2

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [ Kerry Leifer, Inert Ingredient Assessment Branch (I I AB) 703

- 308

- 8811 ]

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In cases where the outline element does not apply, please insert “NA

- Remove” and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply re place the instructions that appear in green , i.e., “ [ insert

company name ] ,” with the information specific to your action.

TEMPLATE:

[ Syngenta Crop Protection, LLC

, P.O. Box 18300

, Greensboro, NC 27419

- 8300 ]

[ 2E7986 ]

EPA has received a pesticide petition ( [ 2E7986 ] ) from [ Syngenta Crop Protection, LLC ]

, [ , P.O. Box 18300, Greensboro, NC 27419

- 8300 ] proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

( Options 2. (pick one)

T o establish an exemption from the requirement of a tolerance for

p olymers of one or more diglycidyl ethers of bisphenol A, res orcinol, glycerol, cyclohexanedimethanol

, neopentyl glycol , or polyethylene glycol with one or more of the following : polyoxypropylene diamine, polyoxypropylene triamine, n

- aminoethylpiperazine , trimethyl

- 1,6

- hexanediamine isophorone diamine, N,N

- dimethyl

- 1,3

- diaminopropane, nadic methyl anhydride, 1,2

- cyclohexanedicarboxylic a nhydride and 1,2,3,6

- tetrahydrophthalic anhydride when used as an inert ingredient (carrier) in pesticide formulations under 40 CFR

180.960 Syngenta i s s ub m it t i n g a p e ti t ion t o E P A u nd e r t h e F e de r al F ood D r u g a n d

Cos e m e tic A c t [ F F D C A ], as a m e nd e d b y the F o od Q u al i ty P r o te c tion A c t of 1996 [ F Q P A ] r e qu e sti n g an e x e m p tion f r om t h e re qu ir e m e n t of a tol er a nc e

. T h is p e ti t ion

re qu e sts t h e e l i m i n a t ion of t h e n ee d t o e stab l ish a m ax i m u m p e r m is s i b le l e v e l f or

re si du e s of p olymers of one or more diglycidyl ethers of bisphenol A, res orcinol, glycerol, cyclohexanedimethanol

, neopentyl glycol , or polyethylene glycol with one or more of the following : polyoxypropylene diamine, polyoxypropylene triamine, n

- aminoethylpiperazine , trimethyl

- 1,6

- hexanediamine isophorone diamine , N,N

- dimethyl

- 1,3

- diaminopropane, nadic methyl anhydride, 1,2

- cyclohexanedicarboxylic anhydride and 1,2,3,6

- tetrahydrophthalic anhydride in or on [all] raw agricultural commodities. EPA has determined that the petition

contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted d a ta at this time or whether the data supports granting of the petition. Additional data may be needed

befo re EPA rules on the petition.

A. Residue Chemistry3

1

. Plant m e tabo l ism. [ NA

- R e m o v e b ased on f a c t t h is i n f o r m a t ion is

gene r al l y n ot re qu ir e d w h e n all c r it er ia f or p olym e r e x e m p tion p e r 40 C FR 7 2 3 .250

a r e m e t .]

2. Analytical method. [ N A

- R e m o v e b ased on f a c t t h is inf o r m a t ion is gene r al l y

n ot re qu ir e d w h e n all c r it er ia f or p olym e r e x e m p tion p e r 40 C FR 7 2 3 .250 a r e m e t. In

a dd iti o n , Syngenta i s p e ti t io n i n g f or an e x e m p tion f r om t h e re qu ir e m e n t of a
tol er a n c e w itho u t any n u m e r ical l i m ita t io n s

. ] ]

3. Magnitude of residues. [ NA

- R e m ove b ased on f a c t t h is i n f o r m a t ion is

g e n er al l y n ot re qu ir e d w h e n a l l c r it er ia f or p olym e r e x e m p tion p e r 40 CFR 723.250

a r e m e t. ] ] ]

B. Toxicological Profile

The E P A h a s est a bl i shed a set of c rite r ia whi c h iden t i f y ca t e g o r ies o f

po l y m e rs t h a t pr e s e nt l ow r isk. T h e s e c rite r i a ( c odifi e d in 40 C F R 723.250) identi f y

po l y me r s that a r e re lative l y un r eac t i ve a n d st a ble c ompa r e d to o t h e r c h e m ic a l subs t a n ce s

as w e ll a s pol y m e rs t h a t a r e not r e a di l y a bsorb e d. T h e se pro p e r t ies g e n e r a l l y l i m i t a

po l y m e r ’ s abili t y t o ca use a d v e rse e f f

ec ts. No m a m m a l i a n to x ici t y i s anticip a ted f r om d i e ta r y , inhal a t i on o r d e rm a l e x posure f o r c h e m i ca l sub s tan ce s m e e t i ng the r e quir e ment

f

o r po l y m e rs of low r isk. Syngenta ass e rts that po l y m e rs m e e t i ng t h is po l y mer e x e mp t ion

c rite r ia wi l l pr e s e nt m in i mal or no risk. Th e r e fo r e , Syngenta b e l i e v e s an e x e mp t ion f r om

t he re quir e ment of a t ole ra n c e is j ust i fi e d sin c e in t he ca se of low r isk po l y me r s it c a n be

c le a r l y d e monstr a ted t h a t t he r isks f rom a g g re g a te e x posure to pesti c ide c h e m i ca l

r e s i du e s und e r r ea sona b l y f o r e s e e a ble c i r c ums t a n ce s will pos e s no a ppr e c i a ble r isks to

hu m a n h ea l t h. P olymers of one or more diglycidyl ethers of bisphenol A, res orcinol, glycerol, cyclohexanedimethanol

, neopentyl glycol or polyethylene glycol with one or more of the following : polyoxypropylene diamine, polyoxypropylene triamine, n

aminoethylpiperazine , trimethyl

- 1,6

- hex anediamine isophorone diamine, N,N

- dimethyl

1,3

- diaminopropane, nadic methyl anhydride, 1,2

- cyclohexanedicarboxylic anhydride and
1,2,3,6

- tetrahydrophthalic anhydride meet t he spe c ific crite r ia p e r C F R 40 723.250 a s d e s c rib e d b e low.

• The polymer is not a ca t i onic po l y me r , n o r is it rea sona b l y a nt i c ipat e d to

be c ome a c a t i onic po l y mer in a n a t u r a l aqu a t i c e nvironme n t.

• The polymer contains a s an integ ra l p a rt of i t s composi t ion t he a to m ic e lem e nts

c a rbon a nd h y d r o g e n.

• The polymer do e s not c ontain a s an integ ra l pa r t o f its c omposi t ion a n y

e le m e nts o t h e r th a n those l i sted in 40 C F R 723.250.

• The polymer is not d e si g n e d, n or is r ea sona b l y a nt i c ipa t e d to subs t a nt i a l l y d e g r a d e , d e c ompos e , or de po l y me r i z e

.

• T he polymer is manu fac tur e d on l y f rom mono m e rs a nd or r e ac t a nts t h a t a r e

a lr e a d y includ e d on the TS C A Ch e m i ca l S ubst a n c e I n v e n to r y

.

• The polymer is not a w a ter a b s o r bing po l y me r

.

• The polymer does not c ontain a n y g roup a s a r eac t i ve fun c t i on a l group.• The polymer has a m i ni m um nu m b e r a v e ra g e mo le c ular w e i g ht of > 10,000 D a l t ons.

• The polymer contain s less th a n 2 % ol i g ome r ic m a t e ri a l bel o w mo l ec ular

w e i g ht o f 5 00 D a l t ons a nd less than 5% ol i g ome r ic m a t e ri a l bel o w mo l ec ular w e i g ht
1,0 0 0 D a l t ons

. ]

1. Acute toxicity. [ N/A

– R e move b a s e d u pon polymer c onfo r ming to a ll c rite r ia

f

or low risk po l y m e r s under 40 C F R 7 23.250. ]

2. Genotoxicty. [ N/A

– R e move b a s e d u pon polymer c onfo r ming to a ll c rite r ia f or low risk po l y m e r s under 40 C F R 7 23.250. ]

3. Reproductive and developmental toxicity. [ N/A

– R e move b a s e d u pon polymer

c onfo r ming to a ll c rite r ia f or low risk po l y m e r s under 40 C F R 7 23.250. ]

4. Subchronic toxicity. [ N/A

– R e move b a s e d u pon polymer c onfo r ming to a ll

c rite r ia f or low risk po l y m e r s under 40 C F R 7 23.250.

. ]

5. Chronic toxicity. [ N/A

– R e move b a s e d u pon polymer c onfo r ming to a ll

c rite r ia f or low risk po l y m e r s under 40 C F R 7 23.250.

6. Animal metabolism. [ N/A

– R e move b a s e d u pon polymer c onfo r ming to a ll

c rite r ia f or low risk po l y m e r s under 40 C F R 7 23.250. ]

7. Metabolite toxicology

. [ N/A

– R e move b a s e d u pon polymer c onfo r ming to a ll

c rite r ia f or low risk po l y m e r s under 40 C F R 7 23.250. .]

8. Endocrine disruption

. [ This class of chemistry does not belong to a class of chemicals known or suspected of having adverse effects on the estrogen receptor or endocrine system. ]

C. Aggregate Exposure

1. Dietary exposure. [ N / A

– R e move b a s e d upon c onfo r m i n g to l ow r isk po l y mer c rite r ia

identifi e d in 40 C F R 723.250]

i. Food. [ N/A

– R e move b a s e d upon polymer c onf o rming t o low r isk po l y mer

c rite r i a identifi e d in 40 C F R 723.250 ]

ii. Drinking water

. [ N/A

– R e move b a s e d upon polymer c o n f o r m i ng to l ow r isk5 5

po l y m e r c rite r ia identifi e d in 40 C F R 723.250] ]

2. Non

- dietary exposure

. [ N/A

– R e move b a s e d u p on polymer c onfo r m in g to l ow

r isk po l y mer c rite r ia i d e nt i fi e d in 40 C F R 723.250]

D. Cumulative Effects [ N/A

– R e move b a s e d u p on polymer c onfo r m i n g to l ow r isk

po l y mer c ri t e ria i d e nt i fi e d in 40 C F R 723.250]

,

E. Safety Determination

1. U.S. population. [ B a s e d upon the c onfo r mation to t he c rite r ia us e d to i d e nt if y low risk po l y me r s, Syngenta believ e s th e re is a r e a sona b l e c e rt a in t y o f n o h a rm to the US

popu l a t i on f r om a g g r e g a te e x posure to r e sid u e s of the polymer. ]

2. Infants and children

. [

. Due to t he e x p ec ted low to x ici t y of the polymer and its

conformance t o a ll c rite r ia us e d to i d e n t i f y a low risk p o l y m e r, Syngenta believes that a

s a f e t y f ac tor a n a l y sis is not r e quir e d to ass e ss t he r isk. F or t he same r e a sons Syngenta

bel i e v e s the a ddi t ional ten f o l d sa fe t y f a c tor is unne c e s s a r y

. ]

F. International Tolerances

[ Syngenta is not aware of any country requiring a tolerance for th is polymer nor have any CODEX Maximum Residue Levels been established for any food crops at this time. ]