United States Prevention, Pesticides EP A-738-F-95-022 Environmental Protection And T oxic Substances June 1995 Agency (7508W) 

# R.E.D. F A CTS
Sodium Fluoroacetate Pesticide Reregistration All pesticides sold or distributed inthe United St ates must be r egister ed b y EP A, based on scientific studies sho win g that the y can be used without posin

g unr easonable risk

s t o people or the envir

onment. Because o

f adv ances in scientific kno

wled g e , the la w r equir es that pesticides which w er e fir st r egister edy ear s a g o be r e r egister ed t o ensur e that the y meet t oda y's mor e strin g ent st andar ds

. In e v aluatin g pesticides f

or r er egistr ation, EP A obt ains and r

e vie w s a complete set o

f studies fr

ompesticide pr

oducer s , describin

g the human health and envir

onment al effect s o f each pesticide

. The Ag enc y imposes an y r egulat ory contr ols that ar

e needed t

o effectiv ely mana g e each pesticide's risk

s . EP A then r er egister s pesticides that can be usedwithout posin g unr easonable risk

s t o human health or the envir onment. When a pesticide is eligible f or r er egistr ation, EP A announces this and e xplains wh

y in a R er egistr ation Eligibility Decision (RED) document. This f act sheet summariz

es the inf ormation inthe RED document f or r er egistr ation Case 30

73, sodiumfluor

oacet ate , also kno wn as compound 1 080. 

### Use Profile Sodiumfluor oacet ate is an acute t

o xicant pr edacide which is used a gainst co y otes which pr

e y on sheep and g

oat s . R egister ed end-use pr

oduct s ar e injected int

o the rubber r

eserv oir s o f the Liv est ock Pr otection collar

s , also r eferr ed t o as the "t

o xic collar", which ar

e str apped t o the thr oat s o f sheep or g

oat s . Co y otes attemptin

g t o kill collar

ed liv est ock ar e lik ely t o punctur e the collar

s and t o be f at ally poisoned b

y sodiumfluor

oacet ate as a r esult o f the att ack. When pr

edation is anticipated, up t o 20 collar

s ma y be used in fenced pastur

es up t o 1 00 acr es in siz e; up t o 50 collar

s ma y be used in pastur es o f 1 0 1 t o 640 acr es; and up t

o 1 00 collar s ma y be used in pastur es o f 64 1 t o 1 0,000 acr es . Sodiumfluor

oacet ate is a r estricted use pesticide which ma y be used only b y tr ained, certified applicat

or s and which is only r

egister ed f or use in liv est ock pr otection collar

s . Sodiumfluor

oacet ate will r et ainthe r estricted2 use classification imposed b y the Ag enc y in 1978 due t

o it s high acute t o xicity and the need f

or highly specializ

ed applicat

or tr ainin g. The Ag

enc y also has r e vie w ed concerns about the e

xposur e o f thr eatened and endan

g er ed animal species withthe United St ates Fish and W

ildlife Service (USFW

S). The Mar ch 1993 USFW

S final biological opinion onthe effect s o f sodium fluor oacet ate onthr eatened and endan

g er ed species addr

essed the liv

est ock pr otection collar and includedjeopar dy determinations t

o the gr a y w olf and grizzly bear

. Specific ar

eas w er e identified wher

e the collar could not be used and such r

estrictions ha

v e been incorpor

ated onthe liv

est ock pr otection collar labels

. No additional use r

estrictions t

o further pr

otect thr eatened and endan g er ed species ar

e bein g imposed at this time

. 

### Regulatory History De

v elopment and use o

f sodiumfluor

oacet ate as a pr

edacide and r odenticide inthe U.S. began inthe 1940s prior t o the 1947 enactment o

f the Feder al Insecticide

, Fun gicide , and R odenticide Act b

y which r equir ement s f or feder al r egistr ation o f pesticide pr

oduct s w er e instituted. In 1964 and a

gain in 197

1, the use o

f poisons t

o contr ol pr edat ory mammals w er e r e vie w ed b y selected committees

. In 1972 EP

A cancelled all r egister ed pr edat or contr ol uses o f sodiumfluor

oacet ate , sodiumc

y anide , and stry chnine

. In 1977, the U.S. Department o f the Interior (USDI) applied f or an Experiment

al Use P ermit (EUP) t

o inv estigate the potential risk s and benefit s associated withthe use o f sodiumfluor

oacet ate in "t o xic collar s" whichw ould be placed onthe neck s o f sheep and g

oat s . The t o xic collar cont ainin g sodiumfluor

oacet ate solutionw

ould be positioned ar

ound the animals' thr

oat r egions wher

e the y w ould be lik

ely t o be ruptur

ed b y the teeth o f co y otes that attempted t

o kill the liv

est ock with species-typical thr oat bites

. In 198 1, EP A w as petitioned b

y the USDI and liv

est ock inter est s t o r e visit the 1972 pr

edacide cancellation decisionwith r espect t o sodium fluor oacet ate
. EP A held inf

ormal hearin

g s in 198 1 and f ormal administr ativ e hearin g s in 1982 r

esultin g in a final decisiont

o permit EP

A t o consider applications f

or r egistr ation o f sodiumfluor

oacet ate int o xic collar s and sin gle-dose bait

s . In 1985, EP

A gr anted a r egistr ationt o USDI f or at o xic collar pr

oduct whichw as tr ansferr ed in 1986t

o the Animal and Plant Health Inspection Service (APHIS) o

f the U.S. Department o

f Agricultur

e (USD A). The r odenticide uses o

f sodiumfluor

oacet ate w er e cancelled due t

o lack o f supportin

g dat a. In 1989, all "special local needs" r egistr ations3 issued under § 24(c) o

f FIFRA w

er e cancelled, and all pendin g applications f or Feder al r egistr ationw er e denied b

y August 1990. 

### Human Health Assessment T

oxicity Sodiumfluor

oacet ate is a sodiumsalt o

f fluor oacetic acid which is a t an color ed alk aline po w der with a pH o

f 1 0.3. It melt

s at 197-203 C with

o decomposition. It is soluble inw ater , but pr actically insoluble in all nonpolar solv

ent s . Sodiumfluor

oacet ate is st able in sunlight, at atemper atur e o f 54 C, and intin coated met al cont ainer s . o The t o xicological dat

a base on sodiumfluor

oacet ate is adequate and will support r

er egistr ation eligibility

. Sodiumfluor

oacet ate has been placed inT o xicity Categ

ory I, which indicates the highest degr ee o f acute t o xicity , f or acute or

al t o xicity; T o xicity Categ

ory II, moder

ately t o xic , f or acute dermal t o xicity; T o xicity Categ

ory III, slightly t

o xic , f or primary e

y e irrit ant; and T

o xicity Categ

ory IV , pr actically non-t

o xic , f or dermal irrit ation. The r

equir ement s f or acute inhalation t

o xicity and dermal sensitiz ation studies w

er e w aiv ed due t o the se v er e acute t o xicity o f the compound. Sodiumfluor

oacet ate caused dose-r

elated findin

g s in hist opathology and decr eased siz e and w eight o f testes and epididymides in males in a subchr onic diet ary study in r

at s . In a subchr

onic study o

f sodium fluor oacet ate in drinkin

g w ater o f r at s , no effect

s w er e seen inthe kidne

y or liv er , but testicular atr

oph y and nonr

e v er sible tubular deg

ener ationw er e f ound at the mid-and high-doses

. T esticular atr

oph y with r e v er sible tubular deg ener ationw as f ound at the lo

w dose

. The met

abolismo f sodium fluor oacet ate is under

st ood inthe mammalian body

. It can be absorbed thr oughthe gastr

ointestinal tr

act, r espir at ory tr act, or openw

ounds , but only slo wly thr ough int act skin.
Human Risk Assessment
Because o

f the specific natur

e o f this r egister ed use , EP A's primary concern is f

or the potential risk o

f acute t o xicity
. Under the curr ent limited use pattern, no sodiumfluor oacet ate e xposur e t o the g ener al population is e

xpected. Risk o

f acute t o xicity t o applicat or s is mitigated b

y the pesticide's use r

estrictions and it

s classification as a r

estricted use pesticide

.4



### Environmental Assessment **E nvir** **onment al**  **F ate**  The Ag enc y has r e vie w ed published liter

atur e which sugg

est s that leachin g and met

abolismar

e the major r

outes o f dissipation. Ho

w e v er , undegr aded fluor

oacet ate is consider

ed mobile and consequently has a high potential t

o mo v e do wn w ar d inthe soil and r

each gr ound w ater
. While sodiumfluor

oacet ate has the potential t

o r each gr oundw ater , the Ag enc y's P esticides in Gr

ound W ater Dat abase r eport s no detections f

or the period 197 1 t o 199 1.
**E cological**  **E ffect** 

**s** The Ag enc y has adequate dat

at o assess the haz

ar d o f sodium fluor oacet ate t o nont ar g et or ganisms
. Sodiumfluor

oacet ate is v ery highly t o xic t o the mallar

d duck, chuk

ar , rin g-neck ed pheasant, wid

g eon, g olden ea gle , black vultur

e and the black-billed ma gpie on an acute or

al basis

. Subst antial chr onic e xposur e t o bir ds is not e

xpected withthe use o

f the sodiumfluor

oacet ate liv est ock pr otection collar

. Because the liv

est ock pr otection collar is specifically designed t o kill awild mammal (co y ote), wild mammal t

o xicity testin

g w as r equir ed f or sodiumfluor

oacet ate
. Sodiumfluor

oacet ate can be classified as v ery highly t

o xic t o co y otes , cott on r at, deer mouse

, r accoon, opossumand skunk on an acute or al basis

. It is slightly t

o xic t o r ainbo w tr out and pr

actically non-t

o xic t o bluegill sunfish. Sodiumfluor

oacet ate is pr actically non-t

o xic t o Daphnia ma

gna , a fr eshw ater inv ertebr ate
. The terr

estrial non-f

ood use o f sodium fluor oacet ate will not r

esult in subst

antial e xposur e t o marine and estuarine or ganisms , ther ef or e , these dat

aw er e not r equir ed. Cert ain nont ar g et species o

f bir ds and mammals

, includin g thr eatened and endan

g er ed species

, ma y be e xposed t o sodiumfluor

oacet ate used in liv est ock pr otection collar

s . Based on av

ariety o f studies that ha

v e been r e vie w ed b y the Ag enc y , the principal sour

ce o f risk is e xposur e o f sca v en g er s feedin g onthe head and neck ar ea o f dead liv est ock bearin

g sodiumfluor

oacet ate liv est ock pr otection collar

s . Fact or s that r educe the risk associated with use o f these collar

s include r

apid decomposition o

f car casses , selectiv e feedin g o f sca v en g er s fr omw ounds onthe car

cass r ather than cont aminated skin surf

ace o f the head or neck, and the emetic pr operty o f the chemical. The concerns f or risk t o wildlife can be addr

essed b y haz ar d st atement s , special use r

estrictions

, and endan

g er ed species pr otection st

atement s that ar e r equir ed t o be placed onthe pr

oduct label. 

### Additional Data Required The g eneric dat abase supportin

g the r er egistr ation o f sodium fluor oacet ate f or use in liv

est ock pr otection collar

s has been determined t

o5 be subst antially complete

. No ne w g eneric dat a ar e bein g r equir ed at this time
. The Ag enc y also is r

equirin g pr oduct-specific dat

a includin g pr oduct chemistry and acute t

o xicity studies

, r e vised Confidential St

atement s o f Formula (CSFs), and r

e vised labelin

g f or r er egistr ation. 

### Product Labeling Changes Required The labels o f all r egister ed pesticide pr

oduct s cont ainin g sodium fluor oacet ate must comply with EP A's curr ent pesticide labelin

g r equir ement s as specified in 40 CFR § 156.1 0 and other applicable notices
. The st atement s must also appear onthe labels o f sodiumfluor

oacet ate end use pr oduct s consistentwiththe USD A/APHIS pr

oduct's 18 use r

estrictions

. (See "Use R

estrictions" inthe RED document f or the 18 use r

estrictions). In addition, the st

ates ma y add use r

estrictions consistentwith EP A's r egulat ory position and legal decisions r egar din g pr edacidal uses o

f sodium fluor oacet ate , but no r equir ement s ma y be dr opped or mitigated. An

y chan g es t o the use r

estrictions must be r

equested thr

oughthe amendment pr ocess and must be accepted in adv ance b y E.P .A. 

### Regulatory Conclusion The use o f r egister ed pr oduct s cont ainin g sodiumfluor

oacet ate will not pose unr

easonable risk

s or adv er se effect s t o humans or the envir onment, pr

o vided that these pr

oduct s ar e used in accor

dance withthe r estrictions on pr

oduct labelin

g. Ther ef or e , the curr ent use o f these pr oduct s is eligible f

or r er egistr ation. Sodiumfluor

oacet ate pr oduct s will be r er egister ed once the r

equir ed pr oduct-specific dat

a, Confidential St

atement s o f Formula and r

e vised labelin

g ar e r eceiv ed and accepted b

y EP A. 

### For More Information EP A is r equestin g public comment

s onthe R

er egistr ation Eligibility Decision (RED) document f or SodiumFluor

oacet ate durin g a 60-da y time period, as announced in a Notice o f A v ailability published inthe Feder al R egister
. T o obt ain a cop y o f the RED document or t o submit written comment s , please cont

act the P esticide Dock

et, Public R

esponse and Pr ogr amR esour ces Br anch, Field Oper

ations Division (7506C), Office o f P esticide Pr

ogr ams (OPP), US EP

A, W ashin gt on, DC 20460, telephone 7 03-305-5805. Electr onic copies o

f the RED and this f

act sheet can be do

wnloaded fr omthe P esticide Special R

e vie w and R er egistr ation Inf ormation Sy

stemat 7 03-308-7224. The

y also ar e a v ailable onthe Internet on EP A's g opher serv er , GOP HER.EP A.GO V , or usin g ftp on FTP

.EP A.GO V , or usin g WWW (W

orld W ide W eb) onWWW

.EP A.GO V

. Printed copies o

f the RED and f

act sheet can be obt

ained fr omEP A's National Center f

or Envir onment al Publications and Inf

ormation6 (EP A/NCEPI), PO Bo

x 424 19, Cincinnati, OH 45242-04 19, telephone 5 13-489-8 190, f ax 5 13-489-8695.
Follo win g the comment period, the SodiumFluor oacet ate RED document also will be a

v ailable fr omthe National T

echnical Inf

ormation Service (NTIS), 5285 P

ort R o y al R oad, Sprin

gfield, V A 22 16 1, telephone 7 03-487-4650.
For mor e inf ormation about EP

A's pesticide r

er egistr ation pr ogr am, the SodiumFluor

oacet ate RED, or r

er egistr ation o f individual pr

oduct s cont ainin g SodiumFluor

oacet ate , please cont

act the Special R

e vie w and R er egistr ation Division (7508W), OPP , US EP A, W ashin gt on, DC 20460, telephone 7

03-308-8000.
For inf ormation about the health effect s o f pesticides

, or f or assist ance in r ecognizin g and mana

gin g pesticide poisonin

g s ympt oms , please cont

act the National P

esticides T

elecommunications Netw ork (NPTN). Call t

ollfr ee 1-800-858-7378, betw een 8:00 amand 8:00pmEastern St andar d T ime , Monda y thr ough Frida

y .