### Table of Contents

I. Introduction

................................................................................................ 3

II. Use and Usage

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

III. Scientific Assessments

.............................................................................. ... .. . 6

A. Human Health Risk Assessment..................................................................... ..6

1. Risk Conclusions.............................................................................. .....6

2. Tolerances.......................................................................................

... 7

3. Human Incidents...................................................................................7

B. Environmental Assessment...........................................................................

. . 7 1. Environmental Fate and Exposure

............................................................... 8 2. Ecological Risk Characterization...............

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

3 . Overview of Ecological Risk Conclusions .....................................................8 4. Effects on Aquatic Organisms...................................................................8

5 . Effects on Terrestrial Organisms

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

6 . Ecological Risk Management Conclusions for Non

- listed Species

............... ...... . ..10

C. Endangered Species Assessment

............................................................... . .....10

D. Endoc rine Disruptor Screening Program............................................................11

IV. Interim Registration Review Decision

................................................... ............ .12

V . Next Steps and T imeline

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

A. Registration Review Decision

.......................................... .......... .................. . . 1 3

B. Implementation of Mitigation Measures

......................................................... .. . 1 3

Appendix A: Summary of Actions Taken for Triflumizole ...........................................1 4 Appendix B: Triflumizole Label Table 1, Rate and RTI Label Mitigation.......................... 1 5 Appendix C: Triflumizole Label Table 2, Occupational exposure ...................................16

2I

. Introduction

This document is the Environmental Protection Agency’s (EPA or the Agency) Interim Registration Review Decision for triflumizole ( PC Code 128879, Case 7003 ) and is being issued pursuant to 40 CFR sections 155.56 and 155.58

. A registration review decision is the Agency's

determination on whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicid e, and Rodenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, a n interim registration review decision before co mpleting a registration review final decision

. Among other things, the interim registration review decision

may 1) require new risk mitigation measures ; 2) impose interim risk mitigation measures ; 3) identify data or information requi red to complete the review; and 4) include schedules for submitting the required data, conducting the new risk assessment and comp leting the registration

review. Fo r further information on triflumizole , additional documents can be found in EPA’s public docket ( EPA

- HQ

- OPP

- 2008

- 0657 ) at www.regulations.gov

.

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the continuous review of existing pesticides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on scientific data showing that they will not cause

unreasonable risks to human health or to the environment when used a s directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to

meet th e statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically re

- evaluates pesticides to make s ure that as these changes

occur and products in the marketplace can continue to be used safely. Information on this program is provided a t www.epa.gov/oppsrrd1/registration_review/

.

In 2006, the Agen cy implemented the registration review program pursuant to FIFRA section 3(g) and EPA will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.

This document comprises the interim registration review decision for triflumizole.

Triflumizole is a broad spectrum, systemic imidazole fungicide (Group 3) that inhibits ergosterol biosynthesis in fungi. Triflumizole is registered for use on a variety of agricultural crops, non

agricultural crops, and as a pre

- plant seed treatment. Triflumizole is also registered for uses on

residential/non

- commercially grown apples, pears and grapes

. Registered application methods for triflumizole include broadcast, foliar spray, root dip, soil drench, chem igation, and seed piece

treatment. A Reregistration Eligibility Decision document (RED) for triflumizole was not completed because it was registered after 1984.

Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for

triflumizole (case 7003 )

. The following highlights significant events that have occurred during the registration review of triflumizole:

• March 28, 2007

– Publication of triflumizole Summary Document for a 60

- day public comment period . The Summary Documen t included the Preliminary W ork P lan (PWP) and was accompanied by the scoping document and problem formulation.

3• August 22, 2007

- Final Work Plan (FWP) for triflumizole was issued

– 3 comments were received during the 60

- day comment period for the triflum izole PWP. These comments, which were addressed in the FWP, did not change the work plan or timeline

set out in the PWP.

• September 2 6 , 2008

– Generic Data Call

- In (GDCI) for triflumizole issued.

• June 26, 2013

– The Agency published the Registration Review

– Ecological Risk Assessment and Effects Determination of Triflumizole and the Triflumizole: Human Health Risk Assessment for Registration Review for a 60

- day public comment period.

• August 26, 2013

– 60

- day public comment period for Preliminary Ris k Assessments

closed. No comments were received.

• September 2014

– T he Agency published the Triflumizole Proposed Interim Registration

Review Decision for a 60

- day public comment period. One comment was received from the Center for Biological Diversity reg arding the Agency’s obligations under the Endangered Species Act (ESA).

• March 2014

– The Agency is now publishing the Triflumizole Interim Registration

Review Decision.

Additional information on triflumizole can be found in EPA’s public docket

, EPA

- HQ

- OPP

2006

- 0115, accessed at www.regulations.gov

.

Comments Received from the Center for Biological Diversity ( EPA

- HQ

- OPP

- 2006

- 0115

- 0040 )

Comment : The Center for Biological Diversity’s (CBD) comments foc us on the EPA’s duty to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of triflumizole in accordance with the 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 species and their designated critical h abitat. CBD also expresses concern regarding the rigor of the Agency’s preliminary determinations regarding the effects of triflumizole on endangered and threatened (listed) species and their designated critical habitat for the triflumizole registration r eview.

Response : EPA has reviewed the comments from CBD on the Triflumizole Proposed Interim Registration Review Decision a nd plans to address many of the concerns raised by CBD as part of the implementation plan for assessing the risks of pesticides t o listed species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will

add ress concerns specific to triflumizole in connection with the development of its final registration review decision for this pesticide. See Endangered Species Assessment on page 10 of

this document for more information.

4II. Use and Usage

The Agency conducted a qualitative benefits assessment for triflumizole and some other demethylation inhibiting (DMI) fungicides in June 2014 , which is available in the docket ( Qualitative Assessment of Benefits of Triflumizole and Other Demethylation Inhibiting Fungicides Used on Cherry, Apple, Hazelnut, Grape, Strawberry and Cucurbits ). This

assessment was conducted to better examine the characteris tics and uses of triflumizole and to qualitatively assess its benefits and overall use patterns. As described in that document,

t riflumizole is a Group 3 DMI fungicide, sometimes referred to as sterol biosynthesis inhibitor (SBI). Triflumizole is register ed for use on a variety of agricultural crops, including cherry, hazelnut, apple, grape, strawberry, cucurbit, hazelnut, leafy greens, hops, and papaya. It is also registered for use on a number of non

- food crops including ornamentals in greenhouses/shade houses, interior scapes, and Christmas trees/conifers on nurseries and plantations. It is also registered for use as a pre

- plant seed piece treatment on pineapples.

An updated Screening Level Usage Analysis (SLUA) for triflumizole was conducted in January 2013. SLUA usage data (2004

- 2011) show triflumizole is primarily used, in terms of pounds and/or acres treated, on cherry, hazelnut, apple, grape, strawberry, and cucurbits. In 2011, approximately 93,000 lbs of triflumizole were applied. Apples account f or the majority of

usage
, making up approximately 40,000 lbs active in gredient (a.i) annually, then grapes (20,000 lbs. a.i./year), along with use s on cherries, grapes, and pears (each 10,000 lbs. a.i./year ) representing triflumizole’s other major uses ( Tr iflumizole Screening Level Usage Analysis

, January 30, 2013) . The updated SLUA for triflumizole can be found in the triflumizole registration review docket (EPA

- HQ

- OPP

- 2006

- 0115) at www.regulations.gov

.

DMI fungicides , including triflumizole, are classified by the Fungicid e Resistance Action Committee as Group 3 fungicides. Group 3 fungicides in general are reportedly one of the most important group of fungicides because of their efficacy against economically significant pathogens. They reportedly play an integral role as a component of overall fungicide application programs that seek to limit the development of resistance to several different fungicide

chemistries.

As described in the June 2014 qualitative benefits assessment, for the crops which triflumizole is commonly used, there are generally a few other DMI fungicides registered for the same uses. Because resistance to this group of fungicides has developed for some important diseases, use restriction s are recommended for all of the Group 3 fungicides. Triflumizole is used in disease management programs that alternate triflumizole with applications of other non

DMI fungicides in support of standard stewardship practices to assist in fungicide resistan ce management. Although there is a higher cost per acre for certain uses of triflumizole compared to other DMI fungicides, triflumizole was found to be used at a relatively higher percent crop treated. The higher cost and higher percent crop treated sugg ests benefits specific to the use of triflumizole. DMI fungicides in general have been shown to provide particular value in the control of major diseases such as powdery mildew on apple, cherry, grape, strawberry, and cucurbits (cantaloupe, squash, and wat ermelon) as well as in combating Eastern Filbert Blight in hazelnut production and apple scab.

5I I I. Scientific Assessments

A. Human Health Risk Assessment

A summary of the Agency’s human health risk assessment is presented below. The Agency used the HED scoping document, its supporting documents, and the most updated Agency science policies and risk assessment methodologies to prepare a risk assessment in support of the registration review of triflumizole. The most recent human health risk assessment was completed on May 2, 2012, and revised on June 5, 2014, to include updates to restricted entry intervals (REI) for grapes and hops. The human health risk assessment consists of updated acute and chronic dietary (food and drinking water) , residential (handler and post

- application),

aggregate, and occupational ( handler and post

- application ) exposure assessments. Risk estimates were below the Agency's level of concern (LOC) for all but two human health scenarios (occupational handle r and post

- application ). For a detailed discussion, see the Triflumizole: Human Health Risk Assessment for Registration Review

, June 5, 2014

, in the public docket EPA

HQ

- OPP

- 2006

- 0115

, which can be accessed on h ttp://www.regulations.gov/

.

1. Risk Conclusions

Risk estimates for triflumizole exceed the Agency's level of concern (LOC) for the following two occupational scenarios using currently required personal protective equipment (PPE): long

sleeved shirt, long p lants, chemical resistant gloves, shoes, and socks

-

• Occupational Handler

- Application of sprays with open cab air blast equipment on apples, pears, and cherries; dermal margin of exposure (MOE) = 230 (target MOE = 300)

• Occupational Post

- Application

- Mechanically assisted harvesting for hops and girdling for g rapes (table and raisin), REI 12 hours, dermal MOE = 200 (grapes , table and raisin ), MOE = 270 (hops) (target MOE = 300).

To mitigate the identified occupational handler risks of concern

, the tec hnical registrant, Chemtura Corp., has agreed to amend its registrations and labels to incorporate a chemical resistant hat to the existing occupational handler PPE for the open cab air blast spray application scenario, which re sults in a revised MOE of 1, 900, and is no longer a risk of concern.

For o ccupational post

- application risks to workers engaged in girdling of g rapes (table and raisin), Chemtura has agreed to extend the REI from 12 hours to 1 day (r evised MOEs = 400). To address post

- application w orker risks for mechanically assisted harvesting of hops, the REI at which risks are no longer of concern is 3 days (revised MOEs = 330)

. However, b ecause the PHI of 7 days (for hops) already on the label is greater than a 3

- day REI, the PHI will provide sufficient protection for re

- entry by occupational workers and therefore a 3

- day REI for hops is not required.

62. Tolerances

Tolerances are currently established for residues of triflumizole, including its metabolites and degradates, in or on plants and l ivestock in 40 CFR § 180.476. Codex has not established Maximum Residue Limits (MRLs) for residues of triflumizole in/on various raw agricultural and processed commodities. Tolerance definitions and tolerance levels are harmoni zed between

Canada and the U. S. which can be found in Appendix B of Triflumizole: Human Health Risk Assessment for Registration Review

.

The following tolerance amendme nts are needed for triflumizole: (1) modify the residue definition for the tolerance expression for triflumizole in accordance with the current policy on

tolerance definitions ( described on pg. 3

- 4 of the Human Health Risk Assessment ); and (2) modify the tolerance levels for certain commodities (listed below) to reflect conclusions of a previous review but are not cu rrently reflected in the 40 CFR 180.476 (D346779, W. Cutchin, 10/1/08).

The following tolerances will be deleted from 180.476(a)(1): apple, dry pomace; apple, wet pomace; grape, dried pomace; grape, raisin, waste; and grape, wet pomace. The commodity

lis ted as “cilantro, leaves” will be changed to “coriander, leaves.” Also, the following tolerances will be deleted from 180.476(a)(2): cattle, meat; egg; goat, meat; hog, fat; hog, meat; hog, meat byproducts; horse, meat; milk; poultry, fat; poultry, meat; p oultry, meat byproducts; and sheep, meat. Tolerance levels for the following commodities will be lowered from 0.5 to 0.10 ppm: fat of cattle, sheep, goat, and horse. Tolerance levels for the following commodities will be lowered from 0.5 to 0.20 ppm: meat byproducts of cattle, sheep, goat, and horse.

3. Human Incidents

A small number of minor human health incidents have been reported to the Agency involving triflumizole. From January 1, 2006 to August 5, 2014, there were 3 incidents reported

to the Office of Pesticide Program’s Main Incident Database System. These incidents were classified as moderate severity. A query of SENSOR

- Pesticides 2006

- 2010 identifies a total of 23 cases (2 moderate severity and 21 low severity). Of these c a ses, 5 were single active ingredient cases and all 5 were low severity. Based on the continued low frequency and severity of incident cases reported for triflumizole, there does not appear to be a concern with the current uses of triflumizole when used as directed by labels. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be conducted. For more information please refer to Triflumizole: Tier I Review of Human Incidents for Preliminary

Risk Assessment , August 19, 2 014.

B

. Environmental Assessment

The risk assessment supporting this Interim Registration Review Decision evaluates risks to species that are not subject to the ESA and provides a screening level assessment for potential risks to listed species under ESA. A summary of the Agency’s environmental risk assessment
for triflumizole is presented below. For detail ed discussions of all aspects of the environmental risk assessment, see the Registration Review

– Ecological Risk Assessment and Effects

7Determination of Triflumizole and Refinements to the Triflumizole Preliminary Risk Assessment in Support of Registratio n Review

, published on June 26, 2013 in the public docket EPA

- HQ

OPP

- 2006

- 011 5

- 0030

, which can be accessed on http://www.regulations.gov/

.

1. Environmental Fate and Exposure

Triflumizole is not likely be persistent under most environmental conditions and is unlikely to be very mobile (except for in sandy soils with low organic matter). Triflumizole’s moderate adsorption characteristics suggests that triflumizole has a low potential to reach groundwater. T riflumizole will reach surface water in both the dissolved form and sorbed onto soils and organic material for several weeks following application.

The major pathways of triflumizole degradation are hydrolysis under acidic and alkaline conditions, anaerob ic aquatic metabolism, and to a lesser extent aerobic soil metabolism. Half

lives varied depending on environment conditions at the application site.

2. Ecological Risk Characterization

To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity studies using the risk quotient method. Risk quotients (RQs) are calculated by dividing acute and chronic EECs by ecotoxicity values for various wildlife and pla nt species. RQs are then compared to levels of concern (LOCs) and when the RQ exceeds the LOC for a particular category, the Agency evaluates the potential for a risk of concern to that category. Risk characterization provides further information about p otential adverse effects and the possible impact of those effects by considering the fate of the chemical and its degradates in the environment, organisms potentially at risk, and the nature of the effects observed.

3

. Overview of Ecological Risk Conclu sions

Conservative assumptions were made in the ecological risk assessment for triflumizole to estimate the ecological risks (e.g., risk estimates are based on the maximum application rates and number of applications rather than typical rates). For non

- listed s pecies, chronic RQs for

mammals exceeded the LOCs for all registered uses of triflumizole. For all other non

- listed taxa, RQs were below target LOCs for all uses and there are no risks of concern.

4

. Effects on Aquatic Organisms

The primary route of exposure to aquatic organisms is potential runoff and spray drift from labeled applications of triflumizole. Acute and chronic risk estimates were below the LOC

for non

- listed freshwater and estuarine/marine fish (surrogates for aquati c

- phase amphibians), freshwater and estuarine/marine invertebrates, and aquatic vascular and non

- vascular plants for all uses of triflumizole. Therefore, no risks of concern are anticipated for non

- listed aquatic organisms based on the registered uses of triflumizole.

85

. Effects on Terrestrial Organisms

Mammals

There are no acute risks of concern to non

- listed mammals from the registered uses of triflumizole based on calculated RQs. However, RQs exceed the target LOCs for non

- listed

mammals on a chronic basis for all uses. The June 4, 2013 Ecological Risk Assessment and effects Determination of Triflumizole was conducted using an incorrect mammalian endpoint (NOEC = < 30 mg/kg diet; NOAEL = <1.5 mg/kg bw). T he risk assessment has been updated to

i nclude the correct chronic mammalian reproduction endpoint (NOEC = 70 mg/kg diet; NOAEL = 3.5 mg/kg bw)

. These updates can be found in Refinements to the Triflumizole Preliminary Risk Assessment in Support of Registration Review , May 8, 2014 posted in the docket. The use of this revised endpoint decreased the overall RQs but they still exceed the target LOC for chronic mammalian exposure. Using the correct mammalian endpoint, the chronic RQs in the screening level risk assessment ranged from 0.1 (leafy gree ns) to 74.42 (ornamentals).

Chronic Mammalian Risk Characterization

Conservative assumptions in the screening level risk assessment include the use of (1) maximum labeled rates; (2) upper bound Kenaga values (95 th percentile) to estimate environmental concentrations (EECs) for mammals; and (3) 100% of a mammalian diet is assumed to come from one food type (on a treated field). To better characterize chronic risks to

non

- listed mammals, the following refinements were made to the risk assessment:

(1) Incorporated average Kenaga EECs (50 th percentile), which may more accurately capture long

- term concentrations that are expected to be found in the environment. In addition, the average provides additional information o n the frequency, likelihood, and magnitude of exposure for varied situations. The Kenaga nomograph is based on a large set of field residue data (not triflumizole specific) and is incorporated in to the terrestrial residue exposure model (T

- REX), which was used to assess chronic mammalian exposure

to triflumizole.

(2) The screening level assessment used maximum labeled rates as a conservative screen. Alternative application scenarios were assessed using estimated average maximum application rates, average number of applications, and average application intervals. Based on available use and extension information, the Agency estimated average or typical use rates which were incorporated and may more accurately represent what is generally used by growers.

W hen the average Kenaga values and typical rates are used, the RQs are decreased significantly. For cherries RQs decreased from 58.54 to 20.54. For apples/pears the RQs

decreased from 41.16 to 14.58.

For more information regarding the revisions and additi onal characterization of

mammalian risk see the Refinements to the Triflumizole Preliminary Risk Assessment in Support of Registration Review

.

9Birds, Terrestrial Plants, Terrestrial Invertebrates

There are no acute or chronic risks of concern to non

- list ed birds (and to reptiles and terrestrial phase amphibians for which birds serve as surrogates); terrestrial plants; and terrestrial invertebrates from the registered uses of triflumizole based on calculated RQs.

6

. Ecological Risk Management Conclusions for Non

- Listed Species

The ecological risk assessment for triflumizole identified RQs that exceed the chronic

LOCs for non

- listed mammals for all uses (RQs in the screening level risk assessment range from 0.1 to 74.42). To mitigate the identified risk s, Chemtura (the technical registrant) has voluntarily agreed to (1) increase the re

- treatment interval (RTI) to allow for degradation; (2) reduce the maximum number of applications per year; and, (3) reduce the maximum application rates for several crops. As a result of these changes RQs are reduced; for example, cherries go from an RQ of 58 to 29 with the agreed mitigation. These mitigation measures are in accordance with standard fungicide resistance management practices. See table 1 on pg. 17 of this d ocument for a detailed description of the agreed upon mitigation. EPA is working with the triflumizole technical registrant to amend their labels accordingly. Amended labels for technical and end

- use products registered must be submitted to the Agency for approval within 60 days of the publication of the Interim Registration Review Decision for triflumizole.

The Agency does not believe triflumizole poses an unreasonable risk to mammals. Although RQs exceed the chronic mammalian LOCs for many uses, even w hen the proposed label changes are made to mitigate risk, the Agency believes that ecological risk from triflumizole use is not expected for the following reasons: (1) as is described above, the screening level risk assessment is conservative in nature. R efinements to the assessment likely capture a more realistic estimate of exposure and significantly reduce the chronic mammalian RQ exceedances; (2) the anticipated label changes (mitigation) to the various maximum applications rates, RTIs, and total numbe r of annual applications represent significant reductions to the chronic mammalian risk picture; and (3) in addition, the Agency conducted a qualitative benefits assessment (as described in the “Use and Usage Section” of this Interim Decision) and

determin ed that triflumizole plays an important role in fungicide resistance management practices for controlling major disease pressure.

C

. Endangered Species Assessment

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 registered uses of pesticides in accordance with the Joint Interim Approaches de veloped 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 1 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 triflumizole in connection with the development of i ts final registration review decision for triflumizole

.

1 http://www.nap.edu/catalog.php?record_id=18344

10In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries Services (the Services), and the U.S. Department of Agriculture released a white paper containing a summary of t heir joint Interim Approaches for assessing risks to listed species from pesticides. These 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

age ncies 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 Assessm ents Based on the Recommendations of the National Academy of Sciences April 2013 Report. 2

Given that the agencies 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, the ecological risk assessment supporting this Interim Registration

Review Decision for triflumizole does not contain a complete ESA analysis, including effects determinations for specific listed species or de signated critical habitat. While the agencies continue to develop a common method for ESA analysis, the preliminary risk assessment for the registration review of triflumizole describes the level of ESA analysis completed for this particular registration review case. This 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. Once the agencies have fully

dev eloped and implemented the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats, these methods will be applied to subsequent analyses of triflumizole as part of completing this registration rev iew.

D

. Endocrine Disruption 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, 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 histopatho logy, organ weights, estrus cyclicity, 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 re productive effects in different taxonomic groups. As part of its most recent registration decision for triflumizole, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database . However, as required by FFDCA section 408(p),

triflumizole 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 a nd 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

stat utorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify

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

11the potential of a triflumizole 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 d esigned 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, which included trif lumizole , was published on June 14,

2013 3 and includes some pesticides scheduled for Registration Review and chemicals found in water. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, t he test guidelines and the Tier 1 screening battery, please visit our

website. 4

In this Interim Registration Review Decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of triflumizole . Before

comp leting this Registration Review, the Agency will make an EDSP FFDCA section 408(p)

determination.

I V

. Interim Registration Review Decision

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Interim Registration Review Decision Document for triflumizole . Except for the EDSP and ESA components of the triflumizole registration review case, the Agency has made the following

interim decision: ( 1 ) changes are required to triflumizole products (redu ction of maximum number of applications; reduction in maximum application rate; increase re

- treatment intervals) registered for the following crops to address risk concerns to mammals on a chronic basis: pome fruit crop group 11

- 10, cherry, grape, strawber ry, cucurbits, brassica leafy greens, head & stem brassica, leafy greens (e.g. spinach), filbert/hazelnut, hops, papaya, mango, pineapple (dip application) and ornamentals ; and (2) the following changes are required to mitigate risks to occupational handle rs and post

- application workers : (a) the requirement of a chemical resistant hat for applications using open cab air blast equipment; and (b) increase the REI for table and raisin grapes to 1 day. The Agency has been working with the single technical and end

- use product registrant for triflumizole, Chemtura Corporation, who has voluntarily agreed to revise

all a ffected labels accordingly.

In the interim, EPA is making no human health or environmental safety findings associated with the EDSP screening of t riflumizole . Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination. Likewise, before completing this Registration Review, the Agency will conduct an ecological risk assessment to address the Agency’s obligations under both the ESA and FIFRA. While the risk assessment supporting this Interim Registration Review Decision evaluates risks to species that are not

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of

chemicals.

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

12subject to the ESA, EPA is still in the process of conducting a risk assessment for listed spe cies and their designated critical habitats for triflumizole . In this Interim Decision, therefore, EPA has not completed effects determinations for listed species associated with the registered uses of

triflumizole . The Agency is issuing a n Interim Registration Review Decision pending completion of the ESA and EDSP assessments

.

V. Next Steps and Timeline

A. Registration Review Decision

A final decision on the triflumizole registration review case will occur after an ESA and

EDSP FFDCA s ection 408(p) determination ha ve been mad e.

B. Implementation of Mitigation Measures

EPA is requiring the registrant to submit proposed amended labels that include the agreed

- upon risk mitigation , described in Appendi ces A, B and C below, to the Age ncy for approval within 60 days from the date of issuance of this Interim Registration Review Decision.

13Docket Number EPA

- HQ

- OPP

- 2006

- 0115 www.regulations.gov

Appendix A: Summary of Actions Taken for Triflumizole

Registration Review Case#: 7003

PC Code: 128879

Chemical Type: Systemic broad spectrum fungicide

Chemical Family: Imidazole (group 3) fungicide

Mode of Action: Ergosterol biosynthesis inhibitor in fungi Affected Population(s) Source of Exposure Route of Exposure Duration of Exposure Risk of Concern Action(s) Taken

 Non

- listed

mammals  Direct
application

 Spray drift

 Runoff  Ingestion  Chronic  Direct  See Appendix C

 Occupational

handlers  Direct
application to

crop  Dermal  Short

- /Intermediate

term  Direct  In addition to current labeled PPE requirements, chemical resistant hat during open cab air blast applications to grapes, apples, pear, and cherries

.

 Occupational post

application

workers  Residues on

site of

treatment  Dermal  Short

- term  Direct  Increas e REI from 12 hours to 1 day for girdling grapes (table and raisin).Appendix B: Triflumizole Label Table 1, Rate and RTI Label Mitigation (grayed rows denote label mitigation)

Procure Crops Max. Rate Procure 480SC per Application

(lbs.ai./A) Max.

no. of Appls. / Crop

/ Yr. Max. Appl. Rate

Procure 480SC

per Acre per

Year (lbs. ai./A/yr.) Min.

RTI (days) Label Mitigation Comments Pome Fruit Crop Group 11

- 10 (Apple, pear) 16 fl.ozs. (0.5) 4 64 fl.ozs. (2.0) 7 Current Label Scenario 16 fl.ozs. (0.5) 4 56 fl.ozs. (1.75) 14/21/14 1 st app/14 day RTI/2 nd app/21 day RTI/3 rd app/14 day RTI Cherry 16 fl.ozs. (0.5) 6 96 fl.ozs. (3.0) 7 Current Label Scenario
16 fl.ozs. (0.5) 4 56 fl.ozs. (1.75) 14/21/14 1 st app / 14 day RTI / 2 nd app/ 21 day RTI / 3 rd app / 14 day RTI

Curcurbits 8 fl.ozs. (0.25) 5 40 fl.ozs. (1.25) 7 Current Label Scenario

6

- 8 fl.ozs. (0.1875

- 0.25) 3

- 4 24 fl.ozs. (0.75) 7 3 applications @ 8 fl.ozs . (0.25 lbs. ai.)/A or 4 applications @ 6 fl.ozs. (0.1875 lbs.ai.)/A Brassica Leafy Greens 8 fl.ozs. (0.25) 3 18 fl.ozs. (0.563) 14 Current Label Scenario , 3 rd app made at reduced rate
8 fl.ozs. (0.25) 2 16 fl.ozs. (0.5) 14 2 applications @ 8 fl.ozs. (0.25 lbs.ai.)/A @ 14 days

Head & Stem Brassica 8 fl.ozs. (0.25) 3 18 fl.ozs. (0.563) 14 Current Label Scenario , 3 rd app made at reduced rate
8 fl.ozs. (0.25) 2 16 fl.ozs. (0.5) 14 2 applications @ 8 fl.ozs. (0.25 lbs.ai.)/A @ 14 days Leafy Greens (ex. spinach) 8 fl.ozs. (0.25) 3 18 fl.ozs. (0.563) 14 Current Label Scenario, 3 rd app made at reduced rate
8 fl.ozs. (0.25) 2 16 fl.ozs. (0.5) 14 2 applications @ 8 fl.ozs. (0.25 lbs.ai.)/A @ 14 days

Filbert / Hazelnut 6 fl ozs. (0.1875) 4 24 fl.ozs. (0.75) 10 Current Label Scenario
6 fl ozs. (0.1875) 2 12 fl.ozs. (0.375) 10 2 applications @ 6 fl.ozs. (0

. 1875 lbs.ai.)/A @ 10 days
Hops 12 fl ozs. (0.375) 3 36 fl. ozs. (1.125) 14 Current Label Scenario
12 fl ozs. (0.375) 2 24 fl.ozs. (0.75) 14 2 applications @ 12 fl.ozs. (0.375 lbs.ai.)/A @ 14 days
Papaya, Mango 10 fl.ozs. (0.3125) 3 24 fl.ozs. (0.75) 14 Current Label Scenario , 3 rd app made at reduced rate
8 fl.ozs. (0.25) 1 8 fl.ozs. (0.25) NA Ornamentals (Tguard SC) 64 fl.ozs. (2.0) NS > 96 fl.ozs. (3.0) 7 Current Label Scenario

8

- 16 fl.ozs. (0.5) 2

- 4 32 fl.ozs. (1.0) 14 2 applications @ 16 fl.ozs. (0.5 lbs.ai.)/A @ 14 days or 4 appls. @ 8 fl.ozs. (0.25 lbs.ai.)/A @ 14 days Ornamentals (Tguard SC/LS) 32 fl.ozs. (1.0) NS 96 fl.ozs. (3.0) 7 Current Label Scenario

8

- 16 fl.ozs. (0.5) 2

- 4 32 fl.ozs. (1.0) 14 2 applications @ 16 fl.ozs. (0.5 lbs.ai.)/A @ 14 days or 4 appls. @ 8 fl.ozs. (0.25 lbs.ai.)/A @ 14 days

Denotes label mitigation

15Appendix C : Triflumizole Label Table 2 , Occupational E xposure

Triflumizole Labeled Crops Current PPE New PPE Current

REI New REI

Pome Fruit Crop Group

11

- 10 (Apple, pear) Long

- sleeved shirt & long pants; chemical resistant gloves made of

any waterproof materials; shoes plus socks In addition to current PPE require:

“ chemical resistant hat for applicators using open cab air blast equipment ” 12 hours No change to REI

Cherry Long

- sleeved shirt & long pants; chemical resistant gloves made of

any waterproof materials; shoes plus socks In addition to current PPE require:

“ chemical resistant hat for applicators using open cab air blast equipment ” 12 hours No change to REI

Grape Long

- sleeved shirt & long pants; chemical resistant gloves made of

any waterproof materials; shoes plus socks No change to PPE

12 hours Maintain 12 hours for wine grapes

w/addition of:

“ 1 day REI for gird ling of table and raisin grapes ”

16