# Information to **US EP**  **A Environmental Fate**  **and Effects Division** November 30, 2010

## Physical & chemical characteristics The w ate r solubility of t echnical gr ade chlorphacinone is **13 mg /L** , much lower than the 34 mg /L r eport ed in the CED . The corr ect dat a, reflecting the low solubility , is import an t fo r reflecting the low solubility is import other issues addr essed below.

## Food Intake (FI) V **alues** The Sonor an tiger salamander , Piping plov er

, Black
- ca pped vir eo , and Golden
- cheeked wa rbler ha ve FI v alues that ar e 103%, 110%, 188% and 181% of their body weigh t per da y, using generic con ve rs ion fact ors. using generic con This significantly over - es timat es the Dose
- based EE C v alues used in the risk calculations. The use of such “extr eme” dat a is not appr opriat e when bette r estimat es c an be easily made.

## Residues in prairie dog carcasses The CED uses the maximum r esidue of 2.24 mg /kg in calculations. The large number of samples analyz ed (16) allows the mean r esidue number t o be used in risk calculations. The ave ra ge of r esidues found in the c ombined whole body and liv er (1 c ar ca ss w as missing the liv er) is 1.13 mg /kg.

## Nontarget primary consumer residue The CED uses r esidue dat a t aken fr om an "anon ymous" labor ato ry s tudy on "mouse," with an unknown sample siz e, fr om a cit ation in another s tudy r ather than an original s tudy. This another s ather than an original s dat a does not meet EP

A’ s accept ability crit eria. The highes t re sidue lev el fr om a r eliable s tudy is 3.2 mg /kg
- bw in voles
- st ill ve ry conservat iv e and much larger than the r eport ed field
- deriv ed re sidues (0.264 – 1.58, median of 0.922 mg /kg).

## To**xicity value selection** The “5
- da y r epeat ed dose” LD 50 

### va lue is an “e xtr eme” number with significan t uncert ain ty , deriv ed fr om a single s tudy nev er been v alidat ed or r epeat ed. The ecot oxd ata summary ed. The ecot summary (Appendix E) shows four L C 50 

### diet ary feeding st udies with Rattus nor vegicus , showing L C 50 

### fr om 1.14 mg /Kg t o 1.26 mg /Kg feed. This diet ary r out e of e xposur e would be mor e appr opriat e than the fiv e - da y oral g ava ge study.

### “ ... e xposur e over a five da y period is highly pr obable” jus tifies using this 5 da y t oxv alue. This s tate men t is not support ed by evidence, and fails t o r ec ogniz e the dynamics of bait co nsumption that occurs following application of R oz ol Pr airie Dog Bait. Almos t all of the

airie Dog Bait. all of the ava ilable bait is consumed by the pr airie dogs within a few da ys, as clearly illus trate d by the dat a collect ed in the ef

ficacy s tudy performed by Lee and Hygns tr om (MRID 47333602)

## We **ight adjustment factors**

- Chlor ophacinone (CPN) has not been s tudied fo r scaling , nor an y structurally
- re lated compound;

- Chlor ophacinone interrupts a biochemical cascade of coagulation with e xt ended time for mort ality t o occur;

- CPN is not similar t o chemicals st udied fo r scaling CPN is not similar t o chemicals r scaling fa ct ors (highly wate r soluble, ref ra ct ory t o met abolism;

- Scaling fact ors deriv ed fr om single dose acut e to xicity te star e appr opriately fo r r epeat - dose to xicity v alues;

- Scaling fact or is incorr ectly calculated in the CED, by using 20 grams as the weigh t of a rat;• Scaling fact or calculations in the CED do not conform to calculations in scien tific lit eratur e;
• Scaling fact or calculations in the CED ar e not ex plained or jus tified, no cit ation of an y scien tific evidence to support their use as applied to CPN;


### • Ther efor e, the weigh t - adjus te d t ox icity v alues ca lculat ed in the CED analysis by application of scaling fact ors **cannot be consider** **ed to** **be va**  **lid** unless and un til det ailed e xplanation and jus tification is made.

## Sublethal effects on Birds

• Sec ondary haz ar d s tudies on bir ds show no mort ality t o an y of the t es te d bir ds, and “s ublethal ef

fe cts” showed only with t es t bait co nta ining 50%
- 100% mor e activ e ingr edien t; ining 50% 100% mor e activ
• No science supports the CED s tate men ts that “s ublethal af

fe cts” ar e “equiv alen t t o lethality.”

## Sublethal effects on Mammals

• Studies on mammals support the conclusion of some risk of secondary poisoning;
• Almos t all of the s tudies shown in vo lve very small numbers of t est subjects, with only one has a large enough sample t o be s tat is tically significan t; enough sample t tically significan
• Man y r epr esen t extr eme "worstc ase" scenarios:

– contaminated pr ey fed much mor e bait than would be ava ilable in r eal
- world situations;

– pr eda tor/scave ng er test subjects fed mor e contaminated pr ey than likely;

– te stsubjects fed for mor e than fiv e da ys – mor e than 10 times longer in sev eral of the r eport ed s tudies.

## Exposure data availability

• Liphat ech submits annual re ports t o EP A that specify the amoun t of R oz ol Pr airie Dog Bait that is manufactur ed and sold during the pr evious calendar y ear;
• This pr ovides import an t in fo rmation about the pr ev alence of use, unlike “ anecdot al evidence and the br eadth of the r egis tran t's adv ertising ca mpaign” cit ed in the CED .

## Chlorophacinone incidents

• The majority of the inciden ts re ported in Appendix 1 of the CED ha ve no applicability to the prairie dog contr ol use patte rn;
• Only one of fiv e inciden ts “highly pr obable” fo r cert ain ty ar e applicable to the prairie dog use patte rn;

e applicable airie dog use
• No lis ting of the alleged inciden ts re ported by US FWS;
• no information on the method, conduct or r esults of re views of these ecological inciden t dat a, which “... ar e consider ed to further ref ine the charact eriz ation of potential ecological effects of with e xposur e to chlor ophacinone”

## Species **- specific**  **information** A significant number of the thr ea te ned or endanger ed species lis te d as LAA (Likely t o Adv ersely Af

fe ct) could clearly ha ve been exc luded based on the backgr ound biological dat a pr esen te d in the CED itself .

## Discussion of “risk” & “uncertainty”

• This “Chlor ophacinone Effects Det ermination” assessmen t fails t o assess “risk” , as it does not ta ke int o acc oun t an y pot en tial va riation in ex posur e.
• The R Q v alues ar e only as cert ain as the leas t cert ain elemen t, and these R Q calculations based on simplis tic ex posur e estimat es mus t be r ec ogniz ed as jus t that – simplis tic es timat es with e xtr emely high uncert ain ty.Revised calculations making only 3 changes
– **still v ery**  **conserv ative**  , but:

- excludes data that clearly fails to meet EP A’ s minimum standard for quality;

- uses mean value of prairie dog carcass residues from a data set suf ficiently large to be statistically analyzed, from a GLPdata set of know n source & quality;

- excludes we ight- adjustment factors that have no scientific justification. **Parameter Original**  **Va lue**  **used in CED Revised**  **Va lue**  **Exposure maximum value for**  **direct bait**  **consumption** 100% of diet from bait Same as original **Exposure maximum value for**  **secondary**

**exposure to toxin**  100% of diet from contaminated carcasses Same as original **Exposure maximum use**  Max. application rate and frequency Same as original **Exposure maximum use**  **scenario** Max. application rate and frequency shortest interval between applications Same as original
**Food intake estimate**  Maximum FI calculated with generic equations Same as original **Max nontarget**  **carcass residue**  5.8 mg/kg **CHA NGE:**  **3.2 mg/kg Max**  **prairie dog carcass**  **residue** 2.24 mg/kg **CHA NGE:**  **1.13 mg/kg**  **To xicity**  **value max -**  **mammals** 5 - day repeat dose of 0.16 mg/kg Same as original **To xicity**  **value max -**  **birds** 5 - day LC 50 of 56 mg/kg Same as original **We ight**  **adjustment to tox value**  Applied to each species **CHA NGE:**  **Not applied Species**  **Original RQ Bait**  **Revised RQ**

**Bait Original RQ** 

**BTPD Revised** 

**RQ BTPD Original** 

**RQ Mouse Revised** 

**RQ V ole**  **California condor**  * * 0.04 0.02 **0.104** 0.058 **Whooping crane 0.89**  **0.89** 0.04 0.02 **0.104** 0.058 **Eskimo curlew**  * * ** **0.104** 0.058 **Northern Ap**  **lomado falcon**  * * 0.04 0.02 **0.104** 0.058 **Chirichaua leopard frog**  * * ** **0.104** 0.058 **Mexican spotted ow**  **l Revised**  **Ta ble 5.1 Summary**  **o f RQ V**  **alues for**  **Av ian**  **Species**

**Mexican spotted ow**  **l** * * 0.04 0.02 **0.104** 0.058 **Piping Plover**  * * ** **0.104** 0.058 **New M**  **exican ridge**  **** **nosed rattlesnake** * * ** **0.104** 0.058 **Sonora tiger salamander**  * * ** **0.104** 0.058 **Black -**  **capped vireo** * * ** **0.104** 0.058 **Golden -**  **cheeked wa**  **rbler** * * ** **0.104** 0.058**Species Ingestion Rate**  **(w et**  **weight) (g/day** **) Original** 

**RQ Bait Revised** 

**RQ Bait Original** 

**RQ BTPD Revised** 

**RQ BTPD Original** 

**RQ Mouse**  **Revised**

**RQ vole Grizzly**  **Bear** 3077.07

(dry wt for bait) 9615.85 (carcass) **75.42 0.309**  **3.38 0.569**  **8.75 1.60**  **Black -** **footed ferret**  147.84 ***** ***** **7.45 1.64**  **19.29 4.56**  **Jaguar** 41 18.89 ***** ***** **12.69 0.800**  **32.85 2.26**  **Revised Ta**  **ble 5.3 Summary o**  **f RQ values for Mammalian Species** 

**Jaguar** 41 18.89 ***** ***** **12.69 0.800**  **32.85 2.26**  **Gulf Coast jaguarundi**  739.36 ***** ***** **9.20 1.16**  **23.82 3.30**  **Canada ly nx**  819.48 ***** ***** **9.00 1.14**  **23.30 3.21**  **Preble’ s**  **meadow jumping**  **mouse** 1.94 **41.35 6.432**  ****** ****** ****** ****** **Ocelot** 1575.97 ***** ***** **10.41 0.988**  **26.96 2.79**  **Gray wolf**  2310.74 ***** * **9.49 0.906**  **24.82 2.57**  *does not eat bait ** does not eat prairie dogs or non - target animals

### Note again: 

## These revised RQ values still reflect **the most protective and most conservative**  **data that can be considered scientifically valid**  , including the “extreme” exposure and “extreme” toxicity data and its accompanying uncertainty
.