK® Repellent 326)

, dated October 20, 2014, in the public docket (EPA

- HQ

- OPP

- 2014

- 0578) which can be accessed at www.regulations.gov.

The Agency has completed a screening

- level endangered and thre atened (listed) species

assessment for Morpel® 326. The Agency is currently working with its federal counterparts and other stakeholders to implement an interim approach for assessing potential risk to listed species and their designated critical habitats. Once the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats are finalized, the Agency will complete its endangered species assessment for Morpel® 326

. Based on its registered use pattern,

th e Agency does not anticipate listed terrestrial species to come into contact with Morpel® 326

. Also, based on a conservative analysis, estimated risk quotients for aquatic species are below levels of concern (LOCs). Therefore, the Agency anticipates making a "no effects" determination under the Endangered Species Act (ESA) for all listed species, and no adverse modification of designated critical habitat for such species is expected, unless information provided to the Agency leads to a change in this antici pated determination.

1. Environmental Fate and Exposure

Morpel® 326 remains stable under acidic conditions, and hydrolyzes in neutral and alkaline

environments. Morpel® 326 is not expected to volatize under field conditions. Based on the use pattern, significant environmental exposure (terrestrial or aquatic) is not expected.

2. Risk Conclusions

Aquatic Organisms The Agency estimated potential exposure and acute risk to aquatic organisms. The Agency completed conservative exposure estimates, and re sulting acute risk quotients (R Qs) are far below the Agency's level of concern. While chronic RQs were not estimated, given the large margin of safety observed for acute effects, the Agency believes it unlikely that chronic risks would approach

concern levels. Similarly , risk to aquatic plants is presumed to be below the level of concern based

on Morpel® 326’s low toxicity and low potential to enter aquatic environments.

Terrestrial Organisms Based on the registered use patterns of Morpel® 326, exposure to terrestrial organisms is not expected. Even if a non

- target organism were to inadvertently come into contact with Morpel® 326 the exposure levels would be expected to b e low. Given Morpel® 326’s low toxicity profile,

effects to non

- target organisms would not be expected to exceed the Agency’s levels of concern (LOCs) even if exposure to terrestrial organisms occurred.

3. Ecological Incidents

There are no reported ecological incidents involving Morpel® 326. A review of all available

information in the following databases was completed in April 2014: Ecological Incident Information System 8 (EllS), OPP Aggregate Incident Reports database, Avian Monitoring8 Information System (AIMS ) . For additional discussion of the reported ecological incidents, see Registration Review

– Preliminary Ecological Risk Assessment and Endangered Species Effects Determination for Dipropyl isocinchomeronate (aka Morpel® Repellent 326, formerly MGK® Repellent 326)

.

C. Endangered Species Assessment

Because of Morpel® 326’s low use diffused over a large treatment area and the low probability of non

- target organism exposure to Morpel® 326 , the Agency concludes that effects on the environment are not reasonably expected to occur from the registered use of Morpel® 326

. Therefore, the EPA anticipates making a "no effects" determination under the Endangered Species Act (ESA) for all listed species and that no adverse modification o f designated critical habitat for such species is expected from the registered use of Morpel® 326 , unless information provided to the Agency leads the Agency to change its anticipated determination.

D. Endocrine Disruptor Screening Program

As required by F IFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmenta l, reproductive, and 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, p regnancy rates, reproductive 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 registration decision for Morpel® Repellent 326, 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), Morpel® Repe llent 326 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 o r wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interac t 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 effect s 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 ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 1 and includes some

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.9 pesticides schedul ed for Registration Review and chemicals found in water. 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. 2

In this Proposed Interim Registration Review Decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of Morpel® Repellent 326. Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p)

determination.

VII. COMBINED WORK PLAN

, SUMMARY DOCUMENT

, AND PROPOSED

INTERIM REGISTRATION REVIEW DECISION

Tolerance Amendments

There are no U.S. tolerances established for Morpel® 326 , and so the Agency will not

pursue any tolerance ac tions with Morpel® 326

.

Ris k Mitigation and Rationale The Agency has identified no human health or ecological risks associated with registered

uses of Morpel® 326 . Therefore, the Agency did not identify the need to modify the current registered use of Morpel® 326

.

Interim Registration Review Decision

In accordance with 40 CFR Sections 155.50, 155.56

, and 155.58, the Agency is issuing this

combined Work Plan

, S ummary Document

, and P roposed I nterim Registration Review D ecision. Except for the EDSP component of the Morpel® Repellent 326 registration review case, the Agency has made the following proposed interim decision : (1) no additional data are required at this time; and (2) no changes to the affected registrations or their la beling are needed at this time. EPA has not identified any risks of concern to human health. Currently registered uses of Morpel® Repellent 326 are not expected to result in adverse effects to listed or non

- listed species or critical

habitat s

. As such, EPA anticipates making a “no effect” determination under the ESA for all listed species and no adverse modification of designated critical habitat for such species is expected for all currently registered uses of Morpel® Repellent 326

.

VIII. NEXT STEPS AND TIMELINE

A Federal Register Notice will announce the availability of this combined Work Plan, Summary Document , and P roposed I nterim R egistration R eview D ecision for Morpel® Repellent

326 and allow 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 decision, EPA may issue a n I nterim R egistration R eview D ecision for Morpel® Repellent

326 (c ase 2215 ) , in accordance with 40 CFR Sections 155.56 and 155.58

. A final decision on the Morpel® Repellent 326 registration review case will also occur after an EDSP FFDCA section 408(p) determination has been mad e.

EPA has created the following estimated timeline for the complet ion of Morpel® Repellent

326 registration review:

2 http://www.epa.gov/endo/10 Registration Review for Morpel® Repellent 326

– Projected Registration Review Timeline

Activities Estimated Date Opening the Docket and Combined Work Plan

, Summary Document

, and Proposed Interim Registration Review Decision Open Public Docket and Public Comment Period for Combined Work

Plan

, Summary Document

, and Proposed Interim Registration Review

Decision June 2015

Close Public Comment Period August 2015

Interim Registration Review Decision and Begin Post

- Decision Follow

up 3 December 2015

Total (years) 0.5

3 A final decision on the dipropyl isocinchomeronate registration review case, in accordance with 40 CFR
Section155.158, will occur after an EDSP FFDCA section 408(p) determination has been made.11 Appendix

– Additional Areas Considered in the Morpel® Repellent 326 Registration Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency will work to

harmonize tolerances and international maximum r esidue limits (MRLs) and may modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export market s, providing as much specificity as possible regarding the nature of the concern. Because there are no food/feed tolerances for Morpel® 326, the Agency does not expect any trade

irritant concerns.

Water Quality:

Morpel® Repellent 326 is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 4 In addition, no Total Maximum Daily Loads (TMDL) have been developed for Morpel® Repellent 326

. 5 More information on impaire d water bodies and TMDLs can be found at the Agency’s website. 6 The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Proced ure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 7 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justic e:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to Morpel® Repellent 326 compared to the general population. Please comment if you are aware of any sub

- populations that may have atypical, unusually high exposure compared to the general population.

4 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

5 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_g

roup_name=PESTICIDES

6 http://www.epa.gov/owow/tmdl/

7 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm