EPA Registration Jacket 4‐480
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MATERIAL TO BE ADDElJ TO JACKET 

REG# 

Description: 

checkal! th~~t 

!;;:;a new stamped accepted label ~-

~ newCSF 

o notification 

Instructions: 

Attach this sheet to the top of ALL material sent to the file room (both loose paper and 

new material in jackets), This sheet will be imaged; a clear description will aid in 

finding material in the e-jacket. Remove staples from all material, If returning loose 

paper then hold together with a binder or paper clip. CSFs should be placed in the 

CSF folder (if returning jacket) or covered with a red CBI sheet (if returning loose 

paper).' Material to be returned to file room should bE) plaCE) in the appropriate bin. 

Reviewer's hi 

Name: ''f2)I V;, Q: \1\[\9 §V\LX:~ D 

Phone: 2If'r bEr(1= . 

Date: 

Division: 

l2~lcq 

RO\He> 
3

u.s. ENVIRONMENTAL PROTECTION 

AGENCY EPA Reg. Number: Date of Issuance: 

.$',~UJ ST"~ 

f ... 'l'~ Office of Pesticide Programs 4-480 

,~. Registration Division (7505P) 

\. ~; Ariel Rios Building DEC -') c 2CGj 1200 Pennsylvania Ave., NW ' 0 J:j, PRO'It: 

Washington, D.C. 20460 

NOTICE OF PESTICIDE: Tcnn of Issuance: conditional 

.x... Registration 

_ Reregistration Name of Pes tid de Product: 

(under FIFRA., as amended) Bonide MlMax Lawn Granules 

Name and Address of Registrant (include ZIP Code): 

Bonide Products, Inc. 

630 I Sutliff Road 

Oriskany, NY 13424 

<Nilte::Cb'iiiiMiiS ;iiiJabelirig<di:ffe:rill·:ili~ribsilliic:e'frOmditiaraCci: 'ted_ui'cODncdion";w5th lliis reO lsniti~ii mustbc ~$u!:ll11itted.to and ace ted by t1ie 

':-;ji'igjSf:ci[ronfbiViS'id~"1irioi-toUSb,ti.ilie':laber:jn,cominerce:' :hi'~Y'6oiies'j;bnd'e;;2e'o;i-'ihis'IiJd1ict:3I~Ys 'rfie'?'fi,;fue' abOve' EPA ii:frai'ion 'number. ' 

On the basis of information furnished by thc registranI, the above named pesticide is hereby registered/reregistered UJIder the Federallnsecticide, 

Fungicide and Rodenticide Act. Registration is in no way to be construed as an endorscment or recommendaIion of this product by the Agency. In order 

to protect health and the environment, the Administrator, on his motion, may at any time suspend or cancel the registration ofa pesticide in acco.tdance 

with the Act. The acceptance of any name in connection with the registration ofa product under this Act is not to be construcd as giving the registrant a 

right to exclusive use of the name or to its use if il has been covered by others. 

This product is conditionally registered in accordance with FIFRA sec. 3( c)(7)(A) provided that you: 

1. Submit and/or cite all data required for registration/reregistration review of your product 

when the Agency requires all registrants of similar products to submit data; and submit acceptable 

responses required for reregistration of your products under FIFRA section 4. 

2. Make the following label cbanges: 

a. Revise the "Precautionary Statements" to read: "Harmful if swallowed, inhaled or 

absorbed through skin. Causes moderate eye irritation. Avoid contact with skin, eyes or clothing. 

Avoid breathing dust. Wash thoroughly with soap and water after handling. Remove and wash 

contaminated clothing before reuse." 

3. Revised the order of the "First Aid" statements are so they are listed as follows: "If in 

eyes", "If swallowed", "If on skin", and "If inhaled". 

0 

Signature of Approving Official: I Date: 

~~r~~~:d~:~~~ 

Kathryn V. Montagu. 

23 

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Registration Division (7505P) 

EPA Fonn 8570-6 
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page 2 

EPA Reg. No. 4-480 

year from the date of this Notice, conduct one year studies for guidelines 830.6317 (storage 

stability) and 830.6320 (corrosion characteristics). Samples must be analyzed at 3, 6, 9 and 

and 12 months. They should be submitted in electronic and hard copy format. 

Submit one copy of the revised printed labels for the record. If these conditions are not 

complied with, the registration will be subject to cancellation in accordance with FIFRA sec. 

6( e). Your release for shipment of the product constitutes acceptance of these conditions. 

A stamped copy of the label is enclosed for your records. 
5

i 

Bonide 

MMax 

Lawn Granules 

[*Kills lawn Moss Quickly J 

[*See Results in Hours J 

[*Covers lip to 5/000 sq.ft. 1 

[*Kills patches of unwanted moss J 

[*ReadY-To-Use granules J 

[*Easy to use J 

[ *With 7% Iron J 

[*Turns lawns a deep green J 

[*No excess growth, less mowing} 

Active Ingredient: 

20-0-5 

Ferrous Sulfate Monohydrate .............. 23.5% 

Inert Ingredients: .................................. 76.5% 

Keep out of reach of children 

CAUTION 

ACCEPTED 

witb COMMENTS 

In EPA Letter Dated: 

DEC 2 9 2C09 u~ ~ Federal In: ;ticidc, 

FUIlglcide, and Rcxlerll1cide Act 

as ~ded. for the pesticide 

reg""",," under EPA """ No 

1~ Lj"6D 

See back panel for additional precautionary statements and First Aid 

NET WT. _______ _ ." . 

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PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

CAUTION: Causes eye irritation. Do not get in eyes, on skin or clothing. Harmful if swallowed, 

inhaled or absorbed through skin. Avoid breathing dust. Remove contaminated clothing and 

wash before reuse. Wash thoroughly with soap and water after handling and before eating or 

smoking. Do not allow persons or pets in treated areas until granules have been watered in and 

treated area is dry. 

FIRST AID 

IF SWAllOWED: Call a poison control center or doctor immediately for treatment advice. Have 

person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by a 

poison control center or doctor. Do not give anything by mouth to an unconscious person. 

IF IN EYES: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove 

contact lenses, if present, after the first 5 minutes, then continue rinsing. Call a poison control 

center or doctor for treatment advice. 

IF ON SKIN OR CLOTHING: Take off contaminated clothing. Rinse skin immediately with plenty 

of water for 15-20 minutes. Call a poison control center or doctor for treatment advice. 

iF INHALED: Remove person to fresh air. If person is not breathing, call 911 or an ambulance, 

then give artificial respiration, preferably mouth-to-mouth if possible. Call a poison control 

center or doctor for further treatment advice. Have the product container or label with you 

when calling a poison control center or doctor or going for treatment. 

ENVIRONMENTAL HAZARDS 

Do not apply directly to water. Do not contaminate water when disposing of equipment 

washwaters. To protect the environment, do not allow granules to enter or run off into storm 

drains, drainage ditches, gutters or surface waters. Applying this product in calm weather when 

rain is not predicted for the next 24 hours will help to ensure that wind or rain does not blow or 

wash pesticide off the treatment area. Sweeping any product that lands on a driveway, 

sidewalk, or street, back onto the treated area ofthe lawn or garden will help to prevent run off 

to water bodies or drainage systems. 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in a manner inconSistent with its labeling. 

For residential use only. Not for use indoors. 

" , , , 

IRON Will STAIN. Use this product on lawns and around flowers and orname~tar)s~rubs. 'Reep 

this product off surfaces such as sidewalks, patios, wooden decks, driveways a'nd 'clc'Hhin&. >, 

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Sweep concrete surfaces immediately to prevent staining. If concrete is wet wh~n (;ontact 

occurs, staining may be impossible to prevent. :,' ,; ., , " 

RATE OF APPLICATION ", , 

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For normal infestations of moss, apply this product at the rate of 4 pounds per 1,000 sq.ft. A 20 

lb. bag will cover 5,000 sq.ft. For heavy infestations of moss, apply at the rate of 8 pounds per 

1,000sq.ft. A 20 lb. bag will cover 2,500 sq.ft. 

Lawn moss thrives in damp, shady areas where the soil is acidic and drainage may be poor. If 

steps are not taken, moss can spread and take over a lawn. MMax Lawn Granules wi!! quickly 

kill lawn moss, giving your lawn grass the opportunity to fill in and reclaim the lawn. 

For best results, apply this product when the lawn is moist. Mow before application, to better 

expose existing moss and water in to activate the product. 

[Claim for formula containing no N-P-Kfertilizer:} You can now enjoy a beautiful moss free lawn 

with no excess growth & less mowing. 

As A Spot Treatment In LAWNS and around Ornamental Shrubs and Flowers: 

Apply anytime moss is actively growing and soil is moist. Sprinkle granules over the mossy area. 

Immediately after application, water-in. Wait several days until the moss turns black and dies, 

then gently rake it out. 

IMPORTANT: This product can burn delicate foHage if applied d'lrectly to flowers and 

ornamental shrubs. If contact does occur, use a garden hose to wash the product off of the 

plants immediately. 

SPREADER SETIINGS (Insert standard spreader setting chart) 

GUARANTEED ANALYSIS [example]: 

Total Nitrogen (N) .... 20% 

Soluble Potash (K20) .... 5% 

Iron (Fe) .... 7% 

Derived from ammonium sulfate, urea, muriate of potash, ferrous sulfate. 

Information regarding the contents and levels of metals in this product is available on the 

internet at http://www.aapfco.org/metals.htm. 

STORAGE AND DISPOSAL 

Pesticide Storage: Store and transport in an upright position. 

inaccessible to children. 

Store in a cool dry area 

" " " . " , , , " , 

Pesticide Disposal: Jf partly filled - Call your local solid waste agency for dispo~al (n~trucbon;., ,,'''' ".,"> Never place unused product down any indoor or outdoor drain. ;;' 

Container Disposal: Jf empty - Nonrefillable container. Do not reuse or refill this 'c'ontain~, ' , ; , " " 

Place in trash or offer for recycling if available. 

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To the extent consistent with applicable law, buyer assumes all risks of use, storage or handling 

of this product not in strict accordance with directions given herewith. 

Bonide Products, Inc. 

6301 Sutliff Road 

Oriskany, NY 13424 

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DATE OUT: 10/28/09 

SUBJECT: FEE PRODUCT CHEMISTRY REVIEW OF MP [] EP [X] 

DP BARCODE No.: D368665 REG. No. IFile Symbol No. 4-UIN 

PRODUCT NAME: BONIDE MMAX LAWN GRANULES 

PCC: 050507 Decision No. 418493 

FOOD USE [] 

COMPANY: BONIDE PRODUCTS, INC. 

FROM: 

~ \0\"';;"0"1 

Indira Gairola, Chemist Q-r 

Product Chemistry Team ('M _, h I D\ V I /I I 

Technical Review BranchiRD (7505P) b V oVv , 

TO: Joanne Miller I Dianne Morgan PM 23 

Herbicide BranchiRD (7505P) 

INTRODUCTION: 

BONIDE PRODUCTS, INC is seeking registration for the subject product BONIDE MMAX 

LAWN GRANULES. Applicant claims the subject product BONIDE MMAX LAWN 

GRANULES to be a "Me Too" of EPA Reg. #s 538-223, 802-543, 8660-178 and 9240-8. 

Applicant has submitted Basic CSF dated 08/04/09. 

The submitted package was reviewed and details will be discussed below: 

SUMMARY OF FINDINGS: 

I. The subject product BONIDE MMAX LAWN GRANULES contains 23.5 % of Ferrous 

Sulfate Monohydrate. 

2. BONIDE PRODUCTS, INC has submitted MRlD # 478284-01 for Product Chemistry data 

to support the registration of BONIDE MMAX LAWN GRANULES. 

3. The source of active ingredient listed for the subject product is not registered. 

4. The inert used is approved for non-food use. 
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2 

5. Basic CSF dated 08/04/09 for the subject product meets the label claim of. 23.5 % of 

Ferrous Sulfate Monohydrate. 

6 Data corresponding Sub Group A completely satisfy the data requirements of 

40CFR§ 158.320 to § 158.355. 

7. Product Chemistry Data for the Sub Group B for the proposed New Product have been 

satisfied. 

8. Applicant needs to submit Storage Stability and corrosion characteristics study Data for 3, 6, 

9 and 12 months, these data are a requirement. 

9. The subject product BONIDE MMAX LAWN GRANULES cannot be considered to be a 

"Me Too" of EPA Reg. #s 538-223, 802-543, 8660-178 and 9240-8 since there is difference of 

concentration of active ingredient in all of the cited EPA Reg. #s when compared to the 

concentration of(23.5 % Ferrous Sulfate Monohydrate) for the subject product. 

CONCLUSIONS: 

TRB has reviewed the product chemistry data submitted for the above mentioned subject 

product and has concluded that: 

1. The subject product BONIDE MMAX LAWN GRANULES 23.5 % of Ferrous 

Sulfate Monohydrate. 

2 The label claim is in compliance with PR Notice 91 ~2. 

3. Basic CSF dated 08/04/09 for the subject product meets the label claim of23.5 % of 

Ferrous Sulfate Monohydrate is acceptable conditionally. 

4. The product chemistry data requirements for series 830 Sub Group A and sub group B for 

the proposed New product are completely satisfied. Registration ofJ:h~ __ ~_!lQj~ctp:r:oduc.tis_ -+-

contingent to the registration of the technical used to fonnulate this product. 

5. The registrant to submit sub group a & sub group B data for the unregistered Ferrous sulfate 

monohydrate 
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3 

BARCODE No.: D368665 

LAWN GRANULES 

File Symbol No.: 4-UIN PRODUCT NAME: BONlDE MMAX 

Data Required Fulfilled MRID No. 

PRODUCT CHEMISTRY DATA 

(SERIES 830 Subgrou(;! A & SubgrouQ 

IDSubQroup A 

830.1550. Chemical Identity (Basic CSF) Afw comments Basic 08/04/09 

830.1600. Beainnina Materials A 478284-01 

30.1650. Formulation Process A 478284-01 

830.1670. Discussion of Impurities A 478284-01 

830.1700. Preliminary Analysis NA 

830.1750. Certified Limits (Basic CSF) A Iwith comments Basic 08/04/09 

830.1800. Enforcement Analytical Method A 478284-01 
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PRODUCT CHEMISTRY Qata Reguired Value or Qualitat. DescriQ. MRID No. 

DATA Fulfilled 

(SERIES 830 Subgroup 8) 

830.6302. Color A Black, j:Jrey, yellow and while Qranules 478284-01 

830.6303. Ph sical Slate A Solid qranules 478284-01 

830.6304. Odor A Typical synthetic Fertilizer odor 478284-01 

830.6314. Oxidation/Reduction NA Does not contain any ingredient that is 

Action oxidizing or reducing agent 

830.6315. Flammability NA Does not contain combustible liquid 

830.6316. Explodability NA Product does not contain combustible 

liquids 

830.6317. Sioraqe stability I I 

830.6319. Miscibilit NA Not intended for dilution with pel solvents 

830.6320. Corrosion I I 

Characteristics 

830.6321. Dialect Bkd. Vilg. NA 

830.7000. pH A 6.1 @20'C (5% in water) 478284-01 

830.7100. Viscosity NA 

830.7300. Density/Bulk A 57lbs/cubic ft.lbulk density 478284-01 

Density 

Explanations; Y The Requirements Were Fulfilled; N The Requirements Were Not Fulfilled; NA - Not applicable; 

G - Data Gap, U - ReqUIres Upgrading, I Incomplete or In Progress, W _ - Waived. 
13

#4-UIN P.C. Code 050507 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFICE OF PREVENTION, PESTICIDE AND 

TOXIC SUBSTANCES 

Similarity action 

MEMORANDUM 

November 9, 2009 

_Subject: EPA Reg. No.: 4·UIN 

368666 

418493 

R30l 

050507 

Bonide MMAX Lavvn Granules 

From: 

To: 

DB Code; 

Decision; 

Mail Code: 

P.e. Code: 

Masih Hashim, Toxicologist 

Technical Review Branch 

Registration Division (7505P) 

Dianne Morgan, RM Team 23 

Herbicide Branch 

Registration Division (7505P) 

Applicant: Bonide Products, Inc. 

FORMULA nON FROM LABEL: 

Active Ingredient(s); 

Ferrous sulfate monohydrate 

Inert Ingredient(s): 

Total: 

% bywt. 

24.7 

75.3 

100.0% 

ACTION REQUIRED: To detennine if the cited and the proposed products are substantially 

similar. 
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RECOMMENDATIONS: 

The cited and the proposed products are substantially similar in toxicity. The active in the cited is 

lower (at 17.5%) than the proposed product, however, the data can be bridged between the cited 

product and technical Ferrous sulfate monohydrate for all exposure routes except eye. For eye 

exposure, the Registrant has cited eye irritation study (MRlD 44770403) conducted on a formulation 

containing 24.5% Ferrous sulfate monohydrate. 

The CSF for the proposed product should be approved by Chemistry, as a requirement. 

The proposed product will have the same label as the cited product 

The acute toxicity profile for the File Symbol is as follows: 

acute oral toxicity 

acute dermal toxicity 

acute inhalation toxicity 

primary eye irritation 

primary skin irritation 

dennal sensitization 

LABELING: 

III 

III 

III 

III 

IV 

non~sensitizer 

1. The signal word is "CAUTION". 

bridged #538-223 and technical 

bridged #538-223 and technical 

bridged #538-223 and technical 

cited- MRID 44770403 

bridged #538-223 and technical 

bridged #538-223 and technical 

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-vNYVy",,'iY10 J", ~\ 

;:; 'i}' ~!f:.!! ~\j~ \';~#' ~,V" v'D-)_~, _:c~," i0 2. The precautionary statements should state: ~ '< _ ~ 

"Ranuful if swallowed, inhaled or absorbed thrOU4skin. Causes moderate eye irritation. Avoid 

contact with skin, eyes or clothing. Avoid breathint dust. Wash thoroughly with soap and water 

after handling. Remove and wash contaminated crthing before reuse." 

3. The statements of practical treatment should state) 

"If in eyes: Flush with plenty of water. Call a physician if irritation persists." 

Hlf swallowed: Call a physician or Poison Control Center. Drink 1 or 2 glasses of water and 

induce vomiting by touching back of throat with finger. Do not induce vomiting in or give 

anything by mouth to an unconscious person." 

"If on skin: Wash with plenty of soap and water. Get medical attention," 

"If inhaled: Remove victim to fresh air. lfnot breathing, give artificial respiration, preferably 

mouth-to-mouth, Get medical attention,!! 
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• 

B. Human Health Assessment 

1. ToxicoJogy Assessment 

The toxicological data base on iron (Ill) sulfate"'. iron (D) sulfate 

monohydrate. and iron (II) sulfate heptahydrate is ~:late and wi[. support 

reregistration eligibility. 

a. Acute and Subchronic Toxiclty 

ACUTE TOXICITY VAWl'S 

TEST "RESULT TOXICITY 

Iron 1II Sulfate CATEGORY 

Oral LD,.,--rat 1487 - 2102 mg/kg ill 

Inhalation LC')"o--rat > 1.10 mglL ill 

Dermal LD.)"o~-rabbit >2000 mg/kg III 

Eye Irritation corrosive I 

Dennal Irritation corrosive N 

Dermal Sensitization negative -

Iron (III) sulfate. in an acute .oral study in rats, had an LDso of 

1487 mg/kg in females and 2102 mg/kg in males. An acute dermal 

toxicity test in rabbits with Iron (III) sulfate found an LDso greater than 

2000 mglkg. An acute inhalation toxicity study in rats using iron (ill) 

sulfate determined the LCso to be greater than 1.10 mglL. 

Iron (II) sulfate heptahydrate, in an acute oral study in rats. 

showed an LD .. of 1389 mg/kg and an acute oral study in rabbits 

showed an LD .. of 2778 mglkg(4). The LD", determined for this 

compound in mice was 1520 mg/kg(4). A sensitization study using 

guinea pigs with iron (II) sulfate monOhydrate and iron (llI) sulfate 

found no indication of contact sensitization by this compound. 

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• 

2. 

h. Mutagenicity 

A mutation study in E:. £Q)i reported poJitke r:sult'i at 3'1 

umoIlL(4). With due regard for the continuing ~xposll,e Cla: huna"} 

beings have had to the iron and sulfate components of these chemicals 

over many generations. it is considered unlikely that this reported result 

in microorganisms has any bearing on probable ~~fl!Ct ... in hHtm.nS or 

other mammals at the levels expected from use of the!:e COM}>O·mds as 

pesticides. 

c. Metabolism 

Iron sulfates are normal constituents of the diet and are 

metabolized and utilized by the body. 

d. Other Toxicological Consideration 

The toxicological data on iron sulfates within the A d in 

the literature are adequate for assessi" risk to humans. Not all of the 

tox.icity data usually requIred for pesticide registration or reregistration 

are necessary for the present uses of iron sulfates. There are some 

unusual factors in this case which indicate that specific studies to fulfill 

the usual data requirements are not necessary to regulate these 

substances as pesticides. Iron sulfates are normally present in the 

environment. They may be present in foods naturally and as added 

ingredients. There is no reason to expect that pesticide usage in 

accordance with the product label or labeling accompanying the product 

will constitute any hazard beyond that from ordinary exposure. 

Exposure Assessment 

a. Dietary 

Dietary exposure to iron (HI) sulfate, iron (II) sulfate 

neptahydrate, and iron (II) sulfate monohydrate is not expected to occur 

from pesticidal use. There are no active products involving pesticidal 

uses on food or animal feed. Therefore, there are no tolerances or 

exemptions from the requirements of tolerances established for iron 

salts. Since there are no toxicological endpoints of concern and no 

food uses, no risk assessment was perfonned for dietary exposure. 

Iron (II) sulfate is generally recognized as safe as noted in 40 CFR 

180.2(a). The Food and Drug Administration has affinned that iron 

(Jll) sulfate and iron (II) sulfate (hopta and monohydrate) are generally 

recognized as safe (GRAS) for use in food as flavoring agents and 

nutrient supplements. respectively. with no limitations other than 

8 
17

April 5, 1999 

MEMORANDUM 

EPA File Symbol: 8660-RAI STA-GREEN MOSS CONTROL GRANULES 

DP Barcode: D254800 

Case No: S558453 

PC Code: 050507 Ferrous su~ate monohydrate 

From: Byron T. Backus, PhD., Toxicologist Is/Byron T. Backus 

Technical Review Branch 4/5/99 

Registration Division (7505C) 

To: Dianne Morgan/Joanne Miller, PM 23 

Herbicide Branch 

Registration Division (7505C) 

Registrant: PURSELL INDUSTRIES, INC. 

ACTION REQUESTED: "The registrant has submitted an application for registration of their 

product. They forwarded four acute toxicity studies for review. I have also attached the 

proposed CSF and labeling. Please review for acceptability." 

BACKGROUND: The package, as received by this reviewer, contains the following four 

acute toxicity studies: acute oral LD50 (rat) in MRID 44770401; demnal LD50 (rat) in MRID 

44770402; primary eye irritation (rabbit) in MRID 44770403); and dermal irritation (rabbit) in 

MRID 44770404; however, it does not include a copy of any labeling, and the CSF is for 

EPA Reg. No. 8660-178. According to informati n the regl ofs cover letter the purpose 

of this submission "is to support the continu registration of Pursel Industries, Inc. ferrous 

sulfate monohydrate EPA pesticide product .. 660-178; 8660-248 nd 8660-RAI. .. " and "all 

four tox studies to be placed in the file for golde igoro moss co 01 plus lawn fertilizer 

EPA Reg. No. 8660-178 (A.I. 24.5% ferrous 

sulfate monohydrate)." 

COMMENTS AND RECOMMENDATIONS: 

1. The CSF attached to this action is that for EPA Reg. No. 8660-178, which, according 

to REFS, has 24.5% ferrous sulfate monohydrate as its sole active ingredient. This 

is consistent with the information in the CSF. However, the bean sheet indicates 

1 
18

) . that this action is for Et,-( File Symbol 8660-RAI, and the b~ ,J sheet also indicates 

that this product contains 32.0% ferrous sulfate monohydrate as (presumably) sole 

active ingredient. According to information in each individual report (oral study on 

page 8, dermal study on page 7, eye irritation on page 8, dermal irritation study on 

page 7) the active ingredient in the tested formulation was ferrous sulfate 

monohydrate at 24.5%. 

2. Each of the four studies has been reviewed and classified as acceptable. A partial 

acute toxicity profile of the tested formulation is given below: 

Acute Oral LD50 

Acute Dermal LD50 

Acute Inhalation LC50 

Primary Eye Irritation 

Primary Dermal Irritation 

Dermal Sensitization 

III 

IV 

III 

IV 

Acceptable 

Acceptable 

Not included 

Acceptable 

Acceptable 

Not included 

3. Although each of these four studies has been classified as acceptable, they can only 

be used to support the registration of products containing 24.5% (or less) ferrous 

sulfate monohydrate as sole active ingredient. If, as indicated on the bean sheet, the 

proposed product 8660-RAI contains 32% ferrous sulfate monohydrate, then these 

studies cannot be used (or cited) in support of that registration. 

2 
19

DATA REVIEW FOR ACUTE ORAL TOXICITY TESTING (870.1100, formerly §81·1) 

Product Manager: 23 

MRID No.: 44770401 

Reviewer: Byron T. Backus, PhD. 

Study Completion Date: January 15, 1999 

Study No.: 6764 

Testing Facility: Product Safety Labs 

Author: Moore, G.E. 

Quality Assurance (40 CFR §160.12): Included (p. 20) 

Test Material: Moss Control + Lawn Fertilizer, Code #522228; beigeltan and gray granules, with 

ferrous sulfate monohydrate 24.5% and inert ingredients (fertilizer) 75.5%. 

Species: Rat; Albino, Sprague~Dawley derived 

Age: "Young adult" 

Weight: Males: 215-248 g; Females: 166-204 9 

Source: Ace Animals, Inc., Boyertown, PA 

Conclusion: 

1. LDso (mg/kg): 

Males: between 500 and 5000 mg/kg 

Females: between 500 and 5000 mg/kg 

Combined: between 500 and 5000 mg/kg 

2. The estimated LDso is > 500 mg/kg 

3. Tox. Category: III Classification: Acceptable 

Procedure (including deviations from 870.1100): "Prior to administration, the test substance was 

ground to a fine powder using a coffee mill... The ground sample was then administered as a 50% 

w/w suspension in distilled water. Preliminary solubility testing ... indicated that suspensions in excess 

of 50% 9i.e., 60-80%) were too viscous to be administered properly." 

"Due to a technician error, bodyweights and necropsies for the 500 mg/kg dose level were performed 

on Day 13 instead of Day 14." 

Results' . 

Number of Deaths/Number Tested 

Dosage (mg/kg) Males Females Combined 

500 0/5 0/5 0/10 

5000 515 515 10/10 

Observations: At 500 mg/kg all rats survived and gained weight, with no indication of toxicity. At 

5000 mg/kg all rats died within 21 hours of administration. ''Toxic signs prior to death ... included 

hypoactivity and hunched or prone posture." 

Gross Necropsy: At 500 mg/kg no gross abnormalities were noted at necropsy. At 5000 mg/kg 

"gross necropsy of the decedents revealed discoloration of the lungs, stomach and gastrointestinal 

tract." 

3 
20

April 5, 1999 

MEMORANDUM 

EPA File Symbol: 8660-RAI STA-GREEN MOSS CONTROL GRANULES 

DP Barcode: D254800 

Case No: S558453 

PC Code: 050507 Ferrous sulfate monohydrate 

From: Byron T. Backus, PhD., Toxicologist Is/Byron T. Backus 

Technical Review Branch 4/5/99 

Registration Division (7505C) 

To: Dianne Morgan/Joanne Miller, PM 23 

Herbicide Branch 

Registration Division (7505C) 

Registrant: PURSELL INDUSTRIES, INC. 

ACTION REQUESTED: "The registrant has submitted an application for registration of their 

product. They forwarded four acute toxicity studies for review. I have also attached the 

proposed CSF and labeling. Please review for acceptability." 

BACKGROUND: The package, as received by this reviewer, contains the following four 

acute toxicity studies: acute oral LD50 (rat) in MRID 44770401; dermal LD50 (rat) in MRID 

44770402; primary eye irritation (rabbit) in MRID 44770403); and dermal irritation (rabbtt) in 

MRID 44770404; however, it does not include a copy of any labeling, and the CSF is for 

EPA Reg. No. 8660-178. According to infonnation in the registrant's cover letter the purpose 

of this submission "is to support the continued registration of Pursell Industries, Inc. ferrous 

sulfate monohydrate EPA pesticide products ... 8660-178; 8660-248 and 8660-RAI. .. " and "all 

four tox studies to be placed in the file for golden vigoro moss control plus lawn fertilizer 

EPA Reg. No. 8660-178 (A.I. 24.5% ferrous 

sulfate monohydrate)." 

COMMENTS AND RECOMMENDATIONS: 

1. The CSF attached to this act'lon is that for EPA Reg. No. 8660-178, which, according 

to REFS, has 24.5% ferrous sulfate monohydrate as its sale active ingredient. This 

is consistent with the information in the CSF. However, the bean sheet indicates 

1 
21

that this action is for E, . )File Symbol 8660-RAI, and the bE Isheet also indicates 

. that this product contains 32.0% ferrous sulfate monohydrate as (presumably) sole 

active ingredient. According to information in each individual report (oral study on 

page 8, dermal study on page 7, eye irritation on page 8, dermal irritation study on 

page 7) the active ingredient in the tested formulation was ferrous sulfate 

monohydrate at 24.5%. 

2. Each of the four studies has been reviewed and classified as acceptable. A partial 

acute toxicity profile of the tested formulation is given below: 

Acute Oral LD50 

Acute Dermal LD50 

Acute Inhalation LC50 

Primary Eye Irritation 

Primary Dermal Irritation 

Dermal Sensitization 

III 

IV 

III 

IV 

Acceptable 

Acceptable 

Not included 

Acceptable 

Acceptable 

Not included 

3. Although each of these four studies has been classified as acceptable, they can only 

be used to support the registration of products containing 24.5% (or less) ferrous 

sulfate monohydrate as sole active ingredient. If, as indicated on the bean sheet, the 

proposed product 8660-RAI contains 32% ferrous sulfate monohydrate, then these 

studies cannot be used (or cited) in support of that registration. 

2 
22

DATA REVIEW FOR ACUTE ORAL TOXICITY TESTING (870.1100, formerly §81-1) 

Product Manager: 23 

MRID No.: 44770401 

Reviewer: Byron T. Backus, Ph.D. 

Study Completion Date: January 15, 1999 

Study No.: 6764 

Testing Facility: Product Safety Labs 

Author: Moore, G.E. 

Quality Assurance (40 CFR §160.12): Included (p. 20) 

Test Material: Moss Control + Lawn Fertilizer, Code #522228; beigeltan and gray granules, with 

ferrous sulfate monohydrate 24.5% and inert ingredients (fertilizer) 75.5%. 

Species: Rat; Albino, Sprague~Dawley derived 

Age: "Young adult" 

Weight: Males: 215-248 g; Females: 166-204 9 

Source: Ace Animals, Inc., Boyertown, PA 

Conclusion: 

1. LD" (mg/kg): 

Males: between 500 and 5000 mg/kg 

Females: between 500 and 5000 mg/kg 

Combined: between 500 and 5000 mg/kg 

2. The estimated LD50 is > 500 mg/kg 

3. Tox. Category: III Classification: Acceptable 

Procedure (including deviations from 870.1100): "Prior to administration, the test substance was 

ground to a fine powder using a coffee mill... The ground sample was then administered as a 50% 

w/w suspension in distilled water. Preliminary solubitity testing ... indicated that suspensions in excess 

of 50% 9i.e., 60-80%) were too viscous to be administered properly." 

"Due to a technician error, bodyweights and necropsies for the 500 mg/kg dose level were performed 

on Day 13 instead of Day 14." 

Results-. 

Number of Deaths/Number Tested 

Dosage (mg/kg) Males Females Combined 

500 0/5 0/5 0110 

5000 515 515 10/10 

Observations: At 500 mg/kg all rats survived and gained weight, with no indication of toxicity. At 

5000 mg/kg all rats died within 21 hours of administration. "Toxic signs prior to death ... included 

hypoactivity and hunched or prone posture." 

Gross Necropsy: At 500 mg/kg no gross abnormalities were noted at necropsy. At 5000 mg/kg 

"gross necropsy of the decedents revealed discoloration of the lungs, stomach and gastrointestinal 

tract." 

3 
23

DATA REVIEW FOR ACUTE DERMAL TOXICITY TESTING (870.1200. fonnerly §81·2) 

Product Manager: 23 

MRID No.: 44770402 

Reviewer: Byron T. Backus, Ph.D. 

Study Completion Date: January 15, 1999 

Study No.: 6765 

Testing Facility: Product Safety Labs 

Author: Moore, G.E. 

Quality Assurance (40 CFR §160.12): Included (p. 15) 

Test Material: Moss Control + Lawn Fertilizer, Code #522228; beigeltan and gray granules, with 

ferrous sulfate monohydrate 24.5% and inert ingredients (fertilizer) 75.5%. 

Species: Rat; Albino, Sprague-Dawley derived 

Age: "Young adult" 

Weight: Males: 226-258 g; Females: 211-240 9 

Source: Ace Animals, Inc., Boyertown, PA 

Dermal LD5(} Testing: 

Conclusion: 

1. LD" (mglkg): 

Males: > 2000 mg/kg 

Females: > 2000 mg/kg 

Combined: > 2000 mg/kg (no mortality during the study) 

2. The estimated LD5(} is > 2000 mglkg 

3. Tox. Category: III Classification: Acceptable 

Procedure (including deviations from 870.1200): "Prior to application, the test substance was 

ground to a fine powder, using a coffee mill. .. The ground test substance was then moistened to 

achieve a dry paste by preparing an 80% w/w mixture in distilled water. Two thousand mg/kg of the 

test material was placed on one 2"x3", 4-ply gauze pad, then applied to a dose area of approximately 

2"x3" (approximately 10% of the body surface)." There was 24-hr occluded dermal exposure. 

Results" . 

Number of Deaths/Number Tested 

Dosage (mglkg) Males Females Combined 

2000 015 015 0110 

Observations: No rats died during the study. All gained weight and appeared active and healthy, 

with no signs "of gross toxicity, adverse pharmacologic effects or abnormal behavior." 

Gross Necropsy: No gorss abnormalities were found. 

4 
24

DATA REVIEW FOR PRIMARY EYE IRRITATION TESTING (870.2400, formerly §814) 

Product Manager 23 

MRID No.: 44770403 

Reviewer: Byron T. Backus, Ph.D. 

Study Completion Date: January 15,1999 

Study No.: 6766 

Testing Facility: Product Safety Labs 

Author: Moore, G.E. 

Quality Assurance (40 CFR §160.12): Included (p. 18) 

Test Material: Moss Control + Lawn Fertilizer, Code #522228; beige/tan and gray granules, with 

ferrous sulfate'monohydrate 24.5% and inert ingredients (fertilizer) 75.5%. 

Dosage: 0.1 mL (0.07 to 0.08 g) 

Species: Rabbit; Albino, New Zealand White 

Age: "adult" 

Weight: not reported 

Source: Davidson's Mill Farm, South Brunswick, NJ 

Conclusion: 

1. Toxicity Category: III (Moderate irritant) 

2. Classification: Acceptable 

Procedure (including deviations from 870.2400): Only 3 rabbit eyes were tested. "The test 

substance was instilled after being ground to a fine powder, using a coffee milL .. " A fluorescein dye 

procedure was used at 24 hours. 

Number "positive"/number tested 

Hours Days 

Observations 1 24 48 72 4 7 10 

Unwashed eyes 

Corneal Opacity 01 01 01 0/3 01 nd nd 

3 3 3 3 

Iritis 01 01 01 0/3 01 nd nd 

3 3 3 3 

Conjunctivae: 

Rednessa 31 31 31 0/3 01 nd nd 

3 3 3 3 

Chemosisa 21 31 21 0/3 01 nd nd 

3 3 3 3 

Dischargea 21 31 11 0/3 01 nd nd 

3 3 3 3 

nd - not done 

aScore of 2 or greater considered as a positive response 

Summary: "No corneal opacity or iritis was noted during the study. All animals exhibited conjunctival 

irritation between one and 72 hours. All animals were free of ocular irritation within 4 days ... " 

5 
25

DATA REVIEW FOR PRIMARY DERMAL IRRITATION TESTING (870.2500, formerly §81·5) 

Product Manager: 23 

MRID No.: 44770404 

Testing Facility: Product Safety Labs 

Author: Moore, G.E. 

Reviewer: Byron T. Backus, Ph.D. 

Study Completion Date: January 15, 1999 

Study No.: 6767 

Quality Assurance (40 CFR §160.12): Included (p. 16) 

Test Material: Moss Control + Lawn Fertilizer, Code #522228; beige/tan and gray granules, with 

ferrous sulfate monohydrate 24.5% and inert ingredients (fertilizer) 75.5%. 

Dosage: 0.5 9 

Species: Rabbit; Albino, New Zealand White 

Age: "Adult" 

Weight: not reported 

Source: Davidson's Mill Farm, South Brunswick, NJ 

Conclusion: 

1. Toxicity Category: IV (Slight irritant) 

2. Classification: Acceptable 

Procedure (including deviations from 870.2500): Only three rabbits were used. "Prior to 

application, the test substance was ground to a fine powder, using a coffee mill... The ground sample 

was then applied as an 80% w/w mixture in distilled water." "Five-tenths of a gram of the test 

substance (dry weight basis) was placed on a 1" x 1", 4-ply gauze pad, then applied to one 6 cm2 

intact dose site on each animaL .. " There was 4-hr occluded exposure. 

Results: One of the three animals had a score of "1" for erythema at 1 hour after patch removal, all 

other subsequent scores for erythema (at 24, 48 and 72 hrs) were zero. All scores for edema were 

zero. The PII (average of 1, 24, 48 and 72 hr scores) was 0.075. 

Special Comments: None 

6 
26

ACUTE TOX ONE-LINERS 

1. DP BARCODE: D254800 

2. PC CODE: 050507 Ferrous sulfate monohydrate 

3. CURRENT DATE: April 5, 1999 

4. TEST MATERIAL: Moss Control + Lawn Fertilizer, Code #522228; beige/tan and gray granules, 

with ferrous sulfate monohydrate 24.5% and inert ingredients (fertilizer) 

75.5%. 

Study/Species/Lab Tax. Core 

Study #lDate MRID Results Cat. Grade 

Acute oral toxicity/rat/Product 44770401 LDso > 500 mg/kg (males, III A 

Safety Labs/6764/JAN-15-1999 females, combined) with no 

deaths at this dose level, but 

< 5000 mg/kg (10/10 rats 

died following dosage at this 

level) 

Acute dermal toxicitylratiProduct 44770402 LDso > 2000 mg/kg (males, III A 

Safety Labs/6765/JAN-15-1999 females, combined) with no 

mortalities at this dose level 

Primary eye irritation Irabbit! 44770403 Mildly irritating. Only 3 eyes III A 

Product Safety Labs/6766! tested. No corneal opacity or 

JAN-15-1999 iritis observed, but all 3 eyes 

were positive (score of 2 or 

greater) for conjunctiva! 

redness, chemosis and 

discharge at 24 hours, with 

complete dearing (all scores 

zero) by day 4. 

Primary derma! irritation/rabbit! 44770404 Only 3 animals tested. One IV A 

Product Safety Labs/6767/ animal scored "1" for 

JAN-15-1999 erythema at 1 hr after patch 

removal; other 2 animals 

scored zero. All subsequent 

(24,48 and 72 hr) scores for 

erythema were zero. All 

scores for edema were zero. 

Core Grade Key: A =Acceptable, S = Supplementary, U = Unacceptable, V = Self Validated 

7 
27

PRIA 2 - 21 Day Content Screen Review Worksheet 

(EPA/OPP Use Only) 

3/23109 

21 Day Screen Start Date: :a -1'3 - a ., Experts In-Processing Signature: {VI F 1If/"fi,N6rgN Date rr -/1-1-0"1 Fee Paid: Yes Y 

Division management contacted on issues No Yes Date _____ _ 

EPA Reg. Number: 4 - u "J EPA Receipt Date: ??- /3- 07 

ItemS for Review Yes No N/A* 

1 

2 

3 

Application Form (EPA Fonn 8570-1)(link to fonn) signed & complete 

including package type 

Confidential Statement of Formula all boxes completed, form signed, and )( 

a) All inerts (link to 

including fragrances, approved for the proposed uses (see 

Footnote A) 

yes no 

Certification with Respect to Citation of Data (EPA Form 8570-34) (Link to 

form) completed and signed (N/A iflOO% repack) 

Certificate and data matrix consistent 

If applicant is relying on data that are compensable, is the offer 

to pay statement included. (see Footnote B) 

there a letter 

yes 

Formulator's Exemption Statement (EPA Form 8570-27) (Link to fann) 

no 

4 completed and signed (N/A if source is unregistered or applicant owns the 

Data Matrix (EPA Fonn 8570-35) (Link to fonn) both internal and external 

copies (PR 98-5) (Link to PR 98-5) completed and signed (N/A if 100% X 

5 Selective Method 

b) Cite-All (Fee category experts use) 

c) Applicant owns all data (Fee category experts use) 

5 Copies of Label (link to http://www.epa.gov/oppfeadl/labeling/lrm[) 

6 (Electronic labels on CD are encouraged and guidance is available)( link to y hUp://www.epa.gov/pesticides/regulatingiregistering/submissions/index.htm#labels 

1 

x 
28

7 Is the data package consistent with PR Notice 86-5 (link to PRN 86-5) X--

Notice of Filing (link to 

8 httU:llwww.eI!3.gov/Qesticides/regulatint!/tolerance I!:etitions.htm) included 

with petitions (link to ;X http://www.epa.~ov/pesticides/re~ulatinj(/tolerances.htm) 

9 If applicable for conventional applications, reduced risk rationale (link to 

http://www.epa.gov/opprdOOl/workplanlreducedrisk.html) K 

Required Data (link to 

httQ://Vt'WW.eQ3.goviQesticides/regulatingLdata reguirements.htm) and/or 

data waivers. See Footnote C. 

a) List study (or studies) not included with application 

10 

2 
29

Comments: 

J1/J 12 ( ]) 

* NI A - Not Applicable 

Footnotes 

A. During the 21 day initial content review, all CSFs will be reviewed to determine 

whether all inerts listed, including fragrances, are approved for the proposed uses. If an 

unapproved inert is identified, the applicant must either 1) resolve the inert issue by, for 

example, removing the inert, substituting it with an approved inert, submitting 

documentation that EPA approved the inert for the proposed pesticidal uses, correcting 

mistakes on the eSF, etc. or 2) provide the data to support OPP approval of the inert or 3) 

withdraw the application. Removing or substituting an inert ingredient will require a new 

eSF and may require submission of data. All infonnation. forms. data and 

documentation resolving the inert issue must have been received by the Agency or the 

application withdrawn within the 21 day period, otherwise, the Agency will reject the 

application as described below. 

To successfully complete this aspect of the 21 day initial content screen, applicants are 

strongly encouraged to verify that all inert ingredients have been approved for the 

application's uses even if a product is currently registered by consulting the inert Web 

3 
30

i 

site [link to http://www.epa.gov/opprdOOl/inertsllists.htmIJ and if the inert is not 

approved, to obtain the necessary inert approval prior to submitting an application 

to register a pesticide product containing that inert ingredient. Some inert 

ingredients are no longer approved for food uses or certain types of uses. The name 

and/or CAS number on a CSF 'must match the name and CAS number on this web site. 

Simple typographical errors in the name or CAS number have resulted in processing 

delays. 

If an inert is not listed on the inert ingredient web site and the applicant believes that the 

inert has been approved, the applicant should contact the Inert Ingredient Assessment 

Branch (IIAB) at inertsbranch@epa.gov and resolve the issue. Copies of the 

correspondence with lIAB resolving the issue should accompany the application. All 

new inerts except PIP inerts are reviewed by lIAB. The HAB should also be contacted 

for any questions on what supporting data needs to be submitted for and the Agency's 

inert review process. Questions on PIP inerts should be directed to the Chief of 

Microbial Pesticides Branch [Link to 

http://www.epa.gov/oppbppdllbiopesticides/contacts bppd.htm J. 

When a brand, trade, or proprietary name of an inert ingredient is listed on a esp, 

additional infonnation such as an alternate name of the inert, CAS number or other 

infonnation [link to http://www.epa.gov/opprdOOllinerts/tips.pdf]must also be included 

to enable the Agency to detennine if it has been approved. Each component of an inert 

mixture (including a fragrance) must be identified. In some cases, the supplier of the 

mixture or fragrance may need to provide this infonnation to the Agency. Prior to the 

Agency's receipt of an application, applicants must arrange with a proprietary mixture or 

fragrance supplier to provide the component infonnation to the Agency or promptly upon 

EPA's request. If the inert ingredients in a proprietary blend (including fragrances) 

cannot or are not identified or provided within the 21-day content review period, the 

Agency will reject the application. 

During the 21 day content review, applicants should submit infonnation to the individual 

identified by the Agency when the applicant is infonned of an unapproved inert. 

Unapproved Inerts Identified on CSFs 

All applications except conventional new products and PIPs 

Once an unapproved inert is identified on a CSP, the Agency will contact the 

applicant with the following options: 

L Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the infonnation and data needed for the Agency to approve the 

unapproved inert. If this option is selected and implemented, the Agency may 

request an extension in the PRIA decision review timeframe to accommodate 

the inert review/approval process; 

4 
31

\ 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of these options is selected and implemented by the applicant within the 

21 day content review period, the Agency will reject the application and retain 

25% of the full fee of the category identified. 

Conventional New Product Applications 

When the Registration Division identifies an unapproved inert on a CSF with an 

application for a new product that the applicant has not identified as requiring an 

inert approval (R311, R312 or R313), it will contact the applicant with the 

following·options: 

1. Correct the application by, for instance, correcting the inert's identity or CAS 

number, providing documentation that the inert has been approved, or 

removing the unapproved inert from the CSF or replacing it with one that is 

approved for the application's uses; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert, including any required petition to establish or amend a 

tolerance or exemption from a tolerance. (This option may change the PRIA 

category for the application, which could require a longer decision review 

time and a larger fee. If additional fees are due, they must be received by the 

Agency within the 21 day content review period.) 

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none of the above options is selected and implemented during the 21 ~day 

content-review period, the Agency will reject the application and retain 25% of 

the appropriate fee for the new product-inert approval category. 

PIP Applications 

When the Biopesticide and Pollution Prevention Division identifies an 

unapproved inert on a PIP CSF and a request to approve the inert does not 

accompany the application, it will contact the applicant with the following 

options: 

1. Correct the application by, for instance, correcting the spelling or name of the 

inert to that in 40 CFR 174, or providing documentation that the inert has been 

approved; or 

2. Submit the information and data needed for the Agency to approve the 

unapproved inert. If an inert ingredient tolerance exemption petition is 

required, the petition must be received by the Agency and the B903 fee paid 

within the 21 day period. Ifthis option is selected and implemented, the 

Agency will discuss harmonizing the timeframe for both actions. 

5 
32

3. Withdraw the application (the Agency retains 25% of the full fee for the fee 

category estimated); or 

If none ofthe above options is selected and implemented during the 21 day 

content review period, the Agency will reject the application and retain 25% of 

the fee. 

B. A policy on documentation of offers to pay is still being developed, however, for a 

me-too or fast track (similar/identical) new product, R300 or A530, an application 

without the necessary authorizations of offers to pay will be placed into either R301 or 

A531. The Agency recommends that authorizations of offers to pay be submitted with 

other PRIA applications to avoid delays in the Agency's decision. 

C. Biopesticide applicants are advised to contact the Agency and discuss study waivers 

prior to submitting their application to the Agency. Documentation of such discussions 

should be submitted with the study waiver. 

6 
33

UNI. t:D STATES ENVIRONMENTAL PROTEC11.;N AGENCY 

WASHINGTON, D.C. 20460 

August 14,2009 

OPP Decision Number: D-418493 

EPA File Symbol or Registration Number: 4-UIN 

Product Name: BONIDE MMAX LAWN GRANULES 

EPA Receipt Date: 13-Aug-2009 

EPA Company Number: 4 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Company Name: BONIDE PRODUCTS, INC.EPA File Symbol or Registration Number: 

Matt Vickers 

REGISTRATIONS BY DESIGN INC. 

BONIDE PRODUCTS, INC. 

PO Box 1019 

SALEM, VA 24153-3805 

SUBJECT: Receipt of Application and 50% Small Business Waiver Request 

Dear Registrant: 

The Office of Pesticide Programs has received your application, 50% small business 

waiver request, and cerification of payment. If you submitted data with this application, the 

results of the PRN~86~5 screen will be communicated separately. During the administrative 

screen, the Office of Pesticide Programs has determined that this Action is subject to a Pesticide 

Registration Service Fee as defined in the Pesticide Registration Improvement Act. 

The Action has been identified as Action Code: R301 

NEW PRODUCT;IDENTICAL OR SUBSTANTIALLY SIMILAR IN COMPOSITION AND 

USE TO A REGISTERED PRODUCT;REGISTERED SOURCE OF ACTIVE 

INGREDIENT;SELECTIVE DATA CITATION ONLY FOR DATA ON PRODUCT 

CHEMISTRY! ACUTE TOXICITY! PUBLIC HEALTH PEST EFFICACY, WHERE 

APPLICANT DOES NOT OWN ALL REQUIRED DATA NOR HAS AUTHORIZATION 

LETTER FROM DATA OWNER; 

The fee associated with this action is $ 819. Payment in the amount of$ 2,289 has been 

received. A refund in the amount of $ 1,470 will be issued. 
34

Your request for waiver has been forwarded for review. You will be notified in vvriting when a 

detennination is made regarding your request. If your waiver request is approved, the decision 

review time period will start on the date of approval. If your waiver request is denied, you will 

receive an invoice for the outstanding balance. 

If you have any questions, please contact the Pesticide Registration Service Fee 

Ombudsman at (703) 305-6249. 

Sincerely, ~ 

9Jlt~iilProc~~ ynn9'tDgy & Resources Management Division 
35

IFee for Servicel ~ 

{855762;-

,------

I 

This package includes the following 

@ New Registration 

o Amendment 

for Division 

I ~ Studies? ~ Fee Waiver? 

: v Risk Mgr. []TI i D vol pay % Reduction: 

Receipt No. s-I 855762 i=====: 

EPA File Symbol/Reg. No. :=1 ===4=-=U=IN==: 

Pin-Punch Date: 1 8/13/2009 L______________________________ __ __ 

n This item is NOT subject to FFS action. ~ 

A-ctroITCodB: II Parent/Child Decisions: i 

I Requ . [ 

, [I 

i Gr dO) ,I 

I Amount Due: $ /49 3£ ::::: J [Y/N>1~' ),~ @/n/~ . }!. Inert Cleared for Intended Use I'i: Uncleared Inert In Product 

Reviewer: ~ Date: Sfr1 

Remarks: 

..... /k?;h /- ~ct1't4 C-f;/~~ YO~~~arl~ 

-"\ ~ cJ;rk tf!tt ~Acr ~ -
36
37

FEE FOR SERVICE 
38

BONIDE PRODUCTS, INC. 

6301 SUTLIFF RD. 

ORISKANY, NY 13424 

\ 

***Two Thousand Two Hundred Eighty-Nine & No/100 US do~lars 

DATE 

08/12/09 

PAY 

~6~~ U.S. EPA 

OF 

78131 

7813~ 

AMOUNT 

$2,289.00: 

VOID AFTER 90 OAYS 

~~R~~ · 

BONIOE PRODUCTS, INC. 6301 SUTLIFF RD. ORISKANY, NY 13424 

Vendor No: USEPA / Name: U.S. EPA 

Invoice 

08~209 

Ref Inv Date 

08/12/09 

h:=E jJCI(QN L1~c:-

Inv Amt 

2289.00 

Discount 

0.00 

Adj Amt 

0.00 

78131 

78131 

Amt Paid 

2289.00 

YESTre<OG' t;;a,'S(l\.ilr[~,0 l>47C11 :S(/J,(Oq ']3Gl\lrtt H/v{fI'" L4wrJ tR.MJelleO;, t / 

MPUcA=0 

(Acct: 10109-002) Check Date 08/12/09 

MldCustom 

Tota~ 

" , !J , 

. J' , " 

" , , , " . 

• " , , " , 

, . , ,> >, 

, , , > 

• 

2289.00 

*Commercial/financial information may be entitled to confidential treatment*
39

Print Form .... ". Off ,.".,.. ".,.,. , .. "" .... No. 2070-0000 

United Stat •• .leglst,ation OPP Id.ntifier Number 

oEPA Environmental Protection Agency f--- Amendment 

Wahlngton, DC 20460 Other 

Application for Pesticide· Section I 

1. CompanyJPrDduct Number 2. EPA Product tMnager 3. Propond CI.Hiflcation 

~ UJIv' Joanne I. Miller 

0 NOM o R...tricted 

4. C:re'"J{prodl,lct INam.1 PM. 

Bani e Max lawn Granules 23 

S. Namt and Addr ... of APflUc.nt (Include ZIP CQdaJ 6. Expedited Review. In accordance with FIFRA Section 3/el/31 

Banicle Products, Inc. /bllil. mv product is similar or identical in composition and labeling 

6301 Sutliff Road to, 538-223, 802-543, 8660·178, 9240-8 

Oriskany, NY 13424 II EPA Reg. No. 

D Ch.ck H thi6 is. new .ddrU3 Product Name 

Section - II 

0 Amendment· Explain billow. 0 Final printed 11IbeI, in I'O.pon .. to 

Agancy lano, dated 

0 RalJUbmi-.ion In rolpon" to Agency ,.ttor dated El "Me Too" Application. 

0 Notlflcation· Explain b.low. 0 Oth..- - Explain tHllow. 

Explanation: u •• tdditional p.g"5) II nee ... ary. (For .octlon I .00 S.ctlon 0.1 

Substantially similar in formulation, toxicity characteristics, and application rates to other granular moss control herbicides labeled for 

residential use: EPA Reg. Nos. 538-223, 802-543, 8660-178, 9240-8. 

Section • III 

1. M.ttrit! Thit Product WIllis. P.ck.ged In: 

Child-R.sitt.nt Peck.gin; Unit Packaging Wtt.r Solublo P.ck.g1ng 2. Typ. 01 Container 

~l'". .:.:.;,;. V •• 

~ y" 

X No X No No §~'. X Plutic 

Glo .. 

• Certifit:.tiDn must If -V .. - No. per II-V.s" No. p.r P.p.,. 

Unit P.ck.ging wgl. contein.r P.ck.go wgt contllinot Othor (Specifyl lHI $ubmlttfHI 

I 

3. loc.tion of N.t Contont. Inl.rrna60n 4. Sizols) R.tall Contain.r 5. location of label Oir.ctiont 

I8J Lab. o Container 20lb bag ~on""" On lebeUng aooomp.nying product 

6. MIInner in Whioh label i. Affiud to Product F== Uthograph U Oth.r 

Pep.r ~Utd St.1'ICi iId 

Section· IV 

1. Cont.ct Point IComplttt ittl1l$ diuctly b.!ow for idMtmc.tion of /ndiv/dUfl! to b. conrl'cttd, H ntct$.PI'Y, to proc .. thi$ tppli~tion.J 

N_ Titl. T.lephon. No. (Includ. Are. Cod.1 

Molly Hickman Consultant to Registrant 971-219-8084 

Certif"lCation 6. Otto Applic.tion 

I c.rtify thllt the ttatement. I hav'm.d. on thi. lorm .nd .u attachm.nts thereto aro truo, ..::cur.te.nd compl.te. RltCeived 

I ecknowledge that.ny knowingly flll.o or misl.ading .t.tem.nt may b. puni.habtt by fine or impri.OlV'!'lont or (Stamped' 

both under applieabl' ."". 

2. Slgnatur0'1. j/(A 3. TrtI. 

V.P. Operations " , 

" .. , , , , , " , , 4.T~Neme 5.D.te , · , 

Matt Vickers · 8/4/2009 "'''' , , ,,~,}. 

, , 

• · EPA Form 8570-1 IR.v. 8-$41 Pr.VlOU. aditiont til. obsolete. , , 1.IIt-w "Appllc .... t Copy 

" >, 

" ,J , , , , 
40

Donide Products, Inc. 

August 12, 2009 

Document Processing Desk (REG FEE) 

U.S. Environmental Protection Agency 

6301 Sutliff Road 

oriskany, NY 13424 

Telephone: 315-736-8231 ext 243 

Fax: 315_736_7582 

Email: mattv@bonide.com 

FedEx:868516232767 

Office of Pesticide Programs/RegistrationDiv. (7505P) 

Room S-4400 

One Potomac Yard (South Bldg.) 

2777 S. Crystal Drive 

Arlington, VA 22202-4501 

RE: R310 "Me-Too" Application to Register 

EPA Reg. No. 4-~ Bonide MMax Lawn Granules 

Please accept and process this application for registration of a me-too end-use 

pesticide product containing ferrous su~ate monohydrate as the active ingredient. 

The following documents are submitted in support of this application for registration: 

1) Copy of fee payment with smarr business waiver documentation 

2) Application For Registration Form 8570-1 

3) Basic and Alternate Confidential Statements of Formula, Form 8570-4 (2 copies each) 

4) MSDSs and/or technical data sheets for ferrous sulfate monohydrate 

5) Certification with Respect to Citation of Data, Form 8570-34 

6) Data Matrix, Form 8570-35, with attachments 

7) Product Chemistry Series 830 Data (3 copies) with Transmittal Document 

8) Proposed labeling (5 copies) 

Should you have any questions about this application, or need addRional information, 

please do not hesitate to contact me or our authorized agent for this application, 

Molly Hickman at 971-219-8084, or email.molly.hickman@comcast.net 

Enclosures 
41

TRANSMITTAL DOCUMENT 

SUBMITTOR: 

BONIDE PRODUCTS, INC. 

6301 Sutliff Road 

Oriskany, NY 13424 

REGULATORY ACTION IN SUPPORT OF WHICH THIS PACKAGE IS SUBMITTED: 

Application for Me-Too Registration dated 8/4/2009 

Bonide MMax lawn Granules, EPA Reg. No.4-XXX 

TRANSMITTAL DATE: 

8/4/2009 

LIST OF SUBMITTED STUDIES: 

Subpart 0 - Product Chemistry Series 830 

COMPANY OFFICIAL: 

Signed: 

~ tU.u . :s::: Matt Vickers, . ~ atrons 

315-736-7S82 
42

,OMBI '''" 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

1200 Pennsylvania Avenue, N.W. 

WASHINGTON, D.C. 20460 

Paperwork Reduction Act Notice: The public reporting burden forlhis collection ofinfonnation is estimated 10 aver.tge , ' _' ,. ) , ; , 

and 0.25 hours per response for reregistration and special review activities, including time for reoding the instructions and completing the necessa.;:" f;~~:- -~ , , COl1lllll:nts regarding burden estimate OTany other aspect of this collection ofinfonnation, inchlling suggestions for reducing the burden to: Director, Collection 

Stralegies Division (2822T), U.s. Environmental Protection Agency, 1200 PennsylvaniaA venue, NW", Wa::hington, DC 20460. C'.c ,r.1t.,serd1he completed form 

to this IIddress. : J, 1 1 > 

Certification with Respect to Citation of Data 

Name, Address, and Telephone Number 

: '" , 

EPA Registration 

, , , , 

Active InQredientrs) and/or reofesenlaUve test comoound(s) 

I 

D,~ 

81412009 

General Use Pattem($) (list an those claimed for this product using 40 CFR Pari t58) 

; 

Pmduct Name 

I Boo;'. I 

NOTE: If your product is a 100% repClckaging of another pW'Chased EPA-registered product labeled forall the same uses on yourmbel, you do not need to 

submit this fonn. You must submit the Fonnulato(s Exemption Statement (EPA Fonn 8570-27). 

o 

o 

I am respondino to a Data.call~n Notice, aoo have included w'rth this fonn a list of companies sent offers of compensation (the Data Matrix fonn Should 

be used forthis purpose). 

SECTION I: METHOD OF DATA SUPPORT (Check. 

I am using the cite-all method of support, and have included with this fonn 

a list of companies sent offers of compensation (the Data Matrix fonn 

should be used forthis purpose). 

I am using the selective method of support (or cite-an option 

under the selective method), and have included with this fonn a 

completed list of data requirements (the Data Matrix fonn must be 

used). 

SECTION 11: GENERAL OFFER TO PAY 

IRequired if using the cite-aU method or when using the Clle-all option under the selective method to satisfy one or more data requirements) 

o I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFAA 

; Ii 

Ii ; ',.fu,!" fu" , ; '"" I I, o~o"'?" in effect on the date 

"'" , 

; 

;b;., , , 

; 

SECTION 111: CERTIFICATION 

Ii 

,or this Data-Call .. ln response is supported by all data submitted ordted in the 

~'~~t(~f:50n, i(the cite-an option or cile-all opUon under the selective method Is 

I concem the properties oreffecls of this product or an idenUcal or 

~ and~<:,~!~ .a .. type of data thatwollid be required to be submitted under the data 

I sought the initial registration 01 a product of identical or simUarcomposition and 

I certify that foreach exclllsive use study cited in SllPPort of this registration or reregistration, that I am the original data submitter or that I have obtained 

the wmten pennission 01 the orig'lnal data submitter to cUe that study. 

I ~,~fy that for each study cijed in support of this registration or reregistration that is not an exclusive use study, either. (a) I am the original data 

I ~§~; f~:~'~ "1~~~~~]~~P~·~~ff;"2;:O~"}O~f::.~'~O~";,;g~I"'i'~',~"~.~'~"r:bm~i'ltre!~"rtoi use the study in support of thiS application; (c) all periods of eHgibility for ,; (d) the ~UdX-iS in the public literature; or (e) I have notified in writing the company that submitted the study and have 

. i and/or 3{c)(2)(B) of FIFRA; and 01) to commence negotiations to determine the 

,ifany,to the ~5tudy. 

I :~:~~:~:~~:~~:::~~:~:~~:~;~~~~~~~:~i::1~ h.5ections :~\~. are available is required, and will copies be of all offers to paY compensation and evidence of their delivery in submitted to 1he Agency upon request. Should I fail to produce such 

FI~RA. to the Agency upon request, I the Agency may initiate action to deny, cancel or suspend the regisbation of my product in confonnity with 

I certify that the statements I have made on this fonn and all attachments to it are true, accurate, and complete. I acknoWledge that any 

knowingly false or misleading be punishable by fine or Imprisonment or both under appllcable law. 

I 

0,,. Typed Of Printed Name and ntla 

8/4/2009 Mati Vickers, V.P. OperationS 

il I 
43

.... 

. -l - UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

401 M Street, S.W. 

.. 

. . . . . WASHINGTON, D.C. 20460 

. 

Paperv:<:rk The pubtic reporting burden for this coUecfion of information is estimated to average 0.25 hours per response for reglslratlon activities and 

rereglsl1'8tkln ari{! speclal nrvtevtactMlies, including fule for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate or a

information, ili'cludlng 5l!g'gesJions for reducing the burden to: Director, OPPE IntormaUon Management Division (2137), U.S. Erw!ronmental Protection Agency, 401 M Street, 

send tl:ltf('r,lJt1 this address, 

<. <. 

. 

· DATA MATRIX 

. 

· · 

Date 

- " - " " " EPA Reg No.lFile Symbol 4-XXX (app subm

c • c 

Aop!lcant'slReaistranl's Name & Address Product 

Bonlde Products, Inc., 6301 Sutliff Road, Oriskany, NY 13424 Bonide MMax Lawn Granules 

Ingredienl Ferrous Sulfate Monohydrate 

Guklellne Reference Number Guideline StudY Name MRID Number Submitter 

Series 830 Product Chemistry - EP not assigned Bonlde Products, Inc. 

870.1100 Acute Oral Toxicity - Rat - EP 43313903 Scolts Co 870.1100 Acute Orel Toxicity - Rat - TGAI Waived Iron Salts RED 

870.1200 Acule Dermal Toxicily - EP 43313907 ScoUs Co 

870.1200 Acute Dermal Toxicity - TGAI Waived Iron Selts RED 

870.1300 Acute Inhalation Toxicity - Ra1 - EP 43313905 Scotts Co 

870.1300 Acute Inhalation Toxocity - TGAI Waived Iron Salls RED 

870.2400 Primary Eye trritation - Rabbit 44770403 United Industries 

870.2400 Primary Eye Irr!laHon· Rabbit 43313904 Scotts Co 

8702500 Primary Dermal Irrttallon 43313906 Scotts Co 870.2500 Primary Dermal Irritation Waived Iron SaUs RED 

870.2600 Darmal Sensitization 43313908 Scotls Co 

870.2600 Dermal Sensitization 41763701 Iron Salts Task Force 

II 

Signature Name and TItle 

Mall Vickers, V.P. Operations 

':::CA ,,_ EleclTonic ... ,," .... 
44

• 

.. . . ''-

Unifod Statos 

Environmontal Protedion 

Ag."")' 

OfflCO of Pr8Vontion. Pesticides 

and Toxic Substances 

(H-750SW) 

&EPA ReregistraUor;. .••.. 

EPA 73B-~ 

Fobruary-' 

Eligibility Do.cu."ent 

(RED) ........... . 

Iron Salts 
45

IRON II SULFATE MONOHYDRATE 

GUIDELINE GUIDELINE NAME 

" 

§iS8:I::;O Environmental Fate 

AJI fate data requirements have been waived. 

§158.135 Toxicology 

81-1 Acute oral tox. rat 

81-2 Acute denna!tox. rabbit 

81-3 Acute inhal. tox rat 81-4 Primary eye irrnti6n-rabbit 

81-5 Primary denna! irritation 

8H Dermal sensitization/Guinea pigs 

§l58.145 EcologlCJlI meets 

71-l(a) Acute Avian Oral Toxicity -Quail/Duck 

71-2(a) Avian Dietary Toxicity -Quail/Duck 

71-2(b) Acute avian diet. duck 

72-1(.) Freshw.ter Fish Toxicity -Bluegill 

72-1 (c) Fish toxicity rainbow trout 

72-2(.) Freshwater lnvertdJrale Toxicity 

USE 

SITES 

All All 

AU 

All All 

All All All 

All 

AU 

All 

All 
46

I 

B. 

! 

HUman Health Assessment 

, , , , , , , , 

L ToxlcoJogy Assesstnent " , , , " 

The toxicoJogica1 data base on iron (ID) suJfa~1' i,ro,-, (II) ~l\lfate 

monohydrate, and iron (II) sulfate heptahydrate is ad~.JatO anti wm support 

reregistration eligibility. : ) ,) ,") :' , , ~ 

a. Acute and Subchronic Toxicity 

ACUTE TOXICITY V AWES 

TEST RESULT TOXICITY 

Iron III Sulfate CATEGORY 

Oral LO,,--rat 1487 - 2102 mg/kg m 

Inhalation LCSOM-rat > 1,10 mgiL m 

Dermal LD50~-rabbit >2000 mg/kg III 

Eye Irritation corrosive I 

Dennal Irritation corrosive N 

Dennal Sensitization negative -

Iron (111) sulfate, in an acute oral study in rats. had an LDso of 

1487 mg/kg in females and 2102 mg/kg in males. An acute dermal 

toxicity test in rabbits with Iron (In) sulfate found an LD50 greater than 

2000 mg/kg. An acute inhalation toxicity study in rats using iron (III) 

sulfate determined the LCso to be greater than J. JO rngfL. 

Iron (II) sulfate heptahydrate, in an acute oraJ study in rats, 

showed an LO. of 1389 mg/kg and an acute oral study in rabbits 

showed an LD", of 2778 mg/kg(4). The LO .. determined for this 

compound in mice was 1520 mg/kg(4). A sensitization study using 

guinea pigs with iron (II) sulfate monohydrate and iron (III) sulfate 

found no indication of contact sensitization by this compound. 

7 

) 
47

2. 

) 

b. Mutagenicity 

\ -, , 1 , 

A mutation study in li k!lli reported pp3(tive nsult'5 'af,3,} ~ ; ; 

umoIlL(4). With due regard for the continuing'p';xPOs11'\~ LicP' huciti ~:; 

beings have had to the iron and sulfate components of these chemlcals 

over many generations, it is considered unlikely -~~ t1As, ~~ result 

in microorganisms has any bearing on probable iffect~ in ;In,m¥s or 

other mammals at the levels expected from use of theie' CoMpo»nds as 

pestiCides. ' - '" -, " 

c. Metabolism 

Iron sulfates are normal constituents of the diet and are 

metabolized and utilized by the body. 

d. Other TO"licological Consideration 

The toxicological data on iron sulfates within the A d in 

the literature are adequate for assessin risk to humans. Not all of the 

toxiCity data usually requtred for pesticide registration or reregistration 

are necessary for the present uses of iron sulfates. There are some 

unusual factors in this case which indicate that specific studies to fulfill 

the usual data requirements are not necessary to regulate these 

substances as pesticides. Iron sulfates are normally present in the 

environment. They may be present in foods naturally and as added 

ingredients. There is no reason to expect that pesticide usage in 

accordance with the product label or labeling accompanying the product 

will constitute any hazard beyond that from ordinary exposure. 

Exposure Assessment 

3. Dietary 

Dietary exposure to iron (HI) sulfate, iron (II) sulfate 

heptahydrate, and iron (II) sulfate monohydrate is not expected to occur 

from pesticidal use. There are no active products involving pesticidal 

uses on food or animal feed. Therefore, there are no tolerances or 

exemptions from the requirements of tolerances established for iron 

salts. Since there are !to toxicological endpoints of concern and no 

food useS, no risk assessment was performed for dietary exposure. 

Iron (11) sulfate is generally recognized as safe as noted in 40 CPR 

180.2(a). The Food and Drug Administration has affirmed that iron 

(lll) sulfate and iron (11) sulfate (hepta and monohydrate) are generally 

recognized as safe (GRAS) for use in food as flavoring agents and 

nutrient supplements, respectively, with no limitations other than 

8 

) ) 
Pages 48-64 - *Product ingredient source information may be entitled to confidential treatment*
65
Pages 66-77 - *Confidential Statement of Formula may be entitled to co