# REGISTRATION 88089-1

### (



### SANOGIENE DESCRIPTION OFMATERIALS USED TO PRODUCE THE PRODUCTAND FORMULATINGPROCESS GuidelineReferenceNo. OPPTS 830.1600 and 830.1650
BEGINNING MATERIALS: 

## The beginning materials and purpose in the fonnulation of SANOGIENE 

## are presented below and in the enclosed Confidential Statement ofFonnula, a copy ofwhich is provided at VOLUME 2, NUMBER I, above. 

### Formulation Active Ingredient(s) EPA Reg. No. 

### Purpose in Component Formulation

Page 5 of 30

### (



### RE: Sanogiene, EPA Reg No 88089-R Dick Collier to: Jacqueline Campbell-McFarlane 06/021201110:58AM Cc: Jaclyn Carl, Mark Hartman

### --------~~~~~~~-------------------------------
Dear Jacqueline: Thank you for your agreement with our proposal to characterize in Sanogiene as an inert ingredient. please find attached a revised CSF, label, and a replacement page (Page 5 of 30) of the Product Chemistry Group A Confidential Appendix. The revised CSF shows the purpose of in Sanogiene as a In regard to the revised label, the ingredient statement no longer lists as an active ingredient and the percentage of "other ingredients" has been increased accordingly. In regard to Page 5 of 30 of the Product Chemistry Group A Confidential Appendix, the row in the table on this page has been revised to show not an active ingredient. We request that you replace the original CSF, label and page 5 of 30 with the attached documents. Please let me know if it is necessary that these documents be submitted through the front-end screening process. Best regards, Dick
Richard H. Collier, Ph.D. Senior vice President, Regulatory Affairs Landis International, Inc. P. O. Box 5126 Valdosta, GA 31603-5126 Office: Mobile: FAX: FAX: 229-247-6472 (Valdosta, GA) 229-251-2818 229-242-1562 (valdosta, GA) 866-541-1889 (san Luis, CO)
-----Original Message----- From: Campbell-Mcfarlane.Jacqueline®epamail.epa.gov mailto:Campbell-Mcfarlane.Jacqueline@epamail.epa.gov] Sent: Wednesday, June 01, 2011 1:23 PM To: Dick Collier Cc: Carl.Jaclyn@epamail.epa.gov; Hartman.Mark@epamail.epa.gov Subject: RE: Sanogiene, EPA Reg No 88089-R Dear Mr. Collier, I conferred with the product chemist regarding the potential activity of in this product formulation, and he indicated that it more than likely serves as an inert ingredient in this formulation. Therefore, you will need to submit a revised CSF, label, and product chemistry data reflecting this change. If you have any questions, please contact me or Jaclyn Carl.FPJC: 866-541-1889 (San Luis, CO)

-----original Message----- From: Campbell-Mcfarlane.Jacqueline@epamail.epa.gov mailto:Campbell-Mcfarlane.Jacqueline@epamail.epa.gov] Sent: Tuesday, May 31, 2011 3:57 PM To: Dick Collier Cc: Hartman.Mark@epamail.epa.govj Carl.Jaclyn@epamail.epa.gov Subject: Fw: Sanogiene, EPA Reg No 88089-R

Dear Mr. Collier, I double checked with the product chemist to make sure that I was providing you with the correct information. I apologize if this was not clearly indicated at the time of the preregistration meeting; I need to go back over my meeting notes. However, the Preliminary Analysis must be conducted on each source that you are using for We cannot move forward with registering your product without this data nor can a conditional registration be granted for Tier 1 data. If you have any questions, please contact me. Sincerely, Jacqueline McFarlane EPA (7510P) Antimicrobials Division 1200 Pennsylvania Ave, NW Washington, DC 20460 (703) 308-6416 (703) 308-6467 (fax)

----- Forwarded by Jacqueline Campbell-McFarlane/DC/USEPA/US on 05/31/2011 03:53 PM
----- From: To: Date: Subject:

(Embedded image moved to file: pic21457.gif) Juan Negron/DC/USEPA/US Jacqueline Campbell-McFarlane/DC/USEPA/US@EPA 05/31/2011 08:25 AM Re: Fw: Sanogiene, EPA Reg No 88089-R

(Embedded image moved to file: piC14369.jpg)

Yes! For all unregistered source (integrated system) we always request the 5-batch (under the 830.1700 Preliminary analysis) and a certificate of analysis for the raw material. FYI, make sure that the registrant

### (

submission of these data be a condition of registration. Such treatment is a reasonable request because of the nature of the requirement, the 40 CFR 152.25(£) status of this ingredient, and, during the Pre-Application Meeting, the Agency did not indicate that these data would be required. It would certainly be unfair to hold up registration approval for data that will take several months to generate. There may be another alternative. We could list the as an inert. As we indicated in the Pre-Application Meeting, we have listed 

### it as an active ingredient because is some circumstances it serves that role. We have no data that shows to active in Sanogiene but also have none to prove that it is not active. Efficacy testing has been done on the whole formulation, not its component parts. However, in Sanogiene, its main role is If this is acceptable to the Agency, we can quickly supply a revised CSF changing the "purpose in the Formulation" for Best regards, Dick
Richard H. Collier, ph.D. Senior Vice President, Regulatory Affairs Landis International, Inc. P. O. Box 5126 valdosta, GA 31603-5126 Office: Mobile: FAX: FAX: 229-247-6472 (Valdosta, GA) 229-251-2818

229-242-1562 (Valdosta, GA) 866-541-1889 (San Luis, CO)

-----Original Message----- From: Campbell-Mcfarlane.Jacqueline@epamail.epa.gov mailto:Campbell-Mcfarlane.Jacqueline@epamail.epa.gov] Sent: Thursday, May 26, 2011 1:02 PM To: Dick Collier Cc: Carl.Jaclyn@epamail.epa.gov Subject: RE: sanogiene, EPA Reg No 88089-R Hi, Dick I'm taking a look at your submission, and I noticed that is an active ingredient. You are correct in that there are no registered sources of

, so there is no registration number to disclose on the Formulator's Exemption form. However, you are not exempt from having to address the generic data requirements as well as submit 5 batch analysis to validate that the in the formulation is

. The generic data matrix should list the product chemistry data that you will submit, and cite-all for the remaining generic data requirements. If you have any questions, please contact me. Sincerely, Jacqueline McFarlane EPA (7510P) Antimicrobials Division

### (
Jaclyn has drafted the registration notice which is presently with me for a secondary review. As I was reviewing the proposed label, I notice that there was not a "First Aid" or "Environmental Hazards" section. Also, the "Precautionary Statements" should be consolidated to limit the redundancy of language. Finally, this product is a nonpublic health pesticide, so you will need to qualify bacteria by stating "odor causing, discoloration, or spoilage bacteria." Upon receipt of the revised label, we will email you the registration notice 

### and stamped label. If 

### you have any questions, please contact Jaclyn Carl or myself. Sincerely I Jacqueline McFarlane EPA (7510P) Antimicrobials Division 1200 Pennsylvania Ave, NW Washington, DC 20460 (703) 308-6416 (703) 308-6467 (fax)

From: Collier <DCollier@landisintl.com> 

### To: Carl/DC/USEPA/US@EPA Cc: Campbell-McFarlane/DC/USEPA/US@EPA Date: 10:59 AM Subject: Sanogiene, EPA Reg No 88089-R

Dear Jac1yn: Dick Jaclyn Jacqueline OS/23/2011 RE:

We are prepared to submit the revised label for Sanogiene (3 copies) as soon as we receive the signed official registration notice. Can you tell me when we should expect to receive the notice along with the stamped label (with conditions) and the Chemistry Data Evaluation? Best regards, Dick
Richard H. Collier, Ph.D. Senior Vice President, Regulatory Affairs Landis International, Inc. P. O. Box 5126 valdosta, GA 31603-5126 Office: Mobile: FAX: FAX: 229-247-6472 {Valdosta, GA} 229-251-2818

229-242-1562 {Valdosta, GA} 866-541-1889 {San Luis, CO}

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

DPBARCODE: MRlD:
SUBJECT: REG. NO. OR FILE SYMBOL: DOCUMENT TYPE: Manufacturing-use I] 

### INGREDIENTS (PC Codes) (115501

CAS Numbers: TEST LAB: SUBMITTER: GUIDELINE: COMMODITIES: REVIEWER: ORGANIZATION: APPROVER: OR ApriI26,2011. D386712 OFFICE OF PREVENTION, PESTICIDES A."<D TOXIC SUBSTANCES



### 483711-00, 483711-01, 483711-02, 483711-03, 483711-04, 483711-05 Sanogiene 

### 88089-R Product Chemistry Review End-use Product 

## [Xl I-hydroxymethyl-5-5-dimethyl Hydantoin(115502)

Chitosan (128930) (6440-58-0), (116-25-6), 9012-76-4), 

## Landis International, Inc. Biomed Protect LLC. OPPTS 830 Series. Formulation Salvador Rodriguez AD 

## Karen P. Hicks APROVED DATE: 04/27111.

## ( ( UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY WASHINGTON, DC 20460

April 26, 2011. 

### MEMORANDUM OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES



### Subject: 

### Product Chemistry Review for EPA Reg 

### # 88089-R:r-___**~** 

### From:

Thru:



### To:

APPLICANT: Action code: Due date: Product Formulation Active Ingredient(s) 

### Salvador Rodriguez, Chemist Product Science Branch, CT Team 

## Antimicrobials Division (751OP) Karen P. Hicks, CT Team Leader Product Science Branch Antimicrobials Division (75101U--- 

## Jacqueline Campbell-McFarlane/ Jaclyn Carl PM Team 34 

### Antimicrobials Division (751OP) Biomed Protect LLC. A540 06/21/l1

% 

### bywt Biomed Protect LLC
........................................ 22.58 I-hydroxymethyl-5-5-dimethylhydantoin

................21.42 Chitosan

.........................................................0.40

88089-R_D3867I2_BiomcdProtcctLLC Page 2 of9 

# -------

### ( BACKGROUND:
On behalfofBioMed Protect, LLC, Landis International, Inc. has submitted an application for registration ofa new fungicide and bacteriocide non-integrated end-use product, Sanogiene. This product is for use in controlling the growth ofbacteria and fungi intextiles. The Product ChemistryReviewer has received the following documents:

• The datapackage included a letter from the applicant's representative to EPA, dated January

### 27, 2011; a Confidential Statement ofFormula (CSF) for the basic formulation, dated January 17,2011; EPA Fonn 8570-27 (Formulator's Exemption Statement), dated January 27, 2011; EPA Fonn 8570-34 (Certification withRespectto Citation ofData), dated January 27, 2011; EPA Fonn 8570-35 (Data Matrix), dated January 27, 2011; a draft label (pin-punched 01'31'11); and five studies (MRID 483711-01 through 483711-05). Note: The laboratoryreports assigned MRID 483711-02 and 483711-05 describe studies or methods for the products, Hyramine and HR-2010, respectively. A letter from the applicant's representative to EPA (datedJanuary 27, 2011) states thatHyramine and HR-2010 are names used during development ofthe product, Sanogiene, whichis the product for which registration is sought. 

### FINDINGS: 1. The CSF, dated 01/17111, for the basic formulation is revised 2. Group A product chemistry data requirements applicable to end-use products have been met. MRID #s 483711-01, 483711-04, 483711-05. 3. Group B product chemistry datarequirements applicable to end-use products have been met, with the exception ofOPPTS 830.6317 (Storage Stability) and OPPTS 830.6320 (CorrosionCharacteristics). See the "Recommendations" section ofthis report for deficiencies. MRID #s 483711-02 & 

### 483711-03. 4. The CSF and the label have the same nominal. 5. All certified limits meet the EPA standard certified limits. 6. A statement ofGood Laboratory Practice (GLP) compliance was provided for the study assigned MRID 483711-02. The study was conducted in accordance withthe requirements of40 CFR Part 160 FIFRA GLP standards. 7. Certain information onthe product label could be improved, as noted in the "Recommendations" section ofthis report. 8, Certain information on the CSF could be improved. See Recommendation sectionofthis report,
88089-R_D386712_BioMedProteetLLC Page 3 of9

### CONCLUSIONS: The CSF, dated 01117/2011, for the basic formulation, is acceptable. The Group A product chemistry data requirements applicable to end-use products have been met. The Group B product chemistrydata requirements applicable to end-use products have been met, with the exception of OPPTS 830.6317 (Storage Stability) and OPPTS 830.6320 (Corrosion Characteristics). See recommendations. 

### RECOMMENDATIONS:

• To satisfy OPPTS 830.6317 (Storage Stability) and OPPTS 830.6320 (Corrosion Characteristics) requirements, results for a minimumof1 year from a GLP-compliant storage stability and corrosion characteristics study must be provided. Testingofthe product has beeninitiated. The concentration ofthe active ingredients in the product must be determined at the beginning ofthe testperiod and every 3 months thereafter for a period of 1 year. Storage and disposal information ontheproduct label must be revised 

### if product composition(or packaging) deteriorates over time. The product should be tested in its commercial packaging.
The following revisions to the product label are recommended: A "First Aid" section must be included onthe product label. Guidance on infonnationto be included in the "FirstAid" section is available at http://www.epa.gov/oppfeadl/labelingllrml
a. Add the heading "Physical or Chemical Hazards" immediatelybeneath the "Precautionary Statements" section ofthe product label. b. Place the "Storage and Disposal" section on the product label in a text box for prominence.

c. Underthe "Pesticide Storage" section on the product label, add instructions that specify whatto do ifthe product leaks or spills from the product container. d. Add page numbers to each page ofthe product label.

• The following revisionto the CSF is recommended.

a. In box # 10, change dihyrdoxymethyl" to read "dihydroxymethyl."

88089-R_D386712_BioMedProtecILLC Page 4 of9

### PRODUCT CHEMIS!l.SREVIEW I. CONFIDENTIAL STATEMENT OF FORMULA

a. Type offormulation and source registration:

• Non-integrated formulation system 

## [X]

• Are all TGAIs used registered? Yes [ ] No [ ]

• Integrated formulation system 

### [ ]

• If"ME-TOO," specify EPA Reg. No. ofexisting product: ___ _ b. Clearance ofinerts for non-food or food use: Theproduct is cleared for food use under40 CFR §§180.940 and 180.950. Yes[] No[] 

### Note: Thisproduct is not intended for/Dod use. Theproduct labelstates: 

## "Do notuse articles thathave been treatedwith SANOGIENEas components in materials usedin/ood packaging andfood-holding. "


### c. Physical state ofproduct: Liquid d. The chemical IDs and analytical information (including that for the TGAIs), density, pH, and flammability are consistent withthat given in 830 Series, Group B. Yes [X] No [ ]


### e. The Nes

### and CLs are acceptable. Yes [X] No [ ] 

### f. Active ingredients NC LCL UCL (%) (%) (%) 

### 1,3-Bis (hydroxymethyl)-5,5-dimethylhydantoin 22.58 21.90 23.25 Hydroxymethyl-5,5-dimethylhydantoin 21.42 20.78 22.06 Chitosan 0.40 0.36 0.44 g. Forproducts produced by an integrated formulation system:

• Do all impurities oftoxicological significance have a VCL? Yes [ ] No[] Not applicable [X]

• Have all impurities of2: 0.1% 

### in the product been identified? Yes [ ] No[] Not applicable [X]

88089-R_D386712_BioMcdProlcctLLC Page 5 of9

### ( 

### II PRODUCT LAbd
a. The active ingredient(s) statement (chemical IDs and NC) is consistent withthe 

### CONFIDENTIAL STATEMENT OF FORMULA. Yes [ 

# 1 No 

# [Xl b. The formula contains one ofthe following: 

# • 10% ormore ofapetroleum distillate: 

### Yes [ 

# 1 No 

## [Xl 

# • 1.0% ormore ofmethyl alcohol: 

### Yes [ 

# 1 No 

## [Xl 

# • sodium nitrite at any level: Yes [ 

# 1 No 

## [Xl 

# • a toxic List 1 inert at any level: 

### Yes [ 

# 1 No 

## [Xl 

# • arsenic in any form: 

### Yes [ 

# 1 No 

## [Xl
c. 

## If"yes"to any ofthe above, does the inert ingredients statement contain a footnote 

### indicatingthis? Yes [ 

# 1 No [ 

# 1 Not applicable 

### [Xl d. Appropriate warning statements regarding flammability orexplosive characteristics of the product are listedonthe label. 

### Yes [ 

## 1 No [ 

## 1 Not applicable 

## [Xl
e. The storage and disposal instructions for the pesticide containerare incompliance with PRNotice 84-1 for household use products orPRNotice 83-3 for all otheruses. 

### Yes 

# [Xl No[ 

# 1 f. The product requires an expiration date at whichtime the NC falls belowthe LCL (based onthe I-year storage stability data orother information). 

### Yes [ 

# 1 No[ 

# 1 Note: Storage stabilitystudies are ongoingandhave not been completed.

88089-R_D386712_BioMcdProtectLLC Page 6 of9

### TableA: 

### Product Chemistry (Series 830, GroupA) 

## Data Requirements Acceptance ofInformation MRIDNo. 830.1550 Product Identity' A 

### 483711-01 830.1600 DescriptionofMaterials A 

### 483711-01 

### 830.1620 Production Process" 

## NR 830.1650 FormulationProcess A 483711-01 830.1670 Fonuation of A 483711-01 Impurities4 

### 830.1700 Preliminary Analysis' 

## NR 830.1750 Certified Limits' A 483711-01 830.1800 EnforcementAnalytical A 483711-04 Method' 483711-05 830.1900 Submittal ofSamples 

### [Samples are to beprovidedon a case-bycase basis for end-useproducts., ExplanatIon: A-acceptable;N-not acceptable (I.e., 

### Item was submltled

### but 

### 15 notacceptable); NA=technically not applicable (i.e., notrequired); G=data gap (Le., item was not submitted but is required); U=requires upgrading (Le., item is unacceptable butupgradeable); W=waived; 

### E=EPA estimate. ISee Confidential Appendix A for additional information. 2

### For MP/EP products producedbyan integrated formulation system. 3

### For products from a TGAI or MP. 4

### Maybewaivedunless actual/possible impurities are oftoxicological concern. 5

### Five batch analysis required for products produced by an integrated formulation system. 

### 6Ifdifferent from standard CLsrecommended in 40 CFR 158.175,this should be discussed in Confidential Appendix A. 7

### Abbreviate method used as follows: gas chromatography (GC), infrared (lR), ultraviolet absorption (UV), nuclear magnetic resonance (NMR), etc.

Table B: 88089·R _0386712_ BioMedProtectLLC Page 7of9

### Physical and Chemici. ,-,'haracteristics (Series 830, Group Bj Physical/Chemical Acceptance Value or QualitativeDescription MRIDNo. Properties* ofData 830.6302 Color A The product has avery light yellow 483711-02 tint. 830.6303 Physical State A The product is a liquid, based on 483711-02 visual observation. 830.6304 Odor A The product has an extremely faint 483711-02 sweet odor. 830.6313 StabilitytoNormal NA 

### [Not required/or end-useproducts.] and Elevated Temperatures, Metals, and Metal Ions 830.6314 Oxidation! A This product does not contain 483711-02 Reduction; Chemical oxidizing orreducing agents. Incompatibility 

# --- 830.6315 F1ammabi1ity/ A The product does not contain 483711-03 Flame Extension combustible liquids. 830.6316 Exp10dabi1ity A The product does not contain 483711-03 explosive materials and is not potentially explosive. 830.6317 Storage Stability G 

### A storage stability study has been initiated. 830.6319 Miscibility A The product is not an emulsifiable 483711-03 liquid to be diluted withpetroleumbased solvents. 830.6320 Corrosion G 

### A corrosion characteristics study has Characteristics been initiated. 830.6321 Dielectric A The product is notto be used around 483711-03 Breakdown Voltage electrical equipment. 830.7000 pH A The pH ofthe product was reported 483711-02 to be 3.1. A 1 % 

### by weight solution ofthe product was tested. 830.7050 UVNisib1e NA 

### [Not required/or end-useproducts.] Absorption 830.7100 Viscosity A The kinematic viscosity ofthe 483711-02 productwas reportedto be 30.2 centipoises at 23°C and 18.7 centipoises at 39°C. 830.7200 Melting NA 

### [Not required/or end-useproducts.] PointlMelting Range 830.7220 Boiling NA 

### [Not required/or end-useproducts.] PointIBoiling Range

88089-R_D386712_BioMcdProtcctLLC Page 8 of9I 

### i 

### Physical/Chemical Acceptance Value or QualitativeDescription 

### MRlDNo. Properties* ofData 830.7300 DensityIRelative 

## A The specific gravity oftheproduct 483711-02 DensitylBulkDensity was reported to be 1.137 at 23°C and 1.130 at39"C
.. 830.7370 Dissociation 

## NA [Not required/or end-useproducts.} Constants 

### inWater 

### 830.7550/830.7560/830.7570 

## NA [Not reqUired/or end-useproducts.] Partition Coefficient 

### 830.7840/830.7860 Water 

## NA [Not required/or end-useproducts.} Solubility 830.7950 Vapor Pressure 

## NA [Not required/or end-useproducts.)



## . ExplanatIOn: A-acceptable; N-notacceptable (l.e., 

### Item 

### was submIttedbut IS 

### not acceptable); NA=technicaIIynot applicable (i.e.,not required); G=data gap (i.e., item was not submittedbut is required); U=requires upgrading (i.e., item is unacceptable butupgradeabIe); W=waived; E=EPA 

### estimate. 

# * Provide briefdescription, e.g., color

- yeIIow orpropertyvalue, e.g., density 1.25 

### glee. Unless otherwise indicated, the property shouldbe at 25°C.
1 

## Ifproduct is an emulsifiable liquid 

## 2Ifproduct is dispersible withwater

88089.R_ D386712_BioMedProtectLLC Page 9 of9

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
May 13, 2011 MEMORANDUM SUBJECT: Acute Toxicity Review forEPAReg. No.: 88089-R DP Barcode: D386713 FROM: 

### Chris Jiang, Chemist Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (751OP)

# ~~ 5/13{11
THRU:

TO:

Applicant: 

### Karen Hicks, Team Leader Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (751OP) Jacqueline Campbell-McFarlane PM 34/Jaclyn Carl 

### Regulatory Management Branch II Antimicrobials Division (751 OP)
BioMed Protect, LLC FORMULATION FROMLABEL: 

### Active Ingredient(s):

1,3-Bis (Hydroxymethyl)-5,5-dimethylhydantoin Hydroxymethyl-5,5-dimethylhydantion 

### Chitosan Other Ingredient(s): Total: % 

### bywt. 19.92 % 18.90 

### %

0.40% 100.00 %

## BACKGROUND: The registrant has submitted an acute toxicity package to register this end-use product to be used as a preservative. The package includes a label, a Confidential Statement ofFonnula, an acute oral study (MRID

## 48371106), an acute dermal study (MRID 48371107), 

## an acute inhalation study (MRID 48371108), 

## an acute eye irritation study (MRID

## 48371109), an acute dermal irritation study (MRID 48371110), 

## and a denmal sensitization study (MRID 48371111). 

## FINDINGS: I. 

### Th 

### fil fc 

## e acute toxIcity pro 1

## e or 88089-R

## is:

. . Study MRID 

### ToxiCIty

## SWjy~4tus . Number Category ,,--""'" , 

## Acute Oral Toxicity 48371106 

## IV Acceptable Acute Dermal Toxicity 48371107 

## IV Acceptable Acute Inhalation Toxicity 48371108 

## IV Acceptable

PrimaryEye Irritation 48371109 

## IV Acceptable Primary Skin Irritation 48371110 

## IV Acceptable

Dermal Sensitization 48371111 

## Nonsensitizer Acceptable LABELING 1. 

## The signal word is**CAUTION~** 

## however, this signal word is not required because all toxicity categories for this product are all IV. 2. 

## No precautionary language or first aid statements are required forthis**product~** 

## however, the registrant may use the precautionary language and first aid statements for product with toxicity category III. 3. 

## The precautionary labeling may read, "Causes moderate eye irritation. Avoid contact with skin, eyes, or clothing. Avoid breathing vapor. Harmful ifswallowed, absorbed through skin, or inhaled. Wash thoroughlywith soap and water after handling and before eating, drinking, chewing gum, using tobacco, orusing the toilet. Remove and wash contaminated clothing before reuse." 4. 

## The first aid statements may read: IfswalIowed: -Call a poison control centerordoctor immediately for treatment advice. -Have a person sip a glass ofwaterifable to swallow. -Do not induce vomiting unless told to by a poison control center ordoctor -Do not give anything by mouth to an unconscious person. Ifon 

## skin: -Take offcontaminated clothing. -Rinse skin immediately with plenty ofwater for 15-20 minutes. -Call a poison control center or doctor fortreatment advice.

### If

### inhaled: -Movepersonto fresh air. -Ifperson is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth, 

### ifpossible. -Call a poison control center or doctor for further treatment advice. 

### Ifin eyes: -Hold eye open and rinse slowly and gently with waterfor 15-20 minutes. Remove contact lenses, 

## ifpresent, afterthe first 5 minutes, then continue 

## rinsing. -Call a poison control centeror doctor for treatment advice.

### (



### DATAREVIEW FORACUTE ORALTOXICITY TESTING (81-1, 870.1100) Product Manager: Jacquie McFarlane 

### MRID No.: 48371106 

## Reviewer: Chris Jiang Study Completion Date: May 14,2010 ReportNo.: 13808-10 Testing Laboratory: 

## Stillmeadow Incorporated Author: 

## Janice O. 

## Kuhn Quality Assurance (40 CFR 160.12): A statement ofGLP compliancewas included. 

### Test Material: Hyramine, LotNo. 20I0043A, lighttan transparent liquid Dosage: 170 mg/kg, 550 mglkg, 1750 mglkg, 5000 mg/kg 

## Species: Female albino Sprague-Dawley rats Age: Eightto nine weeks at time ofdosing Weight: 161-196 grams (fasted) 

## Source: Texas Animal Specialties, Humble, TX Conclusions: 1. 

### LDso (mglkg): LD"**~** 

### 5000 mglkg 2. The estimated LDso is equal to 5000 mglkg. 

## 3. Toxicity Category: IV Classification: Acceptable 

## Procedure (Deviations from 81-1): The Up-aod-Down Procedure was used. The relative humiditywas outside the range ofthe protocol. These deviations had no impact on the integrity ofthe 

## study. Results: Reported Mortality 

## Animal No. Dose Level**(m~/k~)** 

## Result 161 5000 D 162 175 S 163 550 S 164 1,750 S 165 5,000 S 166 5,000 S 167 5,000 D 168 1,750 S 169 5,000 S 170 5,000 S 171 5,000 S S
- SurvIval; D - Death

### (



### Observations: 

### 175 mg/kg): The animal appeared normal and healthythroughoutthe study. 

## 550 mg/kg: 

## The only clinical sign observed was slight hypoactivity. 1,750 mg/kg: The animals appeared normal and healthy throughoutthe study. 

## 5,000 mg/kg): 

## Two animals died in this dose group. Clinical signs ofthe 

## decedents included slight to moderate piloerection and very slight salivation. Clinical signs ofthe 

## survivors included acrust aroWld the eye, slight polyuria, slight to moderate piloerection, slight to moderate hypoactivity. Gross Necropsy Findings: 

## Gross necropsies were unremarkable except for the decedents who had bright red discolored lungs, liquid in the stomach, a stomach full ofyellow 

## liquid, and empty intestines.

### ( (



### DATA REVIEW FORACUTE DERMAL TOXICITY TESTING (81-2, 870.1200) Reviewer: Chris Jiang ProductManager: JacquieMcFarlane 

### MRID No.: 48371107 Study CompletionDate: March 31, 2010 ReportNo.: 13809-10 Testing Laboratory: StiIlmeadow Incorporated 

### Author: Janice 

### O. Kuhn 

### QualityAssurance (40 CFR 160.12): A statementofGLP compliancewas included. Test Material: Hyramine, LotNo. 2010043A, lighttantransparent liquid Dosage: 5050 mg/kg Species: Five male and five female albino Sprague-Dawley rats Age: Eightweeks at time ofdosing 

### Weight: \': 175 to 213 grams before dosing; 

# 0: 245 to 307 gramsbefore dosing Source: Texas Animal Specialties, Humble, TX Conclusions: 

### 1. LD50 (mglkg): LD50 

## > 5050 mg/kg 2. The estimated LDso is greaterthan 5050 mg/kg. 

## 3. Toxicity Category: IV Classification: Acceptable Procedure (Deviations from 81-2): No deviations occurred during the study. Results: 

### Reported Mortality (NumberDeathslNumber Tested) Dosage (mglkg) Males 

### Females Combined 5050 0/5 0/5 

### 0/10 Observations: All animals appeared nonnal and healthy for the duration ofthe study. Only one male experienced very slight erythema on day 1. All animals had test substance staining throughoutthe study. GrossNecropsy Findings: Gross necropsies were unremarkable.

## (

DATA REVIEW FORACUTE INHALATION TOXICITY (§81-3, 870.1300) Product Manager: Jacquie McFarlane Reviewer: Chris Jiang 

### MRID No.: 48371108 Study Completion Date: Apn120, 2010 ReportNo.: 13810-10 Testing Laboratory: Stillmeadow Incorporated Author: Andrew Doig 

### Quality Assurance (40 CFR 160.12): A statement ofGLP compliancewas included. Test Material: Hyramine, Lot No. 2010043A, light tan transparent liquid 

### Dosage: 2.08 mgIL (Nominal concentration: 9.82 

## mgIL) (Gravimetric concentration: 2.08 mgIL) Species: Five male and five female albino Sprague-Dawley rats Age: Eight weeks at time ofdosingO.s 

### Weight: 

## 'j': 176 to 199 grams before dosing; (S: 

### 263 to 289 grams before dosing Source: Texas Animal Specialties, Humble, TX Summary: 

### 1. 

## 2. 3. 

## 4. LC" (mglL): > 

### 2.08 mgIL The LCso is greater than 2.08 mgIL. 

### MMAD:**2.8~m** 

### Toxicity Category: IV Classification: Acceptable 

### Procedure (Deviations from 81-3): The relative humidity and the temperature 

## ofthe exposure chamber were outside the range specified in the protocol. These deviations had no impact on the integrity ofthe study. Results: 

### Reported Mortality (Number DeathslNumberTested) Dosage (mglL) Males Females Combined 

### 2.08 0/5 0/5 0110

### (

ChamberAtmosphere 

## DoseLevel MMAD 

## GSD particles < 

### 4.2 Ilm 

### (mgIL)**(~m) (~m)** 



### 2.08 2.7 5.2 12.77 2.16 2.9 5.4 6.35 ChamberEnvironmentDuring Exoosure 

### ChamberVolume (L) 500 Average TotalAirflow Volume (Lpm) 218 Air Changes Per Hour 

### 26.2 Mean Temperature (OC) 

### 24.1 to 25.0 Mean Relative Humidity (%) 

### 41.2 to 46.4 Clinical Observations: 

## Clinical observations included very slight to slight piloerection and very slight to slight hypoactivity. Gross Necropsy Findings: 

## Gross necropsies were unremarkable.

### (



### DATA REVIEW FORPRIMARY EYEIRRITATION TESTING (81-4, 870.2400) Product Manager: Jacquie McFarlane Reviewer: Chris Jiang 

### MRID No.: 48371109 Study Completion Date: April 13, 2010 ReportNo.: 13811-10 Testing Laboratory: StiIImeadow Incorporated Author: Janice O. Kuhn 

### QualityAssurance (40 CFR 160.12): A statement ofGLP compliance was included. Test Material: Hyramine, 

## Lot No. 2010043A, light tan transparent liquid 

### Dosage: 0.1 mL 

### Species: One male and two female albino NewZealand White rabbits Age: Thirteen weeks at time ofdosing 

### Initial Weight: 2.425 to 2.875 kg Source: Myrtle's Rabbitry, Thompsons Station, TN Summary: 

### 1. 

### Toxicity Category: IV 2. Classification: Acceptable 

### Procedure (Deviations from 81-4): The relative humidity was outside ofthe 

### range specified in the protocol. This deviation had no impact on the integrity ofthe 

### study_ Results: Individual Scores for Ocular Irritation 

### • 

### RabbitNo. 4726 RabbitNo. 4693 RabbitNo. 4695 Observations 

### (Male) 1 24 I. Corneal Opacity 

## + 0 ll. Iritis I 

### 0 ID. Conjunctivae A. Redness 

### 2 I 

### B. Chemosis I I 

### C. 

### Discharge I I



## . -Ammal vocahzed dunng dosmg 

## +-Slight dulling ofnonnal luster 

## *- Fluorescein staining used 

### 48 0 0 0 0 0 72 

### 0 0 0 0 0 (FemaleL _(Female)v Hours After Treatment 

### 1 24 48 72 

### 1 24 48 72 

## + 0 0 0 0 0 0 0 I 

### 0 0 0 I 

### 0 0 0 2 I 

### 0 0 2 I 

### 0 0 2 I 

### 0 0 2 0 0 0 2 I 

### 0 0 2 0 0 0

### (

DATA REVIEW FORPRIMARY SKIN IRRITATION TESTING (81-5, 870.2500) Product Manager: Jacquie McFarlane Reviewer: Chris Jiang 

### MRlDNo.: 48371110 Study Completion Date: April 6. 2010 ReportNo.: 13812-10 

### Testing Laboratory: Stillmeadow Incorporated Author: Janice O. Kuhn QualityAssurance (40 CFR 160.12): A statement ofGLP compliancewas included. 

### Test Material: Hyramine, Lot No. 2010043A, light tan transparent liquid Dosage: 0.5 

## mL Species: One male and two female albino New Zealand White rabbits Age: Twelve weeks at time ofdosing InitialWeight: 2.725 to 3.100 kg 

### Source: Myrtle's Rabbitry, Thompsons Station, TN Summary: 1. Toxicity Category: IV 

## 2. Classification: Acceptable Procedure (Deviations from 81-5): The relative humidity was outside ofthe

### range 

## specified in the protocol. This deviation had no impact on the integrity ofthe 

## study. Results: 

### Animal number Erythema/edema after unwrap 

### 1 24 48 72 

### 4716-M 110 

## 0/0 0/0 0/0 4713-F 110 110 

## 0/0 0/0 4715-F 

## 1/0 0/0 0/0 0/0

### (



### DATA REVIEW FORDERMAL SENSITIZATION TESTING (81-6, 870.2600) 

### ProductManager: Jacquie McFarlane Reviewer: Chris Jiang MRID No.: 48371111 Study Completion Date: May 18, 2010 ReportNo.: 13813-10 Testing Laboratory: StiIlmeadow Incorporated Author: Janice O. Kuhn QualityAssurance (40 CFR 160.12): A statement ofGLP compliance was included. Test Material: Hyramine. Lot No. 

### 2010043A, light tan transparent liquid Positive Control: a-Hexylcinnamaldehyde (HCA) 

### Species: Hartley albino guinea pig Weight on day 0: 

# 0': 374 g to 494, \': 348 g to 484 g 

### Age: Six to sevenweeks Source: Charles River, Hdq.,Wilmington, MA Method: Buehler Method Summary: 1. This Product is nota dermal sensitizer. 

### 2. Classification: Acceptable Procedure (Deviation From §81-6): No deviations occurred during the study. 

### Procedure: After preliminary tests, the definitive studywas undertaken. Once each week forthree weeks, either 0.4 mL ofthe undiluted test material ornothingwas applied to the clipped left front quadrant using gauze patches. After chamber application, the trunks ofthe animals werewrapped with elastic wrap thatwas secured with adhesive tape. After the exposure period, the chambers and bindings were removed and the test sites were cleansed ofresidual test substance. Theguinea pigs were scored at 24 and at 48 hours after each induction. Twoweeksafterthethird induction, all animals were challenged with 0.4 mL ofthe undiluted test substance onthe right rear quadrant. The guinea pigswere scored at 24 

### and at 48 hours after challenge. Results: At 24 hours and at 48 hours after each induction, therewas no irritation. At 24 hours and at 48 hours after challenge, there was no sensitization response. The historical positive control showed appropriate results.

### ( F A orm I\pprove o. - 060 dDMBN 20700
;

## .....



# _

.....



## '" UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

# \SlIt. 401 M Street, S_W_



### -y WASHINGTON, D_C_ 20460 Paperwork Reductton Act Nollce: The public reporting burden for this collection of infonnation Is estimated to average f.25 hours per response for registration and 0.25 hours per response for reregistration and special review activitres, including time for reading the Instructions and completing the necessaryforms. Send comments regarding burden estimate or anyother aspect ofthis collection of information, including suggestions for reducing the burden 10: Director, OPPE Informalion Management Division (2137), U.S. Environmenlal Protection Agency, 401 M Street, S.W., Washinglon, DC 20460. Do notsend the completed form to this address. Certification with Respectto Citation of Data Applicant'S/Regislranfs Name, Address, and Telephone Number EPA Registration Number/File Symbol BioMed Protect, LLC, 44Weldon Parkway, St. Louis, MO 63043 c/o Landis Int'l, 229-247-6472 

# .. 88089-R AcUve Inqredient(s) and/or reoresentative test comoound(s) Date dihyrdoxymethyl-5,S-dimethylhydantoin, hydroxymethyl-5,5-dimelhylhydantoin, chitosan, January S, 2011 General Use Patlem(s) (list alilhose claimed for lhis oroduct usinQ 40 CFR Part 158) Product Name Industrial Sanogiene NOTE: Ifyour producl isa fOO% repackaging ofanother purchased EPA-registered product labeled for all the same uses on your label, you do not need to submij this form. You must submitlhe Formulator's Exemption Statement (EPA Form 8570-27). 

# 0 I am responding to a Dala-Call-In Notice, and have included with this form a list ofcompanies sent offers ofcompensation (the Data Matrix form should be used for this purpose).
SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

# 0 I am using the cile-all method ofsupport, and have included with this form 

# 0 I am using the selective method ofSlIppOrt (orcite-all option a list ofcompanies sent offers ofcompensation (the Data Matrix form underthe selectwe method), and have included with this form a should be used for this purpose). completed list ofdata requiremenls (the Dala Mallix form must be used). SECTtDN II: GENERAL OFFERTO PAY (Required ifusing the cite-all melhod orwhen using the cite-all option underthe selective method to satisfy one or more deta requirements] 

# 0 t hereby offer and agree to paycompensation, to other persons, with regard to the approval ofthis application, to the extent required by FIFRA.

SECTION III: CERTIFICATION I certify that this applicationfor registration, this form for reregistration, or Ihis Data-Gall-In response is supported byall dala submitted orcited inthe apptication for regislration, the form for reregistration, orthe Data-Call-In response. In addition, ifthe cile-all option orcite-all option underthe setective method is indicaled in Seclion I, this applicaUon is supported byall dala in the Agency's files that (1) concern the properties oreffects of this product oran Identical or subslantially similar product, orone or more ofthe ingredients in this producl; and (2) is a type o( data thatwould be required to be submitted under the data requirements in effect on the date ofapproval ofthis application ifthe application sought the initial registration ofa product of identical orsimilar composition and uses. I certify that for each exclUSive usestudy cited in support ofthis registration or reregistration, that I am the original data submitter or'thai 

### i have obtained thewritten permiSSion ofthe original data submitterto cite that sludy. I certify that foreach study cited in supportofthis registration or reregistration that is not an exclusive use study, either. (a) I am the**ori~inal** data submitter; (b) I have obtained the permission ofthe original data submitterto use Ihe study in supportofthis application; (c) all peliods ofeligihilityfor 

# I compensation have expired for the study; (d)the study is in the public literature; or (e) I have notified in writing the company that submitted**It,~** stl..Jy ..lnd have offered (I) to pay compensation to the extent required by seclions 3(c)( f)(F) and/or 3(c)(2)(B) of FIFRA; and (ii) 10 commence negotiations to**ch~terin'ine** the 

## I amount and terms ofcompensation, ifany, to be paid for the use of Ihestudy. 

## I I certify that in all Instanceswhere an offerofcompensation is required, copies ofall offers to pay compensation and evidence oftheir r'elivery in 

### I accordancewith sections 3(c)( f)(F} and/or 3(c)(2)(B} of FIFRAare available and win be submitted totheAgency upon request. Should Ifail to produce such evidence to the Agency upon request, I undersland that the Agency may initiate action to deny, cancel orsuspend the registration of my proJIot.; :" cJnformity with FIFRA. I certify1hatthe statements I have made on this form and all attachments to It are true, accurate, and complete. I ackr.owledge that any knowingly false or misleading statement may be punishable byfine or imprisonment or both underapplicable law. 

# ,... Signature 

# a·I .r;v{JJ/-- Date Typed or Printed Name and TWe r.nu.ry n,**~Oll** Richard H. Collier, Ph.D., Regulalory Agenl

. . EPA Form 8570 34 (g 97) ElectroniC and Paperversions avallable. Submit onl 

# , , y P pe version.<""""'. Form Approved OMB No. 2070-0060 

# (.wi UNITED STATES ENVIRONMENTAL PROTECTION AGENCY "::;>' 401 M Street, 

### S.W. WASHINGTON, D.C. 20460 PapelWork Reduction Act Notice: The public reporting burden forthis collection of information is estimaled to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessaryforms. Send comments regarding the burden estimate orany other aspect ofthis collection of information, including suggestions for reducing the burdento: Director, OPPE Information Management Division (2137), U.S. Environmentat Protection Agency, 401 M Street. S.W., Washington, DC 20460. Do not send theform to this address. DATA MATRIX Date January27,2011 EPA Reg NoJFite Symbol 88089·R Page 1 of 2 Applicarrt's/ReQistrnnt's Name & Address Product BioMed Protect, LLC, 44 Weldon Parkway, SI. Louis, MO 63043 c/o Landis Int'!, PO Box 5126, Valdosta, GA31603 San09iene 

# - Ingredient 1,3-dihyrdoxymethyl.5,5.dimethylhydantoin {CAS 6440·S8·0}, 1-hydroxymethyl·S,S·dimethy!hydantoin (CAS 116-25-6). chitosan {CAS 9012-76-4}, and Guideline Reference Number Guide!ine Study Name MR!D Number Submitter Status Nct, 830.1550 Sanogiene: Product Identity and Disclosure of Ingredients BioMed Protect, LLC OWN In this subm!sslon 830.1600 Sanogiene: Product**!dent~y** and Disclosure of Ingredients BioMed Protect, LLC OWN tn this submission 830.1650 Sanogiene: Product Identityand Disclosure of Ingredients BioMed Protect, LLC OWN tn this submission 830.1670 Sanogiene: Product Identityand Disclosure of tngredients BioMed Protect, LLC OWN In this submission 830.1750 Sanogiene: Product Identity and Disclosure of tngredients BioMed Protect, LLC OWN In this submission 830.1800 Enforcement Analytical Method BioMed Protect, LLC OWN ' In this submission 

### • 830.1800 EnforcementAnalytica! Method BioMed Protect. LLC OWN 

### , fin this submission 830,6302 Chemica! and Physical Characteristics of Hyramine BioMed Protect, LLC OWN In this submission 830.6303 Chemical and Physicat Characteristics of Hyramine BioMed Protect, LLC OWN In this submission 830.6304 Chemical and Physical Characteristics of Hyramine BioMed Protect, LLC OWN In this submission 830.6314 Sanogiene:Oxidation/Reduction,Ftammability, Explod BioMed Protect, LLC OWN !n this submission 830.6315 Sanogiene: Oxidation/Reduction, Flammability, Explod BioMed Protect, LLC OWN tn this submission 830.6316 Sanogiene: Oxidation/Reduction, Flammability, Explod BioMed Protect, LLC OWN In this submission 830.6319 Sanogiene: Oxidation/Reduction, Flammability. Explod BloMed Protect, LLC OWN In this submission 830.6321 SJnOf>:ene:**OXid~tton~qe:Juction,** Ftammability, Explod BioMed Protect, LLC OWN !n this submission Signature

# i?~ J

# 7r).!~ Name and Title Date Richard H. Collier, Ph,D. 1/27/2011

------- EPA Form 8570-35 (9-97) Etec:ror:ic and Paper.verstons available. Submlt only Paperversion. Agency tnternat Use Copy

### ....'."


### ... Form Approved OMB No. 2070-0060

### (~l UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**,.~---"** 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and special review activities, including time for reading the instruC\tons and completing the necessary forms. Send comments regarding the burden estimate orany other aspect ofthis coltecUon of information. including suggestions for reducing the burden to: Director. OPPE Information Management Division (2137). U.S. Environmental Protection Agency, 401 M Street, S.W., Washington. DC 20460. Do not send the form to this address. DATA MATRIX Date January 27. 2011 EPA Reg NoJFile Symbol 88089-R 

# IPage2 of 2 AppHcanl'sJReqistranl's Name & Address Product BioMed Protect. LLC. 44 Weldon Parkway, St. Louis, MO 63043 c/o Landis Int'l, PO Box 5126. Valdosta. GA 31603 Sanogiene In9redient 1,3-dihyrdoxymethyl-5,5-dimethylhydantoin (CAS 6440-58-0), 1-hydroxymethyl-5.5-dimethylhydanloin (CAS 116-25-6), chitosan (CAS 9012-76-4). and Guideline Reference Number Guideline Study Name MRtD Number Submil\er Status Note 830.7000 Chemical and Physical Characteristics of Hyramine BioMed Protect, LLC 

### OWN In this submission 830.7100 Chemical and Physical Characteristics of Hyramine BioMed Protect, LLC 

### OWN tn this submission 830.7300 Chemical and Physical Characteristics of Hyramine BioMed Protect, LLC 

### OWN In this submission 870.1100 Hymmine
- Acute Oral Toxicity Study (UDP) BioMed Protect. LLC 

### OWN In this submission 870.1200 Hyramine
- Acute Dermal Toxicity Study BioMed Protect. LLC 

### OWN tn this submission 870.1300 Hyramine
- Acute Inhalation Toxicity Study BioMed Protec\, LLC 

### OWN In this submission 870.2400 Hyramine
- Acute Eye Irritation Study BioMed Protect. LLC 

### OWN In this submission 870.2500 Hyramine
- Acute Dermal trritation Study BioMed Protect. LLC 

### OWN In this submission 870.2600 Hyramine
- Skin Sensitization Study BioMed Protect, LLC 

### OWN In this submission**~"**



## --'.'.--"

. 

## . Signature 

# 771**fl-fi~** Name and Title Date Richard H. Collier. Ph.D. fl2712011 EPA Form 8570-35 (9-97) Elec:ror.lc am! Paperversions available. Submit only Paperversion. Agency tnternat Use Copy

# - Form Approvo ' .B. ,_ 2070.0060. Aoprovol**~xpiro,** 5-31-98. 

## ( United Statn 

# &EPA Environmental Protection Agency W••hinaton, ac 2.0480 

## Formulator's ExemJltion Statement (40 CFR 

### 1 2.85) Applicant's Nama and Address EPA Filo Symbo(/Rolliatrat(on Numi:lor

BioMed Protect, LLC 88089-R 44 Weldon Parkway Produot Nama St. Louis, MO 63043 Sanogiene Data ofConfidontial Stotomont of Formula (EPA Form 8570-4) January 17, 2010 

### As an authorized representative ofthe applicant for registration ofthe product identified above, I certify that:

(1 ) This product contains the following active ingredient(s): 1,3-dihydroxymethyl-5,5-dimelhylhydanloin 1-hydrox ymelhyl-s,5-dimethylhydantoin chilosan

(2) 

### Ofthese, each active ingredient listed in paragraph (41 is present solely as the result ofthe use ofthat active ingredient in the manufacturing, formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 3, is purchased by us from another producer, and is labeled for at least each use for which my product is proposed to be labeled. 

### (3) Indicate by checking (AI or (8) below which paragraph applies: 

# IJig (AI An accurate Confidential Statement of Formula (EPA FORM 857D-4) for the above identified product is attached to this statement. That formula statement indicates, by company name, registration number, and product name, the source ofthe active ingredient(sl listed in paragraph (1 I. 

# D OR (81 The Confidential Statement ofFormula (CSFI (EPA Form 

### 8570·41 referenced above and on file with the EPA is complete, current, and accurate and contains the information required on the current CSF. (4) The following active ingredients in this product qualify for the formulator's exemption. 

## Source ActivO) IngredIent Product Name RegIstration NumbO)r 1.3-dihydroxymethyl-S,5-dimethylhydantoin

1.hydroxymethyl-5,5-dimethylhydanloin

chitosan



# r .--,

## S;gr~·**~/()** Name and Title

### ~, 

# ..,.**~~omer,** Ph.D., RegulatoryAgent EPA Fonn 8570-27 {RO)v. 8-951 Date January

### 27, 2011 White

- EPA oopy YeUow
- ApplIcant CO)Pv

# (

.!RIAAssessment FM
PRIAMeetingDate 

# 2/f5/11 Reviewerffeam#

## ---,f.",e"am",)~ __ CompanyName: 

### R;ol\\P'\ 

# p,'Hd- ProductName S<tVlOCy,C<'U 

### Reg/file#880"d?-IWecision# 

## 4'1'1 (PL/O PRIA Code (MBnths),..<4:L2SLflL()'---___ _ 

## PRIA Code Description: I\It"W Qvru"d,**Nc\.'\~** 

## Fa..cl- 

## -hAd: EPAReceive Date 1-31- \ I 

### TentativeDueDate (+2Ida@) 

# 2-
-**~**

# -Ii FeeAmount$ Y(p31 00 

### FeeWaiverRequested(Y ___ FeePd. 

## , Are there currently otherregisteredpesticideproducts for each active ingredientinthisproduct? Yes 

## 0 No Ifso,Registration#s______________**~** 

### UsePattem______________________ _ 

# InertIngredients 

# Dee JUYl,2

### 0 

# I!
Has all inerts been cleared for use inpesticide registration: YES 

## IiI NO 0 , lfno, list


# Submission Description Nole: Y/o (>(ceis 

# 11, rPl\PI.v 

## [AmendmentNon-Fast TrackAPPliCationliend. Form**~** 

### __ NewLabels ,(]'[) 

# -

-- NewCSF( ) __ _ Formulator's Exemption Form@N) __ MethodofSupportForm (YIN)__ _ Selective Method

### lflPN) Cite-All Method 

## (i;[ IN)__ EPIMUP DataMatrix 

## et/N) TGAIDataMatrix(yiNJ

-- List ofUses onthe label: 

# -trecv\- ,'"be-. 1<> Ingredient Statement: l-

.. 

### lA.'-dC_.f( ,t,

### 1_~-his(JHf(\\fl;l.tt!""H\- 

## S;

.. C ,I ':ld."tJ{ 

### J ("I**?f)~~>** 

### H

## Lfchc><yn.1f-....f-t.

# tyC
- Cire;
- cLVll

..

### d 

# t,!;f t

### 1'/ 

### "hi{ -or',,!



### dLtlh> S I{ PI**IB~** 

### "')0"'/<,) 

## 0, <-10ft.::>


### Are all ofthe uses onthe label approved for each ofthe actives onthe label and source?
Whatare the pesticidal claims? (i.e., Disinf., Sanitizer, Preservative, Microbiocide)



## _ Cvv}UVcvh v<:--,.'-,- 

### \" --..;-:, 

### -'



### January27,2011


### DELIVERED VIAFED-EX Document ProcessingDesk

- (REGFEE) Office ofPesticidePrograms (7504P) U.S. Environmental ProtectionAgency OnePotomacYard 2777 S. Crystal Drive Arlington, VA22202 SUBJECT: InitialApplicationfor Registration: Sanogiene,EPAFile Symbo188089L

### R Attention: JacquelineMcFarlane,**PM~34** 

### Landis International, Inc. (herein afterLandis), Consultant andRegulatoryAgentherein subnnts on behalfofBioMedProtect, LLC, EPACompanyNumber 88089, (hereinafter BioMedProtect) the enclosed application forinitial registrationofa new antimicrobial**end~use** 

### fonnulation. 483711·00

The formulationproposed for registrationcontains several currently registered active ingredients in

### a combination that is different from other currentlyregistered formulations. Eachofthe active ingredients 

### in Sanogiene is currentlyregistered for its proposeduses, which are ofthetype defined in

### FIFRA §2(mrn)(1)(A)(ii). Consequently, Landis considersthat the appropriate PRIAcategory for this application is A540. The $4, 631.00 PRIAII fee for this applicationwas paid onJanuary27,2011. Atvarious times during the development ofSanogiene, theproducthas hadthe experimental names HR2010 andHyramine. Productsreferredtobythese names are identical to Sanogiene_ BioMed Protect, LLC had a company name cbange in June, 2010 and was formerly kncv:n as BioMedChem. Thefollowing materials are enclosed

### insupport ofthis application:
o Coverletter

o EPAFonns and OtherAdministrative Materials o ApplicationForm 8570-1 o Agent AuthorizationLetter o PRIAFeeReceipt o DraftLabel (5 copies) o Confidential StatementofFonnula 

### 8570A (2 copies) o CertificationwithRespectto Citation ofData 8570-34 o DataMatrix**8570~35** 

### (EPAandPublicVersiOns) o Formulator'sExemption Statement**8570~27** 3185**M~dlson** Highway Ll P.O. Box 5126 0 Valdosla, GeorgIa 31603-5126 USA:J (229) 247-6472 'J Fax (229) 242-1562 0 laJJdTs@tandlslntt.comInitial RegistrationApplication, Sanogim( 'Ai'deNo. 88089-R January27,2011 Page20f2


# • Thre

### e COpIes 0

### fdata supportmg th 

# r Btl e app lcatron., as 0 

### ows: GuidelineNumber Description MRID 

### 830.1550,830.1600, Sanogiene: Product IdentityandDisclosure of 830.1650,830.1670, Ingredients,DescriptionofMaterialsUsedto Produce and 830.1750 theProduct, Formulating Process, Discussionof 

### 48371101 FormationofImpurities, and CertifiedLimits 830.6302,830.6303, 830.6304,830.7000, Physical and Chemical Characteristics ofHyramine 830.7100, and 

### 48371102 830.7300 830.6314,830.6315, Sanogiene: OxidationlReduction, Flammability, 830.6316,830.6319, Explodability,Miscibility, and Dielectric Breakdown and 830.6321 Voltage 

### 48371103 830.1800 Detenninationof and HydantoinsbyHPLC 

### 48371104 QuantitativeDetermination ofChitosan in

### HR.-2010 by 830.1800 HPLC Post-ColumnDerivatizationwithUV-Vis Detection 

### 48371105 870.1100 HyramineFinal Report Acute Oral Toxicity Study 

### 48371108 (UDP) in

### Rats 870.1200 HyramineFinal Report
- Acute Dermal Toxicity Study 

### 48371107 inRats 870.1300 HyramineFinal Report
- Acute InhalationToxicity 

### 48371108 Study

### inRats 870.2400 HyramineFinal Report
- Acute EyeIrritation Studyin 

### 48371109 Rabbits 870.2500 HyramineFinal Report
- AcuteDermal Irritation Study 

### 48371110 in

### Rabbits 870.2600 HyramineFinal Report Skin Sensitization Study

### in 

### 48371111 GuineaPigs In addition to the above referenced studies, a combined GLDN 830.6317/6320 Storage Stability/Corrosion Characteristics study has been initiated at Analytical 

### & Regulatory Chemistry, Inc., Sumter, SC. Weanticipatetheresultswill be available for submissionnot laterthan June 30, 2012. Please direct any questions regardingthis applicationto: Dr. Richard H. Collier, Landis International, Inc. at 229-247-6472 (Valdosta, GA office), 229-251-2818 (mobile) orvia email atdcoIlier@landisintl.com. Sincerely,

RichardH.CoIlier, Ph.D. SeniorVicePresident, RegulatoryAffairs Landis International, Inc. COllSultantiRegulatory Agent for BioMedProtect, LLC
3t85 Madison Highway 0 P.O. Box 5126 Valdosta, GeorSla 31603-.5126 USA [1 (22S) 247-6472 Q Fax (22S) 242-1562 Dlaoors@landislntlcom) ':,\f.jl\,-,t t.',[ '1



### January 27, 2011
DELIVEREDVIAFED-EX DocumentProcessingDesk

- (REGFEE) Office ofPesticidePrograms (7504P) U.S. EnvironmentalProtectionAgency OnePotomac Yard 2777 S. Crystal Drive Arlington, VA22202 

### SUBJECT: InitialApplication for Registration: Sanogiene,EPAFile Symbol 880891..R Attention: Jacqueline McFarlane, PM-34 Landis International, Inc. (herein after Landis), Consultant andRegulatory Agentherein submits on behalfofBioMedProtect, LLC, EPA CompanyNumber 88089, (hereinafterBioMedProtect) the enclosed application for initial registration ofa new antimicrobial end-use fonnulation. The fonnulationproposed for registrationcontains several currentlyregisteredactive ingredients 

### in a combinationthat is different from othercurrentlyregistered fonnulations. Each ofthe active ingredients in Sanogieneis currently registered for its proposeduses, which are ofthetype defined in FIFRA §2(mm)(1)(A)(ii). Consequently, Landis considersthatthe appropriate PRIA category for this application isA540. The$4, 631.00 PRIA II fee for this applicationwaspaidonJanuary 27, 2011. At various times duringthe development ofSanogiene, theproduct has hadthe experimental names HR2010 andHyramine. Products referred tobythese names are identicalto Sanogiene. BioMed Protect, LLC had a company name change 

### in June, 2010 and was formerly kncv:n as BioMedChern. The following materials are enclosed in support ofthis application:

• Cover letter

• EPAForms and OtherAdministrative Materials o ApplicationForm 8570-1 o Agent AuthorizationLetter o PRIAFeeReceipt o Draft Label (5 copies) o Confidential Statement of Formula 8570-4 (2 copies) o Certificationwith Respect to 

### CitationofData 8570-34 o DataMatrix 8570-35 (EPA andPublicVersions) o Formulator'SExemption Statement 8570-27
3185**Madi~on** Highway 'J P a Box 51;26 _, ValdoSlil, Georgia 31B03·5126 USA c, (229) 247-6472 Fax (229) 242·1562,**l;)ndl,,-@l'lndi~m)Lcom**F A 

## "m**pprov~** . 2070-0060 A pprovo l(**IrO)~** 

### - 

# -, . IE' 531 8 Unlt"d St"t". 

# &EPA Environmental Protection Agency Wuhington. OC 20460 

## Formulator's ExemJltion Statement (40 CFR 

### 1 2.85) Applicant's Noma ond Address EPA Rio SvmbolfRogilltrolion Numa(lr

BioMed Protect, LLC 88089-R 44 Weldon Parkway 51. louis, MO 63043 Product Nome) Sanogiene Ooto of Confidontilll Stolnman! of Formula tEPA Form 8570-4{ January 17,201t1 

### As an authorized representative ofthe applicant for registration ofthe product identified above, Icertify that:



### 11) This product contains the following active ingredient(5); 1,3-dihydroxymethyl-5,5-dimethylhydanloin 1_hydroxymethyl_5,5-dimelhythydanloin chitosan

(2) 

### Ofthese, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active ingredient in the manufacturing, formulation or repackaging another product which contains that active ingredient which is registered under FIFRA Section 

### 3, is purchased by us from another producer, and is labeled for at least each use for which my product is proposed to be labeled. (3) Indicate by checking (A) or (8) below which paragraph applies: 

# IJg] (A) An accurate Confidential Statement of Formula (EPA FORM 8570-4) for the above identified product is attached to this statement. That formula statement indicates, by company name, registration number, and product name, the source of the active ingredient(s) listed in paragraph (1). 

### OR 

# D (8) The Confidential Statement of Formula (CSF) (EPA Form 8570·4) referenced above and on file with the EPA is complete, current, and accurate and contains the information required on the current CSF. (4) The following active ingredients in this product qualify for the formulator's exemption. 

## Source Activo Ingr(ldiont Product Nomo 1.3-dihydroxymelhyl.5,5-dimethylhydanloin

1.hydroxymethyl-5,5-dimethylhydantoin

chitosan



# r .--.**Sig~%.4J;)/(1** Name and Title

### :,R'~~ottier, Ph.D., Regulatory Agent EPA Fonn 8570-27 (Rav, 8·95) 

## * u.s. GPO: UIIIIS-38G-a2.OJ204r3 Rogistration Numb(lr

Date January 

### 27, 2011 Whito • EPA copy Yottow

. Applicant COpy 

# IPrintForm FormA rovod. OMS '-_. 2070..()OeO Unitod Stotoe OPP Idontifior Numbnr 

# &EPA Environmental Protection Agency

# ~ Registration Amendment Other

1. Compony/Product Numbor BioMed Protect LLC/BBOB9-R 4. Compony/Product (Name) BioMed ProtectLLClSanogiene Washington, DC 20460 

## Application for Pesticide**~** 

## Section I 2. EPA Product Manogor Jcqueline McFarlane 

### PM' Team 34 3. Propollod Closlrificotion 

# D None 

# 0 Roctrictod
5. Nomo ond Addrogo of Applicont /lnc/udll ZiP Cedo}

BioMed ProtectLLC 44Weldon Parkway, St. Louis, MO 63043 6. Expedited Review. In accordance wilh FIFRA Section 31cH3) iblli), my ptoduct is similat at identical in composition and labeling to: D EPA Reg. No._______________ _ 

# o Chuck ifthisis. now oddrD$$

Amendmont

- Explain bolow. Product Name 

### Section

- IIFinB! printed llilbelo in rocponao to Agency lottor doted 

# o 

# o o RosiJbmission In rOllponoo to Agoncy lottar datod______ _ 

# o o o -Me Too- Applicetion. Notificetion

- Explain bolow. Othor- Explain bolow. Explanation: Uue edditional pogola} if nOllllaaory. IFor aoction land Soction II.)

1. Motoriel This Product WiU Be Pock;ogod In: Child·Ro;ictant Packoging 

# Dy"- IiJ No Unit Packaging 

# n y .,

### ~No If -VOII- No. par 

### Section

- III

Water Soluble Packaging 

# D y" 

## [8J No 2. Typo of Contolnor
GlaOIl Popor " Certification must bosubminod Unit Packaging wgt. contoinor II -VosPackago wgt No. por contoinor

# ~:::c Othor (Spocify)_______

## 1
3. Locotion ofNot Contonts Information



## l8] Loblll 

# o Container 6. Manner in Which Lobol iii Affixed to Product 4. Sizo(s) Ratail Contoinor 1gallon, 2.5 gallon, 55 gallon Uthograph Popor gluod Stoncilod I



## Section· IV S. Location of Labol Dboctione [K'l On Lobel 

### I:::J On Laboling occomponVirD,'p'!,oduct 

# o Other

--_________ 

### "c"C-C-C"c"_



# . "**~"''''H.C.** 1. Contact Paint ,. 

# . ""'.-;- }CompllJto itoms diroctlyblJlaw for fdonrlffcoticn offndivfduol 

### ro be confocrod, iffl{IC(1$$ory. 

### ro proCD$$ this 1JfJ!?-':clJ!i0,;.J**~ '~**  Nomo litlo Tolephontl**No~**nnclU'do Aroil**'i::~t:II":** RegulatoryAgent 229.247--ti47;' Ot<:ZQc251-2818 " Richard H. Collier, Ph.D. Certification I certify thll.1 tho ctolumontG I havo modo on thiG form and allottachmants tharoto oro truo, accurattl ond complote. locknowlodgo that any knowingly falGo ormisloading IItolomont maybe punillhab!o by fino or impriGotlmont or both undar oppliceblo low. 2.

# S;,"~. I 

# rl /. /) _. 4 /'

# ~ 

# --.-3,' T;,o, 

# 1-/**~A**

# ... N 

# fit**~4";~** RegulatoryAgem 4. Typod Name 5. Data Richard H. Collier, Ph.D. Jan 27, 2011 EPA Form 8510-t IRev. 8-94} PreVIous oditiona 010 obGo!oto. Whhe

- EPA Ale Copy lorIglnall '"
, 6. Da(..t AppliclitblO**~** , ,

'Roco:vod

, c , , " , (Stamped) 

### , , 

### " , 

### , , ,

v.now - Applicant Copy

### i, 

# 535 -0001-.)

December 13,2010 

# <:> :::IISteven P. Bradbury, Director**~.** 

### EPA Office of

### Pesticide Programs QJgistrationDivision (H7504C)**~ument** 

### ProcessingDesk (ADMIN)**~l** 

### Rio Building .,0PennsylvanjaAvenue, N.W. lMashington, 

### DC20460 R

### OOOl III 

### SUBJECT: ASSIGNMENT OFAGENTFORBioMedProtect, LLC DearDr, Bradbury: 

### PursuanttoEPNsrequirementsregarding assignmentof an agent fOf

### regulatory activities, wehereby designate andassign Dr. Richard H. Collier ofLANDISJNTERNATIONAL, INC. as agentfor 

### BioMedProtect, LLC, as follows: Richard H. CoWer,Ph.D. LANDIS INTERNATIONAL,INC. P. O. Box 5126 3185 Madison Highway 

### Valdosta, GA 

### 31603-5126 USA 

### Phone: (229)247-6472 Mobile: (229) 251-2818 Fa.x: (229) 242-1562 

### email: dcollier@landisintl.com Dr. Collier is authorizedto actin Ollr 

### behalfconcerning any regulatory activitiesrelatingtopesticide registrationjnthe United States, including butnot limited to obtaining an EPA CompanyNumber, registeringpesticide producingestablishments,. and 

### submittingproductregistration applications. Specifically, we authorize the EPA to pennitDr. Collierto accessto any datawhich have been submitted to 

### the 

### EPAand are onfile. He may obtain apbotocopy any ofthis data, 

### as required.

### <'FRC duration ofthis assignment as agentisuntil further notice to 

### the 

### EPA. f,e" 6

### ~**~**

### Sinc~ 

### Howard S. Rosing,

# M~ President BioMed Protect, LLC Sworn to and 

### subscribedbeforeme this**~day** 

### ofl:l&1!- ,2010.
Notary Public

# ~~ ':){

# :.~?**~** f , " < 

### , " 

## , 

# .

### i Initial Rcgistr.llion Application. Slinogicne. EPA, ,IeNo. 88089-R January27,201] Page2of2


# • Thr eecopIes 0

### fdata supportmg th 

## r f 

### DII e appllca lon, as 0 

### ows; GuidelineNumber Deseriplion 

### 830.1550,830.1600, Sanogiene: Product Identity andDisclosure of 830.1650,830.1670, Ingredients, Description of Materials Usedto Produce and 830.1750 

### the Product, FormulatingProcess, Discussion of 

### Formation ofImpurities,and Certified Limits 830.6302, 830.6303, 830.6304,830.7000, Physical and Chemical Characteristics ofHyramine 830.7100, and 830.7300 830.6314,830.6315, Sanogiene: OxidationIReduction, Flammability, 830.6316,830.6319, Explodability, Miscibility, andDielectricBreakdown and 830.6321 

### Voltaae 830.1800 Determination of and HydantoinsbyHPLC QuantitativeDeterminationofChitosaninHR-20IO by 830.1800 HPLCPost-ColumnDerivatization

### with UV-Vis Detection 870.1100 HyramineFinal Report
- Acute Oral 

### Toxicity Study 

### rUDP) 

### inRats 870.1200 

### Hyramine Final Report AcuteDermalToxicity Study 

### inRats 870.1300 

### Hyramine Final Report**~**

### Acute Inhalation Toxicity Study inRats 870.2400 

### Hyramine FinalReport
- Acute EyeInitation Study in Rabbits 870.2500 

### Hyramine Final Report
- Acute DennalIrritation Study in Rabbits 870.2600 

### Hyramine Final Report**~** 

### Skin Sensitization Study in Guinea PiO's MRID



### In addition to the above referenced studies, a combined GLDN 830.6317/6320 Storage Stability/Corrosion Characteristics study has been initiated at Analytical & 

### Regulatory Chemistry, Inc., Sumter, SC. Weanticipate the results will

### beavailable for submission not laterthanJune 30, 2012. Please direct any questions regardingthis applicationto: Dr. Richard 

### H. Collier, Landis International, Inc. at 229-247-6472 (Valdosta, GA office), 229-251-2818 (mobile) orvia email atdcollicrrwlandisintLcom. Sincerely,

Richard H. Collier, Ph.D. SeniorVice President, RegulatoryAffairs Landis International, Inc. ConsultantlRegulatoryAgent for BioMed Protect, LLC
3185**Mad;~on** H;gh\\laY ,P 0 Box 5126 Valdosto, Georgia 31603_5t26 USA ,- (229) 247-$472 u Fax (229) ;142·1562

.**!i:mO'~@1,1nd;~;(lti** com

### ( FormApproved OM6 No. 2070·0060 

### r"', UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

### (~]**,-~"** 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection of infonnation is estimated to average t.25 hours per response for regislralion and 0.25 hours per response for reregistration and special reView activities, including lime for reading the inslructions and completing the necessaryfonns. Send commenls regarding burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing Ihe burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Proteclion Agency, 401 M Sireet, S.W., Washington, DC 20460. Do not send the completed form to this address. Certification with Respectto Citation of Data Applicanl'siReRistrant's Name, Address, and Telephone Number EPA Re[:lislralion NumberfFile Svmbol 6ioMed Protecl, LLC, 44 Weldon Parkway, SI. Louis, MO 63043 clo Landis Inl'l, 229-247-6472 

# " 88089-R Active Inoredient(s) and/or represenlalive test compound(s) Date dihyldoxymethyl-5,5-dimethylhydantoin, hydroxymethyl-5,5-dimethylhydantoin, chilosan, January6,2Ql1 General Use Pallem(s) (list att those claimed for this product usinQ 40 CFR Part 158) Product Name Industrial Sanogiene NOTE: Ifyour product isa 100% repackaging ofanother purchased EPA-registered product labeled for all the same uses on your label, you do not need to submit tIlis form. You must submitthe Formulator's Exemption Statement (EPA Fonn 8570-27). 

# D I am responding to a Data-Call-In Notice, and have included IVith this form a list ofcompanies sent offers ofcompensation (the Data Matrixform should be used for this purpose).
SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

# D I am using the cite-all melhod ofsupport, and have included with this form 

# [2] I am using the selective method ofsupport (or cite-att option a list ofcompanies sent offers ofcompensalion (the Data Malrixform underthe selective method), and have included with this form a should be used for this purpose}. completed list ofdata requirements (the Data Matrix form must be used). SECTION II: GENERAL OFFERTO PAY (Required if using the cite-all method orwhen using the cite-all oplion under the selecllve method to satisfy one or more data requirementsl 

# D I hereby offer and agree to pay compensation, 10 olher persons, IVith regard tothe approval ofthis apptication, to the extent required by FtFRA.
SECTION III: CERTIFICATION I certify that this application for regislralion, this form for reregistration, or this Data-Catt-In response is supported by att data submilled or cited in the application for registration, the fonn for reregislration, or the Data-Catt-tn response. In addllion, ifthe cite-all option or cite-all opb'on under the selective method is indicated in Section**~** this application is supported byall dala in the Agency'sfiles that (t) concem the properties oreffects ofthis product or an identical or subslantially similar product, or one or more ofthe ingredients in this product; and (2) is a type ofdala thatwould be required to be submilled underthe data requirements In effecl on the date ofapproval ofthis application ifthe application sought the initial registration ofa product of identical or Similar composition and uses.**~ce¢** 0 0 I certify that for each exclusive use study cited in support ofthis registration or reregistration, that I am the original data submiller or\h"afl'have obtained the wrillen permission ofthe original data submillerto cile Ihat study. 0 

## , "0000" 0 I certify thatfor each study clled in support ofthis registration or reregistrab'on that is not an exclusive use sludy, either. (a) Iam the oriCinal data**~** <., ,.

# Ii submitter; (b) I have oblained the permission ofthe original dala submiller to use Ihe study in support ofthis applicalion; (c) all periods ofeligibility fOJ**~'** compensation have expired for the sludy; (d) !he study is in the public literature; or (e) I have notified in writing the company that submllled**1Il~** stlJji'Jnd have offered (I) to pay compensation tothe extent required by sections 3(c}(1 )(F) and/or 3(C)(2)(6) of FIFRA; and (it) to commence negoliations to**(j'e~erm<'ne** the**~** '-'**~ ~**  

### , , amount and tenns ofcompensalion, ifany, to be paid for !he use ofthe study. 

### , 

## , 

# ,,1 < < , ,**~.** G 

### , I certify that in all instanceswhere an offer ofcompensation is required, copies ofall offers to pay compensation and evidence oftheir delivery in 

### ' , , , < • accordance with sections 3(c)(1 )(F) and/or 3(c)(2)(6) ofFIFRAare available and will be submitted 10 the Agency upon request. Shoutd IfaD to prQduce such evidence 10 the Agency upon request, I undersland that !he Agency may initiate action 10 deny, cancel or suspend the registration of my**pro;jL~;i,,'oJnfonnity** IVith FIFRA. < 

### , ,**"V~C~** I certify thatthe statements t have made on this form and all attachments to itare true, accurate, and complete. I ackr.owtedge that any knowingly false or misleading statement may be punishable byfine or imprisonment or both under appticable law. 

# ,- Signalure 

# 6:.-1**.c;;,.t~** Dol, Typed or Printed Name and Title r.nu.ry 27, 2011 Richard H. Collier, Ph.D., Regulatory Agent EPA Fonn 8570 34 (9-97) Electronic and Paperversions available. Submitonly Paper verSion. 

### -

# ....'.,. Form Approved OMB No. 2070-0060

## (~i UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

### "'-';! 401 M Street, S.W. WASHINGTON, D.C. 20460 Paperwork Reduction Act Notice: The public reporting burden for this collection ofinformation Is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistration and speciat reView actiVities, including time for reading the instructions and completing the necessary forms. Send comments regarding the burden estimate orany other aspect ofthis collection of information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.w., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date January 27, 2011 EPA Reg No.lFile Symbot 88089-R Page1 of 2 Applicant'sJRegistrant's Name & Address Product BioMed Protect, LLC, 44 Weldon Parkway, SI. Louis, MO 63043 clo Landis Int'l, PO Box 5126, Valdosta, GA31603 Sanogiene Ingredient 1,3-dihyrdoxymethyl-5,5-dimethylhydantoin (CAS 6440-58-0), 1-hydroxymethyl-5,5-dimethylhydantoin (CAS 116-25-6), chitosan (CAS 90f2-76-4), and Guideline Reference Number Guideline Study Name MRID Number Submitter Status Nole 830.1550 Sanoglene: Product Identity and Disclosure of tngredients BioMed Protect, LLC OWN In this submission 830.1600 Sanoglene: Product Identity and Disclosure of Ingredients BioMed Protect, LLC OWN In this submission 830.1650 Sanoglene: Product Identity and Disclosure of Ingredients BioMed Protect, LLC OWN In this submission 830.1670 Sanogiene: Product Identny and Disclosure of Ingredients BioMed Protect, LLC OWN In this submission 830.1750 Sanogiene: Product Identity and Disclosure of Ingredients BioMed Protect, LLC OWN In this submission 830.1800 Enforcement Anatytical Method BioMed Protect, LLC OWN i In this submission 830.1800 Enforcement Analytical Method BioMed Protect, LLC OWN lin this submission 830.6302 Chemical and Physical Characteristics of Hyramine BioMed Protect, LLC OWN In this submission 830.6303 Chemical and Physical Characteristics of Hyramine BioMed Protect, LLC OWN In this submission 830.6304 Chemical and Physical Characteristics of Hyramine BioMed Protect, LLC OWN In this submission 830.6314 Sanogiene:OxidationiReduclion,Rammability, Explod BioMed Protect, LLC OWN tn this submission 830.6315 Sanogiene: Oxidation/Reduction, Flammability, Exptod BioMed Protect, LLC OWN tn this submission 830.6316 Sanogiene: Oxidation/Reduction, Flammability, Exptod BioMed Protect, LLC OWN In this submission 830.6319 '" Sanogiene: Oxidation/Reduction, Flammability, Exptod BloMed Protect, LLC OWN In this submission 

# .'.**~~os::n"e: Oxi~i;onrR:Buction,**  Flammability, Explod 830.6321 , 

# . BioMed Protect, LLC OWN In this submission 

# . . 

# .**~ ~** **~ ~**  B**~** Signature

# al.,f!{~ Name and Tille O'le Richard H. Collier, Ph.D. f127/2011 EPA Form 8570-35 (9-97) Ele92r;ic**a~d~Pape~verslons** available. Submit only Paperversion. Agency Internal Use Copy 

# .'.

### ......,.,. Form Approved OMB No. 2070-0060**,~** 

# , UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

### \~, 401 M Street, S.W. 

### 'J WASHINGTON, D.C. 20460 PapelWork Reduction Act Notice: The public reporting burden for this collection ofinfonnation is estimated to average 0.25 hours per response for registration activities and 0.25 hours per response for reregistrallon and special review activities, inctuding time for reading the instructions and compteting the necessary forms. Send comments regarding the burden estimate orany other aspect ofthis cottection of informallon, Including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmental ProtectionAgency, 401 M Street, S.W., Washington, DC 20460. Do not send the form to this address. DATA MATRIX Date January 27, 2011 EPA Reg No./File Symbol 66069-R 

# IPage2 of 2 Applicant'slRe!listrant's Name & Address Product BioMed Protect, LLC, 44 Weldon Parkway, SI. Louis, MO 63043 clo Landis Int'I, PO Box 5126, Valdosta, GA 31603 Sanogiene Ingredient 1,3·dihyrdoxymethyl-5,5-dimethylhydantoin (CAS 6440-56-0), 1-hydroxymethyl-5.5-dimethylhydantoin (CAS 116-25-6), chitosan (CAS 9012-76-4), and Guideline Re/erence Number Guideline Study Name MRID Number Submitter Status Note 830.7000 Chemical and PhysIcal Characteristics of Hyramine BioMed Protect, LLC 

### OWN In this submission 830.7100 Chemical and Physical Characteristics of Hyramine BioMed Protect, LLC 

### OWN tn this submission 830.7300 Chemical and Physical Characteristics of Hyramine BioMed Protect, LLC 

### OWN tn this submission 870.1100 Hyramine
- Acute Oral Toxicity Study (UDP) BioMed Protect, LLC 

### OWN In this submission 870.1200 Hyramine
- Acute Dermal Toxicity Study BioMed Protect, LLC 

### OWN In this submission 870.1300 Hyramine
- Acute Inhalation Toxicity Study BioMed Protect, LLC 

### OWN tn this submission 870.2400 Hyramine
- Acute Eye Irritation Study BioMed Protect, LLC 

### OWN In this submission 870.2500 Hyramine
- Acute Dermal Irrilallon Study BloMed Protect, LLC 

### OWN In this submission 870.2600 Hyramine
- Skin Sensitizallon Study BioMed Protect, LLC 

### OWN In this submission**,~ -~** 

### ...**~~~** 

# -- ' ' __ C_C , 

## , , , 0 0 0 

# - 

# - 0 

# - 0 o 0 

# - 

# - - - Signature

# 777;'~~~ Name and Title Date Richard H. Collier, Ph.D. 1I27f2011


# - EPA Form 8570-35 (9-97) Elec.ror.ic and;Pa"pef,versions available. Submit only Paperversion.**~-~ ~~** **~** Agency tnternat Use Copy



# --
-

"

# Sanogiene
INGREDIENTS: Active Ingredients: 1,3-Bis (hydroxymethyl)-5,5-dimethylhydantoin

....................................... Hydroxymethyl-5,5-dimethylhydantoin

.............................."."

............ Chitosan [poly-D-glucosamine[

........................................................ Other Ingredients:

........................................................................ 

### 19.92% 18.90%

0.40%

TotaL

......................................................................................... 100.00%1 

# KEEP OUT OF REACH OF CHILDREN 

# CAUTION

Emergency Contact Number: (as marked on container) NET WEIGHT (as 

### marked on container) EPA Reg. No. XXXXXX-1 EPA Est. No. (as marked on container) 

### Manufactured 

### by: BioMed Protect, LLC 44 Weldon Parkway St. Louis, MO 63043

, 

### , ,**~ ,~~** **~,** ,

, 

### ,
, , 

### , "" " 

### , " , , " "

## PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS !F SWALLOWED: Harmful ifswallowed. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. IF ON SKIN OR CLOTHING: Harmful 

### ifabsorbed through skin. Avoid contact with skin, eyes or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. Remove and wash contaminated clothing before reuse. Wear (specify any appropriate protective clothing, 

### ifappropriate). IF INHALED: Harmful 

### if inhaled. Avoid breathing (dust, vaporor spray mist).* Remove and wash contaminated clothing before reuse. IF IN EYES: Causes moderate eye irritation. Avoid contact with eyes or clothing. Wear (specify protective eyewear, ifappropriate). Wash thoroughly with soap and waterafter handling and before eating, drinking, chewing gum, using tobacco or using the toilet.


### STORAGE AND DISPOSAL Do not contaminate water, food, or feed by storage and disposal. Pesticide Storage Store in a cool, dry area under lock and key. Post as a pesticide storage area. Always store pesticides in the original container. Store away from food, pet food, feed, seed, fertilizers, and medical and veterinary supplies. Place liquid formulations on lower shelves and dry formulations above. Pesticide Disposal To avoid wastes, use all material in this container by application according to label directions. Ifwastes cannot be avoided, offer remaining product to a waste disposal facility or pesticide disposal program (often such programs are run by state or local governments or by industry). Container Handling Nonrefillable container. Do not reuse or refill this container Triple rinse container (or equivalent) promptly after emptying. Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to drip. Fill the container X full with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds afterthe fiow H c begins to drip. Repeat this procedure two more times. Then offerfor recycling ifavailable, or

### pUf1ctur~ and dispose of in a sanitary landfill or by incineration. Do not burn unless allowed by state and Iqaa:lo c c ordinances. 

### DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. 

### , 

## , ,

SANOGIENE preserves and aids in the control of the growth ofbacteria and fungi in textiles. , ,**~** ( : , Do not use articles that have been treated with SANOGIENE as components in materials used in food packaging and food-holding. , , ( , : , How to treat fabrics with SANOGIENE: Begin by diluting the SANOGIENE by one kg of SANOGIENE for every 16 kg ofsolution by adding water to equal the same weight ofthe textile to be treated. 500 kg of fabric is treated with 31.25kg of SANOGIENE and 468.75 ofwater by dipping the fabric in a tank with the ,( (,diluted solution; then remove excess solution from fabric by spinning in a de-watering machine and then place fabric in a tumbler dryer at 150-160 degrees C for two minutes. Letfabric cool and finish the process by simply washing and drying the textile in a normal washing machine and dryer.
WARRANTY STATEMENT NOTICE
- READ CAREFULLY CONDITIONS OF SALE AND LIMITED WARRANTY STATEMENT As its sole express warranty, BioMed Protect, LLC, warrants that this product conforms to the chemical description on the label and is reasonably 

### fit for purposes stated on the label only when used in accordance with directions and instructions specified on the label. Only as permitted by applicable law, in the event of a breach of this limited warranty, BioMed Protect, LLC, shall not be liable for consequential damages. Subject to applicable law, BioMed Protect, LLC, neither makes nor authorizes any of its agents or representatives to make any warranty of fitness or merchantability, guaranty or representation, express or implied, concerning this material. Buyer assumes the responsibility to handle, use, and store this product in accordance with the safety instructions and use directions contained on the label. Buyer/User purchases this product subject to the foregoing Conditions of Sale and Limited Warranty, which, subject to applicable law, may be varied only by a written agreement signed by a duly authorized representative of BioMed Protect, LLC. Ifthese terms are not acceptable, return all products to place of purchase unopened for a full refund.



# . " " , < ,



### , " , " <



# .

.

# ., , 

### " 

### ,',"", 

# .. , " 

### , ,-".,." , '" 

## . , ", ,

# Sanogiene
INGREDIENTS: Active Ingredients: 1,3-Bis (hydroxymethyl)-5,5-dimethylhydantoin

........................................ Hydroxymethyl-5,5-dimethylhydantoin

............................................... Chitosan [poly-D-glucosamine[

........................................................ 

### 19,92% 18.90%

0.40% 

### Other Ingredients:

......................................................................... TotaL

.......................................................................................... tOO.OO% 

# KEEP OUT OF REACH OF CHILDREN 

# CAUTION

Emergency Contact Number: (as marked on container) NETWEIGHT 

### (as marked on container) EPA Reg. No. XXXXXX-1 

### EPA Est. No. (as marked on container) Manufactured 

### by: BioMed Protect, LLC 44 Weldon Parkway St. Louis, MO 63043



### , , " " 

## " ,

, 

### " 

### , " , 

### , ",-, 

### " ( , , "- ,

## PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS AND DOMESTIC ANIMALS IF SWALLOWED: Harmful if swallowed. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. IF ON SKIN OR CLOTHING: Harmful 

### ifabsorbed through skin. Avoid contact with skin, eyes or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. Remove and wash contaminated clothing before reuse. Wear (specify any appropriate protective clothing, 

### ifappropriate). IF INHALED: Harmful jf inhaled. Avoid breathing (dust, vapor or spray mist).* Remove and wash contaminated clothing before reuse. IF IN EYES: Causes moderate eye irritation. Avoid contactwith eyes or clothing. Wear (specify protective eyewear, if appropriate). Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet.
STORAGE AND DISPOSAL Do not contaminate water, food, or feed by storage and disposal. Pesticide Storage Store in a cool, dry area under lock and key. Post as a pesticide storage area. Always store pesticides in the original container. Store awayfrom food, pet food, feed, seed, fertilizers, and medical and veterinary supplies. Place liquid formulations on lower shelves and dry fonnulations above. Pesticide Disposal To avoid wastes, use all material in this container by application according to label directions. Ifwastes cannot be avoided, offer remaining product to a waste disposal facility or pesticide disposal program (often such programs are run by state or local governments or by industry). Container Handling Nonrefillable container. Do not reuse or refill this container Triple rinse container (or equivalent) promptly after emptying. Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to drip. Fill the container14 full with waterand recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds after the**f!6w~ ~**  b begins to drip. Repeat this procedure two more times. Then offerfor recycling ifavailable, or puncture and dispose of in a sanitary landfill orby incineration. Do not burn unless allowed by state and

### IGGal~!" ordinances. v DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. SANOGIENE preserves and aids in the control ofthe growth of bacteria and fungi in textiles. ' Do not use articles that have been treated with SANOGIENE as cornponents in rnaterials used

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## food packaging and**food~holding.** . . , , ; , , Howto treatfabrics with SANOGIENE: Begin by diluting the SANOGIENE by one kg of SANOGIENE for every 16 kg of solution by adding water to equal the same weight ofthe textile to be treated. 500 kg of fabric is treated with 31.25kg of SANOGIENE and 468.75 ofwater by dipping the fabric in a tank with the , 

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### '" 'diluted solution; then remove excess solution from fabric by spinning in a de-watering machine and then place fabric in a tumbler dryer at 150-160 degrees C for two minutes. Let fabric cool and finish the process by simply washing and drying the textile in a normal washing machine and dryer.
WARRANTY STATEMENT NOTICE
- READ CAREFULLY CONDITIONS OF SALE AND LIMITED WARRANTY STATEMENT As its sole express warranty, BioMed Protect, LLC, warrants that this product conforms to the chemical description on the label and is reasonably fit for purposes stated on the label only when used in accordance with directions and instructions specified on the label. Only as permitted by applicable law, in the event of a breach of this limited warranty, BioMed Protect, LLC, shall not be liable for consequential damages. Subject to applicable law, BioMed Protect, LLC, neither makes nor authorizes any of its agents or representatives to make any warranty offitness or merchantabmty, guaranty or representation, express or implied, concerning this material. Buyer assumes the responsibility to handle, use, and store this product in accordance with the safety instructions and use directions contained on the label. Buyer/User purchases this product subject to the foregoing Conditions of Sale and Limited Warranty, which, subject to applicable law, may be varied only by a written agreement signed by a duly authorized representative of BioMed Protect, LLC. If these terms are not acceptable, retum all products to place of purchase unopened for a full refund.

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