Docket Number EPA-HQ-OPP-20 15-0061 www.regulations

.gov



# Tetraconazole Final Work Plan Registration Review

Case Number 7043 February 2016

Approved by:

Date: Yu- Ti g Guilaran, Director Pesticide Re-evaluation Division (7508P) Office of Pesticide Programs US Environmental Protection Agency Phone: 703-308-8157

### INTRODUCT ION This is the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for the registration review of tetraconazole

. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), w hich was posted in the tetraconazole registration review docket (EPA

-HQ-OPP-2015-0061). Tetraconazole is a demethy lation inhibiting (DMI) fungicide registered for use on soybeans, sugar beets, corn (field, pop), peanuts, and pecans, to control Cercospora blight, frogeye leaf spot, powdery mildew, brown spot, and anthracnose

. It is also registered for some crops in the crop subgroups 13-07F (small fruit vine climbing subgroup , except fuzzy kiwifruit) and 13-070 (low growing berry subgroup, excluding cranberry)

. Currently , there are no registered non-agricultural uses for tetraconazole. The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide , Fungic ide , 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 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. The public phase o f registration review begins when the initial docket is opened for each case. Information on this program is provided on the Agency's website

. ' The FWP begins with sections discussing any updates since the PWP was issued , comments received during the public comment period for the PWP, and agency responses . These sections are followed by registration review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline for tetraconazole. Lastly , there is a discussion of next steps
. 

### UPD ATES S INCE THE PWP WAS ISSUE D Since the PWP , the agency received a new use petition for fruiting vegetables (crop group 9 and I 0) , cucurbit vegetables group (crop group 9) and revising tolerances for sugar beets for tetraconazole , in September 2015
. In the PWP, guide line 875.2100 was cited as a data need but the data were required as a condition of registration. Because it was previously conditionally required , this data requirement will not be included in the FWP or the registration review Data Call-In Notice (DCI)
. The data have been submitted and undergoing review.


### SUMMA RY OF C OMMENT S AND AGE N CY RE SPON SES During the 60-day public comment period on the Tetraconazole Preliminary Work Plan, which opened on September 30 , 2015 , and closed on November 30,2015, the Agency received no public comments. 

### PLANNE D DATA NEED S

1 http ://www2.epa.gov/pesticide-reevaluation 2Table 1 below summarizes the planned data needs for tetraconazole based on the Registration Review: Prelimina r y Problem Formulationfor Environmental Fate Ecological Risk, Endangered Species, and Drinking Wat er Exposure Assessments for Tetraconazole and Tetraconazole, Human Hea lth Risk Assessment Scoping Docum ent in Support of Regis tration Review. The planned data needs have not changed from what was included in the PWP
.

T a bl e 1 : Pl a nn ed Data Nee d s fo r th e Te traco n azo le R egis tra ti o n R ev iew Estimated Guid eline Timefram e N um be.-2 Study Title Test Material (Months from receipt ofDCI) A nticip ated Data Need s for th e Parent Tetraconazol e 835.4200 Anaerobic so il metaboli sm3 TGAI 24 835.4400 Anaerobic aquatic metabolism 4 TGAI 12 860.1380 Storage stability in so il and water TGAI 12 Environmental Chemistry Method s and TGAI 850
. 6100 Associated Independent Laboratory Validation 12 (soil and water) 850.1350 Aquatic invertebrate life cycle (saltwater) TGAI 12 850.1400 Fish early-life stage (saltwater) TGAI 12 850.4100 Terrestrial plant toxicity , seedling emergence TEP 12 850.4150 Terrestrial plant toxicity , vegetative vigor TEP 12 850
. 1500 Fish lif e cycle (freshwater) TGAI 24 850.4500 Algal toxicity (freshwater green alga , freshwater TGAI 12 and marine diatom) 850.4550 Cyanobacteria (Anabaenajlos-aquae) toxicity TGAI 12 850
.2100 Avi an oral toxicity (passerine) TGAI 12 Whole sediment-chronic (Two freshwater Non- amphipods , H yale lla azteca and Chironomus TGAI 12 gu ideline tentans, and one estuarine/marine amphipod , Leptoche irus plumulosus)

. Non- Honeybee adult chronic oral to xi c ity TGAI 12 guideline

Non- Honeyb ee larval acute and chronic oral toxicity TGAI 12 guideline

Non- Semi-field te sting for pollinators 5 TEP 24 gu ideline

2 On June 27, 20 12, EPA anno unced certain rev isio n s in harm o nize d g uideline serie s 850

- Eco lo gica l Effects Tests

- including renumbering an d other de s ig nation s or changes for some guideline s tudi es. See " Final Test Guidelines; OCS PP 850 Series; Notice of Availability " 77 FR 38282, Jun e 27,20 12. http: //www .regulations

.gov/# !docume ntD etai I; D= EP A-1-10-0PPT-2009-0 154-0028 3 Four soil systems 4 One additiona l water/ sed im e nt sys tem 3Table 1: Planned Data Needs for the Tetraconazole Registration Review Estimated Guideline Study Title Timeframe Number Test Material (Months from receipt of DCI)
850.3040 Field testing for pollinators 5 TEP 24

Non- Residues in pollen and nectar5 TEP 24 guideline Prior Data Required as Conditions of Registration for Tetraconazole
875.2100 Dislodgeable foliar residue and turf transferable TGA I 7/21/2015 residues 6 (Received) TGAI = technical grade active mgredient ; TEP = typical end-use product.
RISK ASSESSMENTS FOR REGISTRATION REVIEW During registration review, the Agency wi ll conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all u ses oftetraconazole. For human health , EPA will conduct revised dietary , occupational, and aggregate risk assessments during registration review. If toxicological e ndp oints or points of departure are revised based on data received during registration review, they w ill be considered in the new assessme nt s, as well as any changes to the standard operating procedures or default exposure assumptions. Table 2 below summarizes the planned registration review risk assessments based on the EFED Problem Formulation and HED Scoping Document. The planned assessments have not changed from what was included in the PWP.

5 Pending review of lower Tier studies. 6 This guideline data requirement is based on the conditions of registration ; therefore, it will not be included in the registration review data call-in

. 4

### Table 4: Planned Risk Assessments for the Tetraconazole Registration Review Type of Ri s k Assessment Conduct? Notes Ecological and Environmental Fate Comprehensive ecological 

### y The Agency will conduct a comprehensive ecological including endangered species assessment, including an endangered species assessment. Incidents Will For a discussion of reported ecological incidents for check for tetraconazole, see page 14 ofthe Problem Formulation

.

updates There are currently no ecological incidents reported for tetraconazole. 

### Human Health 

### ,, ' Dietary Food 

### y As part of the registration review , the dietary risk assessment may be revisited. Drinking water 

### y Concentrations in drinking water will be reevaluated as part of registration review

. Occupational Handlers (mixers, loaders , 

### y Occupational handler and post-application dermal and app lic ators) inhalation assessments will be revised to reflect all Post-application 

### y potential exposure scenarios, updated policies , exposure data, and any updated toxicological PODs. Residential Handlers N Tetraconazole is not used in residential settings, so a residential handler assessment is not needed

. Post-application N Tetraconazole is not used in residential settings

. A conventional residential post-application assessment is not needed. The need for drift and volatility assessments will be considered during registration review. Other Aggregate 

### y A revised aggregate assessment may be required to reflect revised dietary exposure estimates and/or changes to the toxicological PODs. Cumulative N Tetraconazole is a member of the triazole-containing class of pesticides

. Structural similarities do not constitute a common mechanism of toxicity and there is currently no evidence to indicate that members of this class share a common mechanism of toxicity

. Tolerances 

### y The Agency will revisit the tolerances during registration review. Incidents Will For a discussion of reported human incidents for check for tetraconazole , see page 1 1 of the Scoping Document and

updates the 

### Tetraconazole: Tier I (Scoping) Review of Human Incidents.
5T IMEL INE EPA has created the following estimated timeline for the completion of the tetraconazole registration review in Table 3 be low. The projected timeline has not changed since the PWP.

Ta bl e 5: Proj ected T etraconazole Regi stration Rev iew Tim elin e A cti v ities Es tim ated D ate Opening the Docket Open Docket and 60-day Pub lic Comment Period September-20 15 Close Public Comment November-20 15 Case Deve lopment Final Work Plan February-20 16 Issue DCI April-June -2016 Data Submission Apri l-June -2018 60-day Public Comment Period for Draft Risk October-December-2019 Assessments7 Registration Review Decision 60-day Public Comment Period for Proposed July-September-2020 Registration Review Decision Registration Review Decision and Begin Post

-Decision 2021 Follow-up Total (years) 6

7 The re g ulations 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
. 6

### NEXT STEPS As noted previously, the Agency plans to require several environmental fate, ecological effects, and human health studies for tetraconazole through a Data Call-In Notice, expected to be issued in between April and June of2016.

7