OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION **UNITED ST AT**  **ES ENVIRONMENT AL**  **PROTECTION A GENCY** 

WA SHINGTON, D.C. 20460



### MEMORANDUM
**DATE: August 23, 2011**  **SUBJECT** : Preliminary Environmental Assessment for the Registration Review of AVI Glycine

Hydrochloride (AVG) **Registration Review Case #:** 6070 **PC Code:** 129104 **CAS #:** 55720
- 26
- 8 **Chemical Class:** Biochemical
**FROM:** Gina M. Casciano, M.S., Biologist

Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P)
**THROUGH:** Mike Rexrode, Ph.D., Senior Scientist

Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P)
**TO:** John Fournier , Regulatory Action Leader Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P) **ACTION REQUESTED** The following is the preliminary environmental assessment for AVI Glycine Hydrochloride (AVG), in support of the Registration Review Preliminary Work P lan.

### 2

**Executive Summary** Based on the available data, AVG is characterized as moderatel y toxic to avian species (acute LD 50


### = 121 mg/kg , LC 50 

### = 230 ppm; reproductive NOAEC = 50 ppm) and practically non - toxic to mammalians on an acute basis ( LD 50 

### = 6,480 mg/kg). 

### The Rat Reproductive Toxicity study , however, produced a NOAEL = 2.5 mg/kg/day and a LOAEL= 4.0 mg/kg/day for F 1 

### offspring and showed decreased viability of pups and retarded growth of F 1 

### and F 2 

### pups. Test diet was administered continuous ly

for at least 70 day s prior to F 0 

### mating and during mating, gestation, and lactation until the litters were weaned. The F1 pups were weaned onto the same diet received by their parents. AVG is practicall y non - toxic to coldwater fish ( LC 50 

### > 139 mg/L) and aquatic invertebrates ( 48 hr EC 50 

### = 1.81
- 137 mg/L ). AVG is also practicall y non - toxic to honey bees (oral and contact LD 50 

### > 100μg/bee) and exposure to plants should not result in adverse effects on seedling emergence, growth, weight or condition. The Agency assessed the potential risk of AVG (0. 11 lbs ai/A) to no n target organisms b y using the Tier I aquatic model, GENEEC , for evaluating exposure and to aquatic organisms and actual field residues for terrestrial species. All calculated RQ values were less than the Agency LOC (aquatic LOC = 0.05

– 0.5; and terrestrial LOC = 0.1

– 1.0). The Agency also has concluded a **No Effect** for endangered/ threatened species based on the risk assessment for non

- target aquatic and terrestrial species, the persis tence of AVG in the environment (1.7

- 4.7 day s), and the application rate (50 grams/A; 0.11 lbs ai/A). **STUDY SUMMARIES 1.0**  **Environmental Chemistry and**  **Fate Assessment** AVI gl ycine h ydrochloride (AVG) is a plant growth regulator used on apples, pears, and ornamentals. As a naturall y occurring chemical , AVG prevents the biosy nthesis of eth yl ene in plants by interfering with the functioning of the enzy me aminocyclopropanecarbox yl ate s ynthase (ACC synthase). When applied to apples, it may

delay fruit maturity , leading to benefits such as a reduction in pre

- harvest fruit drop and improved fruit quality . In pears, AVG may help maintain fruit firmness. For specific ornamentals (miniature carnations, hibiscus, and rooted geranium cuttings and seedlings), AVG may reduce problems such as flower senes cence and flower bud abscission that occur during shipping. Registered products containing AVG are intended for use as spray solution s , applied to apples or pears as a single application 28 day s prior to the anticipated b eginning of the normal harvest period, and to specified ornamentals 24 to 48 hours prior to boxing/shipping. AVG is very solub le in water at **674 ± 23 g/L** (pH =6.0) , has a very low vapor pressure, and a low potential to volatilize. AVG is hydrol ytically stable (sterile conditions) with an e xpected half

- life of greater than 5day s. Photodegredation data for water or soil was not available, but models indicate the half life of AVG in the atmosphere to be 0.7 hours during daylight and 4 hours at night (assuming ozone mediated decay and h ydrox ylmediated decay , respectivel y). No data is available on leaching rates of AVG. Degradation of AVG into two major metabolites has been observed in water and soil with ethox yv inylg lycine as the predominate degradate , and ω -N
- acetyl

- AVG as a slightly less predominate metabolite. AVG migrates rapidl y from the aqueous phase to the sedi ment phase and strongl y adsorbs to sediment.

### 3

AVG is easil y desorbed from soils with low clay content (humic sand and low humic content sandy loam) and degrades rapidly in sandy loam and loam during adsorption and desorption. Generally , AVG degrades rapidl y in soil, with half

- life ranging from **1.7** to **4.7** day s depending on soil ty pe. The half life for the two metabolites in soil ranged from 0.3

- 8.2 day s. A summary of the environmental chemistry and fate properties for AVG appear in Table 1.0.

### 4

**Table 1 .0 Summary of**  **AVG Environmental Chemistry and Fate Properties**  **Study Value (units)**  **Major Degradates Minor Degradates**  **MRID # Study Status**  Sediment and Soil Adsorption/ Desorption Sandy loam :

Kd

- ads = 59.96 mL/ g Koc - ads = 7,495 mL/g Kd

- des = 76.22 mL/g Lo w humic content sandy loam : Kd

- ads = 4.11 mL/g Koc - ads = 1,028 mL/g Kd

- des = 5.18 mL/ g Loam : Kd

- ads = 73.86 mL/ g Koc - ads = 7,386 mL/g Kd

- des = 82.66 mL/g Humic sand : Kd

- ads = 7.86 mL/g Koc - ads = 561 mL/g Kd

- des = 18.01 mL/g Degraded rapidly in sandy loam and loam during adsorption and desorption. Stable during adsorption in low humic sand and sand, but some degradation during desorption. Two d egradates we re observed but were not identified. 45359607 Acceptable

Hydroly sis Hydroly tically stable at pH 7, 9. Slight hydrolysis (6%) at pH 4. Test performed at 50 o C over five days. Degradates were not identified. 46791701 Acceptable
Aerobic Soil Metabolism Degraded very rapidly in sandy

loam and loam soils with a half life of 1.7 and 2.4 days, respectively. Half life in humic sand and low humic content sand soils were 3.0 and 4.7 days, respectively. HPLC confirmed that parent degraded rapidly and two major metabolites were formed . The half life of the two metabolites in the four soil types ranged from 0.3

- 8.2 days. 46066803 Acceptable

Aerobic/Anaerobic a quatic metabolism Moved rapidly from water column

to sediment in an anaerobic sediment/aerobic water system. Less than 1% test substance remaining in aqueous phase after 9 days of incubation. HPLC detected two metabolites , which were identified via LC

- MS/MS. Metabolite appearing in greatest quantity (and eluding first) was identified as ethoxyvinylglycine. Metabolite of lesser quantity was identified as ω -N
- acetyl

- AVG. 457 96502 4579650 3 Acceptable

Photodegredation in air Model results indicate a half life of

0.7 hours during daylight and 4 hours during night

- time. - 46066802 Non
Guideline/ Acceptable


### 2 **.0 Measures of Ecological**  **Exposure** Measures of exposure are based on aquatic and terrestrial models that predict estimated environmental concentrations (EECs) of a pesticide using maximum labeled application rates and methods of application. The use patterns for the three currently registered end

- use products (EPs) containing AVG

### 5

are applied as spray solutions to flowers, orchard fruit and foliage. Therefore, runof f and spray

drift are potential transport mechanisms of AVG to non - target aquatic and terrestrial sites. However , all end

- use product labels currentl y i nclude the statement “For Terrestrial Uses: Do not apply directl y to water, to areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water when disposing of equipment wash water or rinsate. ” The maximum use rate for AVG on o utdoor crops is 50 grams/acre applied twice pre

- har vest on apples and once pre

- harvest on all other approved crops. For aquatic exposure estimates, the Agency estimated environmental concentrations (EECs) of AVG that may impact aquatic organisms by applying a Tier I aquatic model, GENEEC Version 2.0 (Appendix B ). Terrestrial exposure was assessed by using actual residues taken in the field (peach orchard) for a similar compound ABG

- 3168 (50 grams ai/A). **3 .0**  **Measures of Effect** Measures of effect for AVG are obtained from the registrant

- submitted guideline studies for this biochemical . Th e acute measures of effect routinely used for non

- target animals in screening level assessments are the LD 50 

### , L C 50 

### or EC 50 

### , depending on taxa

. LD stands for "Lethal Dose", and LD 50 

### is the amo unt of a material, given all at once, that is estimated to cause the death of 50% of a group of test organisms. L C stands for “Lethal Concentration” and L C 50 

### is the concentration of a chemical that is estimated to kill 50% of a sample population. EC stan ds for “Effective Concentration” and the EC 50 

### is the concentration of a chemical that is estimated to produce some measured effect in 50% of the test population. Endpoints for chronic measures of exposure for listed and non

- listed animals are the NOAEL or NOAEC. NOAEL stands for “No Observed

- Adverse

- Effect

- Level” and refers to the highest tested dose of a substance that has been reported to have no harmful (adverse) effects on a test population. The NOAEC ( i.e ., “No
- Observed

- Adverse

- Effect

- Concentration” ) is the highest test concentration at which none of the observed results were statisticall y different from the control. **5 .0**  **Terrestrial Species Hazard Assessment Avian**  An acute oral toxicity

study using the technical grade of the active ingredient (TGAI) is required to establish the toxicity

of AVG to birds. The preferred test species is either mallard duck ( Anas platyrhynchos ; a waterfowl) or Bobwhite quail ( Colinus vir ginianus ; an upland game bird). Through two acute studies o n Bobwhite quail , AVG has been shown to be moderatel y toxic to avian species with **LD 50**  

### = **121 mg/kg**  and **LC 50**  

### = **230 ppm**  . A c hronic study in Bobwhite quai l showed reproductive effects in the 125ppm treatments groups (decline in offspring weight) , thus setting the NOAEC at **50 ppm**  (Table 5 .0). **Mammalian** The Agency

relied on the Acute Oral Rat study (OPPTS 870.1100) and the Two

- Generation Rat Reproduction study

(OPPTS 870.3800) as surrogates for predic ting the potential for mammalian hazard from exposure to AVG (Table 5
. 1 )

. The Acute Oral LD 50 

### for rats was calculated at **> 6,480**  **mg/kg** suggesting that this compound is practicall y non toxic to mammals on an acute basis (MRID 42672203)

. The Reproductive Tox icity study , however, produced a **NOAEL = 2.5 mg/kg/day** and a **LOAEL = 4.0 mg/kg/day**  for F 1 

### offspring and showed decreased viability of pups and retarded growth of F 1 

### and F 2 

### pups. Test diet was administered continuously for at least 70 day s prior to F 0 

### mating and during mating,

### 6

gestation, and lactation until the litters were weaned. The F1 pups were weaned onto the same diet received b y their parents (MRID 44946501 ). **Non Target Insects** AVG pro d

uced **LD 50**  

### > **100μg/bee** for oral and contact honey bee ( Apis mellifera L .) studies, indicating that AVG is practic ally

non - toxic to honey

bees ( Table 5. 2 )

. **Plants** In a single pre

- emergent application of 124 g a.i./ha, AVG application to corn, onion, ryegrass, wheat, bean, cabbage, lettuce, radish, tomato, and soy b ean seeds resulted in no adverse effects on seedling emergence, growth, weight or condition . In addition, n o phy totoxicity was observed i n any of the plants ( **NOEC = 124 g a.i./ha** , and **EC 25**  

### > 124 g a.i./ha ; MRIDs 45359611 and 45359612). **Table 5**  **.0 Summary of Avian Toxicity for AVG**  **Test Species % ai**  **Endpoint Toxicity**  **Category MRID No.** 

**Author/Year Study** 

**Classification** 

### Acute Toxicity Bobwhite quail (Colinus virginianus) 80.6 **LD 50**  **= 121**  **mg ai/kg**  Moderately toxic 43183610 Campbell et al. ,/1993 Acceptable Bobwhite quail (Colinus virginianus) 80.6 **LC 50**  **= 230**  **ppm** Moderately toxic 43183611 Campbell and Beavers, 1993. Acceptable **Chronic Toxicity** Bobwhite quail (Colinus virginianus) 88 No reproductive effects at 20 or 50 ppm. Effects observed at 125ppm were a decline in offspring body weight

. **NOAEC = 50**  **ppm.** 45796504 Frey et al ./2002 Acceptable



### Table **5 .**  **1 Summary of Mammalian Toxicity for AVG**  **Study** Test

Species **Endpoint Toxicity**  **Category MRID No.** 

**Author/Year Study** 

**Classification** 

### Acute Toxicity Ac ute Oral (OPPTS 870.1100) Rat **LD 50**  **= 6,480 m g**  **ai/kg** Practically non

toxic 42672203 Acceptable **Chronic Toxicity** Two - Generation Reproduction study (OPPTS 870.3800) Rat NOAEL = 2.5 mg/kg/day and **LOAEL = 4.0 m**  **g/kg/day** for F 1 offspring (decreased viability of pups and retarded grow th of F 1 and F 2 pups)

. 44 946501 Acceptable



### Table 5.2 Toxicity of AVG to Honey Bee **Test Species % ai**  **Endpoint Toxicity**  **Category MRID No.** 

**Author/Year Study** 

**Classification** Honey bee ( Apis mellifera L .) 82 4 8 hour oral and contact studies: **LD 50**  **>100μg/bee** for each study Practically non

toxic 45402204

Wainw right/2001 Acceptable

### 7

**6 .0 Aquatic Hazard Assessment**  **Fish** The acute freshwater fish study available for AVG concludes that this biochemical is practically non toxic ( **LC 50**  

### > 139 **mg/L** ) to coldwater fish (Table 6 .0). There are no chronic fish studies available for AVG. **Aquatic Invertebrates** Acute toxicity

studies on Daphnia magna are equivocal, with 48 hr EC 50 

### = 1.81
- 137 mg/L. This spans the range of moderate to practicall y non - toxic to freshwater invertebrates on an acute basis (Table 6.1 ). There are no chronic toxicity studies available for AVG in freshwater invertebrates. There are no studies on AVG involving estuarine or marine invertebrate s. **Table 6**  **.0 Freshwater**  **Fi sh Toxicity Studies for AVG**  **Species % ai**  **Results MRID**  **Classification Freshwater Species**  Rainbow trout ( Oncorhynchus mykiss ) 80.6 96hr LC 50 > 139 mg/L 43183612 Acceptable



### Table **6.1 Freshwater Invertebrates Toxicity Studies**  **for AVG**  **Species % ai**  **Effect MRID**  **Classification Acute Toxicity**  Daphnia magna 80.6 48 hr. EC 50 > 135 mg/L 43183613 Acceptable Daphnia magna 15 48hr. EC 50 = 11.9 mg/L (1.81 mg ai/L) 45402301 Acceptable



### 7 **.0 Risk Characterization**  Risk characterization is the integration of exposure and ecological effects characterization to determine the potential ecological risk from registered uses of AVI gl ycine hydrochloride (AVG) and the likelihood of direct and

/or indirect effects to non - target aquatic and terrestrial species

. For the screening

- level portion of this assessment, the deterministic risk quotient method (RQ) is used to provide a metric of potenti al risks. The RQ is a comparison of exposure estimates to toxicity endpoints; estimated or actual exposure concentrations are divided by acute and chronic toxicity values. The resulting unit less RQs is compared to the Agency’s levels of concern (LOCs) ( Table 7 .0). LOCs are used to indicate when the use of a pesticide, as directed on the label, has the potential to cause adverse effects on non

- target organisms. **Table 7**  **. 0**  **Agency Levels of Concern (LOC). Risk**  **Description RQ**  **Taxa** Ac ute Potential for acute risk to non

- target organisms

which may warrant regulatory action in addition to restricted use classification acute RQ > 0.5 aquatic animals, mammals, birds

### 8

**Risk Description**  **RQ Taxa**  Ac ute Restricted Use Potential for acute risk to non

- target organisms,

but may be mitigated through restricted use classification acute RQ > 0.1 aquatic animals acute RQ > 0.2 mammals and

birds Ac ute Listed Species Listed species may be potentially affected by

use acute RQ > 0.05 aquatic animals and terrestrial invertebrates acute RQ > 0.1 mammals and

birds Chronic Potential for chronic risk may warrant

regulatory action, listed species may potentially be affected through chronic exposure chronic RQ > 1 all animals

Non
- Listed and Listed Plant Potential for effects in non

- listed and listed

plants RQ > 1 all plants 

### Aquatic Risk Assessment Risk quotients (RQ) were calculated as an exposure/hazard ratio in order to determine the potential ecological risk from AVG exposure to non
- target aquatic species. The Agency has calculated the potential for exposure through GENEEC ( Generic Estimated Environmental Concentration Model Version 2.0; Aug. 2001 ) a Tier I computer program, that uses soil/water partition coefficient and degradation kinetic data to estimate runoff from a ten hectare f ield into a one hectare by two meter deep "standard" pond. This first tier is designed as a coarse screen and estimates conservative pesticide concentrations in surface water from a few basic chemical parameters and pesticide label use and application info rmation . Tier I is used to screen chemicals to determine which ones potentially pose sufficient risk to warrant higher level modeling. GENEEC is a program to calculate acute as well as longer

- term estimated environmental concentration (EEC) values. It cons iders reduction in dissolved pesticide concentration due to adsorption of pesticide to soil or sediment, incorporation, degradation in soil before wash off to a water body , direct deposition of spray drift into the water body, and degradation of the pestic ide within the water body (Appendix B ). The acute risk to freshwater fish and invertebrates form AVG exposure is not expected to be an environmental concern (RQ = 0.00) , all RQ values are below the Agency

L OC values (Table 8.0). **Table 8**  **. 0 GENEEC**  **( Version**  **2. 0**  **) E**  **EC Values (** **ppb )**  **for AVG**  **Application to Peaches**  **( 0.1**  **1 lbs.**  **ai/A, One**  **Applications/Year )**  **and Acute RQ Values Calculated for Fish and Aquatic Invertebrates Species**  **Toxicity End**

**Point Peak EEC (**  **ppb )**  **RQ (acute)**  **4 Day EEC** 

**( ppb**  **) RQ** 

**(acute)** 

### Acute **Exposure LOC = 0.05**

**– 0.5**  Rainbow trout ( Oncorhynchus mykiss ) **96 hr LC 50**  **> 139 mg/L**  **1.18 0.00**  **1.10 0.00**  Daphnia magna **48 hr EC 50**  **> 135 mg/L**  **1.18 0.00**  **1.10 0.00** 

### 9

**Terrestrial Risk Assessment** The Agency assessed the potential risk to terrestrial species from AVG exposure by evaluating actual field residues of ABG

- 3168 (S

- trans
- 2
- amino

- 4
- (2

- aminoethox y)

- 3
- butenoic acid hydrochloride) on peaches (Table 8.1). This compound is similar to AVG and also acts as a fruit ripening inhibitor with a treatment rate of 50 g active ingredient per acre (0.11 lbs ai) administered through a spray application to peach trees. Residues were collected at the day of application, as well as, 3, 5, 7, 9, 11, and 14 day s post application. Based on avian and mammalian toxic ity data and one application per year (ABG

- 3168; 15% ai) the Agency

calculated p otential acute and chronic RQs to these species. **Table 8.1 Residues Collected for ABG** **- 3168 (15% ai)**  **Date Sampled Days Post**  **Application Residues Found**  **for Parent**

**(ppm) Residues**  **fo r 15% ai**  **(ppm)** 6/02/99 0 0.29

– 0.39 0.04

– 0.06 6/05/99 3 0.21

– 0.31 0.03

– 0.05 6/07/99 5 0.13

– 0.14 0.02

– 0.02 6/09/99 7 0.10

– 0.09 0.01

– 0.01 6/11/99 9 0.06

– 0.06 0.01

– 0.01 6/13/99 11 0.03

– 0.04 0.00

– 0.01 6/16/99 14 < Level of Detection < Level of Detection 

### The acute and chronic risk to terrestrial species form AVG exposure is not expected to be an environmental concern (RQ = 0.00), all RQ values are below the Agency L OC values (Table 8.2) **Table 8.2 Acute and Chronic RQ Value**  **s Calculated for Avian and Mammalian Exposure to One**  **Application of ABG -**  **3168 (15% ai) Species**  **Toxicity End Point**  **Peak**

**Residue (**  **ppm )**  **RQ**

**(acute) 3 Day** 

**Residue (**  **ppm )**  **RQ**

**(acute) 7 Day** 

**Residues (ppm)**  **RQ**

**(chronic)** 

### Acute **Avian Exposure LOC = 0.**  **1**

**– 0.5**  Bobwhite quail (Colinus virginianus) **LD 50**  **= 121m g**  **ai/kg 0.06**  **0.00 0.05**  **0.00** 

### Chronic **Avian Exposure LOC = 1.0**  Bobwhite quail (Colinus virginianus **NOAEC = 50 ppm.**  **0.01 0.00**  

### Acute **Mammalian Exposure LOC = 0.**  **1**

**– 0.5**  Rat **LD 50**  **= 6,480 m g**  **ai/kg 0.06**  **0.00 0.05**  **0.00** 

### Chronic **Mammalian Exposure LOC = 1.0**  Rat **LOAEL = 4.0 m g**  **ai /kg/day**  **0.01 0.00**  

### Risk to **Terrestrial Endangered Species**  The Agency

used surrogate toxicity

information on the rat and Bobwhite quail and actual field residues (ABG

- 316 8 applied to peaches) order to assess possible risk to terrestrial species from exposure to AVG
. RQ values for acute avian and mammalian were at 0.00. These low RQ values combined with information that AVG degrades rapidly in the environment (about 1.7

– 4.7 day s) shows that residues will not exceed the Agency ’s LOC =0.1 for avian and mammalian endangered species concerns.

### 10

The Agency

has also calculated the potential risk to endangered/threatened terrestrial species by relying on the Individual Effects Model Version 1.1 (Table 8. 3 ) that predicts the chance of individual effect at about 1 in 1,610,000,000,000,000 . Based on the avian and mammalian toxicity data that has been submitted on the active ingredients, there should not be toxic risk to endangered/ threatened species from exposure to the end use product. AVG should present a **No Effect**  to terrestrial threatened or endangered species, if used in accordance with approved labeling. **Table 8. 3**  **Individual Effects Chance Model for Predicting the Chance of Individual Effects**  **of AVG**  **to Terrestrial Endangered Species**

**Risk to Aquatic Endangered Species**  Acute risk to endangered/threatened freshwater fish and invertebrates from AVG (0.11 lbs ai/A) exposure is not expected The Agency has also calculated the potential risk to endangered/threatened aquatic species b y rel yi ng on the Individual Effects Model Version 1.1 (Table 8. 4 ) that predicts the chance of individual effect at about 1 in 418,000,000 . Based on the fish and aquatic invertebrate toxicity data on the active ingredients, there should not be toxic risk to endangered/ threatened species from exposure to the end use product. AVG should present a **No Effect**  to aquatic threatened or endangered species, if used in accordance with approved labeling. **IE C**  **V1 .1**  **- In di**  **vi dual**  **E ffe**  **ct C hance**  **Mo del**  **V er**  **si on**  **1. 1**  **Pr ed**  **ic to**  **r of** 

**c ha**  **nc e**  **of**

**indiv idua**  **l e ffe**  **ct us** **ing probit dos**  **e- re**  **sp ons** 

**e cu**  **rve s** **lope a**  **nd me dia**  **n le th**  **al e**  **st imat** **e** En te r LC 50 o r LD 50 121
En te r des ir

ed th res hol d 0. 1 En te r slo pe of

d os e-res pons e 8 z sco re res ul t -8 z is the s tandar d nor ma l dev iate Pr obabil it y a sso cia te d wi th z 6. 22E -16 Us es E xce l N OR

MDIST fu nc tion to es ti ma te P w it h low erreporti ng limitof 1.0 E -1 6 Chanc e of

in div idual ef fec t, **~1 in . . .**  1. 61E +1 5 Ca lc ulated as 1/P Th is is b as ed on th e fo rm ul a lo gLC k = lo gLC 50 +( z/b ) where: z i s th e sta ndard norm al d ev ia te a nd b equal s sl ope Wo rk s fo r dos e- re sp ons e m odels bas ed on a probit as su mp ti on ( i. e. l og nor ma l dis tri bution ofindiv idual s ens it iv ity ) Note: E xce l c annot c alc ulate probabilities f orex trem es i n z s co re s bey ond - 8.2 P ro bability is def aulted to 10-1 6 , w h ic h is the l imitof E xce l r eporti ng. Ed O denk irch en, J une 2 2, 2 004 EFED/O PP/U SEPA Res et Mo del

### 11

**Table 8.4 Individual Effect Chance Model for Predicting Effects to Aquatic Endangered Species a**  **fter exposure to AVG**

**Conclusions** The Agency

assessed the potential risk of AVG (0.11 lbs ai/A) to non target organisms by using the Tier I aquatic model, GENEEC, for evaluating exposure and to aquatic organisms and actual field residues for terrestrial species. All calculated RQ values were less than the Agency LOC (aquatic LOC = 0.05

– 0.5; and terrestrial LOC = 0.1

– 1.0). If used according to label instructions, exposure to this compound will not have a toxic impact on non target species. The Agency also has concluded a **No Effect** for endangered/ threatened species based on the risk assessment for non target aquatic and terrestrial species, the persistenc e of AVG in the environment (1.7

- 4.7 day s), and the application rate (50 grams/A; 0.11 lbs ai/A). **IE C**  **V1 .1**  **- In di**  **vi dual**  **E ffe**  **ct C hance**  **Mo del**  **V er**  **si on**  **1. 1**  **Pr ed**  **ic to**  **r of** 

**c ha**  **nc e**  **of**

**indiv idua**  **l e ffe**  **ct us** **ing probit dos**  **e- re**  **sp ons** 

**e cu**  **rve s** **lope a**  **nd me dia**  **n le th**  **al e**  **st imat** **e** En te r LC 50 o r LD 50 139
En te r des ir

ed th res hol d 0. 05 En te r slo pe of

d os e-res pons e 4. 5 **Is this**  **a d ef**  **ault s lo**  **pe e**  **st im**  **at e?**  **Y es**  **or No**  z sco re res ul t -5. 85463498 z is the s tandar d nor ma l dev iate Pr obabil it y a sso ciate d wi th z 2. 39E -09 Us es E xce l N OR

MDIST fu nc tion to es ti ma te P w it h low erreporti ng limitof 1.0 E -1 6 Chanc e of

in div idual ef fec t, **~1 in . . .**  4. 18E +0 8 Ca lc ulated as 1/P Th is is b as ed on th e fo rm ul a lo gLC k = lo gLC 50 +(z/b ) where: z i s th e sta ndard norm al d ev ia te a nd b equal s sl ope Wo rks fo r dos e- re sp ons e m odels bas ed on a probit as su mp ti on ( i. e. l og nor ma l dis tri bution ofindiv idual s ens it iv ity ) No te: E xce l c annot c alc ulate probabilities f orex trem es i n z s co re s bey ond - 8.2 P ro bability is def aulted to 10-1 6 , w h ic h is the l imitof E xce l r eporti ng. Ed O denk irch en, J une 2 2, 2 004 EFED /O PP/U SEPA Res et Mo del

### 12



## Appendix **A . The Risk Quotient Method and Levels of Concern**  Risk characterization integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. The means of this integration is called the quotient method. Risk quotients (RQs) are calculated b y dividing expos ure estimates b y acute and chronic ecotoxicity values. RQ = EXPOSURE/TOXICITY RQs are then compared to OPP's levels of concern (LOCs). These LOCs are used b y OPP to anal yz e potential risk to nontarget organisms and the need to consider regulatory ac tion. The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on nontarget organisms. L OCs currently address the following risk presumption categories: (1) acute risks

- regulatory

action may

be warranted in addition to restricted use classification, (2) acute restricted use

- the potential for acute risk is high, but may be mitigated through restricted use classification, (3) acute endangered species

- endangered species may be adversel y affected, and (4) chroni c risk

- the potential for chronic risk is high regulatory action may

be warranted. Currentl y, EFED does not perform assessments for chronic risk to plants, acute or chronic risks to insects, or chronic risk from granular/bait formulations to birds or m ammals. The ecotoxicity

test values (measurement endpoints) used in the acute and chronic risk quotients are derived from required studies. Examples of ecotoxicity values derived from short

- term laboratory studies that assess acute effects are: (1) LC 50 

### (fish and birds), (2) LD 50 

### (birds and mammals), (3) EC 50 

### (aquatic plants and aquatic invertebrates) and (4) EC 25 

### (terrestrial plants). Examples of toxicity test effect levels derived from the results of long

- term laboratory studies that assess chronic ef fects are: (1) LOAEL or LOAEC (birds, fish, and aquatic invertebrates) and (2) NOAEL or NOAEC (birds, fish and aquatic invertebrates). For birds, mammals, fish and aquatic invertebrates the NOAEL or NOAEC generall y is used as the ecotoxicity test value in assessing chronic effects, although other values may be used when justified. Risk presumptions and the corresponding RQs and LOCs, are tabulated below.

### 13

**Table 1. Risk**

**presumptions for terrestrial animals based on risk**  **quotients (RQ) and levels of concern (LOC). Risk**  **Presumption RQ**  **LOC Birds**  **Acute Risk EEC**  **1 /LC**  **50 or LD**  **50 /ft**  **2 or LD**  **50 /day**  **3 0.5**  **Acute Restricted Use EEC/LC**  **50 or LD**  **50 /ft**  **2 or LD**  **50 /day (or LD**  **50 < 50 mg/k**  **g) 0.2**  **Acute Endangered Species EEC/LC**  **50 or LD**  **50 /ft**  **2 or LD**  **50 /day**  **0.1 Chronic Risk**  **EEC/NOAEC 1**  **Wild Mammals Acute Risk**  **EEC/LC 50**  **or LD 50** **/ft 2**  **or LD 50** **/day 0.5**  **Acute Restricted Use EEC/LC**  **50 or LD**  **50 /ft**  **2 or LD**  **50 /day (or LD**  **50 < 50 mg/k**  **g) 0.2**  **Acute Endangered Species EEC/LC**  **50 or LD**  **50 /ft**  **2 or LD**  **50 /day**  **0.1 Chronic Risk**  **EEC/NOAEC 1**  **1 abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items**  **2 mg** **/ft 2**  **3 mg** **of toxicant consumed/day LD**  **50** *** wt. of bird LD**  **50** *** wt. of bird Table 2.**  **Risk**

**presumptions for aquatic animals based on risk quotients (RQ) and levels of concern (LOC).**  **Risk Presumption**  **RQ LOC**  **Acute Risk EEC**  **1 /LC**  **50 or EC**  **50 0.5**  **Acute Restricted Use EEC/LC**  **50 or EC**  **50 0.1**  **Acute Endangered Species EEC/LC**  **50 or EC**  **50 0.05**  **Chronic Risk**  **EEC/NOAEC 1**  **1 EEC = (ppm or ppb) in water**  **Table 3. Risk**

**presumptions for plants based on risk quotients (RQ) and levels of concern (LOC).**  **Risk Presumption**  **RQ LOC**  Terrestrial and Semi

- Aquatic Plants Acute Risk EEC 1 /EC 25 1 Acute Endangered Species EEC/EC 05 or NOAEC 1 Aquatic Plants Acute Risk EEC 2/EC 50 1 Acute Endangered Species EEC/EC 05 or NOAEC 1 1 EEC = lbs ai/A 2 EEC = (ppb/ppm) in water

### 14

**Appen dix**  **B .**  **GENEEC Run for AVG Application to**  **Peaches**

---------------------------------------------- -------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPLTYPE NO
- SPRAY INCORP ONE(MULT) INTERVALKoc (PPM ) (%DRIFT) (FT) (IN)

------------------------------------------------------------------------------------------------------- ---- ------ .110( .110) 1 1 4028.0 4121.0 ORCHAR ( 9.7) .0 .0
FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

------------------------------------------------------------------------------------------------------------------ METABOLIC DAYS UNTIL HYDROLYSI S PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND

- EFF) (POND) (POND)

--------------------------------------------------------------------------------------------------------------- ------ ------ 4.70 0 N/A .70
- 8 6.80 9.00 8.15
GENERI C EECs (IN MICROGRAMS/LITER **(PPB)** Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

--------------------------------------------------------------------------------------------------------------- ----- ------- **1.18 1.10 .72**  .35 .24