ICR Attachment 10: Screenshots from ePMN Software

Opening Screen

Create/Open choices

Screen Shots of the PMN Form
PMN Form - Instruction page

PMN Form - Page 1 continued

PMN Form - Certification page (PMN page 2)

PMN Form - General information page (PMN page 3)

PMN Form - Header page for ID pages (PMN pages 4, 5 and 6)

PMN Form - PMN page 4

PMN Form - PMN page 4a

PMN Form - PMN page 5

PMN Form - PMN page 5a

PMN Form - PMN page 6

PMN Form - PMN page 7

PMN Form - Header page for exposures/releases (PMN pages 8, 9 and 10)

PMN Form - PMN page 8

PMN Form - PMN page 9

PMN Form - PMN page 10

PMN Form - Optional Pollution Prevention (PMN page 11)

PMN Form - Attachments (PMN page 12)

PMN Form - Properties Worksheet (PMN page 13)

PMN Form - Cover letter (optional)

Screen Shots of the Support Form
Support form – Main page

Support form – Attachments section

Screen Shots of the NOC Form
NOC Form – Main page

NOC Form – CBI Substantiation form

NOC Form – Optional Cover letter form

Biotechnology form – Main page

Biotechnolgoy form – Attachments section

Biotechnology form Cover letter – optional

NON-CBI SUBMISSION

Cover Letter
Cover letter information goes here.

Page 1

NON-CBI SUBMISSION

PMN Page 1

PMN2009P1

U.S. ENVIRONMENTAL PROTECTION AGENCY

EPA
When
completed,
send this
form to:

Date of receipt:

PREMANUFACTURE
NOTICE
FOR NEW CHEMICAL SUBSTANCES

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

Total Number of Pages

AGENCY USE ONLY

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

Submission Report Number

User Fee Payment ID Number

TS Number

49
•
•
•

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)

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.

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.

Environmental fate data

Other Data

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.)
Test data not in the possession or control of the submitter

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.

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.

TYPE OF NOTICE (Check Only One)

X

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
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).
Mark (X) if any information in this notice is claimed as confidential.

EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 2

PMN2009P2

NON-CBI SUBMISSION

PMN Page 2

Public reporting burden for this collection of information is estimated to average 110 hours per response, including time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for
reducing this burden, to Director, Collection Strategies Division (2822), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., N.W.,
Washington, D.C. 20460; and to the Office of Management and Budget, Paperwork Reduction Act (2070-0012), Washington, D.C. 20503.

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.
Signature and title of
Authorized Official (Original
Signature Required)

Confidential

Date

EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 3

NON-CBI SUBMISSION

PMN Page 3

PMN2009P3

Part I -- GENERAL INFORMATION
Section A – SUBMITTER IDENTIFICATION
Mark (X) the "Confidential" box next to any subsection you claim as confidential

1a.

Confidential

Person Submitting Notice (in U.S.)

Name of Authorized Official

(first)

(last)

Position
Company
Mailing Address (number & street)
City

State

Postal Code

email

b.

Agent (if Applicable)

Name of Authorized Official

Confidential

(first)

(last)

Position
Company
Mailing Address (number & street)
City

State

Postal Code
Telephone
(include area code)

e-mail

c.

Joint Submitter (if applicable)

Confidential

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

(first)

(last)

Position
Company
Mailing Address (number & street)
City

State

Postal Code
Telephone
(include area code)

e-mail

2.

Technical Contact (in U.S.)

Name of Authorized Official

Confidential

(first)

(last)

Position
Company
Mailing Address (number & street)
City

State

Postal Code
Telephone
(include area code)

e-mail

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

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.
1.

Type of Notice – Mark (X)
Manufacture Only
Binding Option

2.

Import Only

3.

Binding Option

EPA FORM 7710-25 (Rev. 5-95)

Both

Replaces previous editions of EPA Form 7710-25.

Page 4

NON-CBI SUBMISSION

PMN Page 4

PMN2009P4

Part I – GENERAL INFORMATION -- Continued
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

Section B – CHEMICAL IDENTITY INFORMATION:

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.
1. Class 1 or 2 chemical substances (for definitions of class 1 and class
2 substances, see the Instructions Manual)

Class 1

Class 2

CBI

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
Method 2
IES Order
Identification report obtained from the CAS Inventory Expert
(Other
Number
Services must be submitted as an attachment to this notice)
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.

EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 5

PMN2009P4A

NON-CBI SUBMISSION

PMN Page 4a

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)

EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 6

PMN2009P5

PMN Page 5
Part I -- GENERAL INFORMATION – Continued

NON-CBI SUBMISSION

Section B -- CHEMICAL IDENTITY INFORMATION -- Continued
2. Polymers (For a definition of polymer, see the Instructions Manual.)
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.

Confidential

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

Other (Specify Below)

GPC
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.
Max
Typical Include in
Monomer or other reactant specific chemical name
CBI residual CBI
CBI composition identity
(1)
(6)
(4)
(3)
(7)
(5)
(2)

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.
EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 7

PMN2009P5A

PMN Page 5a

NON-CBI SUBMISSION

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
IES Order
Method 2
- a copy of the identification report obtained
Number
(other source)
from CAS Inventory Expert Service must be
submitted as an attachment to this notice)

CBI

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.
EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 8

PMN2009P6

PMN Page 6
Part I -- GENERAL INFORMATION -- Continued

NON-CBI SUBMISSION

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 %.
CAS Registry
Maximum
ConfiImpurity (a)
Number
Percent %
dential
(a)
(b)

Mark (X) this box if the data continues on the next page.
Enter Attachment filename for Part I, Section B, 3.
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.
CAS Registry Number
ConfiByproduct (1)
(2)
dential

Mark (X) this box if the data continues on the next page.
EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 9

NON-CBI SUBMISSION

PMN Page 7
Part I -- GENERAL INFORMATION -- Continued

PMN2009P7

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)

Binding Option
Mark (X)

Confidential

CBI

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

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
% in
Prod
Binding
Category of use (1)
(8)
CBI
FormCBI
uction
CBI
Option
CBI
(by function and application i.e. a dispersive dye for
ulation
%
Mark (X)
SiteConComBinding
finishing polyester fibers)
Industrial
limited
sumer*
mercial
Option
(9)
(7)
(5)
(2)
(6)
(4)
(3)

* 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
description

If you claim any category of use description in subsection 2a as confidential, enter a generic description of that category.
Read the Instruction Manual for examples of generic use descriptions.

CBI

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

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.
EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 10

NON-CBI SUBMISSION

PMN Page 8
Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE

PMN2009P8

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

Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER
1

The information on pages 8 and 8a refer to consolidated chemical number(s):

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

Use

Processing

Confidential

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

1. Batch

2. Continuous

Maximum kg/batch
(100% new chemical
substance)

Hours/batch

Batches/year

Maximum kg/day
(100% new chemical substance)

Hours/day

Days/year

Mark (X) to indicate your willingness to
have your process description binding.

d. Process description
(1)
(2)
(3)

Æ

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.).
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.).
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.

EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

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PMN2009P8A

PMN Page 8a

NON-CBI SUBMISSION

Confidential

Diagram of the major unit operation steps.

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

EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 12

NON-CBI SUBMISSION

PMN Page 9

PMN2009P9

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued
Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER -- Continued
1
2
3
4
The information on pages 9 and 9a refer to consolidated chemical number(s):

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
(i.e., bag dumping, filling
drums)
(1)

Protective Equipment/
CBI
(2)

Engineering Controls
(3)

Binding
Option
Mark (X)
(4)

Physical
form(s)
& % new
substance
(5)

Binding
Option
Mark (X)
(6)

# of
CBI Workers CBI
Exposed
(7)
(8)
(9)

Maximum Duration
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.

EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 13

NON-CBI SUBMISSION

PMN Page 9a

PMN2009P9A

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).
Release
Number
(1)

Amount of New
Substance Released
(2a)

(2b)

CBI

Medium of release
e.g. Stack air

(3)

(4)

Control technology and efficiency (you may wish to
optionally attach efficiency data)
(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.
EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 14

PMN2009P10

NON-CBI SUBMISSION

PMN Page 10

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE – Continued
Section B -- INDUSTRIAL SITES CONTROLLED BY OTHERS
1
2
3
4
The information on pages 10 and 10a refer to consolidated chemical number(s):

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

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

Confidential

Confidential

Enter Attachment filename for Part II, Section B on the bottom of page 10a.
EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 15

NON-CBI SUBMISSION

PMN Page 10a

PMN2009P10A

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

(1)

(2)

(3)

Release
Number

Duration of
Exposure
(4a)

(4b)

CBI

Protective Equip./Engineering Controls/Physical
Form

% new
substance

% in
Formulation

CBI

(5)

(6)

(6)

(7)

(8)

Amount of New Substance Released

(9)

(10a)

(10b)

CBI

Media of Release & Control Technology

CBI

(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.

EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 16

PMN2009P11

NON-CBI SUBMISSION

PMN Page 11

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.

EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 17

PMN2009P12

NON-CBI SUBMISSION

PMN Page 12
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.
#

001

Attachment Name

PMN attachment

Attachment Filename

blank page.doc

Number
of Pages

Associated
PMN Section
Number

CBI

30

Mark (X) this box if the data continues on the next page.
EPA FORM 7710-25 (Rev. 5-95)

Replaces previous editions of EPA Form 7710-25.

Page 18

NON-CBI SUBMISSION

PMN Page 13

PMN2009P13

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET
1
2
3
4
The information on this page refers to chemical number(s):

5

6

To assist EPA’s review of physical and chemical properties data, please complete the following worksheet for data you provide and include it in the
notice. Identify the property measured, the value of the property, the units in which the property is measured (as necessary), and whether or not the
property is claimed as confidential. Give the attachment number (found on page 12) in column (b). The physical state of the neat substance should be
provided. These measured properties should be for the neat (100% pure) chemical substance. Properties that are measured for mixtures or
formulations should be so noted (% PMN substance in __). You are not required to submit this worksheet; however, EPA strongly recommends that
you do so, as it will simplify the review and ensure that confidential information is properly protected. You should submit this worksheet as a
supplement to your submission of test data. This worksheet is not a substitute for submission of test data.
Property
(a)

Unit

Mark X if
Provided

Attachment
Number
(b)
(solid)

Physical state of neat substance
Vapor Pressure @
Temperature

°C

Measured
or Estimate
(M or E)

Value
(c)
(liquid)

(gas)

Torr

Density/relative density

g/cm3

Solubility
@ Temperature

°C

g/L

°C

g/L

Solvent
Solubility in Water @
Temperature
Melting Temperature
Boiling / Sublimation
temperature @

°C
Torr

°C

Spectra
Dissociation constant
Octanol / water partition coefficient
Henry’s Law constant
Volatilization from water
Volatilization from soil
pH@ concentration
Flammability
Explodability
Adsorption / Coefficient
Other – Specify

Other – Specify

Page 19

CBI
Mark (X)
(d)

ATTACHMENT HEADER SHEET

Attachment Number 001
Attachment Name
PMN attachment

Associated PMN Section Number
N/A

Does not contain CBI

Report Number

NON-CBI SUBMISSION
SUP2009P1

EPA Support Form
Mark (X) if anything is CBI

Support Form Report Number
I. ORIGINAL NOTICE SUBMISSION IDENTIFICATION
TS
Report Number
Number

Case
Number

Original Submission Date
Original Submission Media Type
II. ORIGINAL NOTICE SUBMITTER IDENTIFICATION
Authorized Official
Name

(first)

CBI
(last)

Position

Company Name

Mailing Address
(Number & Street)
City

State

e-mail

Postal Code
Telephone
(include area code)

III. CURRENT SUPPORT DOCUMENT IDENTIFICATION INFORMATION
(first)

Name

CBI

(last)

Position

Company Name

Mailing Address
(Number & Street)
City

State

Postal Code
Country

Province

Telephone
(include area code)

e-mail
IV. TYPE OF SUPPORT (Check One)

Letter of Support (Mark the certification statement checkbox below)
All information provided in this Letter of Support is complete and truthful
as of the date of the submission.

Withdrawal Request
Other Correspondence
TEST DATA (Health/Eco/Fate)
Amendment (Changes made to PMN pages 1-13, MSDS or Physical/Chemical
properties)
Check if requested by EPA/ contractor
EPA person/ contractor
Submitter Signature

NON-CBI SUBMISSION
SUP2009P2

V. TEXT / DESCRIPTION OF CHANGES

Insert Attachment

CBI

NON-CBI SUBMISSION
SUP2009P3

LIST OF ATTACHMENTS

#

001

Attachment Name

Support attachment

Attachment Filename

blank page.doc

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

Number
of Pages

2

Associated
Section
Number

CBI

NON-CBI SUBMISSION

ATTACHMENT HEADER SHEET

Attachment Number 001
Attachment Name
Support attachment

Associated PMN Section Number
N/A

Does not contain CBI

Report Number

NON-CBI SUBMISSION

Cover Letter
NOC cover letter information goes here.

NON-CBI SUBMISSION
O.M.B. No. 2070-0012 Approval Expires 10/31/96

NOC2009P1

U.S. Environmental Protection Agency

EPA

Part I - SUBMITTER IDENTIFICATION
Manufacturer/
Importer
(in U.S.)

(first)

Report Number

NOTICE OF COMMENCEMENT OF
MANUFACTURE OR IMPORT (40CFR§720.102)
Document Control #:

Name of Authorized Official
(last)

Mailing Address (number and street)

Company Name

Technical
Contact
(first)
(in U.S.)

City

Name

State

CBI*

Zip

Telephone Number

(last)

Part II - Premanufacture Notice (PMN) "P" Case Number:
Part III - Check the appropriate box and provide the exact date of manufacture or importation:
First Commercial Manufacture**
Date:

First Commercial Importation***
Date:

**Date of commencement is the date of completion of non-exempt manufacture of the first amount (bath, drum, etc.)
***For importees, the date of commencement is the date that the new chemical substance clears U.S. customs.

Part IV - Manufacturing Plant Site(s) or Importing Site(s): (Importers, provide street address of destination)

Part V - Specific Chemical Identity: (For Consolidated submissions, each substance must have a separate NOC form with the specific
identity of each chemical substance.)

Part VI - Generic Chemical Name (if chemical identity is claimed CBI*):

Part VII - Substance Identity Confidentiality Status:
I wish to continue to claim the substance identity confidential and the substantiation to support this claim is attached. Failure to submit
the required substantiation in accordance with 40 CFR 720.85(b) will result in a waiver of your claim.
I previously claimed the substance identity as confidential and hereby relinquish that claim.
I did not claim the substance identity as confidential in my original PMN submission.
You must submit your completed notice no later than 30 calendar days after the first date of commercial manufacture/importation to the address
shown below:
U.S. Environmental Protection Agency
OPPT Document Control Office (7407M)
1200 Pennsylvania Ave., NW
Washington, D.C. 20460
ATTN: Notice of Commencement
Signature of authorized official
Note: CBI* - refers to the term "Confidential Business Information". Mark (X) in the box if the information is to be held Confidential.

EPA Form 7710-56 (8-95)

Date

NON-CBI SUBMISSION

NOC2009P2

CBI Substantiation
NOC CBI substantiation goes here.

NON-CBI SUBMISSION

Cover Letter
Cover letter information goes here.

NON-CBI SUBMISSION
BIO2009P1

EPA Biotech Form
Biotech Form Report Number

Mark (X) if anything is CBI

I. SUBMITTER IDENTIFICATION INFORMATION
First Name
Position
Mailing Address

CBI
Last Name
Company

(Number & Street)

City

State

e-mail

Postal Code
Telephone

(include area code)
Ia. JOINT SUBMITTER -- If you are submitting this notice as part of a joint submission, mark (X)

First Name
Position
Mailing Address

CBI

Last Name
Company

(Number & Street)

City

State

e-mail

Postal Code
Telephone

(include area code)

II. TECHNICAL CONTACT IDENTIFICATION INFORMATION
First Name
Position
Mailing Address

CBI

Last Name
Company

(Number & Street)

City

State

e-mail

Postal Code
Telephone

(include area code)

III. TYPE OF SUBMISSION (Check One)
MCAN (Microbial Commercial Activity Notice)
TERA (TSCA Experimental Release Application)
Tier I Exemption
Tier II Exemption
Biotech TME (Test Market Exemption)
IV. TEXT / COMMENTS

CBI

NON-CBI SUBMISSION
BIO2009P2

LIST OF ATTACHMENTS

#

001

Attachment Name

Biotech attachment

Attachment Filename

blank page.doc

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

Number
of Pages

50

Associated
Section
Number

CBI

NON-CBI SUBMISSION

ATTACHMENT HEADER SHEET

Attachment Number 001
Attachment Name
Biotech attachment

Associated PMN Section Number
N/A

Does not contain CBI

Report Number