REGISTRATION

88089-1 
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SANOGIENE 

DESCRIPTION OF MATERIALS USED TO PRODUCE THE PRODUCT AND 

FORMULATING PROCESS 

Guideline Reference No. 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 of which is provided at 

VOLUME 2, NUMBER I, above. 

Formulation Active Ingredient(s) EPA Reg. No. Purpose in 

Component Formulation 

Page 5 of 30 

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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. 

25 *Inert ingredient information may be entitled to confidential treatment*
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 

26 *Inert ingredient information may be entitled to confidential treatment*
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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 

27 *Inert ingredient information may be entitled to confidential treatment*
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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} 

28
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. 

29 *Inert ingredient information may be entitled to confidential treatment* *Product ingredient source information may be entitled to confidential treatment*
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

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 (751 OP) 

Karen P. Hicks, CT Team Leader 

Product Science Branch 

Antimicrobials Division (75101U---

Jacqueline Campbell-McFarlane/ Jaclyn Carl 

PM Team 34 

Antimicrobials Division (751 OP) 

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_D3867I 2_BiomcdProtcctLLC Page 2 of9 

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30 *Inert ingredient information may be entitled to confidential treatment*
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BACKGROUND: 

On behalf of BioMed Protect, LLC, Landis International, Inc. has submitted an application for 

registration of a new fungicide and bacteriocide non-integrated end-use product, Sanogiene. 

This product is for use in controlling the growth of bacteria and fungi in textiles. The Product 

Chemistry Reviewer has received the following documents: 

• The data package included a letter from the applicant's representative to EPA, dated 

January 27, 2011; a Confidential Statement of Formula (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 with Respect to Citation of Data), 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 laboratory reports 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 (dated January 27, 2011) states that Hyramine and HR-2010 are names 

used during development of the product, Sanogiene, which is 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 data 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 the "Recommendations" section of this 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 of Good Laboratory Practice (GLP) compliance was provided for the study 

assigned MRID 483711-02. The study was conducted in accordance with the 

requirements of 40 CFR Part 160 FIFRA GLP standards. 

7. Certain information on the product label could be improved, as noted in the 

"Recommendations" section of this report. 

8, Certain information on the CSF could be improved. See Recommendation section of this 

report, 

88089-R_D386712_BioMedProteetLLC Page 3 of9 

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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 

chemistry data 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 minimum of 1 year from a GLP-compliant 

storage stability and corrosion characteristics study must be provided. Testing of the 

product has been initiated. The concentration of the active ingredients in the product 

must be determined at the beginning of the test period and every 3 months thereafter for a 

period of 1 year. Storage and disposal information on the product 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 on the product label. Guidance on 

infonnation to be included in the "First Aid" section is available at 

http://www.epa.gov/oppfeadl/labelingllrml 

a. Add the heading "Physical or Chemical Hazards" immediately beneath the 

"Precautionary Statements" section of the product label. 

b. Place the "Storage and Disposal" section on the product label in a text box for 

prominence. 

c. Under the "Pesticide Storage" section on the product label, add instructions that 

specify what to do if the product leaks or spills from the product container. 

d. Add page numbers to each page of the product label. 

• The following revision to the CSF is recommended. 

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

88089-R_D386712_BioMedProtecILLC Page 4 of9 

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PRODUCT CHEMIS!l.S REVIEW 

I. CONFIDENTIAL STATEMENT OF FORMULA 

a. Type of formulation 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. of existing product: ___ _ 

b. Clearance of inerts for non-food or food use: 

The product is cleared for food use under 40 CFR §§180.940 and 180.950. 

Yes[] No[] 

Note: This product is not intended for/Dod use. The product label states: "Do 

not use articles that have been treated with SANOGIENE as components in 

materials used in/ood packaging andfood-holding. " 

c. Physical state of product: Liquid 

d. The chemical IDs and analytical information (including that for the TGAIs), density, 

pH, and flammability are consistent with that 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. For products produced by an integrated formulation system: 

• Do all impurities of toxicological 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 

33 *Inert ingredient information may be entitled to confidential treatment*
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II PRODUCT LAbd 

a. The active ingredient(s) statement (chemical IDs and NC) is consistent with the 

CONFIDENTIAL STATEMENT OF FORMULA. Yes [ 1 No [Xl 

b. The formula contains one of the following: 

• 10% or more of a petroleum distillate: Yes [ 1 No [Xl 

• 1.0% or more of methyl 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 of the above, does the inert ingredients statement contain a footnote 

indicating this? Yes [ 1 No [ 1 Not applicable [Xl 

d. Appropriate warning statements regarding flammability or explosive characteristics of 

the product are listed on the label. 

Yes [ 1 No [ 1 Not applicable [Xl 

e. The storage and disposal instructions for the pesticide container are in compliance 

with PR Notice 84-1 for household use products or PR Notice 83-3 for all other uses. 

Yes [Xl No[ 1 

f. The product requires an expiration date at which time the NC falls below the LCL 

(based on the I-year storage stability data or other information). 

Yes [ 1 No[ 1 

Note: Storage stability studies are ongoing and have not been completed. 

88089-R_D386712_BioMcdProtectLLC Page 6 of9 

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Table A: 

Product Chemistry (Series 830, Group A) 

Data Requirements Acceptance of Information MRIDNo. 

830.1550 Product Identity' A 483711-01 

830.1600 Description of Materials A 483711-01 

830.1620 Production Process" NR 

830.1650 Formulation Process 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 Enforcement Analytical A 483711-04 

Method' 483711-05 

830.1900 Submittal of Samples [Samples are to be provided on a case-bycase basis for end-use products., 

ExplanatIon: A-acceptable; N-not acceptable (I.e., Item was submltled but 15 not acceptable); 

NA=technically not applicable (i.e., not required); G=data gap (Le., item was not submitted but 

is required); U=requires upgrading (Le., item is unacceptable but upgradeable); W=waived; 

E= EP A estimate. 

ISee Confidential Appendix A for additional information. 

2For MP/EP products produced by an integrated formulation system. 

3For products from a TGAI or MP. 

4May be waived unless actual/possible impurities are of toxicological concern. 

5Five batch analysis required for products produced by an integrated formulation system. 

6If different from standard CLs recommended 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 

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Physical and Chemici. ,-,'haracteristics (Series 830, Group Bj 

Physical/Chemical Acceptance Value or Qualitative Description MRIDNo. 

Properties* of Data 

830.6302 Color A The product has a very 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 Stability to Normal NA [Not required/or end-use products.] 

and Elevated Temperatures, 

Metals, and Metal Ions 

830.6314 Oxidation! A This product does not contain 483711-02 

Reduction; Chemical oxidizing or reducing 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 with petroleumbased solvents. 

830.6320 Corrosion G A corrosion characteristics study has 

Characteristics been initiated. 

830.6321 Dielectric A The product is not to be used around 483711-03 

Breakdown Voltage electrical equipment. 

830.7000 pH A The pH of the product was reported 483711-02 

to be 3.1. A 1 % by weight solution 

of the product was tested. 

830.7050 UVNisib1e NA [Not required/or end-use products.] 

Absorption 

830.7100 Viscosity A The kinematic viscosity of the 483711-02 

product was reported to be 30.2 

centipoises at 23°C and 18.7 

centipoises at 39°C. 

830.7200 Melting NA [Not required/or end-use products.] 

PointlMelting Range 

830.7220 Boiling NA [Not required/or end-use products.] 

PointIBoiling Range 

88089-R_D386712_BioMcdProtcctLLC Page 8 of9 

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I i 

Physical/Chemical Acceptance Value or Qualitative Description MRlDNo. 

Properties* of Data 

830.7300 DensityIRelative A The specific gravity of the product 483711-02 

DensitylBulk Density was reported to be 1.137 at 23°C and 

1.130 at 39"C .. 

830.7370 Dissociation NA [Not required/or end-use products.} 

Constants in Water 

830.7550/830.7560/830.7570 NA [Not reqUired/or end-use products.] 

Partition Coefficient 

830.7840/830.7860 Water NA [Not required/or end-use products.} 

Solubility 

830.7950 Vapor Pressure NA [Not required/or end-use products.) 

. ExplanatIOn: A-acceptable; N-not acceptable (l.e., Item was submItted but IS not acceptable); 

NA=technicaIIy not applicable (i.e., not required); G=data gap (i.e., item was not submitted but 

is required); U=requires upgrading (i.e., item is unacceptable but upgradeabIe); W=waived; 

E=EPA estimate. 

* Provide brief description, e.g., color - yeIIow or property value, e.g., density 1.25 glee. 

Unless otherwise indicated, the property should be at 25°C. 

1 If product is an emulsifiable liquid 

2If product is dispersible with water 

88089.R_ D386712_BioMedProtectLLC Page 9 of9 

37
UNITED STATES ENVIRONMENTAL PROTECTION 

AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

May 13, 2011 

MEMORANDUM 

SUBJECT: Acute Toxicity Review for EPA Reg. 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 (751 OP) 

Jacqueline Campbell-McFarlane PM 34/Jaclyn Carl 

Regulatory Management Branch II 

Antimicrobials Division (751 OP) 

BioMed Protect, LLC 

FORMULATION FROM LABEL: 

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 % 

38 *Inert ingredient information may be entitled to confidential treatment*
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 e acute toxIcity pro fil 1 e fc 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 

Primary Eye 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 for this 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 if swallowed, 

absorbed through skin, or inhaled. 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." 

4. The first aid statements may read: 

If swalIowed: 

-Call a poison control center or doctor immediately for treatment advice. 

-Have a person sip a glass of water if able to swallow. 

-Do not induce vomiting unless told to by a poison control center or doctor 

-Do not give anything by mouth to an unconscious person. 

If on skin: 

-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. 

39
If inhaled: 

-Move 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. 

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. 

40
( 

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

Product Manager: Jacquie McFarlane 

MRID No.: 48371106 

Reviewer: Chris Jiang 

Study Completion Date: May 14,2010 

Report No.: 13808-10 

Testing Laboratory: Stillmeadow Incorporated 

Author: Janice O. Kuhn 

Quality Assurance (40 CFR 160.12): A statement of GLP compliance was included. 

Test Material: Hyramine, Lot No. 20I0043A, light tan transparent liquid 

Dosage: 170 mg/kg, 550 mglkg, 1750 mglkg, 5000 mg/kg 

Species: Female albino Sprague-Dawley rats 

Age: Eight to nine weeks at time of dosing 

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 humidity was outside the range of the protocol. These deviations had no impact 

on the integrity of the 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 

41
( 

Observations: 

175 mg/kg): The animal appeared normal and healthy throughout the study. 

550 mg/kg: The only clinical sign observed was slight hypoactivity. 

1,750 mg/kg: The animals appeared normal and healthy throughout the study. 

5,000 mg/kg): Two animals died in this dose group. Clinical signs of the decedents 

included slight to moderate piloerection and very slight salivation. Clinical signs of the 

survivors included a crust 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 of yellow liquid, and empty 

intestines. 

42
( ( 

DATA REVIEW FOR ACUTE DERMAL TOXICITY TESTING (81-2, 870.1200) 

Product Manager: Jacquie McFarlane Reviewer: Chris Jiang 

MRID No.: 48371107 Study Completion Date: March 31, 2010 

Report No.: 13809-10 

Testing Laboratory: StiIlmeadow Incorporated 

Author: Janice O. Kuhn 

Quality Assurance (40 CFR 160.12): A statement ofGLP compliance was included. 

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

Dosage: 5050 mg/kg 

Species: Five male and five female albino Sprague-Dawley rats 

Age: Eight weeks at time of dosing 

Weight: \': 175 to 213 grams before dosing; 0: 245 to 307 grams before dosing 

Source: Texas Animal Specialties, Humble, TX 

Conclusions: 

1. LD50 (mglkg): LD50 > 5050 mg/kg 

2. The estimated LDso is greater than 5050 mg/kg. 

3. Toxicity Category: IV Classification: Acceptable 

Procedure (Deviations from 81-2): No deviations occurred during the study. 

Results: 

Reported Mortality 

(Number DeathslNumber Tested) 

Dosage (mglkg) Males Females Combined 

5050 0/5 0/5 0/10 

Observations: All animals appeared nonnal and healthy for the duration of the study. 

Only one male experienced very slight erythema on day 1. All animals had test substance 

staining throughout the study. 

Gross Necropsy Findings: Gross necropsies were unremarkable. 

43
( 

DATA REVIEW FOR ACUTE INHALATION TOXICITY (§81-3, 870.1300) 

Product Manager: Jacquie McFarlane Reviewer: Chris Jiang 

MRID No.: 48371108 Study Completion Date: Apn120, 2010 

Report No.: 13810-10 

Testing Laboratory: Stillmeadow Incorporated 

Author: Andrew Doig 

Quality Assurance (40 CFR 160.12): A statement of GLP compliance was 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 of dosingO.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 of the 

exposure chamber were outside the range specified in the protocol. These deviations had 

no impact on the integrity of the study. 

Results: 

Reported Mortality 

(Number DeathslNumber Tested) 

Dosage (mglL) Males Females Combined 

2.08 0/5 0/5 0110 

44
( 

Chamber Atmosphere 

Dose Level 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 

Ch amber Environment During Exoosure 

Chamber Volume (L) 500 

Average Total Airflow 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. 

45
( 

DATA REVIEW FOR PRIMARY EYE IRRITATION TESTING (81-4, 870.2400) 

Product Manager: Jacquie McFarlane Reviewer: Chris Jiang 

MRID No.: 48371109 Study Completion Date: April 13, 2010 

Report No.: 13811-10 

Testing Laboratory: StiIImeadow Incorporated 

Author: Janice O. Kuhn 

Quality Assurance (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 New Zealand White rabbits 

Age: Thirteen weeks at time of dosing 

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 of the range 

specified in the protocol. This deviation had no impact on the integrity of the study_ 

Results: 

Individual Scores for Ocular Irritation • 

Rabbit No. 4726 Rabbit No. 4693 Rabbit No. 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 of nonnal 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 

46
( 

DATA REVIEW FOR PRIMARY SKIN IRRITATION TESTING (81-5, 870.2500) 

Product Manager: Jacquie McFarlane Reviewer: Chris Jiang 

MRlD No.: 48371110 Study Completion Date: April 6. 2010 

Report No.: 13812-10 

Testing Laboratory: Stillmeadow Incorporated 

Author: Janice O. Kuhn 

Quality Assurance (40 CFR 160.12): A statement ofGLP compliance was 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 of dosing 

Initial Weight: 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 of the range 

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

47
( 

DATA REVIEW FOR DERMAL SENSITIZATION TESTING (81-6, 870.2600) 

Product Manager: Jacquie McFarlane Reviewer: Chris Jiang 

MRID No.: 48371111 Study Completion Date: May 18, 2010 

Report No.: 13813-10 

Testing Laboratory: StiIlmeadow Incorporated 

Author: Janice O. Kuhn 

Quality Assurance (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 seven weeks 

Source: Charles River, Hdq., Wilmington, MA 

Method: Buehler Method 

Summary: 

1. This Product is not a dermal sensitizer. 

2. Classification: Acceptable 

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

Procedure: After preliminary tests, the definitive study was undertaken. Once each 

week for three weeks, either 0.4 mL of the undiluted test material or nothing was applied 

to the clipped left front quadrant using gauze patches. After chamber application, the 

trunks of the animals were wrapped with elastic wrap that was secured with adhesive 

tape. After the exposure period, the chambers and bindings were removed and the test 

sites were cleansed of residual test substance. The guinea pigs were scored at 24 and at 

48 hours after each induction. 

Two weeks after the third induction, all animals were challenged with 0.4 mL of the 

undiluted test substance on the right rear quadrant. The guinea pigs were scored at 24 

and at 48 hours after chall enge. 

Results: At 24 hours and at 48 hours after each induction, there was no irritation. At 24 

hours and at 48 hours after challenge, there was no sensitization response. 

The historical positive control showed appropriate results. 

48
( 

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

; ..... _ ..... '" 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 necessary forms. Send 

comments regarding burden estimate or any other aspect of this 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 not send the completed form to this address. 

Certification with Respect to Citation of Data 

Applicant'S/Regislranfs Name, Address, and Telephone Number EPA Registration Number/File Symbol 

BioMed Protect, LLC, 44 Weldon 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: If your producl is a fOO% repackaging of another 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 of companies sent offers of compensation (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 of support, and have included with this form 0 I am using the selective method of SlIppOrt (or cite-all option 

a list of companies sent offers of compensation (the Data Matrix form under the selectwe method), and have included with this form a 

should be used for this purpose). completed list of data requiremenls (the Dala Mallix form must be 

used). 

SECTtDN II: GENERAL OFFER TO PAY 

(Required if using the cite-all melhod orwhen using the cite-all option under the selective method to satisfy one or more deta requirements] 

0 t hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA. 

SECTION III: CERTIFICATION 

I certify that this application for registration, this form for reregistration, or Ihis Data-Gall-In response is supported by all dala submitted or cited in the 

apptication for regislration, the form for reregistration, or the Data-Call-In response. In addition, if the cile-all option or cite-all option under the setective method is 

indicaled in Seclion I, this applicaUon is supported by all dala in the Agency's files that (1) concern the properties or effects of this product or an Identical or 

subslantially similar product, or one or more of the ingredients in this producl; and (2) is a type o( data that would be required to be submitted under the data 

requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and 

uses. 

I certify that for each exclUSive use study cited in support of this registration or reregistration, that I am the original data submitter or 'thai i have obtained 

the written permiSSion of the original data submitter to cite that sludy. 

I certify that for each study cited in support of this 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 of the original data submitter to use Ihe study in supportofthis application; (c) all peliods ofeligihility for 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 

amount and terms of compensation, if any, to be paid for the use of Ihe study. I I 

I certify that in all Instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their r'elivery in I 

accordance with sections 3(c)( f)(F} and/or 3(c)(2)(B} of FIFRA are available and win be submitted to the Agency upon request. Should I fail to produce such 

evidence to the Agency upon request, I undersland that the Agency may initiate action to deny, cancel or suspend the registration of my proJIot.; :" cJnformity with 

FIFRA. 

I certify1hat the 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 by fine or imprisonment or both under applicable 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 Paper versions avalla ble. Submit onl , , y P pe version. 

49 *Inert ingredient information may be entitled to confidential treatment*
<""""'. 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 necessary forms. Send comments regarding the burden estimate or any other aspect of this collection of 

information, including suggestions for reducing the burden to: Director, OPPE Information Management Division (2137), U.S. Environmentat 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 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, GA 31603 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 Identity and Disclosure of Ingredients BioMed Protect, LLC OWN tn this submission 

830.1670 Sanogiene: Product Identity and 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 Enforcement Analytica! 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 Paper version. Agency tnternat Use Copy 

50 *Inert ingredient information may be entitled to confidential treatment*
.... '." ... 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 of information 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 or any other aspect of this 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 I Page2 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! Paper versions available. Submit only Paper version. Agency tnternat Use Copy 

51 *Inert ingredient information may be entitled to confidential treatment*
- ( 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 

St. Louis, MO 63043 Produot Nama 

Sanogiene 

Data of Confidontial Stotomont of Formula (EPA Form 8570-4) 

January 17, 2010 

As an authorized representative of the applicant for registration of the product identified above, I certify that: 

(1 ) This product contains the following active ingredient(s): 

1 ,3-dihydroxymethyl-5,5-dimelhylhydanloin 

1-hydroxymelhyl-s,5-dimethylhydantoin 

chilosan 

(2) Of these, each active ingredient listed in paragraph (41 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 (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 of the active ingredient(sl listed in paragraph (1 I. 

D OR 

(81 The Confidential Statement of Formula (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., Regulatory Agent 

EPA Fonn 8570-27 {RO)v. 8-951 

Date January 27, 2011 

White - EPA oopy 

YeUow - ApplIcant CO)Pv 

52 *Inert ingredient information may be entitled to confidential treatment*

*Product ingredient source information may be entitled to confidential treatment*
( . !RIA Assessment FM 

PRIA Meeting Date 2/f5/11 

Reviewerffeam# ---,f.",e"am",)~ __ 

Company Name: R;ol\\P'\ p,'Hd- Product Name 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: 

EPA Receive Date 1- 31- \ I Tentative Due Date (+2Ida@) 2- -~ -Ii 

FeeAmount$ Y(p31 00 FeeWaiverRequested(Y ___ Fee Pd. , 

Are there currently other registered pesticide products for each active ingredient in this product? 

Yes 0 No Ifso,Registration#s ______________ ~ 

UsePattem ______________________ _ 

InertIngredients Dee JUYl,2 0 I! 

Has all inerts been cleared for use in pesticide registration: YES IiI NO 0 , lfno, list 

Submission Description Nole: Y/o (>(ceis 11, 

rPl\PI.v 

[ Amendment Non-Fast TrackAPPliCationliend. Form ~ __ 

New Labels ,(]'[) - -- NewCSF( ) __ _ 

Formulator's Exemption Form@N) __ 

Method of Support Form (YIN) __ _ 

Selective Method lflPN) 

Cite-All Method (i;[ IN) __ 

EPIMUP Data Matrix et/N) 

TGAIDataMatrix(yiNJ --

List of Uses on the 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',,! 

dLtl h> S I{ PI 

IB~ "')0"'/<,) 

0, <-10ft.::> 

Are all of the uses on the label approved for each 

of the actives on the label and source? 

What are the pesticidal claims? (i.e., Disinf., 

Sanitizer, Preservative, Microbiocide) 

_ Cvv}UVcvh v<: 

53 *Inert ingredient information may be entitled to confidential treatment*
--,.'-,-

\" 

--..;-:, -' 

January 27,2011 

DELIVERED VIA FED-EX 

Document Processing Desk - (REGFEE) 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

One Potomac Yard 

2777 S. Crystal Drive 

Arlington, VA 22202 

SUBJECT: Initial Application for Registration: Sanogiene, EPA File Symbo188089LR 

Attention: Jacqueline McFarlane, PM~34 

Landis International, Inc. (herein after Landis), Consultant and Regulatory Agent herein subnnts on 

behalf ofBioMed Protect, LLC, EPA Company Number 88089, (hereinafter BioMed Protect) the 

enclosed application for initial registration of a new antimicrobial end~use fonnulation. 

483711·00 

The formulation proposed for registration contains several currently registered active ingredients in a 

combination that is different from other currently registered formulations. Each of the active ingredients 

in Sanogiene is currently registered for its proposed uses, which are of the type defined in FIFRA 

§2(mrn)(1 )(A)(ii). Consequently, Landis considers that the appropriate PRIA category for this application 

is A540. The $4, 631.00 PRIA II fee for this application was paid on January 27, 2011. 

At various times during the development of Sanogiene, the product has had the experimental names HR2010 and Hyramine. Products referred to by these names are identical to Sanogiene_ 

BioMed Protect, LLC had a company name cbange in June, 2010 and was formerly kncv:n as 

BioMedChem. 

The following materials are enclosed in support of this application: 

o Cover letter 

o EPA Fonns and Other Administrative Materials 

o Application Form 8570-1 

o Agent Authorization Letter 

o PRIA Fee Receipt 

o Draft Label (5 copies) 

o Confidential Statement ofFonnula 8570A (2 copies) 

o Certification with Respect to Citation of Data 8570-34 

o Data Matrix 8570~35 (EPA and Public VersiOns) 

o Formulator's Exemption 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.com 

54
Initial Registration Application, Sanogim( 'A i'de No. 88089-R 

January27,2011 

Page20f2 

• Thre e COpIes 0 fd ata supportmg th e app r lcatron., as Btl 0 ows: 

Guideline Number Description MRID 

830.1550,830.1600, Sanogiene: Product Identity and Disclosure of 

830.1650,830.1670, Ingredients, Description of Materials Used to Produce 

and 830.1750 the Product, Formulating Process, Discussion of 48371101 Formation of Impurities, and Certified Limits 

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 Detennination of and Hydantoins by HPLC 48371104 

Quantitative Determination of Chitosan in HR.-2010 by 

830.1800 HPLC Post-Column Derivatization with UV -Vis 

Detection 48371105 

870.1100 Hyramine Final Report Acute Oral Toxicity Study 48371108 (UDP) in Rats 

870.1200 Hyramine Final Report - Acute Dermal Toxicity Study 48371107 in Rats 

870.1300 Hyramine Final Report - Acute Inhalation Toxicity 48371108 Study in Rats 

870.2400 Hyramine Final Report - Acute Eye Irritation Study in 48371109 Rabbits 

870.2500 Hyramine Final Report - Acute Dermal Irritation Study 48371110 in Rabbits 

870.2600 Hyramine Final Report Skin Sensitization Study in 48371111 Guinea Pigs 

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. We anticipate the results will be available for submission not later than June 30, 2012. 

Please direct any questions regarding this application to: 

Dr. Richard H. Collier, Landis International, Inc. at 229-247-6472 (Valdosta, GA office), 229-251-2818 

(mobile) or via email atdcoIlier@landisintl.com. 

Sincerely, 

Richard H. CoIlier, Ph.D. 

Senior Vice President, Regulatory Affairs 

Landis International, Inc. 

COllSultantiRegulatory Agent for BioMed Protect, LLC 

3t85 Madison Highway 0 P.O. Box 5126 Valdosta, GeorSla 31603-.5126 USA [1 (22S) 247-6472 Q Fax (22S) 242-1562 D laoors@landislntlcom 

55 *Inert ingredient information may be entitled to confidential treatment*
) ':,\f.jl\,-,t t.',[ '1 

January 27, 2011 

DELIVERED VIA FED-EX 

Document Processing Desk - (REGFEE) 

Office of Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

One Potomac Yard 

2777 S. Crystal Drive 

Arlington, VA 22202 

SUBJECT: Initial Application for Registration: Sanogiene, EPA File Symbol 880891..R 

Attention: Jacqueline McFarlane, PM-34 

Landis International, Inc. (herein after Landis), Consultant and Regulatory Agent herein submits on 

behalf of BioMed Protect, LLC, EPA Company Number 88089, (hereinafter BioMed Protect) the 

enclosed application for initial registration of a new antimicrobial end-use fonnulation. 

The fonnulation proposed for registration contains several currently registered active ingredients in a 

combination that is different from other currently registered fonnulations. Each of the active ingredients 

in Sanogiene is currently registered for its proposed uses, which are of the type defined in FIFRA 

§2(mm)(1)(A)(ii). Consequently, Landis considers that the appropriate PRIA category for this application 

is A540. The $4, 631.00 PRIA II fee for this application was paid on January 27, 2011. 

At various times during the development of Sanogiene, the product has had the experimental names HR2010 and Hyramine. Products referred to by these names are identical to 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 of this application: 

• Cover letter 

• EPA Forms and Other Administrative Materials 

o Application Form 8570-1 

o Agent Authorization Letter 

o PRIA Fee Receipt 

o Draft Label (5 copies) 

o Confidential Statement of Formula 8570-4 (2 copies) 

o Certification with Respect to Citation of Data 8570-34 

o Data Matrix 8570-35 (EPA and Public Versions) 

o Formulator'S Exemption 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 

56
F A "m pprov~ . 2070-0060 A pprovo IE' l( IrO)~ 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 of the applicant for registration of the product identified above, I certify that: 

11 ) This product contains the following active ingredient(5); 

1 ,3-dihydroxymethyl-5,5-dimethylhydanloin 

1_hydroxymethyl_5,5-dimelhythydanloin 

chitosan 

(2) Of these, 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.OJ204 r3 

Rogistration Numb(lr 

Date January 27, 2011 

Whito • EPA copy 

Yottow . Applicant COpy 

I 

57 *Inert ingredient information may be entitled to confidential treatment*

*Product ingredient source information may be entitled to confidential treatment*
Print Form 

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 Protect LLClSanogiene 

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 Protect LLC 

44 Weldon 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 if this is. now oddrD$$ 

Amendmont - Explain bolow. 

Product Name 

Section - II 

FinB! printed llilbelo in rocponao to o Agency lottor doted 

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 of Not Contonts Information 

l8] Loblll o Container 

6. Manner in Which Lobol iii Affixed to Product 

4. Sizo(s) Ratail Contoinor 

1 gallon, 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 diroctly blJlaw for fdonrlffcoticn of fndivfduol ro be confocrod, if fl{IC(1$$ory. ro proCD$$ this 1JfJ!?-':clJ!i0,;.J ~ '~ 

Nomo litlo Tolephontl No~ nnclU'do Aroil 'i::~t:II": 

Richard H. Collier, Ph.D. Regulatory Agent 229.247--ti47;' Ot<:ZQc251-2818 " 

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 or misloading IItolomont may be punillhab!o by fino or impriGotlmont or 

both undar oppliceblo low. 

2. S;,"~. I rl /. /) _. 4 /' ~ --.-3,' T;,o, 1-/ ~A ... N fit ~4";~ Regulatory Agem 

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 

58
i 

, 535 -0001-.) 

December 13,2010 

<:> :::II Steven P. Bradbury, Director 

~. EPA Office of Pesticide Programs 

QJgistration Division (H7504C) 

~ument Processing Desk (ADMIN) 

~l Rio Building 

.,0 PennsylvanjaAvenue, N.W. 

lMashington, DC 20460 R OOOl 

III 

SUBJECT: ASSIGNMENT OF AGENT FOR BioMed Protect, LLC 

Dear Dr, Bradbury: 

Pursuant to EPNs requirements regarding assignment of an agent fOf regulatory activities, we hereby 

designate and assign Dr. Richard H. Collier ofLANDISJNTERNATIONAL, INC. as agent for 

BioMed Protect, 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 authorized to act in Ollr behalf concerning any regulatory activities relating to pesticide 

registration jn the United States, including but not limited to obtaining an EPA Company Number, 

registering pesticide producing establishments,. and submitting product registration applications. 

Specifically, we authorize the EPA to pennit Dr. Collier to access to any data which have been 

submitted to the EPA and are on file. He may obtain apbotocopy any of this data, as required. <'FRC 

duration of this assignment as agent is until further notice to the EPA. f, e" 6 ~ ~ 

Sinc~ 

Howard 

President 

S. Rosing, M~ 

BioMed Protect, LLC 

Sworn to and subscribed before me 

this ~day ofl:l&1!- ,2010. 

Notary Public ~~ ':){ :.~? 

~ f , " < 

, " , . 

59
i 

Initial Rcgistr.llion Application. Slinogicne. EPA, ,Ie No. 88089-R 

January27,201] 

Page2of2 

• Thr ee copIes 0 fd ata supportmg th e appllca r f lon, as D 0II ows; 

Guideline Number Deseriplion 

830.1550,830.1600, Sanogiene: Product Identity and Disclosure of 

830.1650,830.1670, Ingredients, Description of Materials Used to Produce 

and 830.1750 the Product, Formulating Process, Discussion of 

Formation ofImpurities, and Certified Limits 

830.6302, 830.6303, 

830.6304,830.7000, Physical and Chemical Characteristics of Hyramine 830.7100, and 

830.7300 

830.6314,830.6315, Sanogiene: OxidationIReduction, Flammability, 

830.6316,830.6319, Explodability, Miscibility, and Dielectric Breakdown 

and 830.6321 Voltaae 

830.1800 Determination of and Hydantoins by HPLC 

Quantitative Determination ofChitosan in HR-20IO by 

830.1800 HPLC Post-Column Derivatization with UV-Vis 

Detection 

870.1100 Hyramine Final Report - Acute Oral Toxicity Study 

rUDP) in Rats 

870.1200 Hyramine Final Report Acute Dermal Toxicity Study 

in Rats 

870.1300 Hyramine Final Report ~ Acute Inhalation Toxicity 

Study in Rats 

870.2400 Hyramine Final Report - Acute Eye Initation Study in 

Rabbits 

870.2500 Hyramine Final Report - Acute Dennal Irritation 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. We anticipate the results will be available for submission not later than June 30, 2012. 

Please direct any questions regarding this application to: 

Dr. Richard H. Collier, Landis International, Inc. at 229-247-6472 (Valdosta, GA office), 229-251-2818 

(mobile) or via email at dcollicrrwlandisintLcom. 

Sincerely, 

Richard H. Collier, Ph.D. 

Senior Vice President, Regulatory Affairs 

Landis International, Inc. 

ConsultantlRegulatory Agent 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 

60 *Inert ingredient information may be entitled to confidential treatment*
( 

Form Approved 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 necessary fonns. Send 

commenls regarding burden estimate or any other aspect of this collection of information, 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 Respect to 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 

dihyl doxymethyl-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: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to 

submit tIlis form. You must submit the 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 of companies sent offers of compensation (the Data Matrix form should 

be used for this purpose). 

SECTION I: METHOD OF DATA SUPPORT (Check one method only) 

D I am using the cite-all melhod of support, and have included with this form [2] I am using the selective method of support (or cite-att option 

a list of companies sent offers of compensalion (the Data Malrix form under the selective method), and have included with this form a 

should be used for this purpose}. completed list of data requirements (the Data Matrix form must be 

used). 

SECTION II: GENERAL OFFER TO PAY 

(Required if using the cite-all method or when 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 to the approval of this 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, if the cite-all option or cite-all opb'on under the selective method is 

indicated in Section ~ this application is supported by all dala in the Agency's files that (t) concem the properties or effects of this product or an identical or 

subslantially similar product, or one or more of the ingredients in this product; and (2) is a type of dala that would be required to be submilled under the data 

requirements In effecl on the date of approval of this application if the application sought the initial registration of a product of identical or Similar composition and 

uses. ~ce¢ 

0 0 

I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submiller or \h"afl'have obtained 

the wrillen permission of the original data submiller to cile Ihat study. 0 , "0000" 

0 

I certify that for each study clled in support of this registration or reregistrab'on that is not an exclusive use sludy, either. (a) I am the oriCinal data ~ <., ,. Ii submitter; (b) I have oblained the permission of the original dala submiller to use Ihe study in support of this applicalion; (c) all periods of eligibility 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 to the 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 of compensalion, if any, to be paid for !he use of the study. , , ,,1 < < , , ~. G 

, 

I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in ' , , , < • 

accordance with sections 3(c)(1 )(F) and/or 3(c)(2)(6) ofFIFRA are available and will be submitted 10 the Agency upon request. Shoutd I faD 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 that the statements t have made on this form and all attachments to it are true, accurate, and complete. I ackr.owtedge that any 

knowingly false or misleading statement may be punishable by fine 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 Paper versions available. Submit only Paper verSion. 

61 *Inert ingredient information may be entitled to confidential treatment*
.... '.,. 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 of information 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 or any other aspect of this 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 90 f2-76-4), 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 .'. 

830.6321 ~~os::n"e: Oxi~i;onrR:Buction, Flammability, Explod , . . . . 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 Paper version. Agency Internal Use Copy 

.'. 

62 *Inert ingredient information may be entitled to confidential treatment*
...... ,.,. 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 of infonnation 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 or any other aspect of this cottection of 

informallon, 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./File Symbol 66069-R I Page2 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 Paper version. ~-~ ~~ ~ 

Agency tnternat Use Copy 

-- -" 

63 *Inert ingredient information may be entitled to confidential treatment*
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 

, , , ~ ,~~ ~, 

, 

, , , , , "" 

" , " , , " " 

64 *Inert ingredient information may be entitled to confidential treatment*
PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

!F 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 if absorbed 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, if appropriate). 

IF INHALED: Harmful if inhaled. Avoid breathing (dust, vapor or 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, 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 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. If wastes 

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 after the fiowH 

c 

begins to drip. Repeat this procedure two more times. Then offer for recycling if available, 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 of bacteria 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 of solution by adding water to equal the same weight of the textile to be treated. 500 kg of 

fabric is treated with 31.25kg of SANOGIENE and 468.75 of water by dipping the fabric in a tank with the 

,( (, 

65
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 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. If these terms are not acceptable, return all products to place of 

purchase unopened for a full refund. 

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66
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) 

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 

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67 *Inert ingredient information may be entitled to confidential treatment*
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 if absorbed 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, if appropriate). 

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 contact with 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 away from 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. If wastes 

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 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 after the f!6w~ ~ b 

begins to drip. Repeat this procedure two more times. Then offer for recycling if available, or puncture 

and dispose of in a sanitary landfill or by 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 of the growth of bacteria and fungi in textiles. ' 

Do not use articles that have been treated with SANOGIENE as cornponents in rnaterials used i~ 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 of solution by adding water to equal the same weight of the textile to be treated. 500 kg of 

fabric is treated with 31.25kg of SANOGIENE and 468.75 of water by dipping the fabric in a tank with the 

, " , 

'" ' 

68
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 of fitness 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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, , " " " 

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69
Pages 70-72 - *Confidential Statements of Formula may be entitled to confidential treatment*