### Novaluron Preliminary Work Plan

– Table of Contents

OVERVIEW

................................ ................................ ................................ ................................ ... 4

ANTICIPATED DATA NEEDS

................................ ................................ ................................ .... 5

STATU TORY AND REGULATORY AUTHORITY

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

CHEMICAL FACTS

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

USE AND USAGE INFORMATION

................................ ................................ ............................ 8

RECENT ACTIONS

................................ ................................ ................................ ....................... 9

ANTICIPATED R ISK ASSESSMENTS FOR REGISTRATION REVIEW

................................ 9

TIMELINE

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

NEXT STEPS

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

Appendix

– Additional Areas Considered in the Novaluron Registration Review

.................. 14

References:

This Preliminary Work Plan summarize s the Environmental Protection Agency's current position based on the following documents:

1. Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for

Novaluron

. Ryan Mroz and He Zhong. February 26, 2015.

2. Novaluron: Human Health Assessment Scoping Document in Support of Registration

Review. Julie L. Van Alstine, Lata Venkateshwara, a nd Anwar Y. Dunbar

. March 16, 2015

.

3. Novaluron : Tier I Review of Human Incidents

. Elizabeth Evans and Shanna Recore. March 3, 2015

.

4. BEAD Chemical Profile (BCP) for Registration Review: Novaluron (124002)

. Colwell Cook, Rafael A. Prieto, and Elizabeth Hill. March 11, 2015

.

5. Novaluron (124002) Screening Level Usage Analysis (SLUA) . June 18, 2014.

26. Novaluron EFED Label Data Report

. September 30, 2014.

7. Novaluron HED Master Label Report. September 30, 2014.

These and other supporting documents for the novaluron registration review case may be found

in the docket EPA

- HQ

- OPP

- 2015

- 0171 at http://www.regulations.gov

.

3OVERVIEW

The docket for novaluron (PC Code 124002 ) is now open , initiating the first public comment period for this registration review (docket number EPA

- HQ

- OPP

- 2015

- 0171 )

. Novaluron is a

non

- systemic insecticide insect growth regulator (IGR) that inhibits chitin biosynthesis and

cuticle formation in molting/developing insects but has no effect on adult insects which have completed all successive molts. It is effective on many different insect pests, including the

immature s tages of mosquitoes, flies, lepidopterans, beetles, and heteropterans. It is formulated as an emulsifiable concentrate, su spension concentrate, flowable, water dispersible granule, bait cartridge, pellet, granule, and ready

- to

- use solution depending on the use. Novaluron has a variety of both agricultural crop and non

- agricultural crop uses

. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about novaluron

, highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing the registration review for novaluron

.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends, by sharing this inf ormation in the docket, to inform the public of what it knows about novaluron and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on

novaluron . The Agency encourages all interested stake holders to review the PWP and Appendix and to provide comments and additional information that will help the Agency’s decision

making process for this chemical. In addition to general areas on which persons may wish to comment, there are some areas identi fied in the PWP and Appendix about which the Agency specifically seeks comments and information. Interested stakeholders could include:

environmental non

- profit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commerci al, institutional, residential, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for novaluron

. Next, it discusses the statutory and regulatory authority for R egistration R eview . Then the document provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline for novaluron

. Finally, the Appendix to

this document includes identification and discu ssion of some areas that are considered genera lly

in R egistration R eview along with some additional chemical case

- specific information.

4ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for novaluron . For additional discussion of the anticipated data needs, see the documents Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Novaluron and Novaluron: H uman Health Assessment Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for the N ovaluron Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent N ovaluron

850.6100 Environmental Chemistry Methods and

Associated Independent Laboratory Validation (Soil & Water) 2 TGAI 12

850.1400 Fish early

- life stage toxicity (Saltwater only) TGAI 12

850.1740 Whole sediment

– chronic freshwater

invertebrates 3 TGAI 2 4

850.3040 Semi

- Field Toxicity Test with Honeybee TGAI and TEP 24

850.4500 Algal toxicity

– Non

- vascular plant toxicity (freshwater diatom) TGAI 12

850.4550 Algal toxicity

– Non

- vascular plant toxicity (estuarine/marine diatom) TGAI 12

850.4100 Terrestrial plant toxicity, Seedling emergence and Seedling growth 4 TEP 12

850.4150 Terrestrial plant toxicity, vegetative vigor TEP 12

860.1380 Storage Stability TEP 8

875.1400 Inhalation indoor exposure TEP 24

Non

guideline Whole sediment

– chronic freshwater

invertebrates 5 TGAI 24

1 On June 27, 2012, EPA announced certa in revisions in harmonized guideline series 850

– Ecological Effects Tests

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Availability” 77 FR 38282, June 27, 20 12. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0028

2 It is preferred if the novaluron ECM/ILV (850.6100, soil and water) is to include both degradates (chlorophenyl

urea and chloroaniline) in a s ame analytical method protocol.

3 An estuarine/marine organism is required for sediment testing. A 28

- day TGAI1 test with additional Leptocheirus plumulosus should be performed to evaluate the potential differential sensitivity among sediment organisms. A protocol should be submitted in advance of conducting the study.

4 A study has been submitted and is currently under review. Results indicate a non

- definiti ve NOAEC for dicots (bean). Without a definitive NOAEC risks for listed plants cannot be precluded.

5 A test with Hyalella azteca for potential differential sensitivity among sediment organisms is required. A protocol

should be submitted in advance of cond ucting the study.

5Table 1: Anticipated Data Needs for the N ovaluron Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Non

guideline Honeybee larval chronic toxicity (including

Acute endpoints) TGAI 12

Non

guideline Residues in pollen and nectar 6 TGAI 24

Anticipated Data Needs for the C hlorophenyl urea (275

- 352I) Degradate

850.6100 ECM/ILV (soil and water) TGAI 12

850.1035 Mysid acute t oxicity (invertebrate acute toxicity) 7 TGAI 12

850.1300 Freshwater invertebrate life cycle TGAI 12

850.1350 Saltwater invertebrates life cycle TGAI 12

850.1400 F ish early

- life stage (f reshwater ) TGAI 12

850.4400 Aquatic plant Toxicity Test using Lemna spp. TGAI 12

850.4500 Algal toxicity

– n on

- vascular plant toxicity (freshwater or saltwater diatom) TGAI 12

Anticipated Data Needs for the Chloroaniline (275

- 309I) Degradate

850.6100 Environmental Chemistry Methods and

Associated Independent Laboratory Validation (Soil & Water) TGAI 12

850.1075 Freshwater fish acute toxicity TGAI 12

850.1300 Freshwater invertebrate life cycle TGAI 12

850.4500 Algal toxicity

– Non

- vascular plant toxicity (green algae) TGAI 12

TGAI = technical grade active ingredient; TEP = typical end

- use product

6 These studies may be necessary if risk concerns are identified for juvenile bees at the tier I level. A protocol should

be submitted in advance of conducting the study.

7 A study is requested to establish the toxicity of chlorphenyl ure a to invertebrates, a group sensitive to the parent.

6STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program

. All pesticides distributed or sold in the United States (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agency), based on scientific data showing that they will not cau se 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 p esticides 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 Age ncy periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Informatio n on this program is provided on EPA’s website

. 8

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

, and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing registration review begin at 40 CFR 155.40

. T he 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. After reviewing and responding to comments and data received i n the docket during this initial comment period, the Agency will develop a F inal W ork P lan (FWP) and anticipated schedule for the registration review of novaluron

.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for novaluron

.

Table 2: Chemical Facts for N ovaluron

PC code 124002

Case Number 7615

CAS Number 116714

- 46

- 6

Year first registered 2001 Pesticide Type Insecticide

Chemical class Benzoylphenyl urea

R eregistration Eligibility Decision (R E D) Because it was registered after November 1984, novaluron was not subject to reregistration.

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

– none conducted.

Cumulative group Not applicable. Novaluron has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

8 http://www.epa.gov/oppsrrd1/registration_review/

7Table 2: Chemical Facts for N ovaluron

40 CFR Citation Tolerances for novaluron are established in §180.598

. Dual

- use Novaluron is registered for conventional pesticidal uses only and has no registered anti microbial or biopesticidal uses.

Non

- pesticidal uses There are no identified no n

- pesticidal uses of novaluron.

Pesticide Re

- evaluation Division, Chemical Review Manager Margar et Hathaway, hathaway.margaret@epa.gov , 703

- 305

- 5076

Registration Division

, Product Manager Richard Gebken, gebken.richard@epa.gov , 703

- 305

- 6701

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for novaluron

. Please see the BEAD Chemical Profile (BCP) for Registration Review: Novaluron (124002) in the registration review

docket for more details

.

Table 3: N ovaluron Use and Usage Information

Summary of Use Novaluron is a non

- systemic insecticide insect growth regulator (IGR) in the benzoylphenyl urea family of chemicals effective on many different insect pests, including immatures of mosquitoes, flies, lepidopterans, beetles, and heteropterans.

Novaluron inhibits chitin biosynthesis and cuticle formation in molting/developing insects , resulting in adverse effects on insect growth and development , but has no effect on adult insects which have completed all successive m olts

. Novaluron acts primarily by ingestion, but also has some contact activity.

Use Sites Novaluron has a variety of both agricultural crops and non

agricultural crop uses. Agricultural crop uses include: n ovaluron is registered for use on a lfalfa

, apple

, beans , b rassica (head and stem) vegetables

, carrot s, Swiss chard, corn, c otton, cranberry

, cucurbit vegetables

, fruiting vegetables

, leafy greens

, peanuts

, pome fruits

, potato es , small fruits

, sorghum , soybeans, stone
fruits

, sugarcane
, sweet potato es, t omato es, and turnip greens

.

Non

- agricultural uses: Novaluron is registered for use on agricultural drainage systems

, agricultural uncultivated areas

, aquatic areas

, automobiles / taxis / limousines / recreational

vehicles / tires

, barns

, cattle feedlots

,

c ommerc ial/institutional/industrial premises/equip ment (indoor

and outdoor )

, commercial storages/warehouses premises

, commercial transportation vehicles

, dogs/canines (adults/puppies), drainage systems

, eating establishments food handling areas (nonfood contact)

, food processing plant premises (nonfood

8Table 3: N ovaluron Use and Usage Information

contact)

, household/domestic dwellings indoor and outdoor premises

, intermittently flooded areas

, nonagricultural

uncultivated areas/soils , o rnamental ponds/aquaria

, ornamentals

, poultry litter

, sewage systems

, swa mps/marshes/wetlands/stagnant

water

, swimming pool water systems

, wide area/general outdoor treatment (public health use)

, wood protection treatment to buildings/products ( indoor and outdoor ). Summary of Usage EPA has limited usage data for novaluron due to its non

agricultural and diffuse types of use patterns. A ccording to average annual use data reported in the 2012 Novlauron SLUA,

from 2004 to 2012 the crops with the highest pounds a.i. applied

we re apples (10,000 pounds a.i . applied) and cotton (20,000 pounds a.i. applied). In terms of average percent crop treated (PCT), the top crops are pears and strawberries. Formulation Type(s) It is formulated as an emulsifiable concentrate, suspension concentrate, flowable, water disp ersible granule, bait cartridge, pellet, granule, and ready to use solution depending on the use. Application Method(s) Applications are made manually (bait, spot/crack crevice, spot

- on, cattle and poultry operations), aerially (broadcast), by ground (bro adcast, band, direct spray, chemigation, and spot treatment), and directly to water (granule for mosquito control). Some pellets/tablets are applied directly to standing water that is disconnected from natural water ways (bird baths, swimming pool

covers, boat covers, etc.) for mosquito control. Technical Registrant ADAMA Makhteshim Ltd. No. of Registrations 17 Section 3 products ( 1 technical and 16 end

- use products) 9 and 11 and Section 24c registrations

Restricted Use One end

- use product (66222

- 205), which is co

- formulated with bifenthrin, is registered as a restricted use product. No other registered novaluron products are restricted use.

RECENT ACTIONS

In 2014, EPA conducted both a drinking water assessment ( Drinking Water Assessment in Support of IR

- 4 New and Revised Uses of Novaluron (RIM ON® 0.83 EC) on Avocado; Beans, Berries (LowGrowing), Bushberries, Carrot; Cotton, Cucurbit Vegetables, Fruiting Vegetables, Head and Stem Brassica, Leafy Brassica Greens, Ornamentals (Container Grown Ornamentals in Greenhouses, Shadehouses, Outdoor Nurseries), Peanuts, Pears, Pome Fruits, Potatoes / Sweet Potatoes, Sorghum, Soybeans, Stonefruits, Sweet Corn, Sugarcane, Swiss Chard, and Turnip Greens ). D418740

. September 2

, 20 14 ) and an ecological risk assessment ( Novaluron: Ecological Risk Assessment to Support the IR

- 4 New and Revised Uses of Novaluron (RIMON® 0.83 EC) on Avocado, Bean, Carrot, Cherry subgroup 12

- 12A, and Greenhouse

9 Section 3 product labels can be obtained from the Pesticide Produ ct Label System (PPLS) website

( http://oaspub.epa.gov/pestlabl/ppls.home ).

9Cucumbers

. D419642. November 24, 2014) fo r a variety of new and revised agricultural crop

uses

. The proposed appl ication rates for the new uses we re equal to or lower than the previously assessed crop uses.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for novaluron (D409210) was completed on February 5, 2014 in support of proposed Section 3 uses to control fleas, cockroaches, crickets, litter beetles, ants, and flying insect pests on furniture, animal quarters, carpets, kennels, livestock and poultry houses, food and non

- food warehouses, in food

- handling establishments, around perimeters, and lawns

. There is also a pending 2015 human health risk assessment for novaluron in response a p etition for the e stablishment of permanent tol erances for

r esidues of n ovaluron on various crops. T he most recent ecological and environmental fate risk assessment was completed on August 14, 2013 for the following uses: outdoor flea control, outdoor cockroach perimeter treatment, outdoor control of litter beetles in chicken houses
, outdoor control of ants, outdoor control of flying insect pests , indoor control of litter beetles in

chicken houses , cattle and horse operations (flies), and poultry operations (beetles)

. Findings and

conclusions from thes e risk assessments are summarized in the Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Novaluron and Novaluron: Human Health Assessment Scoping Document in Support of Registration Review

.

During registration review, t he Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of

novaluron

. For human health, EPA an ticipates the need to conduct spray drift risk and

volatilization risk assessment s during registration review

.

T able 4 below summarizes the anticipated registration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document

.

10Table 4: Anticipated Risk Assessments for the N ovaluron Registration Review

Type of Risk Assessment Conduct ? Notes

Eco logical and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms ), including endangered species Yes See the document Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Novaluron for

additional details. Previous e cological assessment

work for novaluron indicates that novaluron’s degradates, chlorophenyl urea and chloroaniline, are more toxic to both freshwater fish and aquatic non

vascular plants than the parent novaluron

. Incidents Will check for updates For a di scussion of reported ecological incidents for

novaluron

, see page 21 of the Problem Formulation. An incident search performed on 12/4/14 found no ecological incidents were reported in any of the databases for novaluron or its degradates. Although

incident reporting is required under FIFRA Section 6(a)(2), the absence of reports in EIIS does not indicate that the chemical has no effects on wildlife; rather, it is possible that incidents have gone unreported

Human Health Dietary

Food No None needed at this time. Drinking water No None needed at this time. Occupational Handlers (mixers, loaders, applicators) No None needed at this time.

Post

- application No None needed at this time.

Residential

Handlers No None needed at this time.

Post

- application Yes Spray drift and volatilization assessment needed

. Other Aggregate No E valuates the combined risk from dietary and residential exposures.

Cumulative No None needed at this time.

Tolerances Yes Updates are need to harmonize tolerances with

international standards. See page 9 of the

Novaluron: Human Health Assessment Scoping Document in Support of Registration Review for

details.

11Incidents Will check for updates Based on the low frequency and low severity of human health incidents involving novaluron, there does not appear to be a concern at this time that would warrant further investigation. The Agency

will continue to monitor the incident information and

if a c oncern is triggered, additional analysis will be

included in the risk assessment. For a disc ussion of reported human incidents for novaluron, see Novaluron : Tier I Review of Human Incidents and

page 8 of the Novaluron: Human Health Assessment Scoping Do cument in Support of Registration

Review

.

Guidance for Commente rs: Additional ecological i nformation r equested for this registration r eview , and of particular interest to EPA, is described below.

• Ecological incidents (non

- target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

.

• Water quality monitoring data (see Appendix for further details)

.

• Co

- formulations of novaluron with additional insecticides could pose additional

risks/stress , eithe r additive or synergistic, to both larval and adult honeybees. Information

is welcome on the effects of co

- formulated pesticide products.

• Previous ecological assessment work for novaluron indicates that novaluron’s degradates, chlorophenyl urea and chloroa niline, are more toxic to both freshwater fish and aquatic

non

- vascular plants than the parent novaluron

. Data is welcome on these novaluron degradates.

12TIMELINE

EPA has created the following estimated timeline for the completion of the novaluron registration review in Table 5 below

.

Table 5: Projected N ovaluron Registration Review Timeline

Activities Estimated Dat e Opening the Docket Open Docket and 60

- day Public Comment Period 2015

– March

Close Public Comment 2015

– May Case Development

Final Work Plan 2015

– August

Issue DCI 2015 Oct.

– Dec.

Data Submission 2017 Oct.

– Dec.

6 0

- day Public Comment Period for Draft Risk

Assessments 10 2019 April

- June

Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review Decision 2020 Jan.

- March

Registration Review Decision and Begin Post

- Decision

Follow

- up 2021

Total (years) 6

NEXT STEPS

After the 6 0

- day public comment period closes, the Agency will review and respond to any comments received in a timely manner and then issue a Final Work Plan for the registration

review of novaluron

.

10 The regu lations governing Registration Review generally require the Agency to provide a public comment period

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, t he Agency plans to provide a 60 calenda r day public comment period generally for draft risk assessment s

.

13

### Appendix

– Additional Areas Considered in the Novaluron Registration

Review

PUBLIC COMMENTS AND FEEDBACK :

Guidance for C ommenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or reference to sou rces of additional information c ould 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 (MRL s ) 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.

Water Quality:

Novaluron is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 11 In addition, no Total Maximum Daily Loads (TMDL) have been developed for novaluron

. 12 More information on impaired water bodies and

TMDLs can be found at the Agency’s website

. 13 The Agency invites submission of water quality data for this pesticide. To t he extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 14 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, nat ional 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 novaluron 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.

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

12 http://iaspub. epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant

_group_name=PESTICIDES

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

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

14ENDANGERED SPECIES :

Consistent with EPA’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally listed threatened and endangered (listed) species from registe red uses of pesticides in accordance with the Joint Interim Approaches developed to implement the recommendations of the April 2013 National Academy of Sciences (NAS) report, Assessing Risks to Endangered and Threatened Species from Pesticides

. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA. EPA will address concerns specific to novaluron in connection with the development of its final registration review decision for novaluron

.

In November 2013, EPA, the U.S. Fish and Wildlife Service, National M arine Fisheries (the Services), and USDA released a white paper containing a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. These Interim Approaches were developed jointly by the agencies in response to th e NAS recommendations, and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific

differences between the EPA and the Services. Details of the joint Interim Approaches are contained in the November 1, 2013 white paper

, Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report.

Given that the agenci es are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, this ecological problem formulation supporting the Preliminary Work

P lan for novaluron does not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during registration

review. While the agencies continue to develop a common method for ESA analysis, the planned risk assessment for the registration review of novaluron will describe the level of ESA analysis completed for this particular registration review case. This assessment will allow EPA to focus its future evaluations on the typ es of species where the potential for effects exists, once the scientific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk

assessments f or listed species and their designated critical habitats, these methods will be applied to subsequent analyses of novaluron as part of completing this registration review.

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 toxicity, including assessments of carcinogenicity, neurotoxici ty, developmental, 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 maturati on, fertility, pregnancy 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

15taxonomic groups. Nov aluron was not included in the first group of 67 chemicals nor the second group of 109 chemicals that will or have been issued an order to conduct Tier 1 Endocrine Disruptor Screening Program (EDSP) testing. However, as required by FFDCA section 408(p),

no valuron 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 Tier 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/da ta 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 15 and includes some pesticides scheduled for re gistration 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 lis ts, the test guidelines and the Tier 1 screening battery, please visit our website. 16

HUMAN STUDIES :

Occupationa l and Residentia l

Past novaluron risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides, comprise gen eric pesticide exposure databases such as the Pesticide Ha ndlers Exposure Database (PHED), Agricultural Handlers Exposure Task Force (AHETF) database

, the Agricultural Reentry Task Force (ARTF)

d atabase , and the Outdoor Residential Exposure Task Force (ORE TF) d atabase . EPA has reviewed all the studies supporting these multi

- pesticide generic exposure databases, and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relati ve to the ethical standards prevailing at the time the research was conducted. All applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on these studies.

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.

16 http://www.epa.gov/endo/

16