Date: 

Chemical: 

PC Code: 

DP Barcode: 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

May 30, 2013 

GS-U-ACTX-Hv 1 a-SEQ2 

006100 

D411507 

MEMORANDUM 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Ecological Risk Assessment for the Proposed New Chemical Registration of GSU-ACTX-Hvla-SEQ2 (VersutideTM peptide) on Vegetables and Cole Crops; 

Herbs, Spices, and Mints; Pasture and Hay Crops; Fruit, Nut, and Vine Crops; 

Field Crops; Commercial Flowers and Ornamental Plants; Forest, Shade Tree, and 

Nursery Stock; and Turf 

TO: Mark Suarez, Risk Manager Reviewer 

Marion Johnson, Branch Chief 

Registration Division (7505P) 

FROM: 

Susanne Cerrelli, Regulatory Action Leader 

Kimberly Nesci, Microbial Pesticides Branch Chief 

Biopesticides and Pollution Prevention Division (7511P) 

Meghan Radtke, Ph.D., Biologist 

Environmental Risk Branch 1 ~~ S" /so/13 

Environmental Fate and Effects Division (7507P) 

THROUGH: 

S

Edward 

En

uj

v

a

ir

th

onme

a Sankula, 

Odenkirchen, 

ntal Risk 

Ph.D., 

Branch 

Ph.D

Lead 

., 

1 

Acting 

Biologist 

Br~h · 'v"t"-Chie& ~~>~ ~ 

Environmental Fate and Effects Division (7507P) 

The Environmental Fate and Effects Division (EFED) has completed the request from the 

Registration Division to perform an ecological risk assessment in support of the new insecticide, 

GS-U-ACTX-Hvla-SEQ2 (VersutideTM peptide). The active ingredient is a peptide derived 

from the venom of the Australian funnel spider (Hadronyche versuta) and is being proposed to 

control a variety of insects on vegetables and cole crops; herbs, spices, and mints; pasture and 
hay crops; fruit, nut, and vine crops; field crops; commercial flowers and ornamental plants; 

forest, shade tree, and nursery stock; and turf. The GS-U-ACTX-Hvla-SEQ2 peptide (30% and 

20% ai formulations) is proposed for registration. 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 Recommendations section, below). For applications below the 

maximum rate, application intervals range from 3 to 1 0 days. 

Given that the toxicity data for this chemical are limited and non-definitive, and that little 

information is available about its environmental fate, the assessment qualitatively analyzed the 

anticipated effects ofGS-U-ACTX-Hvla-SEQ2 on non-target organisms in the environment. 

Direct risk concerns could not be precluded for terrestrial invertebrates because acute oral 

toxicity data (adults) and larval toxicity data were unavailable. Given the specificity of GS-UACTX-Hvla-SEQ2 to insects and the oral delivery route (as specified on the label), direct risks 

may be possible for terrestrial invertebrates. Based on this finding, indirect risk concerns are 

identified for terrestrial plants that rely on terrestrial invertebrates for pollination and other 

ecological services. Indirect effects are also possible for taxa that rely on terrestrial invertebrates 

as a food source (amphibians, birds, fish, mammals, 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 invertebrates (contact) 

Key Uncertainties and Information Gaps 

Practically no fate data were submitted for GS-U-ACTX-Hvla-SEQ2. In addition, a limited 

number of ecotoxicity studies 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 effects; the results were extrapolated to other taxa. Additional studies on honeybees would 

reduce the uncertainty of the risk call to honeybees (Table 1 ). The other missing studies that are 

normally required by the Code of Federal Regulations are listed below the table. 

2 
Table 1. Honeybee Toxicity Data Gaps for GS-U-ACTX-Hvla-SEQ2 

Guideline# Data Gap Justification 

GS-U-ACTX-Hv I a-SEQ2 is an oral insecticide. Risk is presumed for adult 

Non-guideline Honeybee Acute honeybees based on an absence of acute oral toxicity data. An acute oral 

OECD 213 Oral Toxicity Test toxicity test would reduce the uncertainty regarding its toxicity via the oral 

exposure route. 

GS-U-ACTX-Hv I a-SEQ2 is an oral insecticide 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 soil) 

• 835.2370 (photodegradation in air- conditional, depending on chemical's properties) 

• 835.4100 (aerobic soil 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 field dissipation) 

• 835.1410 (volatility laboratory- conditional, depending on chemical's properties) 

Additional Ecotoxicity Data Gaps 

• 850.1075 (acute estuarine/marine toxicity) 

• 850.1025/850.1035 (acute estuarine/marine invertebrate toxicity) 

• 850.1300 (freshwater invertebrate life cycle test) 

• 850.1350 (estuarine/marine invertebrate life cycle test) 

• 850.1400 (freshwater fish early life stage test) 

• 850.1400 (estuarine/marine fish early life stage test) 

• 850.2100 (acute avian oral toxicity with mallard and passerine species) 

• 850.2200 (acute avian dietary toxicity) 

• 850.2300 (avian reproduction toxicity) 

• 870.3800 (mammalian reproduction toxicity) 

• 850.4100 (seedling emergence - soybean only) 

• 850.4150 (vegetative vigor - soybean only) 

• 850.4400 (aquatic plant growth- vascular plants) 

• 850.4500 (aquatic plant growth- non-vascular plants) 

Labeling Recommendations 

The label does not specify a yearly maximum application rate. The yearly maximum application 

rate is presumed to be 0.8 lb ail A, based on the maximum single application rate that is stated on 

the label. It is recommended that the yearly maximum application rate be clarified. 

3 
Given 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 visiting the treatment area. 

Threatened and Endangered Species: Federally listed species co-located in states, districts, 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 effects may occur is included in Appendix 

A. 

Table 2. Listed Species Risks Associated with the GS -U -ACTX-Hvla-s E 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 

Terrestrial invertebrates Yes (oral) Yes 

Aquatic vascular plants No No 

Aquatic non-vascular plants No No 

Freshwater fish No Yes 

Aquatic phase amphibians No Yes 

Freshwater invertebrates No No 

Marine/estuarine fish No Yes 

Marine/estuarine invertebrates No No 

4