2 I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of carboxin and oxycarboxin . This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which w ere posted in the carboxin and oxycarboxin registration review docket (EPA

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- 0144 ). Carboxin is a systemic fungicide with products registered for application to seeds 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, bea ns, 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 oxycarboxin 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 no residential uses for either carboxin or oxycarboxin.

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. Changes in science, public policy, and pesticide use practices occur over time. The regi stration 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. The public phase of registration review begins when the in itial docket is opened for each case.

Informatio n on this program is provided on the Agency’s website

. 1

The FWP begins with any updates since the PWP was issued. Next is a summary of substantive

comments received during the public comment period for the PWP concerning anticipated data

needs

, expected risk assessments, or the estimated timeline identified in the PWP

, and a summary of the Agency’s response s to th o se comments

. This section is followed by registration
review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline for carboxin and oxycarboxin

. Lastly, there is a discussion of next
steps.

UPDATES SINCE THE PWP WAS ISSUED

S ince the issuance of the May 2015 National Strategy to Promote the Health of Honey Bees and
Other Pollinators 2 in conjunction with the June 2014 Guidance for Assessing Pesticide Risks to

Bees 3

, some of the names

, study duration timeframes , and test substance have changed for some of the pollinator studies . Th e se changes are reflected in Table 1 of this document, but no additional pollinator studies have been required

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

2 https://www.whitehouse.gov/sites/default/files/microsites/ostp/Pollinator%20Health%20Strategy%202015.pdf

3 http://www2.epa.gov/sites/production/files/2014

- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf3 SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the Carboxin and Oxycarboxin Preliminary Work

Plan (PWP) , which opened on March 30, 2015 and closed on May 29, 2015 , the Agency received

5 public comments. Comments were submitted by non

- profit organizations including the Center for Biological Diversity, Physicians for Responsible Medicine, and FIRFRA En dangered Species Task Force; a registrant, MacDermid Agricultural Solutions; and a registrant task force, the
Creosote Council . The comments do not address the timeline described in the PWP, but they do address the planned ecological and human health risk assessments and data requirements. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water quality

concerns , and trade irritants, but no comments or information were received on those issues.
Comments from the Creo sote Council (EPA

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- 0013) were mistakenly associated with the carboxin and oxycarboxin docket, and responses to comments on the creosote case do not appear in this document. The creosote docket is available at www.regulations.gov (EPA

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- 0823).

This section does not capture every comment made about the PWP nor all of the Agency’s

responses. Summarized below are public comments are of a broad regulatory nature. There
were no comments that resulted in changes to the regulatory timeline, anticipated risk assessments, or data requirements. Public comments and EPA responses in their entirety are located in the docket, EPA

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- 0144 . Summarized public comments and Agency

responses rela ted to the anticipated ecological risk assessment or data needs are in the EFED Response to Comments on the Problem Formulation for the Registration Review of Carboxin/Oxycarboxin

. There were no comments relevant to the anticipated human health risk

assessment

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Comments submitted b y FESTF in EPA

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Comment: FESTF noted that the registrant, MacDermid Agricultural Solutions, is member of the task force and is entitled to make use of the FESTF database on species proximity to use

sites.

Response: The Agency is aware of the data developed by FESTF and will use those data to evaluate risks to listed species, as appropriate.

Comments submitted by MacDermid Agricultural Solutions in EPA

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Comment: The comments submitted by MacDermid Agricultural Solutions focused on their intentions regarding the data requirements specified in the problem formulation, including waivers, and the implications of a proposal to amend their label.

Response : Data submi tted in support of the data requirements will be reviewed an d, if found to

fulfill the Agency ’ s needs, may be used to fulfill or waive the data requirement s . Proposals for4 data waivers will be considered when s ubmitt ed after the Data Call

- In has been issue d and the
official 90

- day response has been submitted to the Agency

.

M acDermid Agricultural Solutions also indicated their intent to amend the label for oxycarboxin to read "for use in enclosed commercial greenhouses'', which would eliminate the need to conduct many ecological toxici ty stud ies for oxycarboxin . The Agency agrees with this label language clarification and, if implemented, w ill waive the requirements fo r applicable studies.

Comments submitted by CBD in EPA

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Comment : CBD’s comments focus on the EPA’s independent duty under the Endangered Species Act (ESA) to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of carboxin and oxycarboxin.

Response : EPA plans to address the concerns raised by CBD as part of the implementation plan for assessing the risks of pesticides to listed species, which will be based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will

a ddress concerns specific to carboxin’s and oxycarboxin ’s effects on listed species in connection with the development of its registration review decision.

At this time, EPA has not fully developed its risk assessment process for listed species. In
Novemb er 2013, the EPA, along with the Services and the U.S. Department of Agriculture, released a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were developed jointly by the Agencies in response to the 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.

The NAS report, available at http://www.nap.edu/catalog.php?record_id=18344 , 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 wi th their obligations under the ESA and FIFRA. The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and

State

- FIFRA Issues Research and Evaluation Group (SFIREG) meetings, allowing additional opportunities for stakeholders to comment on the Interim Approaches. As part of a phased, iterative process for developing the Interim Approaches , the Agencies will also consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions. The details of the joint Interim Approaches are contained in the white paper “Interim Approaches fo r National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report,” dated November 1, 2013, available at http://www.epa. gov/espp/2013/nas.html

.

Comments submitted by Physicians for Responsible Medicine in EPA

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- 0014.5 Comment: Comments submitted by the Physicians for Responsible Medicine focused on the conduct of the acute avian oral toxicity study for oxyc arboxin and the acute toxicity study for estuarine and marine fish for carboxin and oxycarboxin, including alternative test methods.

Response: The Agency will consider these comments when evaluating the registrant

- submitted protocols, data waivers, and studies in response to the Data Call

- In once issued.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for carboxin based on the Registration

review

— Preliminary Problem Formulation for the Drinking Water and Ecological Risk

Assessments of Carboxin and Oxycarboxin

, Carboxin and Oxycarboxin: Human Health Scoping

Document in Support of Registration Review

, and EFED Response to Comments on the Problem Formulation for the Registration Review of Carboxin/Oxycarboxin

. The table has been update d

since the PWP to reflect changes to the names and study duration timeframes for some of the pollinator studies , but the planned data needs have not changed from what was included in the

PWP

.

Table 1: Planned D ata Needs for the Carboxin Registration Rev iew

Guideline

Number 4 Study Title 4 Test Material Estimated

Timeframe

(Months from receipt of DCI)

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 (Tier II) TEP 24

870.3465 90

- Day Inhalation toxicity

- rat 5 TGAI 24

4 On June 27, 2012, EPA announced certain revisio ns 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

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5 Study may be reduced to a 28

- day duration. 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 mechanically pressurized handgun will mitigate the risk concern pro mpting the inclusion of the subchro nic inhalation study. For additional information, please see Carboxin and Oxycarboxin: Human Health Scoping Document in Support of Registration Review.6 Table 1: Planned D ata Needs for the Carboxin Registration Rev iew

Guideline

Number 4 Study Title 4 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Non

Guideline

(OECD

213) Honey bee adult acute oral toxicity (Tier I)

TGAI 12

Non

Guideline

OECD

237) Honey bee larvae acute oral toxicity (Tier I)

TGAI 1 2

Non

Guideline Honey bee adult chronic oral toxicity (Tier I) TGAI 1 2

Non

Guideline Honey bee larvae chronic oral toxicity (Tier I) TGAI 12

Non

Guideline Residues in pollen and nectar/field residue analysis (Tier II) TEP 24

Non

Guideline

(OECD

75) Semi

- field testing for pollinators (tunnel or colony feeding studies) (Tier II) 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 labelled use of oxycarboxin ( i.e., shadehouses) 6

. As discussed in the document EFED Response to

Comments on the Problem Formulation for the Registration Review of Carboxin/Oxycarboxin, applicable requirements may be waived if the label for oxycarboxin is amended to read "for use

in enclosed commercial greenhouses.” For additional discussion of the an ticipated 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 Revi ew.

6 The current oxycarboxin label provides for use of this ingredient in shadehouses. The EPA’s current understanding 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 oxycarboxin.7 Table 2: Anticipated Data Needs for the Oxycarboxin Registration Review

Guideline

Number 7 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated Data 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

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

850.2200 Avian dietary toxicity (waterfowl species) TGAI 12

850.2300 Avian reproduction toxicity (upland gamebird and waterfowl species) TGAI 12

850.4100 Seedling emergence and seedling growth (Tier I)

– 10 species TEP 12

850.4150 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

Guideline

(OECD

237) Honey bee larvae acute oral toxicity (Tier I) TGAI 12

Non

Guideline Honey bee adult chronic oral toxicity (Tier I) TGAI 12

Non

Guideline Honey bee larvae chronic oral toxicity (Tier I) TGAI 12

Non

Guideline (OECD 75) Semi

- field testing for pollinators (tunnel or colony feeding studies) (Tier II) TEP 24

7 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 85 0 Series; Notice of Availability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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- 00288 RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of carboxin and oxycarboxin. For human he alth, EPA anticipates the need to conduct revised dietary and occupational risk assessments during registration review. If toxicological endpoints or points of departure are revised based on the data that are anticipated to be required for registration re view, they will be considered in the new assessments, as well as any changes to the standard operating

p rocedures or default exposure assumptions

.

Table 3 below summarizes the planned registration review risk assessments based on the EFED
Problem Formulation and HED Scoping Document and the planned assessments have not changed from what was included in the PWP

.9 Table 3 : Planned 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 (mixers, loaders, 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 spr ay 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.10 Incidents 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

.

TIMELINE

EPA has created the following estimated timeline for the completion of the carboxin and oxycarboxin registration review in Table 4 below

. The projected timeline has not changed since

the PWP.

Table 4 : Registration Review for Carboxin and Oxycarboxin

– Projected Registration
Review Timeline

Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period March 2015

– Completed

Close Public Comment May 2015

– Completed Case Development

Final Work Plan August

– Completed

Issue DCI 2015 Oct.

– Dec.

Data Submission 2017 Oct.

– Dec.

60

- day Public Comment Period for Draft Risk Assessments 8 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

As noted previously, the Agency plans to require several environmental fate, ecological effects,

and human health studies for carboxin and oxycarboxin through a D ata C all

- I n Notice , expected

to be issued in 2015

.

8 The regulations governi ng 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 co mment period generally for draft risk assessments.