Cover Letter

Cover Letter

TS-R1947B

All text in this letter is Confidential Business Information

{XXX}

Page 1

SANITIZED SUBMISSION
PMN Page 1

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

U.S. ENVIRONMENTAL PROTECTION AGENCY AGENCY USE ONLY 

Date of receipt: 

EPA

PREMANUFACTURE 

NOTICE

FOR NEW CHEMICAL SUBSTANCES

Submission Report Number 

When 

completed, 

send this 

form to: 

If sending by Courier: 

Office of Pollution Prevention and Toxics 

Document Control Office (7407M) 

US EPA, 1201 Constitution Ave NW 

WASHINGTON, D.C. 20460 

Contact Numbers: 202-564-8930/8940 

If sending by US Mail: 

Office of Pollution Prevention and Toxics 

Document Control Office (7407M) 

US EPA, 1200 Pennsylvania Ave NW 

WASHINGTON, D.C. 20460

Total Number of Pages User Fee Payment ID Number TS Number 

GENERAL INSTRUCTIONS 

• You must provide all information requested in this form to the extent that it is known to or reasonably ascertainable by you. Make reasonable estimates if you do not have actual data. 

• Before you complete this form, you should read the “Instructions Manual for Premanufacture Notification” (the Instructions Manual is available from the Toxic Substances Control Act 

 (TSCA) Information Service by calling 202-554-1404, or faxing 202-554-5603). 

• If a user fee has been remitted for this notice (40 CFR 700.45), indicate in the boxes above the TS-user fee identification number you have generated. Remember, your user fee ID number 

 must also appear on your corresponding fee remittance. For mailing address information see the Help instructions in the e-PMN tool.

Part I – GENERAL INFORMATION 

You must provide the currently correct Chemical Abstracts (CA) 

Name of the new chemical substance, even if you claim the 

identity as confidential. You may authorize another person to 

submit chemical identity information for you, but your submission 

will not be complete and the review will not begin until EPA 

receives this information. A letter in support of your submission 

should reference your TS user fee identification number. For all 

Section 5 Notice submissions (paper or electronic) you must 

submit an original notice including all test data; if you claimed any 

information as confidential, an original sanitized copy must also be 

submitted. 

TEST DATA AND OTHER DATA 

You are required to submit all test data in your possession or control and to provide a 

description of all other data known to or reasonably ascertainable by you, if these data are 

related to the health and environmental effects on the manufacture, processing, distribution in 

commerce, use, or disposal of the new chemical substance. Standard literature citations may 

be submitted for data in the open scientific literature. Complete test data (written in English), 

not summaries of data, must be submitted if they do not appear in the open literature. You 

should clearly identify whether test data is on the substance or on an analog. Also, the 

chemical composition of the tested material should be characterized. Following are examples 

of test data and other data. Data should be submitted according to the requirements of 

§720.50 of the Premanufacture Notification Rule (40 CFR Part 720). 

Test Data (Check Below any included in this notice)

 Environmental fate data Other Data 

Part II – HUMAN EXPOSURE AND ENVIRONMENTAL 

RELEASE 

If there are several manufacture, processing, or use operations to 

be described in Part II, sections A and B of this notice, reproduce 

the sections as needed. Health effects data Risk Assessments 

 Environmental effects data Structure/activity relationships

Physical/Chemical Properties (A physical and chemical properties worksheet is 

located on the last page of this form.) 

Part III – LIST OF ATTACHMENTS 

For paper submissions, attach additional sheets if there is not 

enough space to answer a question fully. Label each continuation 

sheet with the corresponding section heading. In Part III, list these 

attachments, any test data or other data and any optional 

information included in the notice. Test data not in the possession or control of the submitter 

TYPE OF NOTICE (Check Only One) 

PMN (Premanufacture Notice)

 SNUN (Significant New Use Notice) 

 TMEA (Test Marketing Exemption Application) 

 LVE (Low Volume Exemption) @ 40 CFR 723.50(c)(1) 

 LOREX (Low Release/Low Exposure Exemption) @ 40 CFR 723.50(c)(2) 

 LVE Modification 

 LOREX Modification 

OPTIONAL INFORMATION 

You may include any information that you want EPA to consider in 

evaluating the new substance. On page 11 of this form, space has 

been provided for you to describe pollution prevention and 

recycling information you may have regarding the new substance. 

“Binding” boxes are included throughout this form for you to 

indicate your willingness to be bound to certain statements you 

make in this section, such as use, production volume, protective 

equipment . . . The intention is to reduce delays that routinely 

accompany the development of consent orders or Significant New 

Use Rules. Checking a "binding" box in a PMN does not by itself 

prohibit the submitter from later deviating from the information 

(except chemical identity) reported in the form; however, in the 

case of exemption applications (such as TMEA, LVE, LOREX) 

certain information provided in such notifications is binding on the 

submitter when the Agency approves the exemption application, 

especially if the production volume "binding" box is chosen in a 

LVE.

 Mock Submission

 Mark (X) if pending Letter of Support 

 IS THIS A CONSOLIDATED PMN (Y/N)?

 # of chemicals or polymers (Prenotice Communication # required, enter # on 

 p. 3).

CONFIDENTIALITY CLAIMS

You may claim any information in this notice as confidential. To 

assert a claim on the form, mark (X) the confidential box next to 

the information that you claim as confidential. To assert a claim in 

an attachment, circle or bracket the information you claim as 

confidential. If you claim information in the notices as confidential, 

you must also provide a sanitized version of the notice, (including 

attachments). For additional instructions on claiming information 

as confidential, read the Instructions Manual. Mark (X) if any information in this notice is claimed as confidential. 

Form Approved. O.M.B. Nos. 2070-0012 and 2070-0038

PMN2011P1

252BNJRN

PMNX110122164583146

R1947B

X

X

86

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SANITIZED SUBMISSION
PMN Page 2

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

. 

CERTIFICATION -- A printed copy of this signature page, with original signature, must be submitted 

with CD or paper submission.

I certify that to the best of my knowledge and belief: 

1. The company named in Part I, section A, subsection 1a of this notice form intends to 

manufacture, import or process for a commercial purpose, other than in small quantities solely for 

research and development, the substance identified in Part I, Section B. 

2. All information provided in this notice is complete and truthful as of the date of submission. 

3. I am submitting with this notice all test data in my possession or control and a description of all 

other data known to or reasonably ascertainable by me as required by §720.50 of the 

Premanufacture Notification Rule. 

Additional Certification Statements: 

If you are submitting a PMN, Intermediate PMN, Consolidated PMN, or SNUN, check the following user fee 

certification statement that applies: 

 The Company named in Part I, Section A has remitted the fee of $2500 specified in 40 CFR 700.45(b), or

 The Company named in Part I, Section A has remitted the fee of $1000 for an Intermediate PMN (defined @ 40 CFR 700.43) in 

 accordance with 40 CFR 700.45(b), or

 The Company named in Part I Section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in 

 accordance with 40 CFR 700.45(b).

If you are submitting a Low Volume Exemption (LVE) application in accordance with 40 CFR 723.50(c)(1) or a 

Low Release and Low Exposure Exemption (LoRex) application in accordance with 40 CFR 723.50(c)(2), check 

the following certification statements: 

 The manufacturer submitting this notice intends to manufacture or import the new chemical substance for commercial purposes, 

 other than in small quantities solely for research and development, under the terms of 40 CFR 723.50. 

 The manufacturer is familiar with the terms of this section and will comply with those terms; and 

 The new chemical substance for which the notice is submitted meets all applicable exemption conditions. 

 If this application is for an LVE in accordance with 40 CFR 723.50(c)(1), the manufacturer intends to commence manufacture of 

 the exempted substance for commercial purposes within 1 year of the date of the expiration of the 30 day review period. 

The accuracy of the statements you make in this notice should reflect your best prediction of the 

anticipated facts regarding the chemical substance described herein. Any knowing and willful 

misrepresentation is subject to criminal penalty pursuant to 18 USC 1001. 

Confidential 

Signature and title of 

Authorized Official (Original 

Signature Required) 

Date 

 

The public reporting and recordkeeping burden for this collection of information is estimated to average 93 hours per response. Send 

comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for

minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies 

Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB 

control number in any correspondence. Do not send the completed EPA Form 7710-25 to this address.

PMN2011P2

X

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SANITIZED SUBMISSION
PMN Page 3

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Part I -- GENERAL INFORMATION 

Section A – SUBMITTER IDENTIFICATION 

Mark (X) the "Confidential" box next to any subsection you claim as confidential 

1a. Person Submitting Notice (in U.S.) Confidential 

Name of Authorized Official 

Position 

Company 

Mailing Address (number & street) 

City State Postal Code

email 

b. Agent (if Applicable) Confidential

Name of Authorized Official 

Position 

Company 

Mailing Address (number & street) 

City State Postal Code 

e-mail Telephone 

(include area code)

c. Joint Submitter (if applicable) Confidential

If you are submitting this notice as part of a joint submission, mark (X) 

Name of Authorized Official 

Position 

Company 

Mailing Address (number & street) 

City State Postal Code

2. Technical Contact (in U.S.) Confidential

Name of Authorized Official 

Position 

Company 

Mailing Address (number & street) 

City State Postal Code 

e-mail Telephone 

(include area code)

Mark (X) if none Confidential 

3. 

If you have had a prenotice communication (PC) concerning 

this notice and EPA assigned a PC Number to the notice, 

enter the number. 

Mark (X) if none Confidential 

4. 

If you previously submitted an exemption application for the 

chemical substance covered by this notice, enter the 

exemption number assigned by EPA. If you previously 

submitted a PMN for this substance enter the PMN number 

assigned by EPA (i.e. withdrawn or incomplete).

Mark (X) if none Confidential 

5. 

If you have submitted a notice of Bona fide intent to 

manufacture or import for the chemical substance covered 

by this notice, enter the notice number assigned by EPA.

6. Type of Notice – Mark (X) 

Manufacture Only Import Only 

1. 

Binding Option 

2. 

Binding Option 

3. Both 

(first) (last)

(first) (last)

(first) (last)

(first) (last)

e-mail Telephone 

(include area code)

PMN2011P3

Brian Hutchison, PhD

Manager of Chemistry

RainDance Technologies, Inc.

44 Hartwell Avenue

Lexington MA 02421

HUTCHISONB@raindancetech.com

Ronald Outen, PhD

President

Ron Outen Associates, LLC

31 Flamingo Road

Rockport TX 78382

ron@ronouten.com 240-418-3385

X

X

X

XXX

X

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SANITIZED SUBMISSION
PMN Page 4

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Part I – GENERAL INFORMATION -- Continued 

Section B – CHEMICAL IDENTITY INFORMATION: You must provide a currently correct Chemical Abstracts (CA) name of the substance 

based on current CA index nomenclature rules and conventions. 

Mark (X) the “Confidential” box next to any item you claim as confidential 

Complete either item 1 (Class 1 or 2 substances) or 2 (Polymers) as appropriate. Complete all other items. 

If another person will submit chemical identity information for you (for either Item 1 or 2), mark (X) the box at the right. Identify 

the name, company, and address of that person in a continuation sheet. 

Class 1 Class 2 CBI 1. Class 1 or 2 chemical substances (for definitions of class 1 and class 

2 substances, see the Instructions Manual) 

a. Class of substance - Mark (X) 

b. Chemical name (Currently correct Chemical Abstracts (CA) Name that is consistent with TSCA Inventory listings for similar 

substances. For Class 1 substances a CA Index Name must be provided. For Class 2 substances either a CA Index Name or CA 

Preferred Name must be provided, which ever is appropriate based on current CA index nomenclature rules and conventions).

CAS Registry Number (if a number already exists for the substance)

c. Please identify which method you used to develop or obtain the specified chemical identity information reported in this notice: (check one).

Method 1 (CAS Inventory Expert Service - a copy of the 

Identification report obtained from the CAS Inventory Expert 

Services must be submitted as an attachment to this notice)

IES Order 

Number 

Method 2

(Other 

Source) 

 Enter Attachment filename for Part I, Section B, 1. c.

d. Molecular formula

e. For a class 1 substance, provide a complete and correct chemical structure diagram. For a class 2 substance, provide a correct 

representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained. 

 Enter Attachment filename for Part I, Section B, 1. e. 

PMN2011P4

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SANITIZED SUBMISSION
PMN Page 4a

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

For a class 2 substance - (1) List the immediate precursor substances with their respective CAS Registry Numbers. (2) Describe 

the nature of the reaction or process. (3) Indicate the range of composition and the typical composition (where appropriate). Confidential

e. (1) List the immediate precursor substance names with their respective CAS Registry Numbers.

 Enter Attachment filename for Part I, Section B, 1. e. (1) 

e. (2) Describe the nature of the reaction or process.

 Enter Attachment filename for Part I, Section B, 1. e. (2) 

e. (3) Indicate the range of composition and the typical composition (where appropriate). 

 Enter Attachment filename for Part I, Section B, 1. e. (3) 

PMN2011P4A

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SANITIZED SUBMISSION
PMN Page 5

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Part I -- GENERAL INFORMATION – Continued

Section B -- CHEMICAL IDENTITY INFORMATION -- Continued 

2. Polymers (For a definition of polymer, see the Instructions Manual.) Confidential 

a. Indicate the number-average weight of the lowest molecular weight composition of the polymer you intend to manufacture. 

Indicate maximum weight percent of low molecular weight species (not including residual monomers, reactants, or solvents) 

below 500 and below 1,000 absolute molecular weight of that composition.

Describe the methods of measurement or the basis for your estimates:

GPC Other (Specify Below)

Specify Other: 

(i) lowest number average molecular 

weight:

(ii) maximum weight % below 500 molecular 

weight:

(iii) maximum weight % below 1000 molecular 

weight:

 

Enter Attachment filename for Part I, Section B, 2. a.

b. You must make separate confidentiality claims for monomer or other reactant identity, composition information, and residual information. Mark 

(X) the “Confidential” box next to any item you claim as confidential 

(1) - Provide the specific chemical name and CAS Registry Number (if a number exists) of each monomer or other reactant used in the 

manufacture of the polymer. 

(2) - Mark (X) this column if entry in column (1) is confidential. 

(3) - Indicate the typical weight percent of each monomer or other reactant in the polymer. 

(4) - Choose “yes” from drop down menu if you want a monomer or other reactant used at two weight percent or less to be listed as part of 

the polymer description on the TSCA Chemical Substance Inventory. 

(5) - Mark (X) this column if entries in columns (3) and (4) are confidential. 

(6) - Indicate the maximum weight percent of each monomer or other reactant that may be present as a residual in the polymer as 

manufactured for commercial purposes. 

(7) - Mark (X) this column if entry in column (6) is confidential.

Monomer or other reactant specific chemical name 

(1) CBI 

(2) 

Typical 

composition 

(3) 

Include in 

identity 

(4) 

CBI 

(5) 

Max 

residual

(6) 

CBI

(7)

CAS Registry Number (1) 

 

CAS Registry Number (1) 

 

CAS Registry Number (1) 

 

CAS Registry Number (1) 

 

CAS Registry Number (1) 

 

Mark (X) this box if the data continues on the next page. 

PMN2011P5

X

XXX XXX XXX

XXX

XXX

X XXX X XXX X

XXX

XXX

X XXX X XXX X

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SANITIZED SUBMISSION
PMN Page 5a

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

c. Please identify which method you used to develop or obtain the specified chemical identity information reported in this notice 

(check one). CBI 

Method 1 (CAS Inventory Expert Service 

- a copy of the identification report obtained 

from CAS Inventory Expert Service must be 

submitted as an attachment to this notice)

IES Order 

Number

Method 2 

(other source)

 Enter Attachment filename for Part I, Section B, 2. c.

d. The currently correct Chemical Abstracts (CA) name for the polymer that is consistent with TSCA Inventory listings for similar 

polymers.

 CAS Registry Number (if a number already exists for the substance)

e. Provide a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably 

ascertained. 

 Enter Attachment filename for Part I, Section B, 2. e.

PMN2011P5A

X

120709-4

001 CAS-IES Report.PDF

X

XXX

XXX

See Attachment 002 (002 Structure and Reaction Sequence-SAN.pdf)

002 Structure and Reaction Sequence-SAN.pdf

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SANITIZED SUBMISSION
PMN Page 6

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Part I -- GENERAL INFORMATION -- Continued

Section B -- CHEMICAL IDENTITY INFORMATION -- Continued 

3. Impurities 

(a) - Identify each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for commercial 

purpose. Provide the CAS Registry Number if available. If there are unidentified impurities, enter “unidentified.” 

(b) - Estimate the maximum weight % of each impurity. If there are unidentified impurities, estimate their total weight %.

Impurity (a)

CAS Registry 

Number 

(a)

Maximum 

Percent % 

(b)

Confidential

 

Mark (X) this box if the data continues on the next page.

4. Synonyms - Enter any chemical synonyms for the new chemical identified in subsection 1 or 2.

 Enter Attachment filename for Part I, Section B, 4.

5. Trade identification - List trade names for the new chemical substance identified in subsection 1 or 2.

 Enter Attachment filename for Part I, Section B, 5.

6. Generic chemical name - If you claim chemical identify as confidential, you must provide a generic name for your substance that reveals the 

specific chemical identity of the new chemical substance to the maximum extent possible. Refer to the TSCA Chemical 

Substance Inventory, 1985 Edition, Appendix B for guidance on developing generic names. 

 Enter Attachment filename for Part I, Section B, 6.

7. Byproducts - Describe any byproducts resulting from the manufacture, processing, use, or disposal of the new chemical substance. Provide the 

CAS Registry Number if available.

Byproduct (1) CAS Registry Number 

(2)

Confidential

Mark (X) this box if the data continues on the next page.

 Enter Attachment filename for Part I, Section B, 3.

PMN2011P6

EA Surfactant

RDT 1000 Sequence Enrichment Carrier Oil (when formulated at 2 weight %).

Fluorosurfactant

XXX XXX X

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SANITIZED SUBMISSION
PMN Page 7

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Part I -- GENERAL INFORMATION -- Continued

Section C -- PRODUCTION, IMPORT, AND USE INFORMATION:

The information on this page refers to consolidated chemical number(s): 1 2 3 4 5 6 

Mark (X) the “Confidential” box next to any item you claim as confidential. 

1. Production volume -- Estimate the maximum production volume during the first 12 months of production. Also estimate the maximum production 

volume for any consecutive 12-month period during the first three years of production. Estimates should be on 100% new chemical substance basis. 

For a Low Volume Exemption application, if you choose to have your notice reviewed at a lower production volume than 10,000 kg/yr, specify the 

volume and mark (x) in the binding box. If granted, you are bound to this volume. 

Maximum first 12-month production (kg/yr) 

(100% new chemical substance basis) 

Maximum 12-month production (kg/yr) 

(100% new chemical substance basis) Confidential Binding Option Mark (X)

 

Enter Attachment filename for Part I, Section C, 1. CBI 

2. Use Information -- You must make separate confidentiality claims for the description of the category of use, the percent of production volume devoted 

to each category, the formulation of the new substance, and other use information. Mark (X) the “Confidential” Box next to any item you claim as 

confidential. 

a. (1) --Describe each intended category of use of the new chemical substance by function and application. 

(2) --Mark (X) this column if entry column (1) is confidential business information (CBI). 

(3) --Indicate your willingness to have the information provided in column (1) binding. 

(4) --Estimate the percent of total production for the first three years devoted to each category of use. 

(5) --Mark (X) this column if entry in column (4) is confidential business information (CBI). 

(6) --Estimate the percent of the new substance as formulated in mixtures, suspensions, emulsions, solutions, or gels as manufactured for 

commercial purposes at sites under your control associated with each category of use. 

(7) --Mark (X) this column if entry in column (6) is confidential business information (CBI). 

(8) --Indicate % of product volume expected for the listed “use” sectors. Mark more than one box if appropriate. Mark (X) to indicate your 

willingness to have the use type provided in (8) binding. 

(9) --Mark (X) this column if entry(ies) in column (8) is (are) confidential business information (CBI). 

% of substance expected per use 

(8) Category of use (1) 

(by function and application i.e. a dispersive dye for 

finishing polyester fibers) 

CBI 

(2) 

Binding 

Option 

Mark (X)

(3) 

Prod 

uction 

% 

(4) 

CBI 

(5) 

% in 

Formulation 

(6) 

CBI 

(7) 

Sitelimited Consumer* Industrial Commercial 

Binding 

Option 

CBI 

(9) 

 

 

 

 

* If you have identified a “consumer” use, please provide on a continuation sheet a detailed description of the use(s) of this chemical substance in 

consumer products. In addition include estimates of the concentration of the new chemical substance as expected in consumer products and describe 

the chemical reactions by which this substance loses its identity in the consumer product.

Mark (X) this box if the data continues on the next page. 

b. Generic use If you claim any category of use description in subsection 2a as confidential, enter a generic description of that category. 

description Read the Instruction Manual for examples of generic use descriptions. 

 Enter Attachment filename for Part I, Section C, 2. b. CBI 

3. Hazard Information -- Include in the notice a copy of reasonable facsimile of any hazard warning statement, label, material safety 

data sheet, or other information which will be provided to any person who is reasonably likely to be exposed to this substance 

regarding protective equipment or practices for the safe handing, transport, use, or disposal of the new substance. List in part III 

hazard information you include. 

Binding Option 

Mark (X) 

 Mark (X) this box if you attach hazard information. 

PMN2011P7

XXX XXX X

X

Surfactant for Laboratory Use Fluid

XXX X XXX X XXX X XXX XXX XXX XXX X

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PMN Page 8

 EPA FORM 7710-25 (Rev. 6-09)

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE

Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER Mark (X) the “Confidential” box next to 

any item you claim as confidential

The information on pages 8 and 8a refer to consolidated chemical number(s): 1 2 3 4 5 6 

Complete section A for each type of manufacture, processing, or use operation involving the new chemical substance at industrial sites 

you control. Importers do not have to complete this section for operations outside the U.S.; however, you may still have reporting 

requirements if there are further industrial processing or use operations after import. You must describe these operations. See

instructions manual

1. Operation description 

 a. Identity -- Enter the identity of the site at which the operation will occur.

Confidential 

Name 

Site address (number and 

street) 

City County 

State ZIP code 

If the same operation will occur at more than one site, enter the number of sites. Identify the additional 

sites on a continuation sheet, and if any of the sites have significantly different production rates or 

operations, include all the information requested in this section for those sites as attachments. Æ

 Mark (X) this box if the data continues on the next page.

 b. Type -- 

 Mark (X) Manufacturing Processing Use

c. Amount and Duration -- Complete 1 or 2 as appropriate Confidential

Maximum kg/batch 

(100% new chemical 

substance) 

Hours/batch Batches/year

1. Batch 

 

Maximum kg/day 

(100% new chemical substance) Hours/day Days/year

2. Continuous 

 

d. Process description 

Mark (X) to indicate your willingness to 

have your process description binding. 

Æ

(1) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specify- e.g. 5 gallon 

pails, 55 gallon drum, rail car, tank truck, etc.). 

(2) Provide the identity, the approximate weight (by kg/day or kg/batch on a 100% new chemical substance basis), and entry point of all starting 

materials and feedstocks (including reactants, solvents, catalysts, etc.), and of all products, recycle streams, and wastes. Include cleaning 

chemicals (note frequency if not used daily or per batch.). 

(3) Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. If 

releasing to two media at the same step, assign a second release number for the second medium.

Replaces previous editions of EPA Form 7710-25

PMN2011P8

X

XXX XXX XXX

X

X

XXX

X

XXX

XXX

XXX XXX

XXX

X

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 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Confidential 

Diagram of the major unit operation steps. 

 Enter Attachment filename for Part II, Section A, 1. d. 

PMN2011P8A

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PMN Page 9

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued

Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER -- Continued

The information on pages 9 and 9a refer to consolidated chemical number(s): 1 2 3 4 5 6 

2. Occupational Exposure -- You must make separate confidentiality claims for the description of worker activity, physical form of the new chemical 

substance, number of workers exposed, and duration of activity. Mark (X) the “Confidential” box next to any item you claim as confidential. 

(1) -- Describe the activities (i.e. bag dumping, tote filling, unloading drums, sampling, cleaning, etc.) in which workers may be exposed to the 

substance. 

(2) -- Mark (X) this column if entry in column (1) is confidential business information (CBI). 

(3) -- Describe any protective equipment and engineering controls used to protect workers. 

(4) and (6) -- Indicate your willingness to have the information provided in column (3) or (5) binding. 

(5) -- Indicate the physical form(s) of the new chemical substance (e.g., solid: crystal, granule, powder, or dust) and % new chemical substance (if 

part of a mixture) at the time of exposure. 

(7) -- Mark (X) this column if entries in columns (3) and (5) are confidential business information (CBI). 

(8) -- Estimate the maximum number of workers involved in each activity for all sites combined. 

(9) -- Mark (X) this column if entry in column (8) is confidential business information (CBI). 

(10) and (11) -- Estimate the maximum duration of the activity for any worker in hours per day and days per year. 

(12) -- Mark (X) this column if entries in columns (10) and (11) are confidential business information (CBI). 

Worker activity Maximum Duration (i.e., bag dumping, filling 

drums) 

(1) 

CBI 

(2) 

Protective Equipment/ 

Engineering Controls 

(3) 

Binding

Option 

Mark (X)

(4) 

Physical 

form(s) 

& % new 

substance 

(5) 

Binding 

Option 

Mark (X)

(6) 

CBI

(7)

# of 

Workers 

Exposed 

(8) 

CBI 

(9) Hrs/Day 

(10) 

Days/Yr 

(11) 

CBI

(12)

 

 

 

 

 

 

 

 

 

 

 Mark (X) this box if the data continues on the next page.

 Enter Attachment filename for Part II, Section A on the bottom of page 9a. 

PMN2011P9

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X

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SANITIZED SUBMISSION
PMN Page 9

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued

Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER -- Continued

The information on pages 9 and 9a refer to consolidated chemical number(s): 1 2 3 4 5 6 

2. Occupational Exposure -- You must make separate confidentiality claims for the description of worker activity, physical form of the new chemical 

substance, number of workers exposed, and duration of activity. Mark (X) the “Confidential” box next to any item you claim as confidential. 

(1) -- Describe the activities (i.e. bag dumping, tote filling, unloading drums, sampling, cleaning, etc.) in which workers may be exposed to the 

substance. 

(2) -- Mark (X) this column if entry in column (1) is confidential business information (CBI). 

(3) -- Describe any protective equipment and engineering controls used to protect workers. 

(4) and (6) -- Indicate your willingness to have the information provided in column (3) or (5) binding. 

(5) -- Indicate the physical form(s) of the new chemical substance (e.g., solid: crystal, granule, powder, or dust) and % new chemical substance (if 

part of a mixture) at the time of exposure. 

(7) -- Mark (X) this column if entries in columns (3) and (5) are confidential business information (CBI). 

(8) -- Estimate the maximum number of workers involved in each activity for all sites combined. 

(9) -- Mark (X) this column if entry in column (8) is confidential business information (CBI). 

(10) and (11) -- Estimate the maximum duration of the activity for any worker in hours per day and days per year. 

(12) -- Mark (X) this column if entries in columns (10) and (11) are confidential business information (CBI). 

Worker activity Maximum Duration (i.e., bag dumping, filling 

drums) 

(1) 

CBI 

(2) 

Protective Equipment/ 

Engineering Controls 

(3) 

Binding

Option 

Mark (X)

(4) 

Physical 

form(s) 

& % new 

substance 

(5) 

Binding 

Option 

Mark (X)

(6) 

CBI

(7)

# of 

Workers 

Exposed 

(8) 

CBI 

(9) Hrs/Day 

(10) 

Days/Yr 

(11) 

CBI

(12)

 

 

 

 

 

 

 

 

 

 

 Mark (X) this box if the data continues on the next page.

 Enter Attachment filename for Part II, Section A on the bottom of page 9a. 

PMN2011P9-1

(1)

XXX X XXX XXX X XXX X XXX XXX X

XXX X XXX XXX X XXX X XXX XXX X

XXX X XXX XXX X XXX X XXX XXX X

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Page 14

SANITIZED SUBMISSION
PMN Page 9a

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

3. Environmental Release and Disposal -- You must make separate confidentiality claims for the release number and the amount of the new chemical 

substance released and other release and disposal information. Mark (X) the “Confidential” box next to each item you claim as confidential. 

(1) -- Enter the number of each release point identified in the process description, part II, section A, subsection 1d(3). 

(2) -- Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch). 

(3) -- Mark (X) this column if entries in columns (1) and (2) are confidential business information (CBI). 

(4) -- Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site or off-site land or incineration, POTW, or 

other (specify)) to which the new substance will be released from that release point. 

(5) -- a. Describe control technology, if any, and control efficiency that will be used to limit the release of the new substance to the environment. 

For releases disposed of on land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste. 

On a continuation sheet, for each site describe any additional disposal methods that will be used and whether the waste is subject to 

secondary or tertiary on-site treatment. b. Estimate the amount released to the environment after control technology (in kg/day). 

(6) -- Mark (X) this column if entries in columns (4) and (5) are confidential business information (CBI). 

(7) -- Identify the destination(s) of releases to water. Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct 

discharges or NPDES numbers of the POTW (Publicly Owned Treatment Works). Mark (X) if the POTW name or NPDES # is confidential 

business information (CBI). 

Amount of New 

Substance Released 

Control technology and efficiency (you may wish to 

optionally attach efficiency data) Release 

Number 

(1) (2a) (2b) 

CBI 

(3) 

Medium of release 

e.g. Stack air 

(4) (5a) 

Binding 

Mark 

(X) 

(5b) 

CBI 

(6) 

 

 Mark (X) this box if the data continues on the next page.

(7) Mark (X) the destination(s) of releases to water. NPDES# CBI 

POTW--provide 

name(s) 

Navigable waterway-

- provide name(s) 

Other--Specify 

 Enter Attachment filename for Part II, Section A.

PMN2011P9A

XXX XXX XXX X XXX XXX X

XXX XXX XXX X XXX XXX X

XXX XXX XXX X XXX XXX X

XXX XXX XXX X XXX XXX X

XXX XXX XXX X XXX XXX X

XXX XXX XXX X XXX XXX X

XXX XXX XXX X XXX XXX X

XXX XXX XXX X XXX XXX X

XXX XXX XXX X XXX XXX X

X

Page 15

SANITIZED SUBMISSION
PMN Page 9a

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

3. Environmental Release and Disposal -- You must make separate confidentiality claims for the release number and the amount of the new chemical 

substance released and other release and disposal information. Mark (X) the “Confidential” box next to each item you claim as confidential. 

(1) -- Enter the number of each release point identified in the process description, part II, section A, subsection 1d(3). 

(2) -- Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch). 

(3) -- Mark (X) this column if entries in columns (1) and (2) are confidential business information (CBI). 

(4) -- Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site or off-site land or incineration, POTW, or 

other (specify)) to which the new substance will be released from that release point. 

(5) -- a. Describe control technology, if any, and control efficiency that will be used to limit the release of the new substance to the environment. 

For releases disposed of on land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste. 

On a continuation sheet, for each site describe any additional disposal methods that will be used and whether the waste is subject to 

secondary or tertiary on-site treatment. b. Estimate the amount released to the environment after control technology (in kg/day). 

(6) -- Mark (X) this column if entries in columns (4) and (5) are confidential business information (CBI). 

(7) -- Identify the destination(s) of releases to water. Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct 

discharges or NPDES numbers of the POTW (Publicly Owned Treatment Works). Mark (X) if the POTW name or NPDES # is confidential 

business information (CBI). 

Amount of New 

Substance Released 

Control technology and efficiency (you may wish to 

optionally attach efficiency data) Release 

Number 

(1) (2a) (2b) 

CBI 

(3) 

Medium of release 

e.g. Stack air 

(4) (5a) 

Binding 

Mark 

(X) 

(5b) 

CBI 

(6) 

 

 Mark (X) this box if the data continues on the next page.

(7) Mark (X) the destination(s) of releases to water. NPDES# CBI 

POTW--provide 

name(s) 

Navigable waterway-

- provide name(s) 

Other--Specify 

 Enter Attachment filename for Part II, Section A.

PMN2011P9A-1

(1)

XXX XXX XXX X XXX XXX X

XXX XXX XXX X XXX XXX X

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Page 16

SANITIZED SUBMISSION
PMN Page 10

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE – Continued

Section B -- INDUSTRIAL SITES CONTROLLED BY OTHERS

The information on pages 10 and 10a refer to consolidated chemical number(s): 1 2 3 4 5 6 

Complete section B for typical processing or use operations involving the new chemical substance at sites you do not control. Importers do not have to 

complete this section for operations outside the U.S.; however, you must report any processing or use activities after import. See the Instructions Manual. 

Complete a separate section B for each type of processing, or use operation involving the new chemical substance. If the same operation is performed at 

more than one site describe the typical operation common to these sites. Identify additional sites on a continuation sheet.

1(a). Operation Description -- To claim information in this section as confidential, bracket (e.g. {}) the specific information that you claim as 

confidential. 

(1) -- Diagram the major unit operation steps and chemical conversions, including interim storage and transport containers (specify - e.g. 5 gallon 

pails, 55 gallon drums, rail cars, tank trucks, etc). On the diagram, identify by letter and briefly describe each worker activity. 

(2) -- Either in the diagram or in the text field 1(b) below, provide the identity, the approximate weight (by kg/day or kg/batch, on an 100% new 

chemical substance basis), and entry point of all feedstocks (including reactants, solvents and catalysts, etc) and all products, recycle 

streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). 

(3) -- Either in the diagram or in the text field 1(b) below, identify by number the points of release, including small or intermittent releases, to the 

environment of the new chemical substance. 

(4) -- Please enter the # of sites (remember to identify the locations of these sites on a continuation sheet):

 Number of Sites Confidential

1(b). (Optional) This space is for a text description to clarify the diagram above. Confidential

Enter Attachment filename for Part II, Section B on the bottom of page 10a.

PMN2011P10

X

See Attachment 006 (006 Flow Charts and Note-Other sites.pdf)

006 Flow Charts and Note-Other sites.pdf

XXX

X

Page 17

SANITIZED SUBMISSION
 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Continuation Sheet

ID Field

PMN2011P10-1

P10SB1(a)(4)1 Part II, Section B, 1(a)(4). Operation Site Locations

XXX

Page 18

SANITIZED SUBMISSION
PMN Page 10a

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

2. Worker Exposure/Environmental Release 

(1) -- From the diagram above, provide the letter for each worker activity. Complete 2-8 for each worker activity described. 

(2) -- Estimate the number of workers exposed for all sites combined. 

(4) -- Estimate the typical duration of exposure per worker in (a) hours per day and (b) days per year. 

(6) -- Describe physical form of exposure and % new chemical substance (if in mixture), and any protective equipment and engineering controls, if 

any, used to protect workers. 

(7) -- Estimate the percent of the new substance as formulated when packaged or used as a final product. 

(9) -- From the process diagram above, enter the number of each release point. Complete 9-13 for each release point identified. 

(10) -- Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology to the environment (in 

kg/day or kg/batch). 

(12) -- Describe media of release i.e. stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land or incineration, 

POTW, or other (specify) and control technology, if any, that will be used to limit the release of the new substance to the environment. 

(14) -- Identify byproducts which may result from the operation. 

 (3), (5), (8), (11), (13) and (15) -- Mark (X) this column if any of the proceeding entries are confidential business information (CBI). 

Letter 

of 

Activity 

# of 

Workers 

Exposed 

CBI Duration of 

Exposure CBI Protective Equip./Engineering Controls/Physical Form 

% new 

substance 

% in 

Formulation CBI 

(1) (2) (3) (4a) (4b) (5) (6) (6) (7) (8) 

 

 

 

 

 

 

 

Release 

Number Amount of New Substance Released CBI Media of Release & Control Technology CBI 

(9) (10a) (10b) (11) (12) (13) 

 

 

 

 

 

 

 

 Mark (X) this box if the data continues on the next page.

(14) Byproducts: (15) CBI 

 Enter Attachment filename for Part II, Section B. 

PMN2011P10A

XXX XXX X XXX XXX X XXX XXX XXX X

XXX XXX X XXX XXX X XXX XXX XXX X

XXX XXX X XXX XXX X XXX XXX XXX X

XXX XXX X XXX XXX X XXX XXX XXX X

XXX XXX X XXX XXX X XXX XXX XXX X

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XXX XXX XXX X XXX X

X

Page 19

SANITIZED SUBMISSION
PMN Page 10a

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

2. Worker Exposure/Environmental Release 

(1) -- From the diagram above, provide the letter for each worker activity. Complete 2-8 for each worker activity described. 

(2) -- Estimate the number of workers exposed for all sites combined. 

(4) -- Estimate the typical duration of exposure per worker in (a) hours per day and (b) days per year. 

(6) -- Describe physical form of exposure and % new chemical substance (if in mixture), and any protective equipment and engineering controls, if 

any, used to protect workers. 

(7) -- Estimate the percent of the new substance as formulated when packaged or used as a final product. 

(9) -- From the process diagram above, enter the number of each release point. Complete 9-13 for each release point identified. 

(10) -- Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology to the environment (in 

kg/day or kg/batch). 

(12) -- Describe media of release i.e. stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land or incineration, 

POTW, or other (specify) and control technology, if any, that will be used to limit the release of the new substance to the environment. 

(14) -- Identify byproducts which may result from the operation. 

 (3), (5), (8), (11), (13) and (15) -- Mark (X) this column if any of the proceeding entries are confidential business information (CBI). 

Letter 

of 

Activity 

# of 

Workers 

Exposed 

CBI Duration of 

Exposure CBI Protective Equip./Engineering Controls/Physical Form 

% new 

substance 

% in 

Formulation CBI 

(1) (2) (3) (4a) (4b) (5) (6) (6) (7) (8) 

 

 

 

 

 

 

 

Release 

Number Amount of New Substance Released CBI Media of Release & Control Technology CBI 

(9) (10a) (10b) (11) (12) (13) 

 

 

 

 

 

 

 

 Mark (X) this box if the data continues on the next page.

(14) Byproducts: (15) CBI 

 Enter Attachment filename for Part II, Section B. 

PMN2011P10A-1

(1)

XXX XXX XXX XXX XXX XXX XXX

XXX XXX XXX XXX

X X X

X X

XXX XXX XXX XXX XXX XXX XXX

XXX XXX XXX XXX

X X X

X X

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XXX XXX X XXX XXX X XXX XXX XXX X

Page 20

SANITIZED SUBMISSION
PMN Page 11

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

 

OPTIONAL POLLUTION PREVENTION INFORMATION

To claim information in the following section as confidential, bracket (e.g. {}) the specific information that you claim as confidential. 

In this section you may provide information not reported elsewhere in this form regarding your efforts to reduce or minimize potential risks 

associated with activities surrounding manufacturing, processing, use and disposal of the PMN substance. Please include new information 

pertinent to pollution prevention, including source reduction, recycling activities and safer processes or products available due to the new chemical 

substance. Source reduction includes the reduction in the amount or toxicity of chemical wastes by technological modification, process and 

procedure modification, product reformulation, and/or raw materials substitution. Recycling refers to the reclamation of useful chemical components 

from wastes that would otherwise be treated or released as air emissions or water discharges, or land disposal. Quantitative or qualitative 

descriptions of pollution prevention, source reduction and recycling should emphasize potential risk reduction in addition to compliance with existing 

regulatory requirements. The EPA is interested in the information to assess overall net reductions in toxicity or environmental releases and 

exposures, not the shifting of risks to other media (e.g., air to water) or nonenvironmental areas (e.g., occupational or consumer exposure). To the 

extent known, information about the technology being replaced will assist EPA in its relative risk determination. In addition, information on the 

relative cost or performance characteristics of the PMN substance to potential alternatives may be provided. 

Describe the expected net benefits, such as 

(1) an overall reduction in risk to human health or the environment; 

(2) a reduction in the generation of waste materials through recycling, source reduction or other means; 

(3) a reduction in the use of hazardous starting materials, reagents, or feedstocks; 

(4) a reduction in potential toxicity, human exposure and/or environmental release; or 

(5) the extent to which the new chemical substance may be a substitute for an existing substance that poses a greater overall risk to human 

health or the environment.

Information provided in this section will be taken into consideration during the review of this substance. See PMN Instructions Manual 

and Pollution Prevention Guidance manual for guidance and examples.

 Enter Attachment filename for Pollution Prevention Page 11.

PMN2011P11

Page 21

SANITIZED SUBMISSION
PMN Page 12

 EPA FORM 7710-25 (Rev. 6-09) Replaces previous editions of EPA Form 7710-25

Part III -- LIST OF ATTACHMENTS

Attach continuation sheets for sections of the form, test data and other data (including physical/chemical properties and 

structure/activity information), and optional information after this page. Clearly identify the attachment and the section of the form 

to which it relates, if appropriate. Number consecutively the pages of any paper attachments. In the Number of Pages column 

below, enter the inclusive page numbers of each attachment for paper submissions or enter the total number of pages for each 

attachment for electronic submissions. Electronic attachments can be identified by filename. 

Mark (X) the “Confidential” box next to any attachment name or filename you claim as confidential. Read the Instructions Manual

for guidance on how to claim any information in an attachment as confidential. You must include with the sanitized copy of the 

notice form a sanitized version of any attachment in which you claim information as confidential.

# Number 

of Pages 

Associated 

PMN Section 

Number 

CBI 

 

 

 Mark (X) this box if the data continues on the next page.

Attachment Name Attachment Filename 

PMN2011P12

001 CAS-IES Report-SAN 001 CAS-IES Report.PDF 1 Pt.I, Sec.B, 2c.

002 Structure and Reaction Chemistry 002 Structure and Reaction

Sequence-SAN.pdf

5 Pt.I, Sec.B, 2e.

003 Specta - SAN 003 11-19F and 1H NMR spectra

-SAN.pdf

2

004 MSDS Carrier Oil 004 - MSDS for Carrier Oil

blend.pdf

8

005 Flow Charts and Notes-Submitter Site-CBI 005 Flow Charts and NoteSubmitter Site- SAN.pdf12

006 Process Flow Charts and Notes -Other Sites -

CBI

006 Flow Charts and Note-Other

sites.pdf

6 Pt.2, Sec.B, 1a.

007 Product Overview 007 -

RainDance_RDT1000_Product_

2

008 Product Application Note 008 -

RainDance_appnote_Nov2008.p

4

009 Application Note - Rare Gene Variant 009 -Application Brief-Rare Gene

Variant.pdf

2

010 MSDS EA Surfactant 010 - EA Surfactant MSDS.pdf 8

011 011 PMN Cover Letter - SAN 011 - PMN Cover Letter -

SAN.pdf

3

Page 22

SANITIZED SUBMISSION
PMN2011P13

X

XXX X

XXX

XXX X

Page 23

SANITIZED SUBMISSION
ATTACHMENT HEADER SHEET

Attachment Number 001

Attachment Name

CAS-IES Report-SAN

Associated PMN Section Number

Pt.I, Sec.B, 2c.

Does not contain CBI

Report Number

PMNX110122164583146
ATTACHMENT HEADER SHEET

Attachment Number 002

Attachment Name

Structure and Reaction Chemistry

Associated PMN Section Number

Pt.I, Sec.B, 2e.

Does not contain CBI

Report Number

PMNX110122164583146
ATTACHMENT HEADER SHEET

Attachment Number 003

Attachment Name

Specta - SAN

Associated PMN Section Number

N/A

Does not contain CBI

Report Number

PMNX110122164583146
ATTACHMENT HEADER SHEET

Attachment Number 004

Attachment Name

MSDS Carrier Oil

Associated PMN Section Number

N/A

Does not contain CBI

Report Number

PMNX110122164583146
ATTACHMENT HEADER SHEET

Attachment Number 005

Attachment Name

Flow Charts and Notes-Submitter Site-CBI

Associated PMN Section Number

N/A

Does not contain CBI

Report Number

PMNX110122164583146
ATTACHMENT HEADER SHEET

Attachment Number 006

Attachment Name

Process Flow Charts and Notes -Other Sites - CBI

Associated PMN Section Number

Pt.2, Sec.B, 1a.

Does not contain CBI

Report Number

PMNX110122164583146
ATTACHMENT HEADER SHEET

Attachment Number 007

Attachment Name

Product Overview

Associated PMN Section Number

N/A

Does not contain CBI

Report Number

PMNX110122164583146
ATTACHMENT HEADER SHEET

Attachment Number 008

Attachment Name

Product Application Note

Associated PMN Section Number

N/A

Does not contain CBI

Report Number

PMNX110122164583146
ATTACHMENT HEADER SHEET

Attachment Number 009

Attachment Name

Application Note - Rare Gene Variant

Associated PMN Section Number

N/A

Does not contain CBI

Report Number

PMNX110122164583146
ATTACHMENT HEADER SHEET

Attachment Number 010

Attachment Name

MSDS EA Surfactant

Associated PMN Section Number

N/A

Does not contain CBI

Report Number

PMNX110122164583146
ATTACHMENT HEADER SHEET

Attachment Number 011

Attachment Name

011 PMN Cover Letter - SAN

Associated PMN Section Number

N/A

Does not contain CBI

Report Number

PMNX110122164583146