2 I NTRODUCTION

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

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- 0290 ). Metiram is a broad

- spectrum, fungicide within the ethylene bisdithiocarbamate (EBDC) group of fungicides registered for agricultural application to apples (foliar) and potatoes (foliar or seed piece). Horticultural uses include a Special Local Need use on leatherleaf ferns (nurseries and greenhouses; Florida use only). There are no registered residential uses.

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

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

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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 res ponse 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 metiram. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

860.1200 Directions for Use: Bananas and Grapes and 860.1560 Reasonable Grounds in Support of the Petition

The Agency erroneously noted 860.1200 Directions for Use: Bananas and Grapes only and 860.1560 Reasonable Grounds in Support of the Petition : Bananas as data gap s in the PWP. In 2011, EPA established import tolerances for metiram in or on wine grapes and bananas (E PA

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- evaluate these toleranc es during registration review. Regar ding 860.1200 Directions for Use: Potato

, the Agency will pursue

identified potato use label changes with metiram registrants outside of the data call

- in process.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the Metiram Preliminary Work Plan , which opened

on June 24, 2015 and closed on August 24, 2015, the Agency received four public comments

. Comments were submitted by BASF Corporation, the Center for Biological Diversity, the FIFRA Endangered Species Task Force (FESTF) and the Northwest Horticultural Society. The

1 http://www.epa.gov/oppsrrd1/registration_review/3 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 t he specific topics of environmental justice, water quality concerns , and trade irritants, but no comments or information were received on those issues.

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

responses. Summa rized below are public comments that resulted in changes to the anticipated registration review data needs, risk assessments, or timeline, or are of a broader regulatory

nature. Public comments and EPA responses in their entirety are located in the docket, EPA

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Comments submitted by BASF Corporation (BASF) in EPA

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1. Comment: BASF commented that the Endangered Species section states "A previous endangered species assessment for the California red

- legged frog was conducted in October 2007", which is not relevant to this assessment as m etiram was not part of the

2007 assessment. BASF also commented that the 1989

- 1990 ethylene

- bi s

dithiocarbamate (EBDC) Market Basket (MB) survey remains relevant for refining the metiram dietary assessment and requests clarification on what specific information the EPA requires to justify the continued use of this survey.

Response: T he Agency co nfirms that an endangered species assessment for the California

red

- legged frog was not conducted for metiram and appreciates the BASF comment for bring ing this error to our attention. For details on what information EPA needs to justify

the continued use of the existing MB survey, please see the HED Response to Comments on the Registration Review Preliminary Work Plan in the metiram registration review

docket

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Comments submitted by Northwest Horticultural Council in EPA

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2. Comment: The NHC requests that metiram be maintained for use in the tree fruit industry, as it is an important tool to prevent apple scab and rusts as part of an Integrated Pest Management (IPM) process.

Response: The Agency appreciates the NHC comments, which cor roborate the Agency’s findings in the BEAD Chemical Profile, o n the utility of metiram to the tree fruit industry.

Comments submitted by FIFRA Endangered Species Task Force (FESTF) in EPA

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3. Comment: The technical registrant for metir am, as identified on the fact sheet in the PWP, is BASF Corporation, which is a FESTF member and is entitled to rely on FESTF

data.4 Response: EPA appreciates FESTF’s comments and will consider this information during registration review.

Comments submitted by the Center for Biological Diversity in EPA

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4. Comment: The Center for Biological Diversity’s comments focus on the EPA’s duty to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries

Se rvice (the Services) on the registration review of metiram in accordance with the Endangered Species Act (ESA). The CBD comments mention various aspects of the risk assessment process, including use of the best available data to develop endangered species risk assessments, and evaluation of effects on endangered and threatened (listed) species and their designated critical habitat. CBD also expresses concern regarding the rigor of the Agency’s preliminary determinations regarding the effects of metiram on

l isted species and their designated critical habitat for the metiram registration review.

Response: EPA has reviewed the comments from CBD on the registration review docket opening for metiram and plans to address many of the concerns raised by CBD as pa rt of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to metiram in connection with the development of its final registration review decision for metiram

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In November 2013, the EPA, along with the Services and the USDA, released a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Approaches we re 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 2 outlines rec ommendations 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.

The joint Interim Approaches were relea sed 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) meetin gs. The agencies also held stakeholder workshops in April and October 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. Additional workshops are planned to enhance

stakeholder involvement. As part of a phased, i terative 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 for National

- Level Pesticide Endangered Species Act Assessments Based on

2 http://www.nap.edu/ca talog.php?record_id=183445 the Recommendations of the National Academy of Sciences April 2013 Report” 3 , dated November 1, 2013.

Given that the agencies are cont inuing 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, the ecological problem formulation supporting this Final Work

Plan for metiram d oes not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during registration review. In the ecological problem formulation document for metiram

, EPA described t he screening

- level risk assessment to determine the potential effects of

metiram on all taxa of non

- target wildlife and plants, which will assume that listed species and their designated critical habitats may be present in the vicinity of the application of metiram

. This screening

- level assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists once the scientific methods being developed by the agencies have been fully vetted. While the agencies continue to develop a common method for ESA analysis, the planned screening

level risk assessment for the registration review of metiram will desc ribe the level of ESA analysis completed for this particular registration review case. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk

assessments for listed species and their designated critical hab itats, these methods will be applied to subsequent analyses for metiram as part of completing this registration review.

PLANNED DATA NEEDS

Table 1 below summarizes planned data needs for m etiram and ethylenethiourea (ETU) , the major degradate of metiram

, based on the Registration Review; Problem Formulation for the Ecological Risk Assessment and Drinking Water Exposure Assessment to be Conducted for

Metiram and Metiram: Human Health Risk Assessment Scoping Document in Support of Registration Review

. The p lanned data needs have not changed from what was included in the

PWP , with the exception of the deletion of 860.1200 Directions for Use: Bananas and Grapes only and 860.1560 Reasonable Grounds in Support of the Petition: Bananas as explained in the Updates section

.

Table 1: Planned Data Needs for the Metiram Registration Review

Guideline

Number 4 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

Planned Data Needs for the Parent Metiram

835.2120 Hydrolysis TGAI 12

3 http://www.epa.gov/espp/2013/nas.html

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 Av ailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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- 00286 Table 1: Planned Data Needs for the Metiram Registration Review

Guideline

Number 4 Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4100 Aerobic soil metabolism TGAI 24 5

835.4400 Anaerobic aquatic metabolism TGAI 24 5

850.2100 Avian oral toxicity (passerine) TGAI 12

850.2300 Avian reproduction (bobwhite quail) TGAI 24 5

850.3020 Honey bee adult acute contact toxicity TGAI 12 6

850.3030 Honey bee toxicity of residues on foliage TGAI 12

850.3040 Full

- Field Testing for Pollinators TEP 24

850.6100 Environmental Chemistry Methods and Independent Laboratory Validation for Soil

and Water TGAI 12

860.1200 Dire ctions for Use: Potato 7 TEP 12

Non

- GLN Honey bee adult acute oral toxicity TGAI 12 6

Non

- GLN Honey bee adult chronic oral toxicity TGAI 12

Non

- GLN Honey bee larvae chronic oral toxicity TGAI 12

Non

- GLN Field trial of residues in pollen and nectar TEP 12

Non

- GLN (OECD Test

GLN 237) Honey bee larvae acute oral toxicity TGAI

12

Non

- GLN (OECD Test

GLN 75) Semi

- field testing for pollinators TGAI or TEP

24

Non

- GLN Residue/Monitoring (Market Basket) Study TEP 36

Planned Data Needs for the Degradate ETU

835.4100 Aerobic soil metabolism Degradate 24

835.4300 Aerobic aquatic metabolism Degradate 24

835.4400 Anaerobic aquatic metabolism Degradate 24

850.6100 Analytical method in soil (ECM/ILV) Degradate 12

Outstanding Data Requirements from GDCI

- 014601

- 26081 8

870.3700 Prenatal developmental toxicity study (rabbits) TGAI 12

TGAI = technical grade active ingredient; TEP = typical end

- use product; GLN = Guideline

5 The PWP has the incorrect timeframe listed for these studies.

6 A study to fulfill this requirement is currently under review (MRID 4940301)

7 The Agency will pursue identified potato use label changes with metiram registrants outsi de of the data call

- in

process.

8 The study listed in this section was p reviously required through a generic data call

- in issued in July 2007 and is still outstanding. This study will not be included in the Registration Review DCI because it is already required through

the earlier DCI.7 RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, t he Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of metiram. For human health, EPA will

conduct revised dietary, residential

, and occupational risk assessment s during registration

review

. If toxicological endpoints or points of departure are revised based on the data that are 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

.

Table 2 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

.8 Table 2: Planned Risk Assessments for the Metiram 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 Y A Total Toxic Residue approach will be taken to

estimate the a quatic environmental concentrations of
parent metiram and its degradate, EBIS.

Incidents Will check for updates For a discussion of reported ecological incidents for metiram, see page 40 of the Problem Formulation.

Human Health Dietary

Food Y The dietary risk assessment may need to be updated if the toxicology endpoints, uncertainty factors, or drinking water exposure estimates change. Drinking water Y

Occupational Handlers (mixers, loaders, applicators) Y An updated handler and post

- application occupational risk assessments (cancer and non

- cancer) will be performed for all currently registered metiram uses. Post

- application Y

Residential

Handlers N There are no residential or homeowner uses registered for metiram; therefore the Agency does not plan to

conduct a quantitative assessment for residential handlers or residential (non

- occupational) post

application exposure. The Agency plans to conduct a

s pray drift assessment and will evaluate the need for a volatilization assessment during registration review. Post

- application Y

Other Aggregate Y Because there are no homeowner or residential uses,
an aggregate assessment w ould consist of food and drinking water only. An updated aggregate

assessment may be needed if the toxicology endpoints, uncertainty factors, or drinking water exposure estimates change.

Cumulative N Metiram has not been identified as a member of a

cumulative group that shares a common mechanism of toxicity.

Tolerances Y During registration review, the Agency will evaluate

the need to harmonize tolerances with Canadian

maximum residue limits and the need to update the current tolerance expressions.

Incidents Will check for updates There are currently no incident cases reported for metiram. See page 16 of the Scoping Document and the Metiram: Tier I (Scoping) Review of Human

Incidents.9 TIMELINE

EPA has created the following estimated timeline for the comple tion of the metiram registration

review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3 : Projected Metiram Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60

- day Public Comment Period 2015

– June

Close Public Comment 2015

– August Case Development

Final Work Plan 2015

– December

Issue DCI 2016 January

– March

Data Submission 2019 January

– March

60

- day Public Comment Period for Draft Risk Assessments 2020 July

– Sept. Registration Review Decision

60

- day Public Comment Period for Proposed Registration Review

Decision 2021 April

- June

Registration Review Decision and Begin Post

- Decision Follow

- up 2022 Total (years) 7

NEXT STEPS

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

and human health studies for metiram through a D ata C all

- I n Notice , expected to be issued in early 2016

.