### Carboxin and Oxycarboxin Preliminary Work Plan

– Table of Contents

OVERVIEW

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

ANTICIPATED DATA NEEDS

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

STATUTORY AND REGULATORY AUTHORITY

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

CHEMICAL FACTS

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

USE AND USAGE INFORMATION

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

RECENT ACTIONS

................................ ................................ ................................ ..................... 11

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

.............................. 11

TIMELINE

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

NEXT STEPS

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

Appendix

– Additional Areas Considered in the Carboxin and Oxycarboxin Registration

Review

................................ ................................ ................................ ................................ ...... 15

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 the Drinking Water and Ecological Risk Assessments of Carboxin and Oxycarboxin

. Aubee, C. and Peck, C

. March 11, 2015.

2. Carboxin and Oxycarboxin: Human Health Scoping Documen t in Support of Registration

Review . Kidwell, J., Khasawinah, A., Cropp

- Kohlligian, B., Hummel, S., and Nieves , I. February 24, 2015.

3. Carboxin and Oxycarboxin: Tier I Review of Human Incidents

. Recore, S., and E. Evans

. November 20, 2014.

4. BEAD Chemical Profile (BCP) for Registration Review: Carboxin (090201) and Oxycarboxin (090202)

. Yourman, L.. Atwood, D., and Ranville, M. March 11, 2015

.

25. Carboxin SLUA. July 28, 2014.

6. EFED Table 1 Report for Carboxin. May 12, 2014

.

7. HED Master Label Report for Carb oxin

. May 12, 2014.

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

- HQ

- OPP

- 2015

- 0144 at http://www.regulations.gov

.

3OVERVIEW

The docket for carboxin and oxycarboxin is now open , initiating the first public comment period

for this registration review (docket number EPA

- HQ

- OPP

- 1015

- 0144)

. Carboxin is a systemic fungicide with products registered for application to seed s prior to planting for control of various fungi that cause seed and seedling diseases (smut, rot, and blight ) on crops including wheat, barley, oats, corn, cotton, soybeans, safflower, beans, and ornamental bulbs

. The seed treatment

uses of carboxin are considered food/feed uses based on data that demonstrate uptake of detectable residues in crops. Carboxin degrades to carboxin sulfoxide and carboxin sulfone, which is known as oxycarboxin. Oxycarboxin is also a registered active ingredient and is

therefore included in this registration review case. Products containing o xycarboxin are registered for foliar application for control of rust diseases on ornamentals grown in enclosed commercial structures such as greenhouses, shadehouses, and interiorscapes. There are n o residential uses for either carboxin or oxycarboxin.

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

knows about carboxin and oxycarboxin 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 these

chemicals

The registration review proce ss was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends, b y sharing this information in the docket, to inform the public of what it knows about carboxin and oxycarboxin and what types o f new data or other information would be helpful for the Agency to receive as it moves toward a

decision on these chemicals

. The Agency encourages all interested stakeholders to review the

PWP and Appendix and to provide comments and additional informatio n that will help the Agency’s decision

- making process for th ese chemical s . In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP and Appendix about which the Agency specifically seeks comments and in formation. Interested stakeholders could

include: environmental non

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

The Preliminary Work Plan begins by listing the anticipated data needs for carboxin and oxycarboxin

. Next, it discusses the statutory and regulatory authority for r egistration r eview. Then the document provides chemical fact s, use and usage information , recent actions, the anticipated risk assessments, and a projected registration review timeline for carboxin and oxycarboxin

. Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally in r eg istration r eview along with some additional

chemical case

- specific information.

4ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for carboxin . For additional discussion of the anticipated data needs, see the Registration review

— Preliminary Problem Formulation for the Drinking Water and Ecological Risk Assessments of Carboxin and Oxycarboxin and Carboxin and Oxycarboxin: Human Health Scoping Document in Support of Registration Review.

Table 1: Anticipated Data Needs for t he Carboxin Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent Carboxin

835.1230 Leaching and adsorption/desorption

– sediment leaching and soil adsorption/desorption TGAI 12

850.1025 Acute toxicity estuarine and marine organisms

-- oyster TGAI 12

850.1035 Acute toxicity estuarine and marine organisms

-- Mysid TGAI 12

850.1075 Acute toxicity estuarine and marine organisms

– estuarine/marine fish TGAI 12

850.2100 Avian oral toxicity

- passerine TGAI 12

850.4100 Seedling emergence and seedling growth (Tier I)

– 10 species TGAI or TEP 12

850.4550 Cyanobacterial Toxicity TGAI 12

850.3040 Field testing for pollinators TGAI and TEP 12

870.3465 28

- Day Inhalation toxicity

- rat 2 TGAI 24

Non

GDLN Field trial of residues in pollen and nectar TGAI and TEP 18

Non

GDLN Pollinator Acute Oral Toxicity

– honeybee adult TGAI 18

Non

GDLN Pollinator Chronic Oral Toxicity

– honeybee

adult TGAI 18

Non

GDLN Pollinator Acute Oral Toxicity

– honeybee larvae TGAI 18

Non

GDLN Pollin ator Chronic Oral Toxicity

– honeybee

larvae TGAI 18

1 On June 27, 2012, EPA announced certain 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 A vailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0028

2 Please note that additional PPE ( ie., a PF5 respirator) on registered labels for carboxin corn seed treatment

involving multiple activities and for oxycarboxin mixing/loading/applying with a mechanic ally pressurized handgun will mitigate the risk concern prompting the inclusion of the subacute inhal ation study. For additional information, please see Carboxin and Oxycarboxin: Human Health Scoping Document in Support of Registration

Review.

5Table 1: Anticipated Data Needs for t he Carboxin Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Non

GDLN Semi

- Field Toxicity Test with Honeybee TGAI and TEP 24

Anticipated Data Needs for the Carboxin Sulfoxide Degradate

850.1300 Aquatic invertebrate life cycle (freshwater) toxicity Degradate 12

850.1350 Aquatic invertebrate life cycle (saltwater) Degradate 12

850.1400 Fish early

- life stage toxicity (freshwater and

marine/estuarine ) Degradate 12

TGAI = technical grade active ingredient; TEP = typical end

- use product

Table 2 below summarizes anticipated data needs for oxycarboxin based on the current understanding of the oxycarboxin use pattern ( i.e., shadehouses) 3 . For additional discussion of the anticipated data needs, see the Registration review

— Preliminary Problem Formulation for the Drinking Water and Ecological Risk Assessments of Carboxin and Oxycarboxin and Carboxin and Oxycarboxin: Human Health Scoping Do cument in Support of Registration

Review.

Table 2: Anticipated Data Needs for the Oxycarboxin Registration Review

Guideline

Number 4 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated D ata Needs for the Parent Oxycarboxin

850.1025 Acute toxicity estuarine and marine organisms

-- oyster TGAI 12

850.1035 Acute toxicity estuarine and marine organisms

-- Mysid TGAI 12

850.1075 Acute toxicity estuarine and marine organisms

– estuarine/marine fish TGAI 12

3 The current oxycarboxin label provides for use of this ingredient in shadehouses. The EPA’s current

understan ding of this use is that the enclosure may be made of permeable material, and that the sides of the structure may be opened. Given this understanding, the data in table 2 are needed to support a quantitative risk assessment for registration review of oxyca rboxin.

4 On June 27, 2012, EPA announced certain 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, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0154

- 0028

6Table 2: Anticipated Data Needs for the Oxycarboxin Registration Review

Guideline

Number 4 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

850.1300 Aquatic invertebrate life cycle (freshwater) toxicity TGAI 12

850.1350 Aquatic invertebrate life cycle (saltwater) TGAI 12

850.1400 Fish early

- life stage toxicity (freshwater and

marine/estuarine ) TGAI 12

850.2100 Avian oral toxicity (upland gamebird and passerine) TGAI 12

850.22 00 Avian dietary toxicity (waterfowl species ) TGAI 12

850.2 3 00 A vian reproduction toxicity (upland gamebird and waterfowl species ) TGAI 12

850.4100 Seedling emergence and seedling growth (Tier I)

– 10 species TEP 12

850.41 5 0 Vegetative vigor (Tier I)) TEP 12

850.4400 Aquatic plant growth (aquatic vascular plant toxicity) (Tier I) TGAI or TEP 12

850.4550 Cyanobacterial Toxicity TGAI 12

Non

GDLN Pollinator Chronic Oral Toxicity

– honeybee

adult TGAI 18

Non

GDLN Pollinator Acute Oral Toxicity

– honeybee larvae TGAI 18

Non

GDLN Pollin ator Chronic Oral Toxicity

– honeybee

larvae TGAI 18

Non

GDLN Semi

- Field Toxicity Test with Honeybee TGAI and TEP 24

7STATUTORY 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 scienti fic 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 t he registration review program, the Agency 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

. 5

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 dock et 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 in 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 carboxin and oxycarboxin.

CHEMICAL FACTS

Table 3 provides a summary of the chemical facts for carbo xin

Table 3: Chemical Facts for Carboxin and Oxycarboxin

Carboxin Oxycarboxin

PC code 090201 090202

Case Number 0012 0012

CAS Number 5234

- 68

- 4 5259

- 88

- 1 Year first registered 19 68 197 1 Pesticide Type Fungicide Fungicide

Chemical class Oxathiin Oxathiin Reregistration Eligibility Decision (RED) 2004 2004

5 http://www.epa.gov/oppsrrd1/regi stration_review/

8Table 3: Chemical Facts for Carboxin and Oxycarboxin

Tolerance

Reassessment Eligibility Decision (TRED) 2002 Not applicable. There were no

food

- uses of oxycarboxin to

necessitate a TRED.

Cumulative group Not applicable. Carboxin has not

been identified as a member of a cumulative group that shares a common mechanism of toxicity. Not applicable. Oxycarboxin

has not been identified as a member of a cumulative group

that shares a common mechanism of toxicity.

40 CFR Citation Tolerances for carb oxin and its

metabolites convertible to aniline (which includes oxycarboxin as a minor metabolite) and expressed as

carboxin are established in 40 CFR§180.301. There are no food

- uses of oxycarboxin as an active ingredient, however, the tolerance expression for

carboxin includes the metabolite oxycarboxin.

Dual

- use Ca r boxin is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses

. Oxy c arboxin is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal

uses

. Non

- pesticidal uses There are no identified non

- pesticidal

uses of carboxin

. There are no identified non

pesticidal uses of oxycarboxin.

Pesticide Re

evaluation Division, Chemical Review Manager Dana L. Friedman, friedman.dana@epa.gov , 703

- 347

- 8827

Registration Division, Product Manager Hope Johnson, johnson.hope@epa.gov , 703

- 305

- 5410

USE AND USAGE INFORMA TION

Table 4 summarizes the use and usage information for carboxin

. Please see the BEAD Chemical Profile (BCP) for Registration Review: Carboxin (090201) and Oxycarboxin (090202) in the registration review docket for more details

.

Table 4 : Carboxin Use and Usage Information

Summary of Use Carboxin is a systemic fungicide registered for use as a seed treatment prior to planting for control of various fungi that cause seed and seedling disease. Carboxin is applied both by

commercial seed treaters and on

- farm applicators.

Use Sites Carboxin is registered for use on the following agricultural use sites: barley, beans, canola, corn, cotton, mustard seed, oats,

9Table 4 : Carboxin Use and Usage Information

onions, peas , rice, rye, safflower, sorghum, soybeans, triticale,

and wheat. Carboxin is also r egistered for use as a dip application

on ornamentals in some locations. Summary of Usage Based on USDA

- NASS (United States Department of Agriculture's National Agricultural Statistics Service), Private Pesticide Market Research, and California DPR (Depar tment of Pesticide Regulation), carboxin use as a seed treatment for wheat is the most extensive use of this chemical at 44,000 pounds of active ingredient per year, which is less than 2.5% of the wh e at

crop. Formulation Type(s) Wettable powder, dust, flowable concentrate, ready

- to

- use liquid

. Several products are co

- formulated with other active ingredients. Application Method(s) Mechanical, slurry, or mist

- type seed

- treatment equipment. Technical Registrant (s) Macdermid Agricultural Solutions , Inc. No. of Registrations 15 Section 3 products 6

, 7 Section 24c products

Restricted Use No

Table 5 summarizes the use and usage information for oxycarboxin. Please see the BEAD Chemical Profile (BCP) for Registration Review: Carboxin (090201) and Oxycarbo xin (090202) in the registration review docket for more details.

Table 5 : Oxycarboxin Use and Usage Information

Summary of Use Oxycarboxin is registered for control of rust diseases by foliar use on ornamentals grown in enclosed commercial structures.

Use Sites Use is limited to ornamentals in enclosed commercial structures such as greenhouses, shadehouses, and interiorscapes. Summary of Usage EPA has no usage data for oxycarboxin

. Formulation Type(s) Wettable powder Application Method(s) Products can be applied by aerosol can s , handheld sprayers, foggers, and mechanical sprayers. Technical Registrant(s) Macdermid Agricultural Solutions , Inc. No. of Registrations 2 Section 3 products 6

Restricted Use No

Guidance for Commente rs: Additi onal areas of use and usage related information requested for this registration r eview , and of particular interest to EPA, are described below.

• The oxycarboxin label is unclear with respect to “shadehouses.” Without further information, EPA expects to use con servative assumptions to approximate these parameters in order to conduct a quantitative risk assessment. However, t he Agency will work with registrants to clarify information on oxycarboxin product labels

.

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

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

10• The maximum application rate should be specified in terms of mass active ingredient (a.i.) per unit area (e.g., lbs a.i./acre).

• C onfirmation of the following label information : sites of application ; formulations ; application methods and equipment ; maximum application rates ; frequency of application, application intervals, and maximum number of applications per season ; and geographic limitations on use

.

• U se distribution ( e.g. , acreage and geographical distribution of relevant use sites )

.

• M edian and 90 th percentile reported use rates (lbs a i/ A ) from usage data

– national, state, and county

.

• Typical a pplication timing (date of first application and application intervals)

– national, state, and county

.

• Usage/use information for non

- agricultural uses

.

• Typical application interval (days)

.

• S tate or local use restrictions

.

• F oreign technical registrants not listed above who supply technical carboxin and/or oxycarboxin to the US market

.

RECENT ACTIONS

There are no recent actions for carboxin or oxycarboxin.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for carboxin and oxycarboxin was completed in 2004 in preparation for the Reregistration Eligibility

. T he most recent ecological

and environmental fate risk assessment wa s completed in 2004 for carboxin for the same

purpose , and for oxycarboxin when it was initially registered . Findings and conclusions from

these risk assessments are summarized in the Registration review

— Preliminary Problem Formulation for the Drinking Wa ter and Ecological Risk Assessments of Carboxin and Oxycarboxin and Carboxin and Oxycarboxin: Human Health Scoping Document in Support of Registration Review

.

During registration review, t he Agency anticipates the need to conduct a comprehensive ecologica l risk assessment, including an endangered species assessment, for all uses of carboxin and oxycarboxin. For human health, EPA anticipates the need to conduct revised dietary and occupational risk assessment s during registration review

. If toxicological endpoints or points of departure are revised based on the data that are anticipated to be required for registration review

, they will be considered in the new assessment s
, as well as any changes to the standard operating

p rocedures or default exposure assumptions

.

T able 6 below summarizes the anticipated registration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document

.

11Table 6 : Anticipated Risk Assessments for the Carboxin and Oxycarboxin 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 A comprehensive ecological risk assessment is needed for carboxin and oxycarboxin.

Incidents Will check for updates For a discussion of reported ecological incidents for carboxin and oxycarboxin

, see page 18 of the

Problem Formulation.

Human Health Dietary

Food Yes A dietary assessment may be needed if changes are made to the toxicological endpoints or uncertainty

factors. Drinking water No A drinking water assessment is not needed as the uses of carboxin and oxycarboxin have not changed since

the previous assessment. Occupational Handlers (m ixer s, loader s, applicators ) Yes The risk assessment will include updated handler risk estimates based on current policies and if any changes are made to the toxicological endpoints or uncertainty

factors.

Post

- application Yes The risk assessment will include updated post

application risk estimates based on current policies and if any changes are made to the toxicological endpoints or uncertainty factors.

Residential

Handlers No There are no residential uses of carboxin or oxycarboxin.

Post

- application /bystander Yes The need for spray drift and volatilization risk assessment will be examined during registration

review.

Other Aggregate No There are no residential uses of carboxin or oxycarboxin so an aggregate assessment is not

needed.

Cumulative No EPA has not made a common mechanism of toxicity finding for carboxin, oxycarboxin, and any other active ingredients.

Tolerances Yes Tolerances in/on cotton gin byproducts, mustard seed, peas, and rye will need to be established.

12Incidents Will check for updates For a discussion of reported human incidents for carboxin and oxycarboxin, see page 10 of the Scoping

Document and the Carboxin and Oxycarboxin: Tier I Review of Human Incidents

.

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

• Ec ological incidents (non

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

.

• Water quality m onitoring data (see Appendix for further details)

.

TIMELINE

EPA has created the following estimated timeline for the completion of the carboxin and oxycarboxin registration review in Table 7 below

.

Table 7 : Projected Carboxin and Oxycarboxin Registration Review Timeline

Activities Estimated Date
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.

60

- day Public Comment Period for Draft Risk

Assessments 7 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

7 The regulations 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, the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.

13NEXT 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 carboxin and oxycarboxin.

14

### Appendix

– Additional Areas Considered in the Carboxin and Oxycarboxin 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 solici t 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 residue 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 markets, providing as much specificity as possible regarding

the nature of the concern.

Water Quality:

Carboxin and oxycarboxin are not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 8 In addition, n o To tal Maximum Daily

Load s (TMDL) have been developed for carboxin or oxycarboxin

. 9 More information on impaired water bodies and TMDLs can be found at the Agency’s website

. 10 The Agency invites submission of water quality data for this pesticide. To the ext ent 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 11 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, national or igin, 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 atypi cal, unusually high exposure to carboxin or oxycarboxin compared to the general population. Please comment if you are aware of any sub

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

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

9 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_

group_name=PESTICIDES

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

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

15ENDANGERED SPECIES :

A risk assessment that supports a complete endangered species determina tion has not been conducted for carboxin and oxycarboxin

. The ecological risk assessment planned during

re gistration review will allow the Agency to determine whether use of carboxin and oxycarboxin has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concl udes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

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 carcinog enicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclic ity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different

ta xonomic groups. As part of its most recent registration decision for carboxin and its reregistration decision for oxycarboxin

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazar d database. However, as required by FFDCA section 408(p), carboxin and oxycarboxin are subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (inclu ding 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 appr oach 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/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 12 and includes some

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.

16pesticides scheduled for registration review and chemicals found in water

. Neither of these lists should be construed as a list of known or likely endocrine disruptors.

For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our

website. 13

HUMAN STUDIES :

Occupational

Past carboxin and oxycarboxin 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) and the Agricultural Reentry Task Force (ARTF) Database

. 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 relative to the ethical standards prevailing at the time the research was

conducted. A ll applicable requirements of EPA’s Rule f or the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied , and t here is no regulatory barrier to continued

reliance on these studies

.

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

17