Date: Chemical: PC Code: DP Barcode: UNIT ED STATES ENVIRONME N TAL PROTEC TION AGENCY WASHINGTON , D

. C. 20460

May 30 , 2013 GS-U-ACTX-Hv 1 a-SEQ2 006100 D411507 

### MEMORANDUM OFFICE OF CHEMICAL SAFETY AND POLLUT I ON PREVENTION

SU BJECT: Ecological Risk Assess ment for the Prop osed New Chemi cal Registration of GSU-ACTX-Hvla-SEQ2 (VersutideTM peptide) on Vegetables and Co le Crops ; Herbs , Spices , and Mints; Pasture and Hay Crops; Fruit, Nut, and Vine Crops; Field Crops; Commer cial F lowers and Ornamental P lant s; Forest , Shade Tree, and Nursery S tock; and Turf TO: Mark Suarez , Risk Manager Reviewer Marion Johnson , Branch Chief Regi stration D ivision (7505 P )



### FROM: Susanne Cerrelli, Regulatory Action Leader Kimberly Nesci, Microbial Pestic ides Branch Chief Biopestici des and Pollutio n Prevention Div is i on (75 1 1P) Meghan Radtke, Ph.D
. , B io l og i st Environmental Risk Branch 1

# ~~ S" /so/13
En vironmental Fate and Effects Di vision (7507 P ) THROUGH : Edward Odenkirchen, Ph.D ., Acting

# Br~h Chie &

# ~~>~ S uj a th a Sankula, Ph.D., Lead B io logist · 'v"t"-

### ~ Env ironme n tal Risk Branch 1 Environmental Fate and Effects Division (7507 P )
The Envi ronmental Fate and Effects Division (EFED) has completed the request from the Regis tration D ivision to perfo rm an ecological risk assessment in support of the new insecticide , GS

- U-ACTX

- Hvla-S E Q2 (VersutideTM peptide). T he active ingredient is a peptide derived 

### from the venom of th e Australian funnel spider 

### (Hadronyche versuta) and is being proposed to control a variety of in sec ts on vegetab les and co le crops; herbs, spices , and mints ; pasture andhay crops; fruit, nut, and vine crops; field crops; commercial flowers and ornamental plants; 

### forest, shade tree, and nursery stock; and turf. The GS-U

-AC TX-H vla

-SEQ2 peptide (30% 

### and 20% ai formulations) is proposed for registrati on. The single maximum application rate is 0
. 8 lb ai/ A and the yearly maximum application rate is assumed to be the same, based on label uncertainties (see Labeling Recommendati ons section , below). For applications below the maximum rate , application intervals range f rom 3 to 1 0 days. Given that the tox icity data for this chemical are limited and non-definitive, and that little information is available about its environmenta l fate, the assessment qualitatively analyzed the anticipated effects ofGS

- U

- ACTX

- Hvla

- SEQ2 on non-target organisms in the environment. Direct risk concerns cou ld not be precluded for terrestrial invertebrates because acute oral tox ic ity data (adults) and larval toxicity data were unavailable. Given the spec ifici ty of GS-U

ACTX-Hvla-SEQ2 to insects and the oral de li very route (as specified on the label), direct risks may be possible fo r terres t rial invertebrates. Based on this finding, indirect risk concerns are i de ntified for terrestrial plants that rely on terrestrial invertebrates for pollination and other ecological services. Indirect effects are also possib le for taxa that rely on terrestrial invertebrates as a food source (amphibians, birds, fish, mammal s, reptiles, terrestrial invertebrates). No direct risk concerns were identified for the following:

• Aquatic

- phase amphibians • Aquatic plants • Birds • Freshwater and estuarine /marine fish • Freshwater and estuarine/marine invertebrates • Mammals • Reptiles • Terrestrial-phase amphibians • Terrestrial plants • Terrestrial inv ertebrates (contact) Key Uncertainties and Information Gaps P racticall y no fate data were submitted for GS

- U

- ACTX -H vla

- SEQ2. In addition, a limited number of ecotoxicity st udies were submitted (vegetative vigor, seedling emergence, acute freshwater invertebrate, acute freshwater fish, acute avian oral, acute mammalian oral, and honeybee acute contact toxicity). These studies were conducted as limit tests and demonstrated no effec ts; the results were extrapolated to other taxa. Addi ti onal st u dies on honeybees would reduce the uncertainty of the ri sk call to honeybees (Table 1 )
. The other missing studies that are normally required by the Code of Federal Regulations are listed below the tab le.

2Table 1. Honeybee Toxicity Data Gaps for GS-U

- ACTX

- Hvla-SEQ2 Guideline# Data Gap Justification GS-U-ACTX-Hv Ia-SEQ2 is an oral insect icide. Risk is presumed for adult No n -guidel in e Honeybee Acute honeybees based on an absence of acute oral toxicity data. An acute oral OECD 213 Oral Tox icity Test toxicity test wou ld reduce the uncertainty regarding its toxicity via the oral exposure route
. GS-U-ACTX-Hv Ia-SEQ2 is an oral in sectic ide and no larval data for Non-guideline Honeybee Larvae terrestrial invertebrates are available. Understanding its toxicity to larvae Toxicity Test would reduce the uncertainty regarding its effects on non-target terrestrial invertebrate larvae
. 

### Additional Fate Data Gaps • 835.2129 (hydrolysis) • 835.2240 (photodegradation in water) • 835.2410 (photodegradation in soi l) • 835.2370 (photodegradat ion in air- conditional, depending on chemical's properties) • 835.4100 (aerobic soi l metabolism) • 835.4200 (anaerobic soil metabolism) • 835.4300 (aerobic aquatic metabolism) • 835.4400 (anaerobic aquatic metabolism) • 835.1230 /835. 1240 (leaching adsorption/desorption) • 835
. 6100 (terrestrial fie ld dissipation) • 835.1410 (vo latili ty labo r ato ry- conditional, depending on chemical's propert ie s) 

### Additional Ecotoxicity Data Gaps • 850.1075 (acute estuarine /marine toxicity) • 850.1025 / 850.1035 (acute estuarine /marine invertebrate toxicity) • 850. 1 300 (f re shwater invertebrate life cycle test) • 850.1350 (estuar ine/marine invertebrat e life cycle test) • 850
. 1400 (freshwater fish early life stage test) • 850.1400 (estuarine/marine fish ea rl y life stage tes t) • 850.2100 (acute avian oral toxic ity with mallard and passerine species) • 850.2200 (acute avian dietary toxicity) • 850.2300 (avian reproduction toxicity) • 870.3800 (mammalian reproduction toxicity) • 850.4100 (seed lin g emergence - soybean only) • 850.4150 (vegetative vigor

- soybean only) • 850.4400 (aquatic plant growth- vascular plants) • 850.4500 (aquatic p l ant growth- non-vascu lar plants) Labeling Recommendations The label does not specify a yearly maximum application rate. The yearly maximum application rate is presumed to b e 0.8 lb a il

A, based on the maximum single application rate that is stated on the label. It is recommended that the yearly maximum application rate be c larified.

3Given the presumed risk to honeybees, the folJowing label statement is recommended from the Label Review Manual:

• This product is toxic to bees exposed to direct treatment or residues on }:>looming crops or weeds
. Do not apply this product if bees are v i siting the treatment area. 

### Threatened and Endangered Species: Federally listed species co-located in states, d istri cts, or commonwealths, known to produce the crops upon which the pesticide will be used were identified using the LOCATES_v.2.2.5 database (query performed on 517/13). Species on which direct and indirect effects may occur because of the proposed new uses are summarized by taxa in Table 2. A specific list of species on which direct effec ts may occur is included in Appendix A. 

### Table 2. Listed Species Risks Associated with the GS U 

## - -ACTX-Hvla- E 

# s Q 2 Proposed Uses Listed Taxa Direct Effects Indirect Effects Terrestrial and semi-aquatic plants No Yes (monocots and dicots) Birds No Yes Terrestrial phase amphibians No Yes Reptiles No Yes Mammals No Yes Terrestria l invertebrates Yes (oral) Yes Aquatic vascular plants No No Aquatic non-vascular plants No No Freshwa ter fish No Yes Aquatic phase amphibians No Yes Freshwater invertebrates No No Marin e/estuarine fish No Yes Marine/estuarine invertebrates No No

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