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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact : PV Shah

- Inert Ingredients branch

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:

Evonik Corporation

IN

- 10754

EPA has received a pesticide petition IN

- 10754 from Evonik Corporation

, 299

Jefferson Rd, Parsippany NJ 07054 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 (pick one)

2. to establish an exemption from the requirement of a tolerance for a low risk

polymer.

2

- propanoic acid, 2

- methyl

- ,2

- methylpropyl ester, homopolymer in or on the

raw agricultural commodity food crops. 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 before

EPA rules on the petition.

A. Residue Chemistry

1. 

### Plant me tabolism.

2. Analytical method. [Insert text.]

3. Magnitude of residues. [Insert text.]

B. Toxicological Profile2



### 1. Acute toxicity. [Practically non

- toxic as the substance is a non

- bioavailable

polymer; LD50 rat, oral > 5200 mg/kg; LD50 rat, dermal > 9000 mg/kg

(analogy; test item was a copolymer c 

### ontaining methyl methacrylate and

acrylates; source: literature* ]

2

- P rop e no i c ac id, 2

- m e t hy l

- , 2

- m e th y lpro p y l e s t e r, homop o l y m e r w ith a n

a v e r a g e mo l ec ula r

w e i g ht 15 8 .000 D a ltons c on f or m s to the d e f

ini t ion of a po l y m e r g i v e n in 40

C F R 723.250 a nd m e e ts the c r i t e r ia th a t a re u s e d to i d e n t ify low r i s k

p ol y m e r s

.

T he f ollo w ing c r i t e r ia a re m e t :

1. N ot a ca tio n ic pol y

m e r nor is it r ea s on a

bly a n t i c i p a t e d to b ec o me a

c a t i onic pol y

m e r in a n a tu r a l a q u a t ic e n v iron m e nt.

a

. I s obu t y l m e th a c r y l a te [ C A S 9 7

- 86

- 9] i s a n e utr a l mono m e r

.

2. Cont a ins a s a n i nt e g r a l p a rt of its c ompo s i tion a t l ea s t t w o of the a t om i c

e l e m e nts c a rbo n

, h y dr o g e n, nitro g e n, ox yg e n, s ili c on, a nd s ul f ur.

a

. T he pol y

m e r is c om p o s e d of a h y dro ca rbon b ac kbo n e a nd c o n t a ins

c a rbon, h y dro g e n a nd o x yg e n.

3. D o e s not c on t a in a s a n int e g r a l p a rt of its c o mpo s ition, e x c e pt a s i mpur i t i e s

,

a ny e l e m e n t ot he r th a n t h o s e l i s t e d in 40 C F R 723.250(d)(2) ( ii).

a

. T h e p ol y

m e r is c ompo s e d of h y dro ca rbon b a c k b o ne w i th no n e of t h e

e x c l u d e d e l e m e n ts l i s t e d in 40 C F R 723.250(d)(2)( i i).

4. T he p o l y

m e r i s n e it h e r d e s i g n e d nor c a n it be r ea s on a bly

a nti c i p a t e d to s ub s t a n t i a l ly d e g r a d e , d e c ompo s e , or d e pol y m e r i z e

.

a

. T h e produ c t do e s n o t c h a n g e dur i ng m a nu f ac t u re or u s e

.

5. T he pol y

m e r is m a nu f

ac tu r e d or im p or t e d f

rom mono m e rs a n d

/or r e a c t a n t s

th a t a r e a lr e a dy in c lu d e d on the T S CA C h e m i c a l S ub s t a n c e I n v e nto r y or

m a nu f ac tu r e d un d e r a n a pp l i c a ble T S CA s ec ti o n 5 e x e m p tion.

a

. I s obu t y l m e th a c r y l a te [ C A S 9 7

- 86

- 9] i s li s t e d on T S C A

.

6. I s not w a t e r a b s orb i ng w ith a numb e r a v e r a g e mol ec u l a r w e i g ht g r ea t e r t h a n or

e qu a l t o 10 .000

D a lton s

.

a

. T h e a v e r a g e m o l e c u l a r w e i g ht of the pol y m e r i s 1 58.000 D a lton s

. D u e to

i s obut y l m e th a c r y l a te

[C A S 97

- 86

- 9] i s a n e ut r a l mono m e r i ts pol y m e r i s in s o luble in w a t e r.

7. T he p o l y

m e r do e s not c ont a in, a s a n in t e g r a l p a r t of its c ompo s i t ion,

e x c e p t a s impu r

it i e s , one or m o r e of the f ollo w i ng p e r f

luoro a lk y l moi e t i e s

c on s i s ting of a C F 3

- or l on g e r c h a in l e n g th: a

. P e r f luoro a lk y l s ul f

on a t e s

( P F AS ), b. P e r f

luoro a lk y l ca rbox y l a t e s ( PFA C),3

c

. F luoro te lo m e r s

, d. P e r f luoro a lk y l moi e t i e s th a t a r e c o v a l e n t ly bound to e ith e r

a ca rb o n or s ul f

ur a tom w h e re the ca rb o n or s ul f ur a tom is a n in t e g r a l p a rt of the

p o l y m e r m ol ec ul e

.

a

. T h e pol y

m e r i s 100% 2

- P rop e noic a c id, 2

- m e th y l

- , 2

- m e t h y lpro p y l e s t e r,

ho m opol y

m e r

. b. N o p e r f

luoro a lk y l c om p on e nts a r e u s e d in t h e m a n u f ac tur i ng pro ce s s of the

p ol y m e r.

8. T he p o l y

m e r m u s t m e e t one of the e x e m p tion c r it e r i a s p ec i f i e d in 40 C F R

723.250( e ):

a

. T he pol y

m e r m e e ts the c r i t e r i a in 40 C F R 723.2 5 0( e )(2) by h a v ing a numb e r

a v e r a g e mol e c u la r w e i g ht g r ea t e r t h a n 10,0 0 0 D a lton, l e s s t h a n 2% o l ig om e r i c

m a t e r i a l b e low M W 500 a nd l e s s th a n

5% o l i g om e r ic m a t e r i a l be low M W 1,000.

A s s t a t e d a

bo v e

, 2

- P rop e noic ac i d, 2

- m e th y l

- , 2

- m e th y lpro p y l e s t e r,

homo p ol y

m e r m ee t s a ll c r it e r ia f

or a p o l y

m e r to b e c on s i d e r e d low r i s k

un d e r 40 C F R 723. 2 50. B a s e d on it c on f or ma n c e to the c r i te r i a in this

un i t, no m a m m a l i a n to x i c ity is a nti c i p a t e d f rom di e t a r y , inh a l a t ion, or

d e r m a l e xpo s ure to 2

- P rop e n oi c a c id, 2

- m e th y l

- , 2

- m e th y lpro p y l e s t e r, homopol y

m er

.



### 2. Genotoxicty. [Practically non

- toxic (see above); Two Ames

- Tests were

negative kg (analogy; test copolymer containing methyl methacrylate

and acrylates; source: literature* ]

3. Reproductive and developmental toxicity. [Practically non

- toxic as the

substance is a non

- bioavailable polymer ]

4. Subchronic toxicity. [ Practically non

- toxic (see above) ]

5. Chronic toxicity. [ Pr actically non

- toxic (see above) ]

6. Animal metabolism. [Not bioavailable, no metabolism expected ]

7. Metabolite toxicology

. [No metabolites expected to be formed ]

8. Endocrine disruption

. [Not expected as the substance is a non

- bioavailable

polymer ]

*Reference: Cosmetic Ingredient Review Expert Panel, Final Report on the Safety

Assessment of Acrylates Copolymer and 33 Related Ingredients. Int J Toxicol 3

(21): 1

- 50 (2002)

C. Aggregate Exposure

1. Dietary exposure. [Insert text.]4



### i. Food. [Insert text.]

ii. Drinking water

. [Insert text.]

2. Non

- dietary exposure

. [Insert text.]

D. Cumulative Effects

[Insert text.]

E. Safety Determination

1. U.S. population. [Insert text.]

2. Infants and children

. [Insert text.]

F. International Tolerances

[Insert text.]