CDX Section 5 Notices and Supports User Guide Secondary Support


Section 5 Notices and Supports
User Guide - Secondary Support

Environmental Protection Agency

Office of Pollution Prevention and Toxics

Delivery Order # GS00Q09BGD0022
Task Order# EP-G11H-00154
Project#TDD 9.21

Version 1.0
December 19, 2014

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Table of Contents

Table of Contents	i

List of Exhibits	iii

1	Introduction	1

2	System Requirements	2

2.1	Supported Browsers	2

2.2	Screen Resolution	2

3	Secondary Support Functions	3

3.1	Log into Section 5 Notices and Supports Application	4

3.2	Home Screen Navigation	5

3.3	Section 5 Notices and Supports Forms	7

3.4	Enter Passphrase Screen	10

3.5	Navigation Tree	10

3.6	Action Bar	17

3.7	Attach Documents	19

3.8	Search Substance Registry Services (SRS)	22

3.9	Add Facility	25

4	Edit Joint Premanufacture Notice (PMN) Form	28

4.1 Edit Joint/Letter of Support PMN	28

4.1.1	General Form Information	28

4.1.2	Agent Information	30

4.1.3	Technical Contact Information	35

4.1.4	Chemical Identification	38

4.1.5	Class 1 or 2 Chemical Substances	40

4.1.6	Class 2 Substances	45

4.1.7	Additional Chemical Information	48

4.1.8	Polymer Identification Information	53

4.1.9	Monomers and Other Reactants	57

4.1.10	Production Volume and Hazard/Safety Information	62

4.1.11	Use Information	65

4.1.12	Physical and Chemical Properties Worksheet	70

4.1.13	Physical and Chemical Properties Worksheet - Continued (Optional)	78

4.1.14	Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents	80

4.1.15	Site Information	84

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4.1.16	Sites Controlled By Others	85

4.1.17	Submitter Operation Information	87

4.1.18	Occupational Exposures	92

4.1.19	Environmental Releases	95

4.1.20	Industrial Sites Controlled By Others	100

4.1.21	Exposures/Releases	103

4.1.22	Byproduct Information	108

4.1.23	Optional Pollution Prevention	110

4.1.24	Additional Attachments	112

4.1.25	Attachment Summary	114

4.1.26	Optional Cover Letter	116

4.1.27	Upload XML	117

5	Edit Joint Biotechnology Form	119

5.1 Edit Joint/Letter of Support Biotechnology Form	119

5.1.1	General Form Information	119

5.1.2	Technical Contact Information	121

5.1.3	Optional Cover Letter	124

6	Edit Letter of Support Bona Fide Form	126

6.1 Edit Letter of Support Bona Fide Form	126

6.1.1	General Document Information	126

6.1.2	Primary Contact Information	128

6.1.3	Technical Contact Information	130

6.1.4	Chemical Identification Information	132

6.1.5	Class 1 or 2/Biotechnology Chemical Substance	134

6.1.6	Class 2/Biotechnology Substances	137

6.1.7	Polymer Identification Information	140

6.1.8	Monomers and Other Reactants	143

6.1.9	Use Information	146

6.1.10	Document Management	147

6.1.11	Optional Cover Letter	149

7	Preview	151

8	Validate	153

9	Resources	155

10	Appendix A	158

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List of Exhibits

Exhibit 3-1 Section 5 Notices and Supports User Roles Matrix	4

Exhibit 3-2 Chemical Information Submission System Screen	5

Exhibit 3-3: Section 5 Notices and Supports Home Screen	7

Exhibit 3-4: Section 5 Notices and Supports Forms Screen	9

Exhibit 3-5: Enter Passphrase Screen	10

Exhibit 3-6: Navigation Prompt	11

Exhibit 3-7: Premanufacture Notice Navigation Tree (Scroll 1)	13

Exhibit 3-8: Premanufacture Notice Navigation Tree (Scroll 2)	14

Exhibit 3-9: Premanufacture Notice Navigation Tree (Scroll 3)	15

Exhibit 3-10: Biotechnology Navigation Tree	16

Exhibit 3-11: Bona Fide Navigation Tree (Polymer)	16

Exhibit 3-12: Bona Fide Navigation Tree (Class 1 or 2 Chemical)	17

Exhibit 3-13: Action Bar-Validate	18

Exhibit 3-14: Action Bar - Save	18

Exhibit 3-15: Action Bar - Preview	18

Exhibit 3-16: Action Bar - Help Links	19

Exhibit 3-17: Attach Documents Pop-Up Window	21

Exhibit 3-18: Search Substance Registry Services Pop-Up Window	23

Exhibit 3-19: Chemical Not Found In Substance Registry Services Pop-Up Window	25

Exhibit 3-20: Add Facility Pop-Up Window	27

Exhibit 4-1: General Form Information Screen (Scroll 1)	30

Exhibit 4-2: Agent Information Screen	32

Exhibit 4-3: Add Agent Pop-Up Window	34

Exhibit 4-4: Technical Contact Information Screen	36

Exhibit 4-5: Add Technical Contact Pop-Up Window	38

Exhibit 4-6: Chemical Identification Screen	40

Exhibit 4-7: Class 1 or 2 Chemical Substances Screen (Scroll 1)	44

Exhibit 4-8: Class 1 or 2 Chemical Substances Screen (Scroll 2)	45

Exhibit 4-9: Class 2 Substances Screen (Scroll 1)	47

Exhibit 4-10: Class 2 Substances Screen (Scroll 2)	48

Exhibit 4-11: Additional Chemical Information Screen (Scroll 1)	52

Exhibit 4-12: Additional Chemical Information Screen (Scroll 2)	53

Exhibit 4-13: Polymer Identification Information Screen (Scroll 1)	56

Exhibit 4-14: Polymer Identification Information Screen (Scroll 2)	57

Exhibit 4-15: Monomers and Other Reactants Screen (Scroll 1)	61

Exhibit 4-16: Monomers and Other Reactants Screen (Scroll 2)	62

Exhibit 4-17: Production Volume and Hazard/Safety Information Screen	65

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Exhibit 4-18: Use Information Screen (Scroll 1)	69

Exhibit 4-19: Use Information Screen (Scroll 2)	70

Exhibit 4-20: Physical and Chemical Properties Worksheet Screen (Scroll 1)	77

Exhibit 4-21: Physical and Chemical Properties Worksheet Screen (Scroll 2)	78

Exhibit 4-22: Physical and Chemical Properties Worksheet - Continued (Optional) Screen	80

Exhibit 4-23: Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents Pop-Up Window (Scroll 1)	82

Exhibit 4-24: Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents Pop-Up Window (Scroll 2)	83

Exhibit 4-25: Site Information Screen	85

Exhibit 4-26: Sites Controlled By Others Screen	87

Exhibit 4-27: Submitter Operation Information Screen (Scroll 1)	91

Exhibit 4-28: Submitter Operation Information Screen (Scroll 2)	92

Exhibit 4-29: Occupational Exposures Screen	95

Exhibit 4-30: Environmental Releases Screen (Scroll 1)	99

Exhibit 4-31: Environmental Releases Screen (Scroll 2)	100

Exhibit 4-32: Industrial Sites Controlled By Others Screen	103

Exhibit 4-33: Exposures/Releases Screen (Scroll 1)	106

Exhibit 4-34: Exposures/Releases Screen (Scroll 2)	108

Exhibit 4-35: Byproduct Information Screen	109

Exhibit 4-36: Optional Pollution Prevention Screen	112

Exhibit 4-37: Additional Attachments Screen	114

Exhibit 4-38: Attachment Summary Screen	115

Exhibit 4-39: Optional Cover Letter Screen	116

Exhibit 4-40: Upload XML Screen	118

Exhibit 5-1: General Form Information Screen (Joint Biotechnology)	121

Exhibit 5-2: Technical Contact Information Screen (Joint Biotechnology)	122

Exhibit 5-3: Add Technical Contact Pop-Up Window (Joint Biotechnology)	124

Exhibit 5-4: Optional Cover Letter Screen (Joint Biotechnology)	125

Exhibit 6-1: General Document Information Screen (Letter of Support Submission)	128

Exhibit 6-2: Primary Contact Information Screen	130

Exhibit 6-3: Technical Contact Information Screen	132

Exhibit 6-4: Chemical Identification Information Screen	134

Exhibit 6-5: Class 1 or 2/Biotechnology Chemical Substances Screen	137

Exhibit 6-6: Class 2/Biotechnology Substances Screen (Scroll 1)	139

Exhibit 6-7: Class 2/Biotechnology Substances Screen (Scroll 2)	140

Exhibit 6-8: Polymer Identification Information Screen	143

Exhibit 6-9: Monomers and Other Reactants Screen	146

Exhibit 6-10: Use Information Screen	147

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Exhibit 6-11: Document Management Screen	149

Exhibit 6-12: Optional Cover Letter Screen	150

Exhibit 7-1: Preview Biotechnology Form Screen	151

Exhibit 7-2 Preview Biotechnology Form PDF	152

Exhibit 8-1: Section 5 Notices and Supports Validation Pop-Up Window	154

Exhibit 9-1 Resources Screen (Scroll 1)	156

Exhibit 9-2 Resources Screen (Scroll 2)	157

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Revision Log

Date

Version
No.

Description

Author

Reviewer

Review
Date

09/20/13

0.01

Initial Draft of User Guide

C. Yeh
J. DeRosa

P. Saari

09/20/13

12/19/14

1.0

Final Section 5 Notices and Supports
Secondary AO User Guide

Incorporated OPPT comments given
on 11/07/2013

Incorporated Release 1.00
enhancements, other OPPT
comments

C. Yeh

J. Bronick

12/19/14

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1 Introduction

This document presents the user guide for the Office of Pollution Prevention and Toxics (OPPT)
Section 5 Notices and Supports Forms application submission process. This document is the user
guide for the Secondary Support user of the Section 5 Notices and Supports application.

The Section 5 Notices and Supports Forms application is the electronic, web-based tool provided
by the Environmental Protection Agency (EPA) for the submission of Section 5 Notices and
Supports data. As a Secondary Support, you can modify a Letter of Support or Joint Submission
for a Premanufacture Notice (PMN), Biotechnology, or a Letter of Support for a Bona Fide form
that a Secondary Authorized Official (AO) has assigned to you.

For questions concerning the Toxic Substances Control Act (TSCA) Section 5 Notices and
Supports software requirements, please contact the Central Data Exchange (CDX) Help Desk at
helpdesk@epacdx.net or call 1-888-890-1995 between the hours of 8 am - 6 pm Eastern
Standard Time (EST). For questions concerning the TSCA Section 5 Notices and Supports
reporting requirements, please contact the TSCA Hotline at TSCA-Hotline@epamail.epa.gov or
call 202-554-1404 between the hours of 8:30 am - 5:00 pm EST.

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2 System Requirements

To use the Section 5 Notices and Supports application to submit a Section 5 Notices and
Supports form, the following are required:

•	An e-mail account

•	JavaScript enabled web browser

•	Internet access

•	Adobe Acrobat Reader 5.0 or higher

•	CDX username and password

2.1	Supported Browsers

•	Internet Explorer (IE) 7 or above (Internet Explorer 8 or higher is recommended; issues found
using IE 7 will be resolved on a case-by-case basis during post-production and known issues
within IE 7 are identified within the appropriate sections of this guide)

-	Go to the following link to download:

-	http://windows.microsoft.com/en-US/internet-explorer/downloads/ie

•	Mozilla Firefox 3.0 or above

-	Go to the following link to download:

-	http://www.mozilla.com/en-US/firefox/all-older.html

•	Safari 4 or above

-	Go to the following link to download:

-	http://support. apple. com/kb/dl 8 77

•	Google Chrome

-	Go to the following link to download:

-	http://www.google.com/chrome

•	Opera

-	Go to the following link to download:

-	http://www.opera.com/download

2.2	Screen Resolution

•	Screen resolution should be set to 1024 x 768 or greater.

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3 Secondary Support Functions

This section describes how to:

• Access the application

• Navigate the Section 5 Notices and Supports 'Home' screen

• Edit the Section 5 Notices and Supports Letters of Support and Joint Submission for a PMN,
Biotechnology, or a Letter of Support for a Bona Fide form

• Upload an Extensible Markup Language (XML) file

The Secondary Support is designated by a Secondary Authorized Official (AO) to provide
supporting information on behalf of a company. A Secondary Support may either work on behalf
of a United States (U.S.)-based company or non-U.S. based company. Examples of a Secondary
Support may include, but are not limited to, a corporate on-site contact, a technical contact, a
paid employee of the company, an outside consultant for the company, or an authorized
representative agent for the company. Secondary Supports do not have the ability to sign the
certification statement required for a form, but they may enter or modify data for the form for
which they have access. The Secondary Support does not have access rights to create or submit a
joint PMN, Biotechnology, or Letter of Support for a Bona Fide form.

Once the Secondary AO creates a new form, the Secondary AO will provide the Secondary
Support with the passphrase to access the form and complete all sections of form. The Secondary
Support can edit a Joint Submission and/or Letter of Support created by the Secondary AO. The
Secondary Support is only allowed to access forms to which the Secondary AO has granted
access.

The system will allow the Secondary Support to save a form at any point during the data entry
process. The save functionality allows you to return to a form at any point in the future. After the
Secondary Support completes a form, the Secondary AO will access, review, and submit the
form to EPA via CDX.

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Exhibit 3-1 displays a table of the capabilities of user roles within the Section 5 Notices and
Supports application.

Exhibit 3-1 Section 5 Notices and Supports User Roles Matrix

Leoend

X=Can Perform Function

J
/



jr
~

j/

w

///
&

~
/

Non Agent/Non
Consultant

Agent/Consultant



Non Agent/Non
Consultant

Agent/ Consultant



US

non-US

US

non-US

US

non-US

US

non-US

US

non-US

us

non-US

Main forms (PMN, Biotechnology, Bona Fide
Or NOC)



Create all oriainal main forms

X

X

X

X

















Submit oriainal main forms

X























Submit amendments (by editing the main
forms}

X

X

X

X

















Unlock all main forms

X

X

X

X

















Edit unlocked main forms

X

X

X

X

X

X













Delete forms

X

X

X

X

















Assign Supports

X

X





















Support and ACM forms



Create Support and ACM forms

X

X

X

X

















Submit oriainal ACM and SuDDort forms

X

X

X

X

















Submit amendment for older cases and
other support forms

X

X

X

X

















Unlock support forms

X

X

X

X

















Edit unlocked supportforms

X

X

X

X

X

X













Delete forms

X

X

X

X

















Assign Supports

X

X





















LOS submissions



Create LOS for PMN. Biotechnology, or Bona
Fide













X

X

X

X





Submit original LOS for PMN. Biotechnology
or Bona Fide













X

X









Unlock LOS for PMN. Biotechnology or Bona
Fide













X

X

X

X





Edit unlocked LOS forms













X

X

X

X

X

X

Delete forms













X

X

X

X





Assign Supports













X

X









Joint submissions



Create Joint for PMN or Biotechnology













X

X

X

X





Submit original Joint for PMN or
Biotechnology













X











Submit amendments to Jointforms













X

X

X

X





Unlock Joint for PMN or Biotechnology













X

X

X

X





Edit Unlocked Joint forms













X

X

X

X

X

X

Delete forms













X

X

X

X





Assign Supports













X

X









3.1 Log into Section 5 Notices and Supports Application

After you create an account in CDX and click the 'Secondary Support' link for the Chemical
Safety and Pesticide Programs (CSPP) data flow, you will be taken to the 'Chemical Information
Submission System' screen.

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Exhibit 3-2 shows a screen capture of the 'Chemical Information Submission System' screen:
Exhibit 3-2 Chemical Information Submission System Screen



¦ Logged In as: Jane Doe, Secondary Support

Log Out

CHEMICAL INFORMATION SUBMISSION SYSTEM

TSCA Section 5 Notices and Supports - ePMN

Section 5 of TSCA, EPA's New Chemicals Program, helps manage the potential risk to human health and the environment
from chemicals prior to entry to the marketplace. Anyone who plans to manufacture or import a new chemical substance (i.e.
one not listed on the TSCA inventory) for a non-exempt commercial purpose is required by Section 5 of TSCA to provide EPA
with notice before initiating the activity. A Premanufacture Notice, or PMN, must be submitted at least 90 days prior to the
manufacture or import of the chemical. Additional notice types which use the PMN form are listed to reflect different
circumstances under which a chemical may be manufactured or imported such as Significant New Use Notices (SNUN), Low
Volume Exemptions (LVE), Test Market Exemption Applications (TMEA), and Low Volume and Low Release Exemptions
(LoREX). Biotechnology notice forms will be used to submit Microbial Commercial Activity Notices (MCAN), TSCA Experimental
Release Applications (TERA), Tier 1 Exemptions, Tier 2 Exemptions, and Biotechnology Test Market Exemption Applications
(Biotechnology TMEA). For a PMN or MCAN, the manufacturing or importing company must also notify EPA via a Notice of
Commencement within 30 days after the start of the first manufacture or import of the chemical for non-exempt commercial
purposes.

Please note: The public reporting and recordkeeping burden for this collection of information is estimated to average 93
hours per response for PMN, SNUN, LVE, and LOREX applications (TMEA is estimated to average 88 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. The public reporting and recordkeeping burden for this collection of
information is estimated to average 290 hours per response for MCAN applications and the NOC is estimated to average 0.8
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 (PMN) or Form 6300-14 (Biotechnology) or Form 7710-56 (NOC) to this address.

The software includes submission forms, embedded help files and a downloadable user manual to guide you through the
Section 5 Notices and Supports submission process. Click OK to complete a Section 5 Notices and Supports reporting form,
using the Section 5 Notices and Supports software. If you are not reporting on Section 5 Notices and Supports, please select
a different application in the drop-down menu.

Navigation: To access the Section 5 Notices and Supports 'Home' screen, select the submission
type of 'TSCA Section 5 Notices and Supports - ePMN' from the drop-down menu and click the
'OK' button.

3.2 Home Screen Navigation

You can access the Section 5 Notices and Supports 'Home' screen by selecting 'TSCA Section 5
Notices and Supports - ePMN' from the submission type drop-down menu on the 'Chemical
Information Submission System' screen and clicking the 'OK' button.

The Section 5 Notices and Supports 'Home' screen is the first screen within the Section 5
Notices and Supports application. It provides you with links and tabs to access the 'Section 5

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Notices and Supports Forms' and 'Resources' screens. To navigate to either of these screens,
click the screen link (highlighted in blue text), or click the screen tab (located within the
application header). The links and tabs provide the same functionality.

There is a ten (10) minute logout timer for this application; the application will automatically log
you out after ten minutes of inactivity and navigate you back to the CDX login screen.

•	Forms: Click the 'Forms' link or tab to navigate to the 'Section 5 Notices and Supports Forms'
screen. You can access a Section 5 Notices and Supports form using the 'Section 5 Notices and
Supports Forms' screen. For additional details about the 'Section 5 Notices and Supports
Forms' screen, please refer to Section 3.3.

•	Resources: Click the 'Resources' link or tab to navigate to the 'Resources' screen. You can
find the Section 5 Notices and Supports user guide, as well as useful links for guidance
documents on the 'Resources' screen. For additional details about the 'Resources' screen,
please refer to Section 9.

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Exhibit 3-3 shows a screen capture for the Section 5 Notices and Supports 'Home' screen:
Exhibit 3-3: Section 5 Notices arid Supports Home Screen

^^Forms^^

Logged in as: Jane Doe, Secondary Support

Log Out

HOME

Forms

The TSCA Section 5 Notices and Supports Reporting rule requires anyone who plans to manufacture or import a new
chemical substance (i.e. one not listed on the TSCA inventory) for a non-exempt commercial purpose is required by
section 5 of TSCA to provide EPA with notice before initiating the activity.

Use the following forms to report new chemicals to EPA: Premanufacture Notice form (EPA Form 7710-25) should be
used to submit PMNs, LVEs, SNUNs, LOREXs. TMEAs. Modifications for LVEs and LoREX submissions; Biotechnology
Notice form (EPA Form 6300-14) should be used to submit MCANs, TERAs, Tier 1 Exemptions. Tier 2 Exemptions,
and Biotechnology TMEAs: Notice of Commencement form (NOC, EPA Form 7710-56) should be used to submit
Notices of Commencement for PMNs and MCANs: ACM 40 CFR 721.30 form (TBD) should be used to report
proposed Alternative Control Measures for published SNURs; or Bona Fide Notice (TBD) for any requests to
determine if a chemical is on the TSCA inventory. The Support form is used to submit supplemental information for
Premanufacture and Biotechnology notices, such as Test Data. Correspondences, and Amendments to older
submissions.

To determine if a substance is on the TSCA inventory, and therefore excluded from the requirement to provide
premanufacturing notification, a submitter may submit a Bona Fide Intent to Manufacture notice ('Bona Fide Notice').

Resources

Displays links to helpful guidance documents and websites for TSCA and Section 5.

Support

A Support has the ability to modify any unlocked form that he/she Is assigned to by the Authorized Official.

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (888} B90-1995

Navigation: Click the 'Forms' link or tab to access the 'Section 5 Notices and Supports Forms'
screen.

3.3 Section 5 Notices and Supports Forms

You can access the 'Section 5 Notices and Supports Forms' screen by clicking the 'Forms' link
from the Section 5 Notices and Supports 'Home' screen, or by clicking the 'Forms' tab located
within the application header.

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Only one Section 5 Notices and Supports form is created per form alias. The form alias is created
by the AO to identify and differentiate forms. Each column within the table of the 'Section 5
Notices and Supports Forms' screen can be sorted by clicking the individual column headers.

Edit an 'In Progress' Form: To modify an existing Section 5 Notices and Supports form, click
the alias link for a form that has a status of 'In Progress.' You are required to enter the
passphrase created by the AO and associated with that particular form to access and edit the
form. Refer to Section 4.1 for further instructions on viewing and modifying a form that is 'In
Progress.'

The 'Section 5 Notices and Supports Forms' screen displays the following columns of
information:

• Alias: Displays the form alias provided on the 'General Information' screen of a Section 5
Notices and Supports form. The 'Alias' column will display a default alias comprised of a form
type, date stamp, and time stamp in the following format: if you accept the system-generated 'Form Alias' on the first screen in
a Section 5 Notices and Supports form. A form alias is helpful when a user or company has
multiple forms and/or when you must differentiate between forms.

• Type: Displays the form type pertaining to the reported chemical substance or mixture. This
column can contain the following values: 'Joint PMN,' 'Joint Biotechnology,' or 'Joint Bona
Fide.'

• Subtype: This value will not be populated.

• Case Number: Displays the form case number pertaining to the reported chemical substance
or mixture after EPA receives the submission. In all cases, the 'XX' represents the fiscal year
in which the form was submitted, and the 'XXXX' represents the order in which the form was
received. A consolidated submission will generate sequential case numbers for each chemical
identified within the form and will display all case numbers associated with that specific form.
If the form has not been submitted and received, the 'Case Number' field remains blank.

• Status: Displays the status of the Section 5 Notices and Supports form. The values will display
as 'In Progress' or 'Submitted.'

• Modify Date: Displays the date the submission was last modified.

• Submission Date: Displays the date when the form was submitted to EPA via CDX. This date
populates only after the form has been submitted.

• Export Options: Displays 'CSV,' 'Excel,' 'XML,' and 'PDF' links for you to export the
'Section 5 Notices and Supports Forms' screen in one of the specified formats as an Excel
spreadsheet, Comma-Separated Values (CSV), Extensible Markup Language, or Portable
Document Format (PDF). The export options section will not display until a form is created.

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Exhibit 3-4 shows a screen capture of the 'Section 5 Notices and Supports Forms' screen:
Exhibit 3-4: Section 5 Notices and Supports Forms Screen

Home J Forms y Resowces

SECTION 5 NOTICES AND SUPPORTS FORMS

To edit an In Progress form, click the form alias link in the Alias column in the table below.

A Logged in as: Jane Doe, Secondary Support

Log Out

4 items found.

Alias A

Joint Biotechnolo
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3.4 Enter Passphrase Screen

To edit a form click the 'Alias' link for a Section 5 Notices and Supports form with a status of
'In Progress' on the 'Section 5 Notices and Supports Forms' screen. The 'Enter Passphrase'
screen requires you to enter the passphrase that is associated with the form.

• Enter Passphrase: Enter the passphrase give to you by the Secondary AO that is associated
with the form.

Exhibit 3-5 shows a screen capture of the 'Enter Passphrase' screen:

Exhibit 3-5: Enter Passphrase Screen

A Logged in as: Jane Doe, Secondary Support

Log Out

ENTER PASSPHRASE

Please enter your form passphrase and click Next

Forgot Your Passphrase?

For security reasons, the system administrator does not have access to your passphrase and cannot retrieve it or reset it to a new one. If
you have forgotten your passphrase, you must complete a new Section 5 Notices and Supports Form and create a new passphrase for
the chemical substances you are intending to import or manufacture.

Navigation: Enter the passphrase that the Secondary AO originally created and associated with
the form and click the 'Next' button to navigate to the 'General Form Information' screen for a
'Joint PMN' or 'Joint Biotechnology' form, or the 'General Document Information' screen in a
'Joint Bona Fide' form.

3.5 Navigation Tree

The navigation tree is located on the left hand side of each screen. It allows you to navigate
between the various screens within the application and the different sections of the form. You
can perform the following functions using the navigation tree:

• Open and close the navigation tree: A navigation arrow that opens and closes the navigation
tree is located to the right of the navigation tree to provide more visual form space. Click the
arrow (*) on the open navigation tree to close the navigation tree and increase the space of the
form content. Likewise, click the arrow (~) on the closed navigation tree to open the
navigation tree.

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• Collapse and Expand folders: Each section of the form falls under a collapsible folder within
the navigation tree which allows you to save space or easily view items in the navigation tree.
When a folder is expanded, you can click the minus sign (-), the 'Folder' icon ( ), or the
folder title link to collapse that section of the navigation tree. When a folder is collapsed, you
can click the plus sign (+), the 'Folder' icon ( ), or the folder title link to expand that section
of the navigation tree. When you place your cursor over a folder title link, it will highlight in
red.

• Navigate between screens: You can use the navigation tree to navigate between the various
screens within the application and the different sections of the form. Each section of the form is
denoted with a 'Form' icon ( ). You can click a 'Form' icon ( ) or a section title link to
navigate between screens. You are required to save all information entered on a particular
screen before navigating to the next screen or all entered information will be lost. A prompt
will appear after you click a link in the navigation tree indicating, 'Are you sure you want to
leave the current page? Any unsaved changes will be lost.' If you click the 'OK' button, you
will be taken to the requested screen without saving any of the data in the previous screen. If
you click the 'Cancel' button, the prompt will close and you will not be taken to the requested
screen.

Exhibit 3-6 shows a screen capture of the navigation prompt window:

Exhibit 3-6: Navigation Prompt

Windows Internet Explorer

• Delete chemical folders: To delete specific chemical folders, a 'Delete' icon ( *) displays at
the bottom of each chemical folder within the navigation tree of a PMN form. When a
chemical folder is deleted, all information entered within the deleted chemical folder is lost and
cannot be retrieved. You can add a new chemical folder by clicking the 'Add Consolidated
Chemical' link, and filling in all corresponding data. This delete functionality is not applicable
to the Biotechnology or Bona Fide module within the Section 5 Notices and Supports
application.

• Copy chemical folders: To copy a specific chemical folder, click the 'Copy' icon ( ) that
displays at the bottom of each chemical folder within the navigation tree of a PMN form. When
a chemical folder is copied, the chemical name, Chemical Abstracts Service Registry Number
(CASRN), and attached documents are removed from the copied chemical. This copy
functionality is not applicable to the Biotechnology or Bona Fide module within the Section 5
Notices and Supports application.

• Delete 'Submitter Controlled Operations' or 'Operations Controlled By Others' folders:

Click the 'Delete' icon ( ¦¦*) that displays at the bottom of each 'Submitter Controlled

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Operations' or 'Operations Controlled by Others' folder within the navigation tree to delete a
specific operations folder. When a 'Submitter Controlled Operations' or 'Operations
Controlled By Others' folder is deleted, all information entered within the deleted operation is
lost and cannot be retrieved. You can add a new 'Submitter Controlled Operations' or
'Operation Controlled By Others' folder by clicking the 'Add Operation' link under the
appropriate folder and filling in all corresponding data. The delete functionality is not
applicable while a user is navigating on a screen within the 'Operations Controlled by Others'
folder. This delete functionality is not applicable to the Biotechnology or Bona Fide module
within the Section 5 Notices and Supports application.

• Upload XML: The system displays an 'Upload XML' button in the navigation tree to allow a
user to upload an XML file into a joint PMN form, or to export an existing joint PMN form
into an XML file format. A user may also upload eTSCA thick client files into a joint PMN
form. If an XML file is uploaded into an existing form, the contents of that XML file overwrite
the contents within the PMN form. For more information about the upload XML functionality,
refer to Section Error! Reference source not found..

• Please note that in IE 7, the scroll bar within the navigation bar may freeze or portions of the
bar may be missing which can prevent you from using the navigation tree. If the scroll bar
freezes, click the 'Previous' and 'Next' buttons on a page to navigate, or click other links
within the navigation tree to continue within the form.

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Exhibit 3-7 shows a screen captures of the 'Premanufacture Notice' navigation tree (Scroll 1):
Exhibit 3-7: Premanufacture Notice Navigation Tree (Scroll 1)

Premanufacture Notice ^

Secondary Support

General Form Information

Agent Information

Technical Contact Information

Chemicals

B jj; Chemical 2303

Chemical
Identification

" JjClass 1 or 2
Chemical
Substances

Class 2 Substances

Additional Chemical
Information

Production Volume
and Hazard/Safety
Information

nz\

Use Information

$ ^Physical 8
Chemical
Properties

Physical and
Chemical
Properties
Worksheet

Physical and
Chemical
Properties
Worksheet -
Continued
(Optional;)

^Remove

S 4Chemical 2304

Chemical
Identification

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Exhibit 3-7 shows a screen captures of the 'Premanufacture Notice' navigation tree (Scroll 2):
Exhibit 3-8: Premanufacture Notice Navigation Tree (Scroll 2)

Premanufacture Notice

Secondary Support

P ^Chemical Alias

= Chemical
Identification

[| Class 1! or 2
Chemical
Substances

Additional Chemical
Information

^Production Volume
and Hazard/Safety
Information

Use Information

P'fij Physical &
Chemical
Properties

gPhysical and
Chemical
Properties
Worksheet

Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

Copy

Add Consolidated
Chemical

P Site Information

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Exhibit 3-7 shows a screen captures of the 'Premanufacture Notice' navigation tree (Scroll 3):
Exhibit 3-9: Premanufacture Notice Navigation Tree (Scroll 3)

Premanufacture Notice ^

Secondary Support

i tt a

Add Consolidated

Chemical

5 Site Infoi motion

1 !¦¦¦¦ Submitter Controlled Site
l Information

j ^'Sites Controlled By Others

Submitter Controlled
Operations

~ [Hope, ation 1

Submitter Operation
l | ! Information

Occupational
i | ! Exposures

Environmental
| i i Releases

j I "JC Remove

'i-.^Add Operation

Operations Controlled by
Others

~ mOperation 1

Industrial Sites
j Controlled By

i ! j Others

I j " Exposures/Releases

; i ;¦"[= Byproduct
! | j Information

""'^Remove

"Lr[2}Add Operation

Optional Pollution Prevention

j"" Additional Attachments

rilAttachment Summary

:""|_=JOptional Cover Letter v

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Exhibit 3-10 shows a screen capture of the 'Biotechnology' navigation tree:

Exhibit 3-10: Biotechnology Navigation Tree

Biotechnology ^

Secondary Support

Joint Bioteclmology-
20130502-14:07:12 EDT
Genei »l Form Infoi motion

r"[S]Technical Contact Information
;—[3]optional Cover Letter

Exhibit 3-11 shows a screen capture of the 'Bona Fide' navigation tree (Polymer):
Exhibit 3-11: Bona Fide Navigation Tree (Polymer)

Bona Fide ^

Secondary Support

"5 General Document
li it oi motion

"5 Primary Contact Information

"2 Technical Contact Information

Chemical

l—plchemical Identification
i Information

- ,4 Chemical 2565

W|Polymer
Identification
Information

J[|Monomers and
Other Reactants

UlUse Information

^Document Management

^Optional Cover Letter

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Exhibit 3-12 shows a screen capture of the 'Bona Fide' navigation tree (Class 1 or 2 Chemical):
Exhibit 3-12: Bona Fide Navigation Tree (Class 1 or 2 Chemical)

Bona Fide ^

Secondary Support

l lplGeneral Document
lufoi motion

jfgPrimary Contact Information

Technical Contact Information

Chemical

j""[=|Chemical Identification
! Information

^Chemical 41510

j""[¥)ciass 1 or 2
Chemical
Substances

l"IS)ciass 2

! Substances
: "[p)Use Information
; "[|]Document Management
:""[?|Optional Cover Letter

3.6 Action Bar

The action bar is located at the bottom of the form section on each screen. You can perform the
following functions using the action bar:

• Validate: You can click the 'Validate' icon ( ) at any stage of completing a Section 5
Notices and Supports form. A 'Section 5 Notices and Supports Validation' pop-up window
generates when you click the 'Validate' icon ( ) if you disable the pop-up blocker within
your internet browser. The 'Section 5 Notices and Supports Validation' pop-up window
displays a report of all warning messages and validation errors. On screens that display an
expandable/collapsible field set, you must click the 'Save' button displayed within the
expandable/collapsible field set to save the information entered within the field set before the
'Validate' functionality initiates. Refer to Section 8 for more information on validating a form.

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The following exhibits, Exhibit 3-13, Exhibit 3-14, and Exhibit 3-15 show a screen captures for
the action bar:

Exhibit 3-13: Action Bar-Validate

Validate

Save

Preview

• Save: Click the 'Save' icon ( ) at any stage of completing a Section 5 Notices and Supports
form to save the form. To generate and access a links to other pages of the form within the
navigation tree, you must click the ' Save' icon ( ) within the action bar. After you click the
' Save' icon ( ), you will receive a prompt indicating that all data entered in the form has been
saved successfully. The save function does not validate any entered data. On screens that
display an expandable/collapsible field set, you must click the 'Save' button displayed within
the expandable/collapsible field set to save the information entered before being able to click
the 'Save' icon ( ) located within the action bar or use the 'Previous' and 'Next' buttons to
navigate to another page. Click the 'Previous' and 'Next' buttons on a form to save the data
entered within a form. Click the 'X' button in the upper right-hand corner of the form in your
browser to close the form without saving.

Exhibit 3-14: Action Bar - Save

Validate Save Preview

• Preview: Click the 'Preview' icon ( ) at any stage of completing a Section 5 Notices and
Supports form to preview the form. After you click the 'Preview' icon ( ), you will be given
the option to view a regular version of the PDF (the confidential business information (CBI)
version of the form or the non-CBI version if the form contains no CBI) or a sanitized version
of the PDF. Choosing either option will generate and display a watermarked PDF of the form
in a separate tab of your internet browser. Please note that attachment header sheets no longer
generate within the PDF.

Exhibit 3-15: Action Bar - Preview

Validate

Save

Preview

Please note that in IE 7, the action bar might align to the left or the right of the screen when
viewing certain sections of the form.

• Help Links: You can click the 'Help' links, located at the bottom of each screen, at any stage
of completing a Section 5 Notices and Supports form.

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- If you click the 'CDX Homepage' link, the application takes you to the CDX Homepage.

- If you click the 'MyCDX Homepage' link, the application takes you to the CDX Login
screen.

- If you click the 'EPA Homepage' link, the application takes you to the EPA Homepage.

- If you click the 'Terms and Conditions' link, the application takes you to the CDX Terms
and Conditions screen.

- If you click the 'Privacy Notice' link, the application takes you to the CDX Privacy and
Security Notice screen.

Exhibit 3-16 shows a screen capture of the action bar 'Help' links:

Exhibit 3-16: Action Bar - Help Links

3.7 Attach Documents

The 'Attach Document' button displays on various screens within a Section 5 Notices and
Supports form, and provides functionality for you to attach supporting documents where needed.
You can access the 'Attach Documents' pop-up window by clicking the 'Attach Document'
button displayed on a screen. You can attach a file and enter a description, number of pages, and
indicate CBI status. There is no limit on the size of the file that can be attached; however, the
application prevents a user from uploading an empty document.

The system allows you to claim an uploaded document as CBI. If you claim a document as CBI,
the system requires you to upload a sanitized version of the attached document. If you wish to
change a CBI attachment to be non-CBI by un-checking the 'CBI' checkbox, a warning appears
to notify you that un-checking the 'CBI' checkbox will delete the sanitized file. If you neglect to
populate a required field and click the 'OK' button, an error message will display to indicate the
missing field and the application will delete the previously attached file.

After you upload a document to be attached, the 'Attach Documents' pop-up window will close
and the document's information will display in a table format on the screen. Depending on the
screen, the attachment table may display the section of the page the file is associated with, the
file name and file extension of the document, a description of the document, the number of pages
in the document, and if the document was claimed CBI. The system allows you to delete
unwanted documents by clicking the 'Delete' icon ( *) located under the 'Actions' column. To
view, open, or edit previously attached documents, click the appropriate file name of the
document within the 'File Name' column of the document table to view previously entered
document information.

Please note that in IE 7, the 'Cancel' button within the 'Attach Documents' pop-up window
disappears and reappears when checking the 'CBI' checkbox.

• Type: Select the document type of the document that you upload. This drop-down menu
contains the following values: 'Aquatic Ecotoxicity,' 'Chemical Structure Diagram,' 'Fate,'
'GPC,' 'Genetic Toxicity,' 'Health Toxicity,' 'IES Report,' 'Safety Datasheet,' and 'Terrestrial
Ecotoxicity.' This is a required field.

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• Subtype: Select the subtype of the document that you upload. This drop-down menu contains
the following values, which are grouped under specific document types: 'Partitioning (e.g.,
Koc, Kd, Kow, Koa, Henry's law constant),' 'Hydrolysis,' 'Fugacity,' 'Photolysis,'

'Monitoring data (e.g. air, water, soil, biota, human),' 'Biodegradation,' 'Bioconcentration
Factors/Bioaccumulation Factors (BCF/BAF),' 'Material Safety Data Sheet/Safety Data Sheet
(MSDS/SDS),' 'Technical Datasheet,' 'Eye Irritation,' 'Combined Repeated-
Dose/Developmental/Reproductive Toxicity,' 'Sensitization,' 'Carcinogenicity,' 'Repeated-
Dose Toxicity,' 'Neurotoxicity,' 'Acute Toxicity,' 'Developmental Toxicity,'
'Pharmacokinetics/Metabolism,' 'Dermal Irritation,' 'Reproductive Toxicity,' 'Fish Chronic
Toxicity,' 'Invertebrate Acute Toxicity,' 'Invertebrate Chronic Toxicity,' 'Algae Toxicity,'
'Fish Acute Toxicity,' 'Chromosomal Aberrations Assay,' 'Unscheduled DNA Synthesis,'
'Genetic Mutation Assay,' 'Plant Toxicity,' 'Invertebrate Toxicity,' 'Avian Toxicity,' and
'Other.' This is a required field when displayed.

• Attachment: Click the 'Browse' button to generate the 'File Upload' window to search for a
document on your hard drive. The application prevents the upload of empty documents. The
attached file can be one of the following file types: .pdf, .ppt, .pptx, .xls, .xlsx, .doc, .docx, .rtf,
.txt, .gif, .jpg, .png, .bpm, .fas, .gbk, or .embl.

• Description: Enter a description associated with the attached document. Submitters should not
include any CBI information in the document description. This is a required field.

• Number of Pages: Enter the number of pages in a document. This is a required field.

• Check to claim the attachment as CBI: Check the 'CBI' checkbox to claim the attached
document as confidential. Un-checking the 'CBI' checkbox for a CBI document generates a
warning notifying you that un-checking the CBI claim will delete the sanitized file.

• Sanitized Attachment: Click the 'Browse' button to generate the 'File Upload' window to
search for a document on your hard drive. The attached file can be one of the following file
types: .pdf, .ppt, .pptx, .xls, .xlsx, .doc, .docx, .rtf, .txt, .gif, .jpg, .png, .bpm, .fas, .gbk, or
.embl. For any attached document claimed as CBI, you will be required to attach a sanitized
version of the document.

• Cancel: Click the 'Cancel' button to cancel the attach document process.

• OK: Click the 'OK' button to attach and link the document uploaded on the 'Attach
Documents' window to the form. If a field is missing, a warning message will display notifying
you that all attachments must be re-attached and the missing field must be populated.

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Exhibit 3-17 shows a screen capture of the 'Attach Documents' pop-up window:
Exhibit 3-17: Attach Documents Pop-Up Window

ATTACH DOCUMENTS

Type and Subtype Type:

Select the type and subtype A^atlc Ecotoxicity

of the attachment

Subtype:

Attachment

Select the file to attach

File:

Browse

Description

Provide a description of the
attachment

**Piease do not inciude any
CBi information in the
description of trie ftie
infdm ation.

Number of Pages

pages

CBI

Check to claim the attachment as CBI 0

Sanitized Attachment Fi|e
Select the sanitized file to

attach

Browse

Attachments containing CBI data require a sanitized copy of the attachment
not containing any CBI data.

Cancel

Navigation: Click the 'Cancel' button or 'X' icon in the upper right-hand corner to cancel the
document attachment process. Click the 'OK' button to attach the document to the form and
navigate back to the original screen from which the document attachment process was initiated.

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3.8 Search Substance Registry Services (SRS)

The 'Search SRS' button displays on various screens within a Section 5 Notices and Supports
form to identify chemicals that may be stored in SRS.

Search SRS: Click the 'Search SRS' button to generate the 'Search Substance Registry
Services' window. You can search for the reported chemical(s) by either the 'Chemical Abstracts
Service Registry Number (CASRN)' or 'CA Index Name or Other Synonym.' The application
also offers the option of entering user-specified chemical information by clicking the 'Create
New Chemical' button. Click the 'Create New Chemical' button to generate the 'Chemical Not
Found In Substance Registry Services' window and enter chemical information by filling in the
'Chemical Name' and 'CASRN' (if desired) field under the manual entry field set.

The system allows you to enter each chemical by clicking the 'OK' button located at the bottom
of the 'Search SRS' window. Once you enter all known chemical information and click the 'OK'
button, the chemical information saves and populates into the chemical description table. The
'Actions' column of the chemical table allows you to delete chemicals that have been added.

The Section 5 Notices and Supports application contains functionality to prevent a user from
adding duplicate chemicals within a multi-component submission. Chemicals are checked in the
following order:

• If both chemicals have CASRNs, they will be compared.

• If only one chemical has a CASRN, they will not be compared and are considered different.

• If neither chemicals have CASRNs, their chemical names will be compared.

An error message generates within the expandable/collapsible field set if a user attempts to add a
duplicate chemical within a multi-component submission.

Please note in IE 7, the CSPP logo might be misaligned in the 'Search Substance Registry
Services' window.

• CASRN: Enter the chemical abstracts service registry number of the chemical; this field
accommodates dashes. Either the 'CASRN' or 'CA Index Name or Other Synonym' field is
required when searching SRS.

• CA Index Name or Other Synonym: Enter the chemical abstract '(CA) Index Name or Other
Synonym' of the chemical. This field displays the following options: 'Matches Exactly,'
'Contains,' and 'Begins With.' Either the 'CASRN' or 'CA Index Name or Other Synonym'
field is required when searching SRS.

• Search SRS: Click the 'Search SRS' button to initiate the database search for the 'CASRN' or
'CA Index Name or Other Synonym' for the desired chemical.

• Create New Chemical: Click the 'Create New Chemical' button to generate the 'Chemical
Not Found In Substance Registry Services' pop-up window.

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Exhibit 3-18 shows a screen capture of the 'Search Substance Registry Services' pop-up
window:

Exhibit 3-18: Search Substance Registry Services Pop-Up Window

(^CSPP

SEARCH SUBSTANCE REGISTRY SERVICES «

Enter the specific or partial, currently correct Chemical Abstracts (CA) Index name or a Chemical Abstract Services
Registry Number (CASRN). Click Search SRS and select the appropriate CA Index name/ CASRN combination from

EPA's Substance Registry Services (SRS)

Please search by CASRN or CA Index Name

1. CASRN: Matches exactly

2. CA Index Name or Other Synonym

Matches Exactly ~

Search SRS

Create New Chemical

Navigation: Click the 'Search' button on the 'Search Substance Registry Services' window to
initiate the database search for the CASRN or CA Index Name or Other Synonym. After SRS
returns results, select the chemical, click the 'OK' button on the 'Search SRS' window, close the

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'Search Substance Registry Services' window, and navigate back to the screen from which the

SRS search was initiated where the chemical information will be populated.

If the chemical is not found in the 'Search Substance Registry Services' window, click the

'Create New Chemical' button to generate the 'Chemical Not Found In Substance Registry

Services' pop-up window.

• CBI: Check the 'CBI' checkbox to claim the entered chemical as confidential. The 'CBI'
checkbox will not be displayed on the 'Chemical Not Found In Substance Registry Services'
window for the 'Class 1 or 2 Chemical Substances,' 'Polymer Identification Information,' or
the 'Monomers and Other Reactants' screen.

• Chemical Name: Enter the chemical name. This is a required field.

• CASRN: Enter the manually entered CASRN, if available.

• Maximum Percent: Enter the maximum percentage for the impurity. This field is displayed
only in the 'Chemical Not Found In Substance Registry Services' window on the 'Additional
Chemical Information' screen.

• Cancel: Click the 'Cancel' button to navigate back to the 'Search Substance Registry Services'
window.

• OK: Click the 'OK' button to enter the manually entered chemical information into the fields
on the screen from which the SRS search was initiated.

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Exhibit 3-19 shows a screen capture of the 'Chemical Not Found In Substance Registry Services'
pop-up window:

Exhibit 3-19: Chemical Not Found In Substance Registry Services Pop-Up Window

c^cspp

CHEMICAL NOT FOUND IN SUBSTANCE REGISTRY SERVICES®

Complete all known chemical substance information in the below fields. Click the 'OK' button when all known chemical

substance information has been fulf lied.

If you need to go back to the Search SRS screen, please click 'Cancel'.

Chemical ID

CBI: ~

Chemical Name:

CASRN:

Maximum Percent:

Navigation: Click the 'OK' button to save the manually entered chemical information and
navigate back to the screen from which the SRS search was initiated where the chemical
information will be populated. Click the 'Cancel' button to navigate back to the 'Search SRS'
pop-up window. Click the 'X' located in the upper right corner to close the pop-up window and
navigate back to the screen from which the SRS search was initiated.

3.9 Add Facility

The 'Add Facility' button displays on the 'Submitter Operation Information' screen and the
'Industrial Sites Controlled By Others' screen within a PIY1N form. This button also displays on
the 'Site Information' screen within a NOC form and the 'Submitter Site Identification' screen

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within a Bona Fide form. The 'Add Facility' button is used to generate the 'Add Facility' pop-up
window and select the applicable sites for which you will be reporting. The 'Add Facility' drop-
down menu contains the sites that all AO users within the same organization are registered for
within CDX registration; additional facilities can be added within CDX to further populate this
drop-down menu.

If you are not registered to any facilities within CDX registration, or you have finished
identifying all possible sites, a message displays within a pop-up window notifying you to add
additional sites within your CDX registration profile to add additional sites to a form.

Click the 'Add Facility' button to generate the 'Add Facility' pop-up window which displays the
following fields: 'Select a site from the drop-down menu below,' 'CBI,' 'Alias,' 'EPA Registry
ID,' 'Facility Name,' 'Facility Address,' 'City,' 'State,' and 'Postal Code.' Each individual site
may be claimed as CBI.

• Select a site from the drop-down menu below: Select a single or multiple sites from the
drop-down menu that you will be reporting on.

• CBI: Check the 'CBI' checkbox to claim the facility information as confidential.

• Alias: Enter the site alias. This is a required field if a Joint Submission or Letter of Support is
pending for the form.

• EPA Registry ID: Displays the EPA registry ID of the site selected from the drop-down menu.

• Facility Name: Displays the name of the site selected from the drop-down menu.

• Facility Address: Displays the address of the site selected from the drop-down menu.

• City: Displays the city of the site selected from the drop-down menu.

• State: Displays the state of the site selected from the drop-down menu.

• Postal Code: Displays the postal code of the site selected from the drop-down menu.

• Add Facility: Click the button to add the selected site to the main page from which you are
initiating the search.

• Cancel: Click the button to cancel the process of adding a site.

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Exhibit 3-20 shows a screen capture of the 'Add Facility' pop-up window:

Exhibit 3-20: Add Facility Pop-Up Window

CSPP

ADD FACILITY

Select a site from the drop-down menu below.

Alias:

EPA Registry ID:
Facility Name:
Facility Address:
City:

State:

Postal Code:

Add Facility

Cancel

Navigation: Click the 'Add Facility' button to add the selected site to the screen from which you
initiated the site identification process.

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4 Edit Joint Premanufacture Notice (PMN) Form

Anyone who plans to manufacture or import a new chemical substance for a non-exempt
commercial purpose is required by Section 5 of TSCA to provide EPA with notice before
initiating the activity, known as a PMN form. A PMN must be submitted at least ninety (90) days
prior to the manufacture or import of the chemical.

4.1 Edit Joint/Letter of Support PMN

To edit a Joint PMN or Letter of Support, navigate to the 'Section 5 Notices and Supports
Forms' screen and click the alias link in the 'Alias' column of a form with a status of 'In
Progress.' Refer to Section 3.3 for additional details regarding the 'Section 5 Notices and
Supports Forms' screen.

Refer to Section 0 for additional details regarding the enter passphrase process.
4.1.1 General Form Information

You can navigate to the 'General Form Information' screen by accessing a Section 5 Notices and
Supports form that is 'In Progress' and entering the passphrase associated with the selected form.

The 'General Form Information' screen provides fields to input identifying information for a
form. You will have the option to assign a 'Form Alias' to identify the form. A unique form alias
is helpful when a user or company has multiple forms and/or when you must differentiate
between forms to the help desk. Upon navigating to the 'General Form Information' screen, the
system auto-generates a default alias comprised of a form type, date stamp and time stamp in the
following format: .

The 'PMN Identification' section provides fields for you to enter information regarding other
communications with EPA by entering a 'TS Number' and 'Payment ID.' The TS number is
determined by a company and is used to identify the form for both payment and to connect
related submissions when additional communications (Letters of Support, Joint Submissions, and
corrections) are sent before a PMN/LVE case number has been assigned. The TS number can be
any six (6) character alphanumeric combination. The TS number should include two (2), three
(3), or four (4) letters. Company names, recognizable words, and numeric series are not
recommended. A unique identification number for the form will generate later if a Letter of
Support or Joint Submission is being filed.

The 'Test Data' section provides checkboxes to identify data that is included in the type of notice
you selected from the 'Type of Notice' drop-down menu. The following values will display as
checkboxes: 'Environmental fate data,' 'Health effects data,' 'Environmental effects data,'
'Physical/Chemical properties,' 'Risk assessments,' 'Structure/Activity relationships,' 'Test data
not in the possession or control of the submitter,' 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 the data is 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. In addition, the chemical composition of
the tested material should be characterized. Data should be submitted according to the

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requirements of §720.50 of the Premanufacture Notification Rule (40 Code of Federal

Regulations (CFR) Part 720).

• Form Alias: Edit the form alias. Upon navigating to the screen, the screen will have auto-
generated an editable form alias for the AO in the following format: . This is a required field.

• TS Number: Enter the TS number related to the PMN form; this field accepts any six (6)
character alphanumeric combination. It is used by the financial institution that receives
payment for EPA when it notifies the Agency that the fee has been received. The TS number
should include two (2), three (3), or four (4) letters. Company names, recognizable words, and
numeric series are not recommended. TS numbers should be unique to the submission and
should not be reused in subsequent submissions. This field is required if 'Premanufacture
(PMN)' or 'Significant New Use Notice (SNUN)' is selected from the 'Type of Notice' drop-
down menu.

• Environmental fate data: Check the 'Environmental fate data' checkbox to indicate that the
form contains environmental fate data.

• Health effects data: Check the 'Health effects data' checkbox to indicate that the form
contains health effects data.

• Environmental effects data: Check the 'Environmental effects data' checkbox to indicate that
the form contains environmental effects data.

• Physical/Chemical properties: Check the 'Physical/Chemical properties' checkbox to
indicate that the form contains physical/chemical properties data.

• Test data not in the possession or control of the submitter: Check the 'Test data not in the

possession or control of the submitter' checkbox to indicate that the form contains test data not
in the possession or control of the submitter.

• Risk assessments: Check the 'Risk assessments' checkbox to indicate that the form contains
risk assessments data.

• Structure/Activity relationships: Check the ' Structure/Activity relationships' checkbox to
indicate that the form contains structure-activity relationships (SAR) data.

• Other data: Check the 'Other data' checkbox to indicate that the form contains other types of
data.

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Exhibit 4-1 shows a screen capture of the 'General Form Information' screen (Scroll 1):
Exhibit 4-1: General Form Information Screen (Scroll 1)

Premanufacture Notice

Secondary Support

i""b General Form Information

j""h Agent Information

["{^Technical Contact Information

B" Chemicals

i B £¦. Class 1 or 2 Alias

I Alchemical

Identification

j-Qciass 1 or 2
Chemical
Substances

| " j Class 2 Substances

!""§ (Additional Chemical
Information

!'"(^ I Production Volume
and Hazard/Safety
i Information

!" 'jj jUse Information

Physical &

Chemical
Properties

'"[^Physical and
Chemical
Properties
Worksheet

| ! "'|j Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

:"X Remove

Polymer Alias

! r"l^Cheraicat

Identification

!'"'[§ 'Polymer
Identification
Information

rj = I Monomers and

Logged in as: Jane Doe, Secondary Support

Log Out

-< Premanufacture Notice (Joint PMN-20130606-16:35:18 EDT) > General Form Information

GENERAL FORM INFORMATION

This form must be submitted using a United States company or subsidiary with a United States
address.

The form alias is an optional field that changes the form name on the Forms Screen Its purpose is to
mate it easier to distinguish between multiple forms. If an alias is not selected, the field will default to the
date it was created The form alias may be changed at any time

Form Alias:

jjoint PMN-20130606-16:35:18 EDT

Please enter the TS Number and/or Payment ID (if applicable) that reference the specific form.
TS Number

Test Data

Select the Test Data that will be included in this notice-

Environmental fate data: [g

Health effects data" p

Environmental effects data: [g

Physical/Chemical properties: [p]
Test data not in the possession or control of the q
submitter:

Risk assessments:
Structure/Activity
relationships:
Other data:

~
~

V ¦

Validate Save

Preview

CDX Homepage |

I MyCDX Homepage |

| EPA Homepage | Terms and Conditions |

Privacy Notice I

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Agent Information' screen. You can also
access this screen by clicking the 'Agent Information' link within the navigation tree.

4.1.2

Agent Information

You can access the 'Agent Information' screen by clicking the 'Next' button from the 'General
Form Information' screen. You can also navigate to this screen by clicking the 'Agent
Information' link within the navigation tree.

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The 'Agent Information' screen provides fields for you to enter information regarding all parties
involved in representing the PMN form. The agent should be a person who can answer questions
about the form. The 'Agent Information' screen displays an 'Add Agent' button that generates
the 'Add Agent' pop-up window for you to input the contact information on behalf of whom the
submission is being made. You will be able to enter multiple agents; if the agent is the same
individual who is filling out the form, click the 'Copy CDX Registration' button to retrieve user
information entered during CDX registration. The system provides a checkbox for you to claim
entered contact information as confidential by checking the 'Check here to claim this
information as CBI' checkbox. Each agent will have an individual CBI claim. You will be able
to enter contact information for each agent, and click the 'OK' button, which will populate the
agent table located on the 'Agent Information' screen. Click the 'Delete' icon ( *£) located under
the 'Actions' column to delete agents. To edit agent information, click the agent name link
within the 'Last Name' column, which will generate the 'Add Agent' pop-up window with the
previously entered agent information.

• Add Agent: Click the 'Add Agent' button to generate the 'Add Agent' pop-up window to
enter information for multiple agents.

• Last Name: Displays the last name of the reported agent. Click the 'Last Name' link to
generate the 'Add Agent' pop-up window and edit the agent information.

• First Name: Displays the first name of the reported agent.

• Address: Displays the mailing address of the reported agent.

• CBI: Indicates the CBI status of the agent information by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete specific agents; a warning message displays to
confirm deletion of the agent information.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 4-2 shows a screen capture of the 'Agent Information' screen:

Exhibit 4-2: Agent Information Screen

Home y Forms y Resources

<5. Logged in as: Jane Doe, Secondary Support

Log Out

Premanufacture Notice
Secondary Support

^General Form Information

i ijjAgent Information

Technical Contact Information

r Chemicals

j B Chemical 2303

"L Chemical
Identification

~[ Class 1 or 2
Chemical
Substances
I ^jClass 2 Substances

Additional Chemical
Information

""[ Production Volume
and Hazard/Safety
Information

"i Use Information

S'Hfphysic.il 8
Chemical
Properties

: -fZ\ „

Physical and
Chemical
Properties
Worksheet
:" "I" Physical and
Chemical
Properties

4 Pierikinufactuie Notice (Joint PMN-20130502-14:09:03 EDT-LOS) > Agent Information

AGENT INFORMATION

To add a new Agent click the Add Agent button! iAdd Agent

jjAdd^||eirtJ

Last Name

First Name

Address

|^NextJ

CBI

Actions

f 1

Validate

Save

Preview

Navigation: Click the 'Add Agent' button to begin the process of adding agent information.
Click the 'Next' button to navigate to the 'Technical Contact Information' screen. You can also
access this screen by clicking the 'Technical Contact Information' link within the navigation
tree.

4.1.2.1 Add Agent

Click the 'Add Agent' button to generate the 'Add Agent' pop-up window. Enter agent
information into the fields displayed on the 'Add Agent' pop-up window. Click the 'Cancel'
button to stop populating agent information. Click the 'OK' button after entering agent
information to populate the information on the main 'Agent Information' screen.

The identification of an agent is optional.

• Copy CDX Registration: Click the 'Copy CDX Registration' button to display a prompt
confirming the import of CDX registration information and allow the system to populate the
agent information fields with your contact information provided during CDX registration

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• Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim agent information as confidential. If the 'CBI'
checkbox is checked before clicking the 'Copy CDX Registration' button, the 'CBI' checkbox
will become unchecked upon navigating back to the pop-up window after copying CDX
registration information. Check the 'CBI' checkbox after importing CDX registration
information to claim agent information as confidential.

• First Name: Enter the agent's first name. Click the 'Copy CDX Registration' button to
populate the fields with CDX registration information. This is a required field only if agent
information will be added to the form.

• Last Name: Enter the agent's last name. Click the 'Copy CDX Registration' button to
populate the fields with CDX registration information. This is a required field only if agent
information will be added to the form.

• Position: Enter the agent's job title.

• Company Name: Enter the agent's company name. Click the 'Copy CDX Registration' button
to populate the fields with CDX registration information. This is a required field only if agent
information will be added to the form.

• Phone Number: Enter the agent's daytime phone number: U.S. or international. This field
does not allow dashes. Click the 'Copy CDX Registration' button to populate the fields with
CDX registration information. This is a required field only if agent information will be added
to the form.

• Phone Extension: Enter the agent's daytime phone number extension. Click the 'Copy CDX
Registration' button to populate the fields with CDX registration information.

• Email Address: Enter the agent's email address. The email address must follow the standard
email address format: John.Doe@abc.com. Click the 'Copy CDX Registration' button to
populate the fields with CDX registration information.

• Mailing Address 1: Enter the first line of the agent's mailing address. Click the 'Copy CDX
Registration' button to populate the fields with CDX registration information. This is a
required field only if agent information will be added to the form.

• Mailing Address 2: Enter the second line of the agent's mailing address. Click the 'Copy
CDX Registration' button to populate the fields with CDX registration information.

• City: Enter the city of the agent's mailing address. Click the 'Copy CDX Registration' button
to populate the fields with CDX registration information. This is a required field only if agent
information will be added to the form.

• State: Select the state of the agent's mailing address from the drop-down menu. Click the
'Copy CDX Registration' button to populate the fields with CDX registration information. This
is a required field only if agent information will be added to the form and if the 'Country' field
is set to 'United States.' This field is disabled if a non-US country is selected from the
'Country' drop-down menu.

• Postal Code: Enter the postal code of the agent's mailing address. Click the 'Copy CDX
Registration' button to populate the fields with CDX registration information. This is a
required field only if agent information will be added to the form and if the 'Country' field is
set to 'United States.'

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• Country: Select the country of the agent's mailing address from the drop-down menu. Click
the 'Copy CDX Registration' button to populate the fields with CDX registration information.
This field is automatically set to 'United States' if a value is selected from the 'State' drop-
down menu. This is a required field only if agent information will be added to the form.

Exhibit 4-3 shows a screen capture of the 'Add Agent' pop-up window:

Exhibit 4-3: Add Agent Pop-Up Window

& CSPP

ADD AGENT

Please enter the information for the agents who will be responsible for supporting the information on the
form. Check to claim information as CBI or click the 'Copy CDX Registration' button to populate from CDX
(if applicable).

Click here to copy your information from CDX Registration Copy cdx Registration
Check here to claim this information as CBI

First Name:

Last Name:

Position:

Company Name
Phone Number:

(Do not enter any dashes (-) in Phone Number field above.)

Phone Extension:

Email Address:

Mailing Address 1:

Street address, P.O. box, company name, etc.

Mailing Address 2

City:

State:

Postal Code
Country:

Apartment, suite, etc.

Navigation: Click the 'Cancel' button or the 'X' icon in the upper right-hand corner to stop
populating agent information and navigate back to the 'Agent Information' screen. Click the
'OK' button to populate the entered agent information and navigate back to the 'Agent
Information' screen.

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4.1.3 Technical Contact Information

You can access the 'Technical Contact Information' screen by clicking the 'Next' button from
the 'Agent Information' screen. You can also access this screen by clicking the 'Technical
Contact Information' link within the navigation tree.

The technical contact should be able to answer, or obtain answers to, questions related to the
chemical submitted to EPA within the joint PMN form or Letter of Support. The technical
contact does not have to physically work at the site reported on the form, but must be readily
available by phone or email. It is required to identify at least one technical contact.

The system provides functionality to enter multiple technical contacts. If the contact is the same
person who is filling out the form, the system presents a 'Copy CDX Registration' button for you
to retrieve your user information from CDX. You will enter the contact information for each
technical contact within the 'Add Technical Contact' window and click the 'OK' button at the
bottom of the window, which will populate the technical contacts table located on the 'Technical
Contact Information' screen. Click the 'Delete' icon ( *) located under the 'Actions' column to
delete a technical contact. Click the technical contact name within the 'Last Name' column to
edit technical contact information.

• Add Technical Contact: Click the 'Add Technical Contact' button to generate the 'Add
Technical Contact' pop-up window, which provides fields for you to enter technical contact
information.

• Last Name: Displays the last name of the reported technical contact. Click the 'Last Name'
link to generate the 'Add Technical Contact' pop-up window that contains previously
identified technical contact information to edit the technical contact information.

• First Name: Displays the first name of the reported technical contact.

• Address: Displays the address of the reported technical contact.

• CBI: Indicates the CBI status of the technical contact information by displaying either a ' Y' or

an 'N'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete specific technical contacts. A pop-up generates
to confirm the deletion of the technical contact information.

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Exhibit 4-4 shows a screen capture of the 'Technical Contact Information' screen:
Exhibit 4-4: Technical Contact Information Screen

Home J Forms y Resouices

*• Logged in as: Jane Doe, Secondary Support

Log Out

Premanufacture Notice
Secondary Support

'^General Form Information
'L5jAgent information
Technical Contact
Information

Chemicals

$ AChemical 2303

Chemical
Identification

"¦(5iClass 1 or 2
Chemical
Substances

Class 2 Substances
i' '2 Additional Chemical
Information

'2 Production Volume
and Hazard/Safety
Information

"'[^lUse information
$ ^Physical 8
Chemical
Properties

i \ nry-

j""| Physical and
I ] Chemical
| i Properties
Worksheet

4 Pi emannfactiire Notice (Joint PMN-20130502-14:09:03 EDT) > Technical Contact Information

TECHNICAL CONTACT INFORMATION

IPhysical and
Chemical

To add a new Technical Contact click the Add Technical Contact button liAdil Technical Contact

Last Name

First Name

Address

| Next |

CBI

Actions

f [

Validate

Save

Preview

Navigation: Click the 'Add Technical Contact' button to begin the process of adding technical
contact information. Click the 'Next' button to navigate to the 'Chemical Identification' screen.
You can also access this screen by clicking the 'Add Consolidated Chemical' link within the
navigation tree.

4.1.3.1 Add Technical Contact

Click the 'Add Technical Contact' button to generate the 'Add Technical Contact' pop-up
window. Enter technical contact information into the fields displayed on the 'Add Technical
Contact' pop-up window. Click the 'Cancel' button to stop populating technical contact
information. Click the 'OK' button to populate the entered technical contact information on the
'Technical Contact Information' screen.

• Copy CDX Registration: Click the 'Copy CDX Registration' button to populate the fields
with your contact information provided during CDX registration. A prompt will display
confirming the import of CDX registration information.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014

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• Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim the technical contact information as confidential. If the
'CBI' checkbox is checked before clicking the 'Copy CDX Registration' button, the 'CBI'
checkbox will become unchecked upon navigating back to the pop-up window after copying
CDX registration information. To claim a technical contact as confidential, check the 'CBI'
checkbox after importing CDX registration information.

• First Name: Enter the technical contact's first name. Click the 'Copy CDX Registration'
button to populate the fields with CDX registration information. This is a required field.

• Last Name: Enter the technical contact's last name. Click the 'Copy CDX Registration' button
to populate the fields with CDX registration information. This is a required field.

• Position: Enter the technical contact's job title.

• Company Name: Enter the technical contact's company name. Click the 'Copy CDX
Registration' button to populate the fields with CDX registration information. This is a
required field.

• Phone Number: Enter the technical contact's daytime phone number. Click the 'Copy CDX
Registration' button to populate the fields with CDX registration information. This is a
required field.

• Phone Extension: Enter the technical contact's phone number extension. Click the 'Copy
CDX Registration' button to populate the fields with CDX registration information.

• Email Address: Enter the technical contact's email address. The email address must follow the
standard email address format: John.Doe@abc.com. Click the 'Copy CDX Registration' button
to populate the fields with CDX registration information.

• Mailing Address 1: Enter the first line of the technical contact's mailing address. Click the
'Copy CDX Registration' button to populate the fields with CDX registration information. This
is a required field.

• Mailing Address 2: Enter the second line of the technical contact's mailing address. Click the
'Copy CDX Registration' button to populate the fields with CDX registration information.

• City: Enter the technical contact's U.S. city of the mailing address. Click the 'Copy CDX
Registration' button to populate the fields with CDX registration information. This is a
required field.

• State: Select the state of the technical contact's mailing address from the drop-down menu.
Click the 'Copy CDX Registration' button to populate the fields with CDX registration
information. This is a required field.

• Postal Code: Enter the postal code of the technical contact's mailing address. Click the 'Copy
CDX Registration' button to populate the fields with CDX registration information. This is a
required field.

• Country: Displays 'United States.'

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Exhibit 4-5 shows a screen capture of the 'Add Technical Contact' pop-up window:
Exhibit 4-5: Add Technical Contact Pop-Up Window

& CSPP

ADD TECHNICAL CONTACT

Please enter information for the technical contacts that will be contacted to answer questions regarding
information in the form. Check to claim information as CBI or click the 'Copy CDX Registration1 button to
populate from CDX (if applicable).

Click here to copy your information from CDX Registration: Copy CDX Registration
Check here to claim this information as CBi:

First Name:

Last Name:

Position:

Company Name:

Phone Number:

(Do not enter any dashes (-) in Phone Number field above.)

Phone Extension:
Email Address:
Mailing Address 1:

Mailing Address 2:

City:

State:

Postal Code:
Country:

Street address, P.O. box, company name, etc.

Apartmentr suite, etc.

JUS

United States

|Cancel|

Navigation: Click the 'Cancel' button or 'X' icon at the upper right-hand corner of the window
to return to the 'Technical Contact Information' screen without saving the technical contact
information. Click the 'OK' button to save and populate the entered technical contact
information and navigate back to the 'Technical Contact Information' screen.

4.1.4 Chemical Identification

You can access the 'Chemical Identification' screen by clicking the 'Next' button from the
'Technical Contact Information' screen. You may also click the 'Add Consolidated Chemical' or
'Chemical Identification' links within the navigation tree access the 'Chemical Identification'
screen.

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The 'Chemical Identification' screen identifies the type of chemical the submitter will be
entering into the application. You will be able to file a Joint PMN form for a class 1 or 2
chemical substance or a polymer. Based on your selection, the appropriate screens for the
respective chemical will appear. If you select the 'Class 1 or 2 Chemical Substance' radio button,
click the ' Save' icon ( ) within the bottom action bar, or click the 'Next' button to generate the
'Class 1 or 2 Chemical Substances' screen within the navigation tree. If you identify the
chemical as a polymer by selecting the 'Polymer' radio button, click the 'Save' icon ( ) within
the bottom action bar, or click the 'Next' button to generate the 'Polymer Identification
Information' screen and the 'Monomers and Other Reactants' screen within the navigation tree.

This screen provides a field to identify an alias for the chemical substance, and allows you to
identify chemicals in a consolidated chemical submission. The chemical alias is required if a
Joint Submission or Letter of Support is being filed and renames the chemical folder within the
navigation tree.

• Class 1 or 2 Chemical Substance: Select the 'Class 1 or 2 Chemical Substance' radio button
to indicate that the chemical is a class 1 or 2 substance. If you select the 'Polymer' radio button
after initially selecting the 'Class 1 or 2 Chemical Substance' radio button, the application
generates a confirmation message warning you that you will lose all data for this chemical if
the chemical type changes. Selecting either the 'Class 1 or 2 Chemical Substance' or 'Polymer'
radio button is required.

• Polymer: Select the 'Polymer' radio button to indicate that the chemical is a polymer. If you
select the 'Class 1 or 2 Chemical Substance' radio button after initially selecting the 'Polymer'
radio button, the application generates a confirmation message warning you that you will lose
all data for this chemical if the chemical type changes. Selecting either the 'Class 1 or 2
Chemical Substance' or 'Polymer' radio button is required.

• Chemical Alias: Enter the chemical alias to associate with a chemical. This field will auto-
generate a chemical alias in the navigation tree upon leaving the screen if this field is left
blank. This field is required.

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Exhibit 4-6 shows a screen capture of the 'Chemical Identification' screen:

Exhibit 4-6: Chemical Identification Screen

Premanufacture Notice
Secondary Support

General Form Information

llUAgent Information

Technical Contact Information

S Chemicals

B & Chemical 2303

|"j~?|Chemical
Identification

Class 1 or 2
Chemical
Substances
Class 2 Substances

Additional Chemical
Information

r Production Volume
and Hazard/Safety
Information

'Ij^jUse Information

^ ^Physical &

Chemical
Properties

"l^jPhysical and
Chemical
Properties
Worksheet

¦S> Logged in as: Jane Doe, Secondary Support

Log Out

Preimimrfactiire Notice (Joint PMN-20130502-14:09:03 EDT) > Chemical Identification

CHEMICAL IDENTIFICATION

Chemical Type

Complete either item 1 (Class 1 or 2 chemical substances, PMN page 4/4a) or item 2 (Polymers, PMN
Page 5/5a) as appropriate. Indicate which selection you intend to complete Pelow.

Physical and

Chemical

Properties

Class 1 or 2 Chemical Substance
Polymer

®
O

Chemical Alias:

Chemical report folder alias is an optional field that changes the folder name in the navigation tree on the
left. The chemical report folder alias is required if a joint submission and/or letter of support is being filed.
Its purpose is to make it easier to distinguish between chemical folders when there is more than one and
for joint and/or letter of support submitters to refer to when they supply information for that chemical.

*To add a consolidated chemical, please click the 'Add Consolidated Chemical' link within the navigatio
have selected 'Class 1 or 2 Chemical Substance' or 'Polymer' above and then selected 'Next' below.

tree after yo

|^NextJ

I 1

Validate

Save

Preview

CDX Homepage I MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDXHelpdesk: (888) 890-1995

Navigation: If you selected the 'Class 1 or 2 Chemical Substance' radio button, click the 'Next'
button to navigate to the 'Class 1 or 2 Chemical Substances' screen. You can also access this
screen by clicking the 'Class 1 or 2 Chemical Substances' link within the navigation tree.

If you selected the 'Polymer' radio button, click the 'Next' button to navigate to the 'Polymer
Identification Information' screen. You can also navigate to this screen by clicking the 'Polymer
Identification Information' link within the navigation tree.

4.1.5 Class 1 or 2 Chemical Substances

You can access the 'Class 1 or 2 Chemical Substances' screen if you selected the 'Class 1 or 2
Chemical Substance' radio button on the 'Chemical Identification' screen and clicked the 'Next'
button. You can also access this screen by clicking the 'Class 1 or 2 Chemical Substances' link
within the navigation tree.

The 'Class 1 or 2 Chemical Substances' screen provides fields for you to enter information
describing the chemical for which the PMN is to be filed. This screen will outline the unique

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chemical properties that show the name, composition, and structure of the chemical. The system
provides fields for you to identify several key aspects concerning a chemical's identity.

For a single component submission, create the field set by clicking the 'Add New Chemical'
button. Upon clicking the 'Add New Chemical' button, the application generates an
expandable/collapsible field set containing numerous fields for you to enter information
pertaining to that particular chemical.

For a multi-component submission, create another field set by clicking the 'Add New Chemical'
button. Multi-component chemical submissions occur when two or more chemicals are always
generated together in a single pot and are never isolated. Upon clicking the 'Add New Chemical'
button, the application generates a field set containing numerous fields for you to enter
information pertaining to that particular chemical. Enter additional chemical components, each
with unique identifying information, by clicking the 'Add New Chemical' button for each
additional chemical that is part of the multi-component mixture. All multi-component chemicals
will reside in one chemical folder in the navigation tree. Duplicate chemicals are not allowed
within a multi-component submission.

For a consolidated submission, create and identify chemicals in separate chemical folders by
clicking the 'Add Consolidated Chemical' link within the navigation tree.

If you select the 'Class 1' radio button on the 'Class 1 or 2 Chemical Substances' screen, click
the 'Next' button to navigate to the 'Additional Chemical Information' screen. If you select the
'Class 2' radio button on the 'Class 1 or 2 Chemical Substances' screen, click the 'Next' button
to navigate to the 'Class 2 Substances' screen.

For a class 1 substance chemical structure diagram, provide a complete and correct chemical
structure diagram. A class 1 structural diagram should clearly and completely indicate the
identity of the atoms and the nature and location of the bonds joining the atoms. Provide ionic
charges and known stereo chemical details. Carbon atoms in ring systems do not need to be
explicitly shown.

For a class 2 substance chemical structure diagram:

• List the immediate precursor substances with their respective CASRN.

• Describe the nature of the reaction or process.

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

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

Provide partial, complete, or representative structural diagrams to the extent possible. The
diagram should indicate the characteristic or variable compositional structural components of the
substance. If you are unsure of the exact structure, provide the best information you have and
indicate that it is your best estimate of the chemical structure.

• Add New Chemical: Click the button to generate the class 1 or 2 chemical substances
expandable/collapsible field set.

• Cancel: Click the 'Cancel' link located in the upper right-hand corner of the
expandable/collapsible field set to prevent edits from saving and to remove a field set. The
'Cancel' link displays when the expandable/collapsible field set is open for editing. A
confirmation message displays to confirm the action.

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• Edit: Click the 'Edit' link located in the upper right-hand corner of the expandable/collapsible
field set to modify the information entered in the fields. The 'Edit' link displays when the
expandable/collapsible field set has been saved and the data is not currently editable.

• Delete: Click the 'Delete' icon ( *) located in the upper right-hand corner of the
expandable/collapsible field set to delete the field set. A confirmation message displays to
confirm the deletion.

• Expand All: Click the 'Expand All' link located at the upper-right of the
expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the 'Collapse All' link located at the upper-right of the
expandable/collapsible field sets to collapse a series of field sets.

• B.l.a. Class of Substance: In section B.l.a., select the 'Class 1' or 'Class 2' radio button to
identify whether a 'Class 1' or 'Class 2' chemical substance is being reported. Selecting the
'Class 2' chemical substance radio button indicates that some portions of the structure may not
be known and a 'Class 2 Substances' screen will appear within the navigation tree after
clicking the 'Next' button for you to enter information concerning how the chemical was
created. If multiple 'Class 2' chemical components are added, only one 'Class 2 Substances'
screen will generate that applies to all the components. Check the 'CBI' checkbox to claim the
chemical substance class as confidential. Either the 'Class 1' or 'Class 2' radio button must be
selected.

• Class 1: Select the 'Class 1' radio button to identify the chemical as a 'Class 1' substance. A
'Class 1' substance is a single molecular entity that can be represented by a single, definite
structural diagram. Either the 'Class 1' or the 'Class 2' radio button in the 'B.l.a. Class of
Substance' section is required.

• Class 2: Select the 'Class 2' radio button to identify the chemical as a 'Class 2' substance. A
'Class 2' substance is a substance whose composition cannot be represented by a single,
definite chemical structural diagram. Class 2 substances include substances of unknown,
variable, or uncertain composition, complex mixtures or reaction products, or well-defined
substances without specific structures. Either the 'Class 1' or the 'Class 2' radio button in the
'B.l.a. Class of Substance' section is required.

• CBI: Check the 'CBI' checkbox to claim the 'Class of Substance' as confidential.

• Search SRS: Click the 'Search SRS' button to generate the 'Search Substance Registry
Services' pop-up window. Refer to Section Error! Reference source not found, for

additional details regarding the search SRS functionality.

• CASRN: Displays the CASRN of the chemical identified on the 'Search Substance Registry
Services' pop-up window, if applicable.

• Chemical Name: Displays the chemical name of the chemical identified on the 'Search
Substance Registry Services' pop-up window. For class 1 substances, a 'Chemical Abstracts
(CA) Index Name' must be provided. For class 2 substances either a 'CA Index Name' or 'CA
Preferred Name' must be provided, whichever is appropriate based on current CA
nomenclature rules and conventions. This is a required field.

• CBI: Check the 'CBI' checkbox to claim the 'Chemical Name' field as confidential and
generate the 'Generic Chemical Name' text field.

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• B.6. Generic Chemical Name: Enter the generic name to associate with a chemical. This field
only displays when 'CASRN' and 'Chemical Name' are marked as 'CBI.'

• Method 1 (CAS Inventory Expert Service): Select the 'Method 1 (CAS Inventory Expert
Service)' radio button to identify the ID method as the CAS Inventory Expert Service (IES)
method and generate the 'IES Order #' field. A copy of the identification report obtained from
the CAS Inventory Expert Services must be submitted as an attachment to this notice; an IES
report is required. For a consolidated submission, each chemical must be 'Method 1' except
when the submission is pending a Letter of Support for that chemical. In the case of an
LVE/LOREX modification form type, this 'Method 1' requirement is not applicable.

• Method 2 (Other Method): Select the 'Method 2 (Other Method)' radio button to identify the
ID method as 'Other Method.' An alternative method of providing a name, such as a Scientific
and Technical Information Network (STN) database report or a CAS Client Services report,
qualifies as 'Method 2.' The chemical can be 'Method 2' if the consolidated submission is
pending a Letter of Support.

• IES Order #: Enter the IES order number of the report. This field only displays when the
'Method 1 (CAS Inventory Expert Service)' radio button is selected. This is a required field if
the 'Method 1 (CAS Inventory Expert Service)' radio button is selected.

• B.l.d. Molecular Formula: Enter the molecular formula associated with a chemical. The
molecular formula must give the correct identity and number of atoms of each element
contained in the PMN molecule or a description if the substance is a class 2 material. The
system will not allow subscripts and superscripts to be used.

• CBI: Check the 'CBI' checkbox to claim the 'Molecular Formula' data as confidential.

• Attachments: Select the section of the page the file is associated with that you intend to attach
from the drop-down menu. This drop-down menu contains the following values: 'Chemical
Structure Diagram' and 'ID Method.' This is a required field to upload an attachment.

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window. Refer to Section Error! Reference source not found, for further details
regarding the attach document functionality.

• Section: Displays the section associated with a document.

• File Name: Displays the file name and file extension of the file that is uploaded on the 'Attach
Documents' pop-up window.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete the entire document row permanently from the
system; a warning message displays to confirm the deletion of the document.

• Save: Click the button to save the information entered within the expandable/collapsible field
set. You must click this button instead of the 'Save' icon ( ) located within the bottom action
bar to successfully save the entered information within the field set before being able to
navigate away from the screen using the 'Previous' and 'Next' buttons. Refer to Section 3.6

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for more information regarding the save functionality in an expandable/collapsible field set.

Exhibit 4-7 shows a screen capture of the 'Class 1 or 2 Chemical Substances' screen (Scroll 1):
Exhibit 4-7: Class 1 or 2 Chemical Substances Screen (Scroll 1)

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Premanufacture Notice
Secondary Support

'0 General Form Information

5 lAgent Information

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$ & Chemical 2303

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4 Preinanufacture Notice (Joint PMN-20130502-14:09:03 EDT) > Class 1 or 2 Chemical Substances

CLASS 1 OR 2 CHEMICAL SUBSTANCES

Expanil AIM| Collapse All

Cancel

B.1 .a. Class of Substance: O Class 1 O Class 2 CBI: ~

Click the button below to search EPA's Substance Registry Services (SRS) for the desired chemical.
Search SRS

CASRN:

Chemical Name:

CBI: 0

B.6. Generic Chemical Name:

B. I .c. ID Method

O Method 2 (Other Method)

Include an attachment for the ID Method below (optional).

CDX Homepage | MyCDX Homepage | EPA Homepage I Terms and Conditions | Privacy Notice I CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide

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Exhibit 4-8 shows a screen capture of the 'Class 1 or 2 Chemical Substances' screen (Scroll 2):
Exhibit 4-8: Class 1 or 2 Chemical Substances Screen (Scroll 2)

Premanutacture Notice

Secertie«

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Properties
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Chetnicat
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B.i.e Chemical Structure Diagram;

include an attachment for the chemical structure diagram below
Choose a section to attach a document

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Attach Document

Section File Name Description

Save

Pages CBI Actions

Click the Add New Chemical button to add chemical name and structural information for a new chemical
Add Nf-wChomicJi

•Consolidated chemicals are entered by cricking the 'Add Consolidated Chemical' (ink within the navigation tree on the
left.

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Pwacy Malice 1

CDXHelpdesk (888)890-1995

Navigation: If you select the 'Class 1' radio button, click the 'Next' button to navigate to the
'Additional Chemical Information' screen. You can also access this screen by clicking the
'Additional Chemical Information' link within the navigation tree. If you select the 'Class 2'
radio button, click the 'Next' button to navigate to the 'Class 2 Substances' screen. You can also
access this screen by clicking the 'Class 2 Substances' link within the navigation tree.

4.1.6 Class 2 Substances

You can access the 'Class 2 Substances' screen by clicking the 'Next' button from the 'Class 1
or 2 Chemical Substances' screen when you select the 'Class 2' radio button for the 'Class of
Substance' field. You can also access this screen by clicking the 'Class 2 Substances' link within
the navigation tree.

The 'Class 2 Substances' screen captures information regarding a class 2 chemical substance. A
class 2 chemical substance is a substance that may not have a defined chemical structure that has
been identified. This screen provides fields to identify specific elements in the creation of the
chemical using the following fields: 'Precursor Substances,' 'Nature of Reaction,' and 'Range of
Composition.'

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Enter precursor substances by searching SRS or using manual entry when the substance is not in

SRS. The selected substances will display in a table listing the 'Chemical Name' and 'CASRN.'

The system provides fields to capture 'Nature of Reaction' and 'Range of Composition' in text

boxes. The 'Nature of Reaction' and 'Range of Composition' text fields can be claimed as CBI.

• B.l.e.l. Precursor Substances: This table captures the chemicals identified as immediate
precursor substances, along with the respective CASRNs, if applicable.

• CBI: Check the 'CBI' checkbox to claim the precursor substances information as confidential.

• Search SRS: Click the 'Search SRS' button to generate the 'Search Substance Registry
Services' pop-up window. Refer to Section 3.8 for further details regarding the search SRS
functionality.

• Chemical Name: Displays the chemical name associated with a precursor substance. Click the
chemical name link to generate the 'Search SRS' pop-up window to make edits.

• CASRN: Displays the CASRN, if applicable, associated with a precursor substance.

• Actions: Click the 'Delete' icon ( *) to delete the entire chemical row permanently from the
system; a warning message displays to confirm the deletion of the chemical.

• B.l.e.2. Nature of Reaction: Enter the nature of the reaction or process description.

• CBI: Check the 'CBI' checkbox to claim the nature of reaction information as confidential.

• B.l.e.3. Range of Composition: Enter the range of composition and the typical composition
description. Provide the range of composition in weight percent for each specific component or
class of components that you intend to manufacture for commercial purposes.

• CBI: Check the 'CBI' checkbox to claim the range of composition information as confidential.

• Attachments: Select the section of the page the document you intend to attach is associated
with from the drop-down menu. This drop-down menu contains the following values: 'B.l.e.l.
Precursor Substances,' 'B.l.e.2. Nature of Reaction,' and 'B.l.e.3. Range of Composition.'
This is a required field.

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window and initiate the document upload process. Refer to Section Error! Reference
source not found, for further details regarding the attach document functionality.

• Section: Displays the section associated with a document.

• File Name: Displays the file name and file extension of a file that is uploaded on the 'Attach
Documents' window.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete the entire document row permanently from the
system; a warning message displays to confirm the deletion.

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Exhibit 4-9 shows a screen capture of the 'Class 2 Substances' screen (Scroll 1):
Exhibit 4-9: Class 2 Substances Screen (Scroll 1)

Premanufacture Notice
Secondary Support

General Form Information

Agent Information

[^Technical Contact Information

5" Chemicals

f A Chemical 2303

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Pi eimanufacture Notice (Joint PMN-20130502-14:09:03 EDT> > Class 2 Substances

CLASS 2 SUBSTANCES

Class 2 Substance Details

In the fields below fora class 2 substance (1) List the immediate precursor substances with their
respective CAS Registry-Numbers (if applicable). (2) Describe the nature of the reaction or process. (3)
Indicate the range of composition and the typical composition (where appropriate).

B.1 .e.1. Precursor Substances CBI: ~

Se.nchSRS Click the 'Search SRS' button to search EPA's Substance Registry1 Services (SRS) for a
precursor substance or to manually enter the Chemical Name and CASRN (if applicable) if it is not found in
SRS.

Chemical Name

B.l.e.2. Nature of Reaction CBI: ~

CASRN

Actions

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| MyCDX Homepage |

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| Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8f

38) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 4-10 shows a screen capture of the 'Class 2 Substances' screen (Scroll 2):
Exhibit 4-10: Class 2 Substances Screen (Scroll 2)

Rremanufacture Notice
Secondary Support

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B. I .6.3. Range of Composition CBI: ~

Attachments

Select which section the attachment applies to and then attach the file.

Click here to attach a file Atwcli Document

Section

File Name

Description Pages CBI Actions

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Navigation: Click the 'Next' button to navigate to the 'Additional Chemical Information'
screen. You can also access this screen by clicking the 'Additional Chemical Information' link
within the navigation tree.

4.1.7 Additional Chemical Information

You can navigate to the 'Additional Chemical Information' screen by selecting the 'Class 1'
radio button on the 'Class 1 or 2 Chemical Substances' screen and clicking the 'Next' button, by
clicking the 'Next' button on the 'Class 2 Substances' screen, or clicking the 'Next' button from
the 'Monomers and Other Reactants' screen. You can also access this screen by clicking the
'Additional Chemical Information' link within the navigation tree.

The 'Additional Chemical Information' screen captures information regarding the chemicals
produced as byproducts and impurities when a chemical is manufactured. This screen also
captures other names for the chemical at hand in the 'Synonyms' and 'Trade Identification'
tables.

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An 'Impurities' table displays information regarding the impurities that may be reasonably
anticipated to be in the respective chemical or polymer as manufactured for commercial purpose.
Click the 'Search SRS' button to access the 'Search SRS' pop-up window and populate the
'Impurities' table. You will also be able to enter a chemical using the 'Chemical Name' and
'CASRN' field (if applicable) on the 'Chemical Not Found In Substance Registry Services' pop-
up window. If there are unidentified impurities, enter "unidentified." You also have the option of
claiming the chemical as confidential by checking the 'CBI' checkbox. A 'Maximum %' field is
also displayed which captures the maximum percentage for the impurity. Documents may be
attached for the 'Impurities' section if necessary.

A 'Byproducts' table provides fields to capture information regarding the byproducts that may be
produced from the manufacture of the respective chemical or polymer. Click the 'Search SRS'
button to access the 'Search SRS' pop-up window and populate the 'Byproducts' table. You may
associate a CASRN with a byproduct (if applicable) and check the 'CBI' checkbox to claim a
byproduct as confidential. Documents may be attached for the 'Byproducts' section if necessary.

A 'Synonyms' table provides fields to capture the synonyms that the respective chemical or
polymer may be referred to in the documentation. A maximum of five synonyms can be entered
in the table. The search SRS functionality cannot be used to populate the 'Synonyms' table. You
may attach documents associated with the 'Synonyms' section to provide additional synonyms if
necessary.

A 'Trade Identification' table provides fields to capture information about the trade names by
which the respective chemical or polymer may be referred in documentation. There is no limit to
the number of trade names that may be added. You may attach documents associated with the
'Trade Identification' section to provide additional information if necessary.

The 'Attach Documents' pop-up window provides fields to upload documents related to the
'Impurities,' 'Byproducts,' 'Synonyms,' and/or'Trade Identification' section(s). Select the
section of the page the document is associated with from the 'Section' drop-down menu, and
click the 'Attach Document' button to generate the 'Attach Documents' pop-up window and
attach a document. The system provides a 'CBI' checkbox to claim the uploaded document as
confidential. If you claim a document as CBI, the system requires you to upload the sanitized
version of the attached document.

If the sanitized version of the document is not provided, the Section 5 Notices and Supports form
will fail validation upon navigating away from the 'Attach Documents' window. To view or edit
previously attached documents, click the appropriate file name of the document within the 'File
Name' column of the attachments table.

The attachments table displays the section of the page the document is associated with, the file
name and file extension of the document, the document description, the number of pages in the
document, and if the document was claimed CBI. Click the 'Delete' icon ( *£) located under the
'Actions' column to delete unwanted documents. Click a file name link in the 'File Name'
column to generate the 'Attach Documents' pop-up window to view and/or edit an attached
document.

• B.3. Impurities - Search SRS: Click the 'Search SRS' button to display the 'Search
Substance Registry Services' pop-up window. Refer to Section 3.8 for further details regarding
the search SRS functionality.

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• Impurity: Displays the name of the impurity. An impurity is a chemical substance that you did
not intend to be present with your PMN substance. List all known impurities that are present,
regardless of their weight percent. List the expected maximum percentage of each impurity and
indicate its confidentiality status. An impurity may be suggestive of chemical precursors or
chemical processes. Click the 'Impurity' link to navigate to the 'Search Substance Registry
Services' pop-up window to edit chemical information for an impurity.

• CASRN: Displays the Chemical Abstracts Service Registry Number for the impurity (if
applicable).

• Maximum %: Displays the maximum percentage for the impurity; decimal values are
accepted.

• CBI: Indicates the CBI status of the impurity by displaying either a 'Y' or an 'N.'

• Action: Click the 'Delete' icon ( *) to delete the entire impurity entry permanently from the
system; a warning message displays to confirm the deletion.

• B.7. Byproducts - Search SRS: Click the 'Search SRS' button to generate the 'Search
Substance Registry Services' pop-up window. Refer to Section Error! Reference source not
found, for further details regarding the search SRS functionality.

• Byproduct Name: Displays the name of the byproduct. Describe any byproducts resulting
from the manufacture, processing, use, or disposal of the new chemical substance. List any
byproducts that you reasonably anticipate will result from the manufacture, processing, use and
disposal of the new chemical substance at sites under your control. Click the 'Byproduct
Name' link to generate the 'Search Substance Registry Services' pop-up window to view
and/or edit byproduct information. Provide the specific chemical name, CAS numbers if they
can be determined, and the confidential status of the byproducts formed. If no byproducts are
formed, enter "None" or leave the section blank.

• CASRN: Displays the CASRN for the byproduct (if applicable).

• CBI: Indicates the CBI status of the byproduct by displaying either a 'Y' or an 'N.'

• Action: Click the 'Delete' icon ( *) to delete the entire byproduct entry permanently from the
system; a warning message displays to confirm the deletion.

• B.4. Synonyms - CBI: Check the 'CBI' checkbox to claim the 'Synonym' field set as
confidential.

• Synonym: Enter the synonym of the chemical; there is a maximum of five chemical synonyms
that can be added in the 'Synonyms' table. Additional synonyms can be provided in an
attachment. Synonyms include common chemical names used in scientific or technical
literature, and code numbers or code names referenced in the PMN and its attachments.

Indicate which synonyms may be proprietary and require CBI protection. Chemical name
synonyms must be consistent with the chemical structure and thus not misleading. If you add a
blank, editable line in this table and click the 'Next' button, no error will display indicating that
the blank line should be saved or deleted. If text is entered in a blank field and you click the
'Next' button, the application will save the entered value. If you click the 'Form' icon (0),
edit the entered values and click the 'Next' button without saving the changed value, an error
will generate.

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• Actions: Click the 'Add' icon ( ) to add a new text field to enter additional synonyms. Click
the 'Save' icon (H) to save a chemical synonym. Click the 'Form' icon (0) that appears after
saving to edit a chemical synonym. Click the 'Delete' icon ( ¦->) to delete a previously added
chemical synonym. To cancel changes to a field, simply clear the data entered in the field.

• B.5. Trade Identification - CBI: Check the 'CBI' checkbox to claim the trade identification
section as confidential.

• Trade Name: Enter the trade identification name. List any trade name that is used or will be
used for the neat chemical substance, whether or not they are registered brands/trademarks.
There is no limit to the number of trade names that can be added. Check the 'CBI' checkbox to
indicate the CBI status of trade names. If you add a blank, editable line in this table and click
the 'Next' button, no error will display indicating that the blank line should be saved or
deleted. If text is entered in a blank field and you click the 'Next' button, the application will
save the entered value. If you click the 'Form' icon (0), change the entered value(s) and click
the 'Next' button without saving the changed value(s), an error message will generate.

• Actions: Click the 'Add' icon ( ) to add a new text field to enter additional trade
identification names. Click the 'Save' icon (H) to save a trade identification name. Click the
'Form' icon (El) to edit a trade identification name. Click the 'Delete' icon ( <) to delete a
previously added trade identification name.

• Attachments: Select the section of the page with which the document is associated from the
drop-down menu. This drop-down menu contains the following values: 'Byproducts Section,'
'Impurities Section,' 'Synonyms Section,' and 'Trade Identification Section.'

• Section: Displays the section of the page with which the document is associated.

• File Name: Displays the file name and file extension of the file that is uploaded on the 'Attach
Documents' pop-up window.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete the entire attached document row permanently
from the system; a warning message displays to confirm deletion of the document.

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Exhibit 4-11 shows a screen capture of the 'Additional Chemical Information' screen (Scroll 1):
Exhibit 4-11: Additional Chemical Information Screen (Scroll 1)

QN i Qi^i _ J

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Premanufacture Notice
Secondary Support

iGeneral Form Information

1 ^[Agent Information

Technical Contact Information

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$AChemical 2303

j Chemical
Identification

"Qciass 1 or 2
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|"'Qciass 2 Substances

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Continued
(Optional)

< Premanufacture Notice (Joint PMN-20130502-14:09:03 EDT) > Additional Chemical Information

ADDITIONAL CHEMICAL INFORMATION

B.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 %.

0 Copy

0 & Chemical 2304

1 biochemical

Click the Search SRS button on the right to search SRS or to manually enter an impurity. jSearchSRS
Impurity CASRN Maximum?.

CBI

Action

B.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.

Click the Search SRS button on the right to search SRS or to manually enter a byproduct. Search SRS
Byproduct Name CASRN CBI Action

B.4. Synonyms CBI: ~

Enter any chemical synonyms for the new chemical substance.

Synonym Actions

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Identification iv|

~ B

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Preview

CDX Homepage | MyCDX Homepage |

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8£

38) 890-1995

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Exhibit 4-12 shows a screen capture of the 'Additional Chemical Information' screen (Scroll 2):
Exhibit 4-12: Additional Chemical Information Screen (Scroll 2)

Premanufacture Notice
Secondary Support

h [General Form Information

Agent Information

Technical Contact Information

B" Chemicals

Chemical 2303

"[^Chemical
| I Identification

! ; I .Class 1 or 2
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$ &Chemical 2304

j Chemical
| Identification

Home y Forms J Resources

Logged in as: Jane Doe, Secondary Support

Log Out

Click the Search SRS button on the right to search SRS or to manually enter a byproduct. Search srs
Byproduct Name CASRN CBI Action

B.4. Synonyms CBI: ~

Enter any chemical synonyms for the new chemical substance.

Synonym

Actions

gx#

B.5. Trade Identification CBI: ~

List trade names for the new chemical substance.

Trade Name

Attachments

Select which section the attachment applies to and then attach the file.

Click here to attach a file Attach Document

Actions

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Section

File Name

Description

Pages CBI Actions

Pi evfous

Validate

Save

Preview

Navigation: Click the 'Next' button to navigate to the 'Production Volume and Hazard/Safety
Information' screen. You can also access this screen by clicking the 'Production Volume and
Hazard/Safety Information' link within the navigation tree.

4.1.8 Polymer Identification Information

You can access the 'Polymer Identification Information' screen by clicking the 'Next' button
from the 'Chemical Identification' screen if you select the 'Polymer' radio button. You can also
access this screen by clicking the 'Polymer Identification Information' link within the navigation
tree after selecting the 'Polymer' radio button on the 'Chemical Identification' screen.

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The 'Polymer Identification Information' screen captures information describing the polymer(s)
for which the PMN will be filed. This screen outlines the unique chemical properties that show
the name, composition, and structure of the polymer. The system will provide fields for you to
identify several key aspects concerning a polymer's identity.

Click the 'Add New Chemical' button to create a chemical field set. Upon clicking the 'Add
New Chemical' button, an expandable/collapsible field set generates that contains numerous
fields that pertain to the particular polymer. You are able to enter multiple chemical substances,
each with unique information, by clicking the 'Add New Chemical' button for each chemical
you wish to identify.

For a single component submission, create the field set by clicking the 'Add New Chemical'
button. Upon clicking the 'Add New Chemical' button, the application generates a field set
containing numerous fields that captures information pertaining to that particular chemical.

For a multi-component submission, click the 'Add New Chemical' button to create a field set.
Multi-component chemical submissions occur when two or more chemicals always generate
together in a single pot and are never isolated. Upon clicking the 'Add New Chemical' button,
the application generates a field set that provides numerous fields to enter information pertaining
to that particular chemical. Enter additional chemical substances, each with unique identifying
information, by clicking the 'Add New Chemical' button for each additional chemical that is part
of the multi-component mixture. All multi-component chemicals will reside in one chemical
folder in the navigation tree.

For a consolidated submission, create separate chemical folders by clicking the 'Add
Consolidated Chemical' link within the navigation tree. A form may contain a maximum of six
(6) separate chemical folders.

• Add New Chemical: Click the 'Add New Chemical' button to generate a polymer
identification information expandable/collapsible field set.

• Delete: Click the 'Delete' icon ( *£) located in the upper right-hand corner of the
expandable/collapsible field set to delete the field set; a confirmation message displays to
confirm the deletion.

• Expand All: Click the link located at the upper-right of the expandable/collapsible field sets to
expand a series of field sets.

• Collapse All: Click the link located at the upper-right of the expandable/collapsible field sets
to collapse a series of field sets.

• Search SRS: Click the button to generate the 'Search SRS' pop-up window. Refer to Section
Error! Reference source not found, for additional details regarding the search SRS
functionality.

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• CASRN: Displays the CASRN of the chemical identified on the 'Search SRS' pop-up window,
if applicable.

• Chemical Name: Displays the name of the chemical that has been identified on the 'Search
SRS' pop-up window.

• CBI: Check the 'CBI' checkbox to identify the chemical as confidential.

• B.6 Generic chemical name: Enter the generic name to associate with a chemical. This field
displays when 'Chemical Name' and 'CASRN' are CBI. This is a required field.

• Method 1 (CAS Inventory Expert Service): Select the 'Method 1 (CAS Inventory Expert
Service)' radio button to identify the ID method as the 'CAS Inventory Expert Service'
method. Submit a copy of the identification report obtained from the CAS Inventory Expert
Services as an attachment to this notice. For a consolidated submission, each chemical must be
'Method 1' except when the submission is pending a Letter of Support for that chemical. Select
the 'Method 1 (CAS Inventory Expert Service)' radio button to generate the 'IES Order #'
field.

• IES Order #: Select the 'Method 1 (CAS Inventory Expert Service)' radio button to generate
this field. Enter the IES order number.

• Method 2 (Other Method): Select the 'Method 2 (Other Method)' radio button to identify the
ID method as 'Other Method.' An alternative method of providing a name, such as a STN
database report or a CAS Client Services report, qualifies as 'Method 2.' If the chemical is
pending a Letter of Support, the method can only be 'Method 2.'

• Attachments: Select the section of the page with which the document is associated from the
drop-down menu. This drop-down menu contains the following values: 'Chemical Structure
Diagram' and 'ID Method.'

• Attach Document: Click the button to generate the 'Attach Documents' pop-up window.

Refer to Section Error! Reference source not found, for additional details regarding the attach
document functionality.

• Section: Displays the section of the page with which the file is associated.

• File Name: Displays the file name and file extension of a document that is uploaded on the
'Attach Documents' window.

• Description: Displays the description of a document.

• Pages: Displays the number of pages in a document.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

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Exhibit 4-13 shows a

1):

Exhibit

screen capture of the 'Polymer Identification Information' screen (Scroll
4-13: Polymer Identification Information Screen (Scroll 1)

Logged in as: Jane Doe, Secondary Support

Log Out

Premanufacture Notice
Secondary Support

Properties
Worksheet -
Continued
(Optional)

X Remove

® Copy

$ &Chemical 2304

Chemical
Identification

Polymer
Identification
Information

Monomers and
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Additional Chemical
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Production Volume
and Hazard/Safety
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^Add Consolidated

Piemaiinfactwe Notice (Joint PMN-20130502-14:09:03 EDT) > Polymer Identification Information

POLYMER IDENTIFICATION INFORMATION

Expand All | Collapse All
Cancel X

Click the button below to search EPA's Substance Registry Services (SRS) for the desired chemical.
Search SRS

CASRW:

Chemical Name:

CEil: 0

B.6. Generic chemical name:

B.l.c. ID Method

® Method 1 (CAS Inventory Expert Setvice)
IES Order#:

O Method 2 (Other Method)

Include an attachment for the ID Method below.

B 1 e. Chemical Structure Diagram:

Include an attachment for the chemical structure diagram below.
Choose a section to attach a document:

Attach Document

Section File Name

Description Pages CBI Actions

Save

| j

Validate

Save

Preview

CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide

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56

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CDY~

Exhibit 4-14 shows a screen capture of the 'Polymer Identification Information' screen (Scroll

2):

Exhibit 4-14: Polymer Identification Information Screen (Scroll 2)

Premanufacture Notice

Secondary Support

Properties

Worksheet -

Continued

(Optional)

X Retrieve

ED Copy

" ^Chemical 2304

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B.1.C, ID Method

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IES Order#

include an attachment for the ID Method below

O Method 2 (Other Method)

B.l.e. Chemical Structure Diagram:

Include an attachment for the chemical structure diagram below.
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Section

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Description

Pages CBI Actions

Physical and
Chemical
Properties
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Physical and

Chctrical

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Coftirwecl

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Click the Add New Chemical button to add chemical name and structural information for a new chemical
Add New Chemical

~Consolidated chemical* are entered by dieting the "Add Consolidated Chemical' link within the navigation tret on the
left

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CDX Homepage | MyCDX Homepage | EPAHomepage | Terms and Conditions | Privacy Notice I CDXHelpdesk (888) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Monomers and Other Reactants' screen.
You can also access this screen by clicking the 'Monomers and Other Reactants' link within the
navigation tree.

4.1.9 Monomers and Other Reactants

You can navigate to the 'Monomers and Other Reactants' screen by clicking the 'Next' button
from the 'Polymer Identification Information' screen. You can also access this screen by clicking
the 'Monomers and Other Reactants' link within the navigation tree.

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The 'Monomers and Other Reactants' screen is used to identify the chemical measurements and
monomers that make up a polymer. The screen is divided into two sections to identify different
elements describing a polymer: 'Polymer Weight Information' and 'Monomers and Other
Reactants.'

In the 'Monomers and Other Reactants' section, enter the typical weight percent of each
monomer or other reactant in the polymer. Enter 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. The maximum residual should be less than the typical composition. Do
not use parts per million (ppm) units (1 ppm = 0.0001 wt%).

To reference a monomer cleared with an LVE, include an attachment detailing any specifics.

Please note that in IE 7, the % symbols that display to the right of the 'max. weight % below 500
molecular weight' and 'max weight % below 1000 molecular weight' fields might be slightly
misaligned.

• CBI: Check the 'CBI' checkbox to claim the 'Polymer Weight Information' section as
confidential.

• Method of Measurement: Only a single response option can be selected for 'Method of
Measurement;' valid values include 'GPC' and 'Other (Specify).' Gel-permeation
chromatography (GPC) is a well-established method for establishing the number average
molecular weight (Mn) and weight fractions below 500 and 1,000 Daltons. It may not be useful
for all polymer evaluations; however, solubility problems and misleading calibration standards
can lead to questionable GPC data. Correction estimates can be documented and presented in
cases where only a soluble fraction of the polymer can be analyzed.

• Specify other method of measurement: Enter the method of measurement when you select
the 'Other (Specify)' radio button as the method of measurement. This is a required field when
the 'Other (Specify)' radio button is selected.

• (i) lowest number avg. molecular weight: Enter the lowest number average molecular
weight; the entered value must be a positive numerical value and can contain decimal values.

• (ii) max. weight % below 500 molecular weight: Enter the maximum weight percentage
below 500 molecular weight; the value entered must be a positive numerical value greater than
or equal to zero (0), but less than or equal to one hundred (100) and can contain decimal
values. This value must be less than or equal to the value specified in the '(iii) max. weight %
below 1000 molecular weight' field.

• (iii) max. weight % below 1000 molecular weight: Enter the maximum weight percentage
below 1,000 molecular weight; the value entered must be a positive numerical value greater
than or equal to zero (0) but less than or equal to one hundred (100) and can contain decimal
values. This value must be greater than or equal to the value specified in the '(ii) max. weight
% below 500 molecular weight' field.

• Add Monomer: Click the 'Add Monomer' button to generate the monomer
expandable/collapsible field set.

• Cancel: Click the 'Cancel' link located in the upper right-hand corner of the
expandable/collapsible field set to prevent edits from saving and to remove a field set. The

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'Cancel' link displays when the expandable/collapsible field set is open for editing. A
confirmation message displays to confirm the action.

• Delete: Click the 'Delete' icon (¦ *) located in the upper right-hand corner of the
expandable/collapsible field set to delete the field set. A confirmation message displays to
confirm the deletion.

• Expand All: Click the 'Expand All' link located at the upper-right of the
expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the 'Collapse All' link located at the upper-right of the
expandable/collapsible field sets to collapse a series of field sets.

• Search SRS: Click the 'Search SRS' button to generate the 'Search Substance Registry
Services' pop-up window. Refer to Section Error! Reference source not found, for additional
details regarding the search SRS functionality.

• Monomer or Other Reactant: Displays the monomer or other reactant name; this field
populates based on information entered on the 'Search SRS' pop-up window. This is a required
field.

• Include in Identity: Check the 'Include in Identity' checkbox to claim the value for 'Monomer
or Other Reactant' as part of the monomer identification. This checkbox is most applicable for
monomers that are less than or equal to 2% since the monomer is not considered to be included
in the identity unless this checkbox is checked. This checkbox appears when a value of '2' or
less is entered into the 'Typical Composition' text field.

• CBI: Check the 'CBI' checkbox to claim the monomer or other reactant name and CASRN as
confidential.

• CAS Registry Number: Displays the CASRN for the specified monomer; this field populates
based on information entered on the 'Search SRS' pop-up window.

• Chemical Name: Displays the name of the chemical identified on the 'Search SRS' pop-up
window.

• Typical Composition: Enter the typical composition value that a monomer contributes to a
polymer; the value entered must be a positive numerical value greater than zero (0) and less
than or equal to one hundred (100) and can contain decimal values. If the value entered is less
than or equal to '2' a warning will be displayed in the global 'Validate' function or during the
submission process indicating that the typical composition is a value that is less than or equal
to 2 percent and asking you whether it should be included in the chemical identity. This is a
required field, and the value must be greater than zero (0).

• CBI: Check the 'CBI' checkbox to claim the 'Typical Composition' and 'Include In Identity'
fields as confidential.

• Maximum Residual: Enter the maximum residual value. 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. Enter a percent value less than or equal to the
maximum weight; do not use ppm units (1 ppm = 0.0001 wt%). The value entered must be a

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positive numerical value that is less than or equal to the typical composition value. This is a
required field.

• CBI: Check the 'CBI' checkbox to claim the 'Maximum Residual' field as confidential.

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window. Refer to Section Error! Reference source not found, for additional details
regarding the attach document functionality.

• File Name: Displays the file name and file extension of the document that is uploaded on the
'Attach Documents' pop-up window. Click the file name link to navigate to the 'Attach
Documents' pop-up window to make any edits.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion of the document.

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Exhibit 4-15 shows a screen capture of the 'Monomers and Other Reactants' screen (Scroll 1):
Exhibit 4-15: Monomers and Other Reactants Screen (Scroll 1)

Home y Forms Y Resources

A Logged in as: Jane Doe, Secondary Support

Log Out

Premanufacture Notice
Secondary Support
Chemical 2304

'"[^Chemical
identification

1 ^IPolymer
Identification
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Premanufacture Notice (Joint PMN-20130502-14:09:03 EDT> > Monomers an
-------
CDX?

Exhibit 4-16 shows a screen capture of the 'Monomers and Other Reactants' screen (Scroll 2):
Exhibit 4-16: Monomers and Other Reactants Screen (Scroll 2)

Premanufacture Notice

Secondary Support
5 Jk Chemical 2304

i""" Chemical

Identification

jj~ Polymer
Identification
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S" Site Information

Submitter Controlled Site
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Sites Controlled By Others
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f Home y Forms J Resources *

Enter a percent value less than or equal to the maximum weight, do not use ppm units. (1 ppm = 0.0001
wt%).

Select the Add Monomer button to add monomers that make up the polymer composition.

Expand All | Collapse All

Cancel

Click the button below to search EPA's Substance Registry Services (SRS)forthe desired
chemical.

Search SRS

Monomer or other reactant: Include in IdentityO
CAS Registry Number:

Chemical Name:

Typical Composition:
Maximum Residual:

cbiD

CBfO
CBlO

Save

Click the Add Monomer button to add a monomer. Add Monomei

Composition Total:0.0%

Attachments
Attach Document

File Name

Description

Pages CBI Actions

Validate Save

Preview

CDX Homepage |

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| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8J

J8) 890-1995

Navigation: Click the 'Add Monomer' button to generate the expandable/collapsible field set.
Click the 'Next' button to navigate to the 'Additional Chemical Information' screen. You can
also access this screen by clicking the 'Additional Chemical Information' link within the
navigation tree.

4.1.10 Production Volume and Hazard/Safety Information

You can navigate to the 'Production Volume and Hazard/Safety Information' screen by clicking
the 'Next' button from the 'Additional Chemical Information' screen. You can also access this
screen by clicking the 'Production Volume and Hazard/Safety Information' link within the
navigation tree.

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The 'Production Volume and Hazard/Safety Information' screen collects different information
regarding a chemical's production and hazard elements.

Production Volume: The 'Production Volume' section captures information about production
for the respective chemical or polymer for the 'Maximum first 12-month production' and the
'Maximum 12-month production.' The 'Maximum first 12-month production' value should be
less than or equal to the 'Maximum 12-month production' value. The maximum volume may not
exceed 100,000,000,000,000 kg/year for either field. The entered values will automatically
display decimal points upon navigating away from the page. Decimals are allowed up to the
milligram (.000001). Estimates should be on a 100% new chemical substance basis. Your
production volumes should be estimated as accurately as possible, but you are not bound to your
estimates unless you check the 'Binding' checkbox. Include amounts you intend to produce for
export. Provide an estimate of the first 12 months of production and the maximum production
volume for any consecutive 12-month period during the first three (3) years of commercial
manufacture. You may upload an attachment to enter additional production information.

Hazard Information: The 'Hazard Information' section captures information regarding hazards
that the company chooses to disclose. For EPA to take respirator use into account when
evaluating risks posed by a new chemical, the MSDS (material safety data sheet) for the
substance must specify a respirator that is appropriate for the types of anticipated exposures. For
the same reason, all respirators must be certified by the National Institute for Occupational
Safety and Health (NIOSH), and be referenced in the MSDS as "NIOSH certified" respirators.

If any type of risk assessment is prescribed to determine personal protective equipment (PPE)
requirements, such risk assessment must be performed by a qualified Industrial Hygienist (IH) or
other authorized occupational safety and health specialist.

Engineering controls are the preferred methods for managing workplace exposures to hazards. If
these controls are inadequate or lacking, personal protective equipment must be used.

For EPA to take glove use into account when evaluating risks posed by a new chemical, the
MSDS for the substance must specify gloves that are impervious to the substances of concern, as
well as suitable for the type of tasks.

Close-fitting goggles or a full-face piece facemask are preferred for vapor, mist, or fume
exposures, or wherever workplace contaminants can readily bypass loose-fitting equipment.

The information is collected in a file attachment. The system will display instructional text for
you to identify which forms should be uploaded.

Provide the MSDS for the PMN substance or intermediate or product mixture (that contains it) as
an attachment to the PMN. Also, include hazard warning statements or labels, if relevant. The
personal protection requirements of the MSDS become integral requirements of an LVE notice.

• CBI: Check the 'CBI' checkbox to claim the production volume information as confidential.

• Binding: Check the 'Binding' checkbox to claim the production volume information as
binding. This checkbox is enabled for LVE or LVE modifications only.

• Maximum first 12-month production: Provide an estimate of the first 12 months of
production. The entered value must be a numerical value and must be greater than zero but less
than 100,000,000,000,000 kg/year. This field accepts decimals to the milligram and is a
required field if you do not have a pending Joint Submission and/or Letter of Support.

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• Maximum 12-month production: Enter the data associated with the production volume.
Provide an estimate of the maximum production volume for any consecutive 12-month period
during the first three (3) years of commercial manufacture. The entered value must be a
numerical value and must be greater than zero but less than 100,000,000,000,000 kg/year. This
value must be greater than or equal to the 'Maximum first 12-month production' value. This
field accepts decimals to the milligram and is a required field if you do not have a pending
Joint Submission and/or Letter of Support.

• Binding: Check the 'Binding' checkbox to claim the hazard information as binding.

• Attachments: Select the section of the page with which the attached document is associated.
This drop-down menu contains the following value: 'Production Information Section' and
'Hazard Information Section.'

• Section: Displays the section with which the document is associated.

• File Name: Displays the file name and file extension of the file that is uploaded on the 'Attach
Documents' pop-up window. Click the file name link to navigate to the 'Attach Documents'
pop-up window to make any edits.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( -) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

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Exhibit 4-17 shows a screen capture of the 'Production Volume and Hazard/Safety Information'
screen:

Exhibit 4-17: Production Volume and Hazard/Safety Information Screen

Home J Forms J Resources

Logged in as: Jane Doe, Secondary' Support

Log Out

Premanufacture Notice
Secondary Support

^Remove

©Copy

$ & Chemical 2304

Chemical
Identification

Polymer

Identification

Information

Monomers and
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Additional Chemical
Information

I Pi oriuction
Volume and
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? _ Site Information

Pi emanufacture Notice (Joint PMN-20130502-14:09:03 EDT> > Pioduction Volume and Hazard Safety Infoimation

PRODUCTION VOLUME AND HAZARD/SAFETY INFORMATION

On a 100% new chemical substance basis, please provide the following production volume information:

Check the binding option if you are willing to submit to being regulated based on the information provided.
LVE submissions that are not bound will be assessed at 10,000 kg production volume.

C.1. Production Volume

Maximum first 12-month production:
Maximum 12-month production:

CBI: ~ Binding: ~

kg/yr
kg/yr

3. Hazard Information Binding: ~

Include in the notice a copy or 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 handling, transport,
use, or disposal of the new substance.

Select which section the attachment applies to and then attach the file.

Click here to attach a file Attach Document

Section

File Name

Description

Pages CBI Actions

| Next |

I 1

Validate

Save

Preview

CDX Homepage | MyCDX Homepage | EPA Homepage I Terms and Conditions | Privacy Notice I CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Use Information' screen. You can also
access this screen by clicking the 'Use Information' link within the navigation tree.

4.1.11 Use Information

You can navigate to the 'Use Information' screen by clicking the 'Next' button from the
'Production Volume and Hazard/Safety Information' screen. You can also access this screen by
clicking the 'Use Information' link within the navigation tree.

The 'Use Information' screen captures data about how the new chemical substance is intended to
be used by function and application. Function refers to the chemical purpose for which the

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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substance is designed and is often based on the physical and chemical properties of the
substance. Application refers to how the substance is used in particular processes or products. An
example of a function and application would be as a dispersive dye for finishing polyester fibers.
When you navigate to the screen, the screen contains instructional text and an 'Add Use' button.
When you click the 'Add Use' button, an expandable/collapsible field set opens and displays the
'Use Information' fields. Upon saving the entry, the expandable/collapsible field set collapses
and displays the 'Category of Use' and 'Production %' values.

You will first enter a description for the 'Category of Use' field. Each use will center on the
'Category of Use' and the different variables surrounding it. The category of use information
should be specific enough to allow EPA reviewers to anticipate potential exposure patterns for
the new substance (e.g. merely indicating "Dye" is not sufficient - is it photographic dye, a
reactive dye for nylon fibers, or a dye to be incorporated in a polymer making film?). LVE
notices limit you to your stated category of use(s), so make sure your description fully
encompasses all intended uses for any LVE. When you claim the 'Category of Use' as CBI, you
are required to enter a 'Generic Use Description.' The generic use description will be available
publicly.

The table captures the different elements of use that the PMN form captures. The 'Production %'
and '% in Formulation' values will be captured to indicate how the product will be used and at
what percent in that use. Each use must capture the percent of the production and percent in
formulation for each category of use. The 'Production %' must equal up to 100% for all uses if
there is no pending Letter of Support or Joint Submission for the form, and the field can be
declared CBI. The '% in Formulation' value can equal up to 100%, and the field can be declared
CBI.

The '% of substance expected' per use is captured for the following categories: 'Site Limited,'
'Consumer,' 'Industrial,' and 'Commercial.' The '% of substance expected' value must total
100%. The '% of substance expected' values can be claimed as CBI or listed as binding. These
use types are used to determine the risks that the chemical will place on society.

• Add Use: Click the 'Add Use' button to add a new use information expandable/collapsible
field set.

• Delete: Click the 'Delete' icon ( -*) located in the upper right-hand corner of the
expandable/collapsible field set to delete the field set. A confirmation message displays to
confirm the deletion.

• Expand All: Click the 'Expand All' link located at the upper-right of the
expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the 'Collapse All' link located at the upper-right of the
expandable/collapsible field sets to collapse a series of field sets.

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• Category of Use: Enter the category of use for the specific chemical substance by function and
application. This is a required field.

• CBI: Check the 'CBI' checkbox to claim the category of use information as confidential and
generate the 'Generic Use Description' field. Claiming the 'Category of Use' field as CBI and
then un-checking the 'CBI' checkbox generates a confirmation message that all attached
documents will be deleted.

• Binding: Check the 'Binding' checkbox to claim the category of use information as binding.

• C.2.b. Generic Use Description: Enter the generic use description of the chemical. This field
displays when the 'Category of Use' field is claimed CBI. If you claim any category of use
description as confidential, enter a generic description of that category. This field is required
when the 'Category of Use' field is claimed CBI.

• Total Production for this Use %: Enter an estimate of the percent of total production for the
first three years devoted to each category of use for the specific chemical. The entered value
must be a value greater than zero (0) but less than or equal to one hundred (100). The
'Production %' must equal up to 100% for all uses if there is no pending Letter of Support or
Joint Submission for the form. This field allows for decimal values. This is a required field.

• CBI: Check the 'CBI' checkbox to claim the 'Total Production for this Use' information as
confidential.

• In Formulation %: Estimate the percent of the new substance as formulated in mixture,
suspensions, emulsions, solutions, or gels as manufactured for commercial purposes at sites
under your control associated with each category of use. The entered value must be a value
greater than zero (0) but less than or equal to one hundred (100) and can include decimal
values. This is a required field.

• CBI: Check the 'CBI' checkbox to claim the 'Percentage in Formulation' information as
confidential.

• CBI: Check the 'CBI' checkbox to claim the percentage of substance expected per use
information as confidential.

• Binding: Check the 'Binding' checkbox to claim the percentage of substance expected per use
information as binding.

• Site Limited %: Enter the site limited percentage of substance expected per use for the
submitted substance. Blank fields are recognized as zeroes. This field allows for decimal
values. Break down the use(s) by percentage for the indicated end user categories. For
example, site-limited means the substance will only be used on the adjacent property unit
where manufactured and will not intentionally be removed from the site except for waste
disposal.

• Consumer %: Enter the consumer percentage of substance expected per use for the submitted
substance. Blank fields are recognized as zeroes. This field allows for decimal values. Break
down the use(s) by percentage for the indicated end user categories. Consumer use means that
private individuals will use the chemical substance or products containing the substance for
personal use or enjoyment.

• Industrial %: Enter the industrial percentage of substance expected per use for the submitted
substance. Blank fields are recognized as zeroes. This field allows for decimal values. Break

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down the use(s) by percentage for the indicated end user categories. Industrial use means that
the chemical substance or product containing the substance will be used at the locations of
other manufacturers or processors.

• Commercial %: Enter the commercial percentage of substance expected per use for the
submitted substance. Blank fields are recognized as zeroes. This field allows for decimal
values. Break down the use(s) by percentage for the indicated end user categories. Indicate
percentage of product volume expected for the listed "use" sectors. Commercial use refers to
the chemical substance or product containing the chemical substance being used by a company
to provide a consumer service.

• If you have provided a "consumer" use, provide details: Enter consumer use details.
Provide 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. This is a required field if the 'Consumer % of substance
expected per use' field is populated and is a value greater than zero (0).

• CBI: Check the 'CBI' checkbox to claim the 'If you have provided a 'consumer' use, provide
details' information as confidential.

• File Name: Displays the file name and file extension of the file uploaded on the 'Attach
Documents' pop-up window. Click the 'File Name' link to navigate to the 'Attach Documents'
pop-up window to make any edits.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( -) to delete the entire attached document row permanently
from the system. A warning message displays to confirm deletion of the document.

• Production Total: Displays the total production percentage for all uses. This value must be
equal to 100, unless a Joint Submission or Letter of Support is pending, in which case the total
value requirement is not immediately applicable.

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Exhibit 4-18 shows a screen capture of the 'Use Information' screen (Scroll 1):

Exhibit 4-18: Use Information Screen (Scroll 1)

¦ Logged in as: Jane Doe, Secondary Support

Log Out

Premanufacture Notice
Secondary Support

Chemical 2304

"'[] Chemical
i I Identification

QPolymer
Identification
Information
Monomers and
Other Reactants
'h Additional Chemical

Information
"(J Production Volume
and Hazard/Safety
Information

Use Information
B ^Physical 8
Chemical
Properties

"f" Physical and

Chemical
{ Properties
Worksheet

"P Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

Bcopy

a^Add Consolidated
Chemical

Site Information

Submitter Controlled Site
Information

Sites Controlled By Others
Submitter Controlled

Premannfactiire Notice (Joint PMN-20130502-14:09:03 EDT) > Use Information

USE INFORMATION

1 i in I All | Coll,ipse All

Cancel

If a use is claimed as confidential, the Generic Use Description (public version of the CBI use) field
must be completed. As you add use information, it will appear below. Click the 'CBI' checkbox for
'Category1 of Use'to hide details. (Click on it again to show those details).

Category of Use: CBI:0 BindingO

(by function and application i.e. a dispersive dye for finishing polyester fibers)

C.2.b. Generic Use Description:

Total Production
for this Use:

In Formulation:

CBlD
]% CBlO

% of substance expected per use:

Site Limited: I 1%
Consumer: | [%
Industrial

CBlD BindingO

~ B

Validate Save

Preview

CDX Homepage

| MyCDX Homepage |

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8S

38) 890-1995

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Exhibit 4-19 shows a screen capture of the 'Use Information' screen (Scroll 2):

Exhibit 4-19: Use Information Screen (Scroll 2)

Logged in as: Jane Doe, Secondary Support

r Forms T Resouices

Log Out

Premanufacture Notice
Secondary Support

Chemical 2304

"(j Chemical
Identification

"!j Polymer
Identification
Information
"f~ Monomers and

Other Reactants
fg Additional Chemical

Information
"|j Production Volume
and Hazard/Safety
Information

Use Information
$ ®Pliysical &

Chemical
Properties

f"! HlPhysical and
Chemical
Properties
Worksheet

*1 and
Chemical
Properties
Worksheet -
Continued
(Optional)

Bcopy

j^Add Consolidated
Chemical

? Site Infor motion

Submitter Controlled Site
Information

"2jSites Controlled By Others

$" Submitter Controlled \

for this Use:

!% cbiD

In Formulation:

% of substance expected per use:

CBlD BindingO

Site Limited:
Consumer*:
Industrial:
Commercial:

J%
>
%

Total: 0 %

* If you have provided a "consumer" use, provide details: CBlO

Attach Document

File Name

Description

Save

Pages CBi Actions

Click the Add Use button to populate a Use. iiAildllse:

Production Total:0.0';

| Next |

y/ S

Validate Save

Preview

CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8S

J8) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Physical and Chemical Properties
Worksheet' screen. You can also access this screen by clicking the 'Physical and Chemical
Properties' link within the navigation tree.

4.1.12 Physical and Chemical Properties Worksheet

You can navigate to the 'Physical and Chemical Properties Worksheet' screen by clicking the
'Next' button from the 'Use Information' screen. You can also access this screen by clicking the
'Physical and Chemical Properties Worksheet' link within the navigation tree.

The 'Physical and Chemical Properties Worksheet' screen is used to capture optional
information about a chemical's properties. EPA uses the chemical properties to determine

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additional safety data about a chemical; the properties are used to determine potential risks and
exposures of the chemicals.

The properties for a chemical are captured in an expandable/collapsible field set format. The
following categories may apply to a chemical: 'Physical state of neat substance,' 'Vapor Pressure

@ temperature,' 'Density/relative density,' 'Solubility @ temperature solvent ,'

'Solubility in water @ temperature ,' 'Melting temperature,' 'Boiling/sublimation

temperature @ ,' 'Spectra,' 'Dissociation constant,' 'Particle size distribution,'

'Octanol/water partition coefficient,' 'Henry's Law constant,' 'Volatilization from water,'
'Volatilization from soil,' 'pH @ concentration [concentration],' 'Flammability,'

'Explodability,' and 'Adsorption/coefficient.' All of the properties will capture the relevant
values for a chemical. Each property may be claimed individually as CBI.

To enter physical/chemical property information, select a physical/chemical property from the
drop-down menu and click the 'Add Property' button. The expandable/collapsible field set
expands and displays all fields that should be entered for that property. You are then able to enter
all relevant information regarding that property. Value fields are able to accept '<' or '>'
symbols. When all information is entered, click the 'Save' button. Each property may only be
entered once per chemical.

You may also enter an option for 'Other.' The 'Other' option will allow you to enter a user-
specified property and any relevant values. The property will capture the relevant values for the
chemical and the property measurement can be identified as 'Measured' or 'Estimate.' The
'Other' option may be claimed individually as CBI. You may enter multiple properties as
'Other.'

You may upload attachments for the chemical properties on the 'Physical and Chemical
Properties Worksheet - Continued (Optional)' screen.

EPA's risk assessment process does utilize physiochemical properties, as some of the attributes
listed here can relate directly to chemical risks. Among the most useful parameters of a new
substance to EPA are the boiling point, the melting point, vapor pressure, the octanol/water
partition coefficient, water solubility, Henry's Law Constant, hydrolysis, spectral data, mass
spectrometry (MS), proton and C13 Nuclear Magnetic Resonance (NMR), Infrared (IR), and
Ultraviolet (UV) absorption, and the soil/sediment absorption coefficient. In the absence of this
data, EPA will estimate to the extent possible physiochemical data to aid in their risk
evaluations.

Indicate whether the value you provide is based on an actual test measurement ('Measured') or is
based on an estimate ('Estimate'). Note that EPA staffers indicate that data qualifiers such as
'negligible' or 'soluble' are not useful descriptions.

You are not required to generate the listed test data if you do not have it.

Physical/chemical properties data may be so unique that they could in the future link the PMN
substance to a commercial product or may tend to identify unique classes of chemical substance,
and therefore some data elements may represent confidential business information. Review the
CBI status of each entry carefully, and avoid making unsupportable claims.

Please note that in IE 7, all physical/chemical properties you wish to add must be identified
before navigating away from this page; otherwise, the properties are removed from the 'Add
Property' drop-down menu. In addition, you will be able to add the 'Henry's Law constant'

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property more than once, and the chemical property fields located within the
expandable/collapsible fields sets on this page will be disorganized. After clicking the 'Next'
button, you will navigate to the 'Physical and Chemical Properties Worksheet - Continued
(Optional)' screen. After clicking the 'Previous' button, the physical/chemical properties have
been removed from the 'Add Property' drop-down menu.

• Add Property: Click the 'Add Property' button to add and open a new 'Property'
expandable/collapsible field set for a selected property.

• Cancel: Click the 'Cancel' link located in the upper right-hand corner of an
expandable/collapsible field set to prevent edits from saving and to remove a field set. The
'Cancel' link displays when an expandable/collapsible field set is open for editing. A
confirmation message displays to confirm the action.

• Edit: Click the 'Edit' link located in the upper right-hand corner of an expandable/collapsible
field set to modify the information entered in the fields. The 'Edit' link displays when the
expandable/collapsible field set has been saved and the data is not currently editable.

• Delete: Click the 'Delete' icon ( -*) located in the upper right-hand corner of an
expandable/collapsible field set to delete the field set. A confirmation message displays to
confirm the deletion.

• Expand All: Click the 'Expand All' link located at the upper right-hand corner of the
expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the 'Collapse All' link located at the upper right-hand corner of the
expandable/collapsible field sets to collapse a series of field sets.

• Adsorption/Coefficient - Value: Enter the adsorption/coefficient value of the chemical
substance. Value fields are able to accept '<' or '>' symbols. This is a required field if the
'Adsorption/coefficient' property is selected.

• Adsorption/Coefficient - Measured or Estimate: Indicate whether the property value is
'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-down
menu. This is a required field if the 'Adsorption/coefficient' property is selected.

• Adsorption/Coefficient - CBI: Check the 'CBI' checkbox to claim the adsorption/coefficient
property as confidential.

• Boiling/sublimation temperature @ - Value: Enter the boiling/sublimation temperature in °C
of the chemical substance. This is a required field if the 'Boiling/sublimation temperature @'
property is selected.

• Boiling/sublimation temperature @ [pressure] torr: Enter the value of the pressure in torr
for which the boiling/sublimation of the chemical substance was determined. Value fields are
able to accept '<' or '>' symbols. This is a required field if the 'Boiling/sublimation
temperature @' property is selected.

• Boiling/sublimation temperature @ - Measured or Estimate: Indicate whether the property
value is 'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-
down menu. This is a required field if the 'Boiling/sublimation temperature @' property is
selected.

• Boiling/sublimation temperature @ - CBI: Check the 'CBI' checkbox to claim the
'Boiling/sublimation temperature @' property as confidential.

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• Density/relative density - Value: Enter the density/relative density value of the chemical
substance in g/cm3. Value fields are able to accept '<' or '>' symbols. This is a required field
if the 'Density/relative density' property is selected.

• Density/relative density - Measured or Estimate: Indicate whether the property value is
'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-down
menu. This is a required field if the 'Density/relative density' property is selected.

• Density/relative density - CBI: Check the 'CBI' checkbox to claim the 'Density/relative
density' property as confidential.

• Dissociation constant - Value: Enter the dissociation constant value of the chemical
substance. Value fields are able to accept '<' or '>' symbols. This is a required field if the
'Dissociation constant' property is selected.

• Dissociation constant - Measured or Estimate: Indicate whether the property value is
'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-down
menu. This is a required field if the 'Dissociation constant' property is selected.

• Dissociation constant - CBI: Check the 'CBI' checkbox to claim the 'Dissociation constant'
property as confidential.

• Explodability - Value: Enter the explodability value of the chemical substance. This field
allows text or numbers to be entered and is also able to accept '<' or '>' symbols. This is a
required field if the 'Explodability' property is selected.

• Explodability - Measured or Estimate: Indicate whether the property value is 'Measured' or
based on an 'Estimate' by selecting the appropriate value from the drop-down menu. This is a
required field if the 'Explodability' property is selected.

• Explodability - CBI: Check the 'CBI' checkbox to claim the 'Explodability' property as
confidential.

• Flammability - Value: Enter the flammability value of the chemical substance. This field
allows text and is also able to accept '<' or '>' symbols. This is a required field if the
'Flammability' property is selected.

• Flammability - Measured or Estimate: Indicate whether the property value is 'Measured' or
based on an 'Estimate' by selecting the appropriate value from the drop-down menu. This is a
required field if the 'Flammability' property is selected.

• Flammability - CBI: Check the 'CBI' checkbox to claim the 'Flammability' property as
confidential.

• Henry's Law constant - Value: Enter the Henry's law constant value of the chemical
substance in atm-m3/mole. Value fields are able to accept '<' or '>' symbols. This is a required
field if the 'Henry's Law constant' property is selected.

• Henry's Law constant - Measured or Estimate: Indicate whether the property value is
'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-down
menu. This is a required field if the 'Henry's Law constant' property is selected.

• Henry's Law - CBI: Check the 'CBI' checkbox to claim the 'Henry's Law constant' property
as confidential.

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• Melting Temperature - Value: Enter the melting temperature of the chemical substance in °C.
Value fields are able to accept '<' or '>' symbols. This is a required field if the 'Melting
Temperature' property is selected.

• Melting Temperature - Measured or Estimate: Indicate whether the property value is
'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-down
menu. This is a required field if the 'Melting Temperature' property is selected.

• Melting Temperature - CBI: Check the 'CBI' checkbox to claim the 'Melting Temperature'
property as confidential.

• Octanol/water partition coefficient - Value: Enter the octanol/water partition coefficient
value of the chemical substance. Value fields are able to accept '<' or '>' symbols. This is a
required field if the 'Octanol/water partition coefficient' property is selected.

• Octanol/water partition coefficient - Measured or Estimate: Indicate whether the property
value is 'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-
down menu. This is a required field if the 'Octanol/water partition coefficient' property is
selected.

• Octanol/water partition coefficient - CBI: Check the 'CBI' checkbox to claim the
'Octanol/water partition coefficient' property as confidential.

• Particle size distribution - Value: Enter the particle size distribution value of the chemical
substance. Value fields are able to accept '<' or '>' symbols. This is a required field if the
'Particle size distribution' property is selected.

• Particle size distribution - Measured or Estimate: Indicate whether the property value is
'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-down
menu. This is a required field if the 'Particle size distribution' property is selected.

• Particle size distribution - CBI: Check the 'CBI' checkbox to claim the 'Particle size
distribution' property as confidential.

• Physical state of neat substance - Value: Select the physical state of a neat substance of
chemicals, which can be either a 'Solid,' 'Liquid,' or 'Gas.' This is a required field if the
'Physical state of neat substance' property is selected.

• Physical state of neat substance - Measured or Estimate: Indicate whether the property
value is 'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-
down menu. This is a required field if the 'Physical state of neat substance' property is
selected.

• Physical state of neat substance - CBI: Check the 'CBI' checkbox to claim the 'Physical
state of neat substance' property as confidential.

• pH @ concentration [concentration]: Enter the concentration at which the pH was measured.
This field allows for text. This is a required field if the 'pH @ concentration [concentration]'
property is selected.

• pH @ concentration [concentration] - Value: Enter the pH value. This field allows text and
is also able to accept '<' or '>' symbols. This is a required field if the 'pH @ concentration
[concentration]' property is selected.

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• pH @ concentration [concentration] - Measured or Estimate: Indicate whether the property
value is 'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-
down menu. This is a required field if the 'pH @ concentration [concentration]' property is
selected.

• pH @ concentration [concentration] - CBI: Check the 'CBI' checkbox to claim the 'pH @
concentration [concentration]' property as confidential.

• Solubility @ temperature solvent: Enter the temperature value in °C for which the solubility
was measured. This field allows text and is also able to accept '<' or '>' symbols. This is a
required field if the 'Solubility @ temperature solvent' property is selected.

• Solubility @ temperature solvent - Solvent: Enter the solvent that will be used for the
chemical substance. Value fields are able to accept '<' or '>' symbols. This is a required field
if the 'Solubility @ temperature solvent' property is selected.

• Solubility @ temperature solvent - Value: Enter the solubility of the chemical substance in

g/L.

• Solubility @ temperature solvent - Measured or Estimate: Indicate whether the property
value is 'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-
down menu. This is a required field if the 'Solubility @ temperature solvent' property is
selected.

• Solubility @ temperature solvent - CBI: Check the 'CBI' checkbox to claim the 'Solubility
@ temperature solvent' property as confidential.

• Solubility in Water @ temperature: Enter the temperature value in °C of the chemical for
which the solubility in water was measured. This is a required field if the 'Solubility in Water
@ temperature' property is selected.

• Solubility in Water @ temperature - Value: Enter the solubility in water of the chemical
substance in g/L. Value fields are able to accept '<' or '>' symbols. This is a required field if
the 'Solubility in Water @ temperature' property is selected.

• Solubility in Water @ temperature - Measured or Estimate: Indicate whether the property
value is 'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-
down menu. This is a required field if the 'Solubility in Water @ temperature' property is
selected.

• Solubility in Water @ temperature - CBI: Check the 'CBI' checkbox to claim the
'Solubility in Water @ temperature' property as confidential.

• Spectra - Value: Enter the spectra value of the chemical substance. Value fields are able to
accept '<' or '>' symbols. This is a required field if the spectra property is selected.

• Spectra - Measured or Estimate: Indicate whether the property value is 'Measured' or based
on an 'Estimate' by selecting the appropriate value from the drop-down menu. This is a
required field if the 'Spectra' property is selected.

• Spectra - CBI: Check the 'CBI' checkbox to claim the 'Spectra' property as confidential.

• Vapor Pressure @ temperature: Enter the temperature value in °C of the chemical for which
the vapor pressure was measured. This is a required field if the 'Vapor Pressure @
temperature' property is selected.

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• Vapor Pressure @ temperature - Value: Enter the value of the Vapor Pressure in torr units
of the chemical substance. Value fields are able to accept '<' or '>' symbols. This is a required
field if the 'Vapor Pressure @ temperature' property is selected.

• Vapor Pressure @ temperature - Measured or Estimate: Indicate whether the property
value is 'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-
down menu. This is a required field if the 'Vapor Pressure @ temperature' property is selected.

• Vapor Pressure @ temperature - CBI: Check the 'CBI' checkbox to claim the 'Vapor
Pressure @ temperature' property as confidential.

• Volatilization from water - Value: Enter the volatilization from water value of the chemical
substance. Value fields are able to accept '<' or '>' symbols. This is a required field if the
'Volatilization from water' property is selected.

• Volatilization from water - Measured or Estimate: Indicate whether the property value is
'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-down
menu. This is a required field if the 'Volatilization from water' property is selected.

• Volatilization from water - CBI: Check the 'CBI' checkbox to claim the 'Volatilization from
water' property as confidential.

• Volatilization from soil - Value: Enter the volatilization from soil value. Value fields are able
to accept '<' or '>' symbols. This is a required field if the 'Volatilization from soil' property is
selected.

• Volatilization from soil - Measured or Estimate: Indicate whether the property value is
'Measured' or based on an 'Estimate' by selecting the appropriate value from the drop-down
menu. This is a required field if the 'Volatilization from soil' property is selected.

• Volatilization from soil - CBI: Check the 'CBI' checkbox to claim the 'Volatilization from
soil' property as confidential.

• Other: Enter any 'Other' property that you may specify.

• Other - Value: Enter an 'Other' property value. Value fields are able to accept '<' or '>'
symbols. This is a required field if the 'Other' property was selected.

• Other - Measured or Estimate: Indicate whether the property value is 'Measured' or based
on an 'Estimate' by selecting the appropriate value from the drop-down menu. This is a
required field if the 'Other' property is selected.

• Other - CBI: Check the 'CBI' checkbox to claim the property as confidential.

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Exhibit 4-20 shows a screen capture of the 'Physical and Chemical Properties Worksheet' screen
(Scroll 1):

Exhibit 4-20: Physical arid Chemical Properties Worksheet Screen (Scroll 1)

Premanufacture Notice

Secondary Support

Substances .

l""2 Class 2 Substances
••••g Additional Chemical

Information
~'g|Production Volume
and Hazard/Safety
Information

' pjUse Information
S-^Physical &

Chemical
Properties

Pr|j= Physical and
Chemical
Properties
Worksheet

"I ^[fifiysical and
Chemical
Properties
Worksheet -
Continued
(Optional)

tJ Copy

^ Add Consolidated
Chemical

@"Cj5ite Information

|"fl i Submitter Controlled Site
Information

Sites Controlled By Others
6" Submitter Controlled

¦ Logged in as: Jane Doe. Secondary Support

Log Out

4 Premanufacture Notice (Joint PMN-20130917-12:26:27 EDT} > Physical and Chemical Properties Worksheet
PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET

To assist ERA'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. 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
should submit this worksheet as a supplement to your submission of test data. This worksheet is not a substitute for
submission of test data.

Expand All ] Collapse All

Adsorption/ Coefficient

Edit

Boiling/sublimation temperature @12 torr pressure

Edit

Dissociation constant

Edit

Density/ relative density

Edit

Explodability

Edit

Flammability

Edit

Henry's Law constant

Edit

Melting Temperature

Edit

Octanol/ water partition coefficient

Edit

Particle size distribution

Edit

Physical state of neat substance

Edit

pH @ concentration 12

Edit

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CDX?

Exhibit 4-21 shows a screen capture of the 'Physical and Chemical Properties Worksheet' screen
(Scroll 2):

Exhibit 4-21: Physical arid Chemical Properties Worksheet Screen (Scroll 2)

Premanufacture Notice

Secondary Support

Substances >

HjfjCbss 2 Substances
p-(j Additional Chemical
Information

[-•[ilProduction Volume
and Hazard/Safety
Information

j-Qifee Information
Physical &

Chemical
Properties

f "jj Physical and
Chemical
Properties
Worksheet

I | i '"jj Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

Bcopy

j^Add Consolidated
Chemical

B Site Information

(Submitter Controlled Site
Information
| : ¦ ij | Sites Controlled By Others
$"¦_ Submitter Controlled

¦6. Logged in as Jane Doe. Secondary Support

Log Out

~ Explodability

Edit

~ Flammability

Edit

~ Henry's Law constant

Edit

~ Melting Temperature

Edit

~ Octanol/ water partition coefficient

Edit

~ Particle size distribution

Edit

~ Physical state of neat substance

Edit

~ pH @ concentration 12

Edit

~ Solubility @temperature 12°C solvent

Edit

~ Solubility in Water @ temperature 12CC

Edit

~ Spectra

Edit

~ Vapor Pressure @ temperature 12°C

Edit

~ Volatilization from water

Edit

~ Volatilization from soil

Edit

~ Other: Other

Edit

f 1

•

Validate

Save

Preview

Navigation: Click the 'Next' button to navigate to the 'Physical and Chemical Properties
Worksheet - Continued (Optional)' screen. You can also access this screen by clicking the
'Physical and Chemical Properties Worksheet - Continued (Optional)' link within the navigation
tree.

4.1.13 Physical and Chemical Properties Worksheet - Continued (Optional)

You can navigate to the 'Physical and Chemical Properties Worksheet - Continued (Optional)'
screen by clicking the 'Next' button from the 'Physical and Chemical Properties Worksheet'
screen. You can also access this screen by clicking the 'Physical and Chemical Properties
Worksheet - Continued (Optional)' link within the navigation tree.

The 'Physical and Chemical Properties Worksheet - Continued (Optional)' screen is used to
capture all the studies and attachments that refer to the chemical properties captured on the
'Physical and Chemical Properties Worksheet' screen. When you first access the 'Physical and

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Chemical Properties Worksheet - Continued (Optional)' screen, instructional text, an 'Attach
Document' button, and an attachments table display.

When you attach a document, the properties that were selected on the 'Physical and Chemical
Properties Worksheet' screen will be listed with checkboxes in the 'Attach Documents' window
for you to select with which properties an attachment is associated. Check the properties that are
relevant to the document, and then select a type and subtype value for the document. You will be
able to attach a document, enter a description of the document, and list the number of pages.

The system provides functionality to claim an uploaded document as CBI. If a document is
claimed as CBI, the system requires you to upload the sanitized version of the attached
document. To view, open, or edit previously attached documents, click the appropriate file name
of the document within the 'File Name' column of the attachment table.

The attachment table displays the 'File Name,' 'Properties,' 'Description,' 'Pages,' 'CBI,' and
'Actions' columns. Click the 'Delete' icon ( *£) located under the 'Actions' column to delete
unwanted documents.

• File Name: Displays the file name and file extension of the original file that is uploaded on the
'Attach Documents' pop-up window. Click the 'File Name' link to navigate to the 'Attach
Documents' pop-up window to make any edits.

• Properties: Displays the chemical properties associated with a document.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( -) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

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Exhibit 4-22 shows a screen capture of the 'Physical and Chemical Properties Worksheet -
Continued (Optional)' screen:

Exhibit 4-22: Physical and Chemical Properties Worksheet - Continued (Optional) Screen

Home J Forms J Resources

Logged in as: Jarie Doe, Secondary Support

Log Out

Premanufacture Notice

Secondary Support
If JL Chemical 2304

j"l "[Chemical
Identification

] j'Qpc^ymer

Identification
Information
Monomers and
Other Reactants
Additional Chemical
Information

¦"(5 production Volume
and Hazard/Safety
Information

j""|3]Use Information
15 ^Physical &

Chemical
Properties

| p[i Physical and
Chemical
Properties
Worksheet

Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

"El Copy

< Pi emanufactui e Notice (Joint PMN-20130502-14:09:03 EDT) > Physical and Chemical Properties Worksheet - Continued
(Optional)

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET - CONTINUED (OPTIONAL)

Select the physical/chemical properties that each attachment applies to, browse for a file, and then upload
to attach a document to chemical properties.

Attach Document

File Name

Properties

Description

Pages

CBI

Actions

¦I

Validate

Save

Preview

Navigation: Click the 'Next' button to navigate to the 'Site Information' screen if you have not
identified another chemical. You can also access this screen by clicking the 'Site Information'
link within the navigation tree. If you would like to add a consolidated chemical, click the 'Add
Consolidated Chemical' link within the navigation tree.

4.1.14 Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents

You can navigate to the 'Attach Documents' window by clicking the 'Attach Document' button
on the 'Physical and Chemical Properties Worksheet - Continued (Optional)' screen.

When attaching a document, the properties selected on the 'Physical and Chemical Properties
Worksheet' screen will display with checkboxes to allow the properties to which the attachment
refers to be selected. Select the type and subtype for the attachment and the properties relevant to
the document, attach the document, and enter the number of pages.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014

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The system allows the uploaded document to be claimed as CBI. If a document is claimed as

CBI, the system requires the sanitized version of the attached document to be uploaded. To

access or edit previously attached documents, click the appropriate file name of the document

within the 'File Name' column of the attachment table.

• Type: Select the document type from the drop-down menu.

• Subtype: Select the document subtype from the drop-down menu.

• Chemical Properties: Displays the physical and/or chemical properties identified on the
'Physical and Chemical Properties Worksheet' screen that can be potentially associated with a
document. Check the appropriate chemical properties that are associated with a document that
is being attached. These checkboxes are enabled only if 'Physical Chemical Property' is
selected from the 'Type' drop-down menu.

• Attachment: Displays the 'Browse' button to search for and identify documents on your local
hard drive to be attached that can be associated with the physical/chemical properties identified
on the 'Physical and Chemical Properties Worksheet' screen.

• Description: Enter the description associated with a document.

• Pages: Enter the number of pages a document contains.

• CBI: Check the 'CBI' checkbox to claim the document as confidential.

• Sanitized Attachment: Click the 'Browse' button to generate the 'File Upload' window to
search for a particular file on your hard drive. For any attached document claimed as CBI, you
are required to attach a sanitized version of the document.

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Exhibit 4-23 shows a screen capture of the 'Physical and Chemical Properties Worksheet -
Continued (Optional) Attach Documents' pop-up window (Scroll 1):

Exhibit 4-23: Physical arid Chemical Properties Worksheet - Continued (Optional) Attach

Documents Pop-Up Window (Scroll 1)

# |T

ATTACH DOCUMENTS

Type and Subtype TYPe:

Select the type and subtype Health To>!lcit/
of the attachment

Subtype:

Chemical Properties

Adsorption/ Coefficient

Boiling/ sublimation temperature @

Density/ relative density

Dissociation constant

Explodability

Flammability

Henry's Law constant

Melting Temperature

Octanol/ water partition coefficient

Particle size distribution

Physical state of neat substance

pH @ concentration [concentration]

Solubility ©temperature solvent

Solubility in Water ©temperature

Spectra

Vapor Pressure ©temperature
Volatilization from water
Volatilization from soil

Attachment File

Select the file to attach Browse

Description

Provide a description of the
attachment

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Exhibit 4-24 shows a screen capture of the 'Physical and Chemical Properties Worksheet -
Continued (Optional) Attach Documents' pop-up window (Scroll 2):

Exhibit 4-24: Physical arid Chemical Properties Worksheet - Continued (Optional) Attach

Documents Pop-Up Window (Scroll 2)

Sanitized Attachment File:

Select the sanitized file to Browse

attach Attachments containing CBI data require a sanitized copy of the attachment

not containing any CBI data.

Cancel I OK

Navigation: Click the 'Cancel' button or 'X' icon located in the upper right-hand corner to stop
the process of adding document information. Click the 'OK' button to save the entered
information and navigate back to the 'Physical and Chemical Properties Worksheet - Continued
(Optional)' screen.

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4.1.15 Site Information

You can navigate to the 'Site Information' screen by clicking the 'Next' button from the
'Physical and Chemical Properties Worksheet - Continued (Optional)' screen. You can also
access this screen by clicking the 'Site Information' link within the navigation tree.

The 'Site Information' screen captures information about the identification of submitter-
controlled sites and sites controlled by others. If a user indicates there are submitter-controlled
sites, the 'Submitter Operation Information,' 'Occupational Exposures,' and 'Environmental
Releases' screens are automatically generated within the 'Submitter Controlled Operations'
folder within the navigation tree. If a user indicates there are sites controlled by others, the
'Industrial Sites Controlled By Others,' 'Exposures/Releases,' and 'Byproduct Information'
screens automatically generate within the 'Operations Controlled By Others' folder within the
navigation tree upon clicking the 'Next' button. Toll manufacturing sites are considered sites
controlled by the submitter.

• Do you have sites controlled by the submitter?: Select the 'Yes' radio button to indicate that
you have submitter controlled sites to identify; this response automatically generates the
screens within the 'Submitter Controlled Operations' folder in the navigation tree upon
clicking the 'Next' button. Select the 'No' radio button if you do not have any submitter-
controlled sites to identify. An error message displays if a submitter-controlled site displays
within the navigation tree and the 'No' radio button is selected.

• Do you have sites controlled by others?: Select the 'Yes' radio button to indicate that you
have sites controlled by others to identify; this response automatically generates the screens
within the 'Operations Controlled by Others' folder in the navigation tree upon clicking the
'Next' button. Select the 'No' radio button if you do not have any sites controlled by others to
identify. An error message displays if a site controlled by others displays within the navigation
tree and the 'No' radio button is selected.

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Exhibit 4-25 shows a screen capture of the 'Site Information' screen:

Exhibit 4-25: Site Information Screen

Logged in as Jane Doe. Secondary Support

Log Out

Premanufacture Notice

SecornJaiy Support

Srte ti if01 mation

Submitter Controlled
Site Irrf oi malion

Sfles Condoled Others

u Subnwttw Controlled
Operations

9 [JJoperattonl

Submtter Operation
tnfonrwfaon

Occupation#
Exposures

Envwonmertal
Releases

X Remove

> jAdd Operation

Operations Controlled by
Others

< Premanuldciure Notice (Joint PMN-20141208 09:34:26 EST) > Site Information

SITE INFORMATION

i Do you have sites controlled Dy the submitter?
«' Yes O No

2. Do you have sites controlled by others'
Yes • No

[iTlopei .vtioii 1

IhdustrHl Sites
Contrived By
Others

Exposures Releases

0fyprocMct
infonnrtion

X Remove

Vairdate

Saive

Preview

CDX Homepage I

I MyCDX Homepage I

I EPA Homepage | Terms and Conditions |

Privacy Notice I

CDX Hetpdesk (898) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Sites Controlled By Others' screen. You
can also access this screen by clicking the 'Sites Controlled By Others' link within the
navigation tree.

4.1.16 Sites Controlled By Others

You can navigate to the 'Sites Controlled By Others' screen by clicking the 'Next' button from
the 'Site Information' screen. You can also access this screen by clicking the 'Sites Controlled
By Others' link within the navigation tree.

The 'Sites Controlled By Others' screen captures information about known and/or unknown sites
not controlled by the submitter. Complete the 'Operations Controlled By Others' section within
the navigation tree for typical processing or use operations involving the new chemical substance
at sites not controlled by the submitter. 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. Complete a separate 'Operations Controlled By Others' section 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. The

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screen first captures whether there is any data for other controlled sites. If there is no data for
sites controlled by others, the screen will not update and the option of selecting the 'Next' button
is available. If there is data for sites controlled by others, an additional question will appear. The
screen then captures whether site-specific data for the chemical is known for 'Sites Controlled
By Others.' If you indicate that there is site-specific data by selecting the 'Yes' radio button, the
screen will generate a text field to enter the '# of unknown sites' and a 'CBI' checkbox to claim
the number of unknown sites as confidential. If there is no site-specific data, the screen displays
a text box to capture the number of unknown sites.

Please note that in IE 7, after adding a site, the '# of unknown sites' text box label disappears but
the text field and 'CBI' checkbox are still displayed.

• Do you have any sites controlled by others for which you have information to report?: If

you select 'Yes' the screen will display the question 'Do you have site-specific information?' If
you select 'No' only the listed navigation options will display. If an operation controlled by
others displays within the navigation tree, the 'Yes' radio button must be selected for this
question.

• Do you have site-specific information?: If you select 'Yes' the screen generates fields to
capture specific site information. If you select 'No,' an error message displays indicating that
any other sites you have will be deleted.

• # of unknown sites: Enter the number of unknown sites; zero (0) is an acceptable value. This
is a required field.

• CBI: Check the 'CBI' checkbox to claim the number of unknown sites as confidential.

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Exhibit 4-26 shows a screen capture of the 'Sites Controlled By Others' screen:

Exhibit 4-26: Sites Controlled By Others Screen

Premanufaeture Notice
Secondary Support
Cftwntea! §

Stte Information

Sitanftttf Contrcied S*e

Infermetwr*

sites coti*tolled By

Others

Submitter Controlled
Opemions

^ OtWeiJiiioft r

Subnntter Operation
Informuiiai

hf CHXNpatonel
Exposures

Envrorsnertal
Releases

X Remove

iAdd Operation

Opci Sites ControlledBy Olhers

SITES CONTROLLED BY OTHERS

Do you have any sites controlled Dy others for which you have information to report"'
€> YesNo

B.1.9. Operation description

Do you have site-specific information?

Yes • No

The "# of Unknown Sites' field is required Enter '0* rf none
# of unknown sites. 0

CBI

I Mai I

—>/

Validate

Save

Preview

CDXHomepag« | MyCDXHomepase I EPAHomepaae I Terns and Conditions I PrivacyNoiice I CDXHelpdesk (888)890-1995

Navigation: Click the 'Next' button to navigate to the 'Submitter Operation Information' screen.
You can also access this screen by clicking the 'Submitter Operation Information' link within the
navigation tree.

4.1.17 Submitter Operation Information

You can navigate to the 'Submitter Operation Information' screen by clicking the 'Next' button
from the 'Sites Controlled By Others' screen. You can also access this screen by clicking the
'Submitter Operation Information' link under the 'Submitter Controlled Operations' folder
within the navigation tree. You can add additional sites by clicking the 'Add Operation' link
within the navigation tree under the 'Submitter Controlled Operations' folder.

The 'Submitter Operation Information' screen captures information about an operation that
occurs at a particular site or group of sites. You are asked a series of questions and, based on the
responses, a series of fields displays regarding a specific operation. The guided approach is
designed to eliminate errors and ensure the completion of all relevant sections for a site. You will
be able to enter an operation alias to identify the operation. Importers are not required to
complete this section for operations outside the U.S.; however, any industrial processing or use

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operation that takes place after import must be described. It should be noted that Toll
manufacturing sites are considered to be sites controlled by the submitter.

You will first be asked to select the site(s) and chemical(s) for the operation and will then select
the applicable operation type checkboxes.

If you select an option other than 'Use' for the operation type, you will be asked whether the
chemical is manufactured or processed as a 'batch' or 'continuous' process. Based on the
property selected, fill in the relevant information. If you select the 'Use' operation type, then
there will be no further options on this screen. The follow-up screens are used to capture specific
information about the operation type process.

The system provides a text box for describing the process description. Additional process
information may also be included in an attachment. In the process description, include the
following information: (1) Diagram the major unit operation steps and chemical conversions.
Include interim storage and specify transport containers (e.g., 5-gallon pails, 55-gallon drum, rail
car, tank truck, etc.). (2) Provide the identity, approximate weight (by kilograms (kg) kg/day or
kg/batch on a new chemical substance basis), and entry point of all starting materials, feedstocks
(including reactants, solvents, catalysts, etc.), 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.

You may claim the process description or attachment as CBI. If an attached document is claimed
as CBI, the system requires a sanitized version of the attached document to be uploaded. To
access or edit previously attached documents, click the file name of the document within the
'File Name' column of the document table.

The document table displays the file name and file extension of the document, the document
description, the number of pages in the document, and whether a sanitized copy of the document
was attached. Click the 'Delete' icon ( *£) under the 'Actions' column to delete unwanted
documents.

• Operation Alias: Enter the operation alias. This field makes it easier to distinguish between
operations in the navigation tree when there is more than one operation. This is a required field
if the form is pending a Joint Submission or a Letter of Support.

• Add Facility: Click the button to generate the 'Add Facility' pop-up window and select a site
from the drop-down menu to add to the ' Submitter Operation Information' screen.

• Site Name: Displays the site name.

• Address: Displays the site address.

• City: Displays the site city.

• State: Displays the site state.

• Postal Code: Displays the site postal code.

• CBI: Indicates the CBI status of the site by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( *) to delete a site from the table. A warning message
displays to confirm the deletion of the site.

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• Select the chemical(s) that this submission pertains to: Displays all consolidated chemicals
in a PMN submission with associated checkbox(es).

• CBI: Check the 'CBI' checkbox to claim the operation type as confidential.

• Manufacturing: Check the 'Manufacturing' checkbox to indicate that manufacturing is taking
place at the site. Checking the 'Manufacturing' checkbox generates the 'Is it batch or
continuous' radio buttons.

• Processing: Check the 'Processing' checkbox to indicate that processing is taking place at the
site. Checking the 'Processing' checkbox generates the 'Is it batch or continuous' radio
buttons.

• Use: Check the 'Use' checkbox to indicate that chemical use is taking place at the site.

• CBI: Check the 'CBI' checkbox to claim the amount and duration information as confidential.

• Is it batch or continuous?: Select the 'Batch' radio button to indicate that the chemical is
produced in a batch process. Select the 'Continuous' radio button to indicate that the chemical
is produced on a continuous basis. Either the 'Batch' or 'Continuous' radio button is required
to be selected.

• Max kg/batch: Enter the maximum number of kilograms produced per batch. This field only
displays when you select the 'Batch' radio button and is a required field. This field accepts
decimal values.

• Hours/batch: Enter the hours of manufacturing or processing time needed per batch. This field
only displays when you select the 'Batch' radio button and is a required field. This field
accepts decimal values.

• Batches/year: Enter the number of batches produced per year. This field only displays when
you select the 'Batch' radio button and is a required field. This field accepts decimal values.

• Max kg/day: Enter the maximum number of kg of a chemical produced per day. This field
only displays when you select the 'Continuous' radio button and is a required field. This field
accepts decimal values.

• Hours/day: Enter the number of hours per day that the chemical is processed or manufactured;
this value cannot exceed 24. This field only displays when you select the 'Continuous' radio
button and is a required field. This field accepts decimal values.

• Days/year: Enter the number of days per year that the chemical is processed or manufactured;
this value cannot exceed 365. This field only displays when you select the 'Continuous' radio
button, and is a required field. This field accepts decimal values.

• CBI: Check the 'CBI' checkbox to claim the process description as confidential.

• Process Description: Enter the process description. In the 'Process Description' text box, or
an attachment, address the following items: (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

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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. Either this field is required
or a document must be attached.

• File Name: Displays the file name and file extension of the file that is uploaded on the 'Attach
Documents' pop-up window.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

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Exhibit 4-27 shows a screen capture of the 'Submitter Operation Information' screen (Scroll 1):
Exhibit 4-27: Submitter Operation Information Screen (Scroll 1)

j FoimsY Resources

Logged in as: Jane Doe, Secondary Support

Log Out

Pre manufacture Notice

Secorolaiy Support

—

A Add Cormidaied
Cheirtcal

Site Intoi motion

"EkiwnjHer Ccntroled Sde
IntormaSion

Stes Cortrdted By Others

Submitter Controled
Opei alJons

~ [jibperation 1

Submitter
Ope i itUon
Information

Oec-ypaSiorwl
Exposures

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Releases

Add Operation

Opei .r* ions Coirti olte-tl by
Others

~ Crbpc «»tion 1

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Inlormshon

^Remove

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Optional PdMion Prevention

AtJdfconot AttacJwent?

Attacfwent Summary

Optional Cover Letter

Pi ern,ih< lecture Notice (Joint PMN-20130502-14:09:03 E0T> > SuNnitlei Operation Information

SUBMITTER OPERATION INFORMATION

Operation Alias:

Trie operation alias Is an optional field that changes the folder name In the navigation tree on the left, its
purpose is to make it easier to distinguish between operations when there Is more than one. The operation
alias is required if a letter of support and/or joint submission is pending

Please select the site to report operations on:

Arte! Facility

Site Name Address City State

Select the chemical(s) that this submission pertains to

Postal Code

CBI

Actions

~ Chemical 1

~ Chemical 2

A.I.b Operation Type CBI:0

Please select the type of operations present at this site

Manufacturing 0

Processing: 0

Use: ~

A,1.c, Operation Description

Amount and Duration (complete 1 or 2 as appropriate)

Is It batch or continuous?

01 Batch 02 Continuous

A.I.d Process Description CBI: Q

Please describe the attached process/operation, [optional)

CBI ~

TT"I

validate

Save

Preview

CDX Homepage I

MyCDXHomepage

EPA Homepage | Terms and Condlllons I

Privacy Notice |

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TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 4-28 shows a screen capture of the 'Submitter Operation Information' screen (Scroll 2):
Exhibit 4-28: Submitter Operation Information Screen (Scroll 2)

Premanufacture Notice
Secondary Support

j&Add Consolidated
Chemical

Site Information

'Submitter Controlled Site
Information

b^ites Controlled By Others

Submitter Controlled
Operations

Bfjtjoperation 1

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Operation
Information

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: JCRemove
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Optional Pollution Prevention
Additional Attachments
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Optional Cover Letter

iey Forms * Resources

A.1.b Operation Type CBI:0

Please select the type of operations present at this site.

Manufacturing: 0

Processing: 0

Use: ~

A.1.C. Operation Description

Amount and Duration (Complete 1 or 2 as appropriate):
Is it batch or continuous?

01 ¦ Batch 02. Continuous
max kg/day:

Logged in as: Jane Doe, Secondary Support

Log Out

CBI: ~

(100% new chemical substance)

hours/day:
days/year:

A.1.d Process Description CBI: ~

Please describe the attached process/operation, (optional)

Attach Document

File Name

Description

Pages

|~Next**j

CBI

Actions

I i

Validate

Save

Preview

CDX Homepage I MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDXHelpdesk: (888) 890-1935

Navigation: Click the 'Next' button to navigate to the 'Occupational Exposures' screen. You
can also access this screen by clicking the 'Occupational Exposures' link within the navigation
tree.

4.1.18 Occupational Exposures

You can navigate to the 'Occupational Exposures' screen by clicking the 'Next' button from the
'Submitter Operation Information' screen. You can also access this screen by clicking the
'Occupational Exposures' link within the navigation tree.

Click the 'Add' button to generate an expandable/collapsible field set to enter occupational
exposure information. The application displays fields for you to enter information for 'Worker

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Category (1),' 'Worker Activity (1),' 'Protective Equipment/Engineering Controls (3),' 'Physical
Form(s) (5),' '% New Substance (5),' '# Workers Exposed (8),' 'Maximum Duration Hours/Day
(10),' and 'Maximum Duration Days/Year (11).' EPA is attempting to estimate exposure levels,
the number of workers potentially exposed, and possible routes and duration of exposure to the
PMN substance. Work with your plant engineers to develop accurate data; review the CBI status
of data you provide.

Information entered into the 'Maximum Duration Hours/Day (10)' and 'Maximum Duration
Days/Year (11)' fields must be a positive whole number or decimal. The system does not allow
special characters to be saved in these fields. If further explanation is required regarding duration
of exposure, please provide this in an attachment.

• Add: Click the 'Add' button to generate the 'Occupational Exposure - Submitter Controlled
Sites' expandable/collapsible field set.

• Cancel: Click the 'Cancel' link located in the upper right-hand corner of the
expandable/collapsible field set to prevent edits from saving and remove the field set. The
'Cancel' link displays when the expandable/collapsible field set is open for editing. A
confirmation message displays to confirm the action.

• Expand All: Click the 'Expand All' link located at the upper-right of the
expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the 'Collapse All' link located at the upper-right of the
expandable/collapsible field sets to collapse a series of field sets.

• Worker Category (1): Select the category of work from the drop-down menu in which a
worker may be exposed to a chemical substance. This is a required field.

• CBI: Check the 'CBI' checkbox to claim worker category information as confidential.

• Worker Activity (1): Select the worker activity (e.g. bag dumping, tote filling, unloading
drums, sampling, cleaning, etc.) in which workers may be exposed to a chemical substance.
Please note that if you are populating this field via an XML file created from the ePMN thick
client, this drop-down menu will not populate. This is a required field.

• User Defined Worker Activity: Enter the worker activity in which workers may be exposed
to a chemical substance. This field displays only for certain worker activity values.

• Protective Equipment/Engineering Controls (3): Enter the protective equipment/engineering
controls used to protect workers. This is a required field.

• CBI: Check the 'CBI' checkbox to claim the protective equipment/engineering controls
information as confidential.

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• Binding: Check the 'Binding' checkbox to claim the protective equipment/engineering
controls information as binding.

• Physical Form(s) (5): Enter the physical forms(s) of the new chemical substance (e.g., solid,
crystal, granule, powder, or dust) at the time of exposure. Be as specific as possible on the
physical form (e.g., is the PMN substance isolated as a crystalline or amorphous powder, wet
cake, flake solid, granular solid, or a fused solid?). If data on particle size of solids are
available, it should be included as an attachment. For wet cakes, a percent moisture estimate
may prevent EPA from making an estimate that is too conservative. Please pay particular
attention to the information within if this field is populated via XML file. The information
contained within the 'Physical Forms and % New Substance' field in the thick client separates
into two (2) separate fields, the 'Physical Form(s)' field and '% New Substance' field when
these fields are populated via an XML file generated from the ePMN thick client. This is a
required field.

• Binding: Check the 'Binding' checkbox to claim the physical form(s) information as binding.

• % New Substance (5): Enter the percentage of new chemical substance (if part of a mixture)
at the time of exposure. A value of zero (0) entered in this field will display an error. Please
pay particular attention to the information if this field is populated via XML file. The
information contained within the 'Physical Forms and % New Substance' field in the thick
client separates into two (2) separate fields, the 'Physical Form(s)' field and '% New
Substance' field when these fields are populated via an XML file generated from the ePMN
thick client. This is a required field that accepts decimal values.

• Binding: Check the 'Binding' checkbox to claim the percentage new substance information as
binding.

• # Workers Exposed (8): Enter the number of workers exposed. Estimate the maximum
number of all workers involved in each activity for all sites combined. This is a required field.

• CBI: Check the 'CBF checkbox to claim the number of workers exposed as confidential.

• Hours/Day (10): Enter the maximum duration occupational exposure occurs for the activity
for any worker in hours per day; this field allows decimal values. A value of zero (0) entered in
this field will display an error. This is a required field.

• Days/Year (11): Enter the maximum duration occupational exposure occurs for the activity for
any worker in days per year; this field allows decimal values. A value of zero (0) entered in
this field will display an error. This is a required field.

• CBI: Check the 'CBF checkbox to claim the maximum duration values as confidential.

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Exhibit 4-29 shows a screen capture of the 'Occupational Exposures' screen:

Exhibit 4-29: Occupational Exposures Screen

* Logged in as Jane Doe, Secondary Support

Lag Out

Pr*manufacture Notice

Secondary Support

'"Sleepy S

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4 Prmnifactiie Notice (Joint PMN-20130502- 14:0&03 EOT) > Occm),ilioii,il Exposures

OCCUPATIONAL EXPOSURES
A.2 Occupational Exposure - Submitter Controlled Sites

Expand All | Collapse All

B [J)op«ij>tiori 1

Sufoirdter Operation
Inlormalion

OccU|)»rt»
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CDXr

(manufacturing, each processing description, and any use diagrams). The information provided
should focus on the PMN substance. EPA reviewers pay particular attention to human exposure
and environmental release date under their TSCA mandate to protect against unreasonable risks
from new chemical substances. In the absence of this information, EPA will make its own
estimates of worker exposure and environmental release, which are usually conservative. You
should present data that is accurate and as complete as possible.

The page displays an 'Add' button to add an expandable/collapsible field set to enter
'Environmental Release and Disposal - Submitter Controlled Sites' information. The page
displays fields to enter information for 'Release Number,' the amount of the new substance
released 'to environment' and the amount of new substance released 'to control technology,'
'Media of Release,' 'Control Technology Description,' and 'Release after Control Technology.'

You will be asked to enter information concerning the release to water, such as Publicly Owned
Treatment Works (POTW), navigable waterways, and others.

• Add: Click the 'Add' button to generate the 'Environmental Release and Disposal - Submitter
Controlled Sites' expandable/collapsible field set.

• Expand All: Click the 'Expand All' link located at the upper-right of the
expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the 'Collapse All' link located at the upper-right of the
expandable/collapsible field sets to collapse a series of field sets.

• Release Number (1): Enter the number of each release point identified in the process
description on the 'Submitter Operation Information' screen. This is a required field.

• CBI: Check the 'CBI' checkbox to claim the release number information as confidential.

• Amount of new substance released to Environment (2a): Select the applicable radio button
and enter the amount of new substance released to environment. Release estimates should be
consistent with the release levels shown on the preceding flow diagram on the 'Submitter
Operation Information' screen. Include intermittent release estimates from cleaning of
equipment and transportation containers, even if cleaned off-site. Either the 'Amount of new
substance released to Environment' or the 'Amount of new substance released to Control
Technology' field should be populated.

• Amount of new substance released to Environment kg/day: Select the radio button to claim
that the amount of new substance released to the environment is measured in kilograms per
day.

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• Amount of new substance released to Environment kg/batch: Select the radio button to
claim that the amount of new substance released to the environment is measured in kilograms
per batch.

• Amount of new substance released to Control Technology (2b): Enter the amount of new
substance released to control technology. Release estimates should be consistent with the
release levels shown on the proceeding flow diagram on the 'Submitter Operation Information'
screen. Include intermittent release estimates from cleaning of equipment and transportation
containers, even if cleaned off-site. Either the 'Amount of new substance released to
environment' or the 'Amount of new substance released to Control Technology' field should
be populated.

• Amount of new substance released to Control Technology kg/day: Select the radio button
to claim that the amount of new substance released to control technology is measured in
kilograms per day.

• Amount of new substance released to Control Technology kg/batch: Select the radio button
to claim that the amount of new substance released to control technology is measured in
kilograms per batch.

• Media of Release (4): Identify the media of release (i.e., stack air, fugitive air, surface water,
on-site or off-site land or incineration, POTW, or other (please specify)) to which the new
substance will be released from that release point from the drop-down menu. This is a required
field.

• CBI: Check the 'CBI' checkbox to claim the media of release as confidential.

• If Other, specify: Enter the other media of release when you select 'Other' from the 'Media of
Release' drop-down menu.

• Control Technology Description (5a): Enter the control technology description. Describe
control technology, if any, and control efficiency 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 Resource Conservation and Recovery Act (RCRA)
hazardous waste. 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. Indicate if you want this
information to bind. Check the 'CBI' checkbox if the information is confidential. This is a
required field.

• Binding: Check the 'Binding' checkbox to claim the control technology description as
binding.

• Release after Control Technology (5b): Enter the release after control technology. Estimate
the amount released to the environment after control technology (in kilograms per day). This is
a required field.

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• POTW Name: Enter the POTW (publicly owned treatment works) name.

• POTW NPDES #: Enter the POTW National Pollutant Discharge Elimination System
(NPDES) number.

• POTW CBI: Check the 'CBI' checkbox to claim the POTW as confidential.

• Navigable Waterway Name: Enter the navigable waterway name.

• Navigable Waterway NPDES #: Enter the navigable waterway NPDES number.

• Navigable Waterway CBI: Check the 'CBI' checkbox to claim the navigable waterway as
confidential.

• Other (Specify) Name: Enter the name of the other destination of release to water.

• Other (Specify) CBI: Check the 'CBI' checkbox to claim the other destination of release to
water as confidential.

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Exhibit 4-30 shows a screen capture of the 'Environmental Releases' screen (Scroll 1):
Exhibit 4-30: Environmental Releases Screen (Scroll 1)

• Logged in as Jane Doe, Secondary Support

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Pre manufacture Notice

Secoitdaiy Support

' ficopy fi

conscfctaec*

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< PieiiiEuvnonnitMrt.ilReleases

ENVIRONMENTAL RELEASES
A,3. Environmental Release and Disposal - Submitter Controlled Sites

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Amount of new substance released
lo Environment (2a)

to Control Technology (2b):

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Kg/Day Kg/Batcn

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Save

Click tbe Add button to add an environmental release and disposal 'Add

Validate

Save

Preview

COX Homepage |

I MyCDX Homepage I

. EPA Homepage ) Terms and Conditions I

Privacy Notice I

COX Helpdesk (088) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 4-31 shows a screen capture of the 'Environmental Releases' screen (Scroll 2):
Exhibit 4-31: Environmental Releases Screen (Scroll 2)

Premanutacture Notice

Sec Miliary Support

£3 Copy -

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Attachment Sumcrary
Optional Cover letter

Release Number (1)

*¦ Logged in as. Jane Doe, Secondary Support

Log Out

Cancel
Binding

Amount of new substance released
to Environment (2a): i

to Control Technology (2b)

Media of Release (4).

Control Technology Description (5a)

Kg/Day Kg.'Satch

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Release after Control Technology (5b):

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Click the Add button to add an environmental release and disposal Add

A.3.7. MatK the destinations ot release to water

POTW: Name:

Navigable Waterway:
Other (Specify):

Name:
Name:

NPDE3#:
NPDES #.

CBI
CBI
CBI

| WMI |

Validate

Save

Preview

CDX Homepage

I MyCDX Homepage

I EPA Homepage I Terms and Condlllons I

Privacy Notice I

CDX Helpdesk (888) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Industrial Sites Controlled By Others'
screen. You can also access this screen by clicking the 'Industrial Sites Controlled By Others'
link within the navigation tree. Click the 'Add Operation' link under the 'Operations Controlled
By Others' folder within the navigation tree to generate the screens for an operation controlled
by others.

4.1.20 Industrial Sites Controlled By Others

Click the 'Add Operation' link under the 'Operations Controlled By Others' folder within the
navigation tree to generate the screens for an operation controlled by others. You can navigate to

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this screen by clicking the 'Next' button from the 'Environmental Releases' screen. You can also
access this screen by clicking the 'Industrial Sites Controlled By Others' link within the
navigation tree under the 'Operations Controlled by Others' folder.

The 'Industrial Sites Controlled By Others' screen captures information about activities
occurring at a particular site or group of sites. You will be able to enter an operation alias to
identify the operation. Importers are not required to complete this section for operations outside
the U.S.; however, any industrial processing or use operation that takes place after import must
be described.

You will first be asked to select the site(s) and chemical(s) for the operation. You will then
proceed to the next screen to enter resources concerning the operation. The system provides a
field to add an operation process description.

The site(s) and chemical(s) for the operation must be identified. The system then navigates to the
next screen to enter resources concerning the operation. The 'Industrial Sites Controlled By
Others' screen also displays a field to add an operation process description. In the operation
description, include the following information: (1) Diagram the major unit operation steps and
chemical conversions, including interim storage and specify transport containers (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, provide the identity,
the approximate weight (by kg/day or kg/batch, on a 100% new chemical substance basis), and
entry point of all feedstocks (including reactants, solvents and catalysts, etc.), 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, identify by number the points of release, including
small or intermittent releases, to the environment of the new chemical substance.

• Operation Alias: Enter the operation alias. This is a required field if the form is pending a
Joint Submission or a Letter of Support.

• Add Facility: Click the button to generate the 'Add Facility' pop-up window and select a site
from the drop-down menu to add to the 'Industrial Sites Controlled By Others' screen. Refer to
Section Error! Reference source not found, for additional details regarding the add facility
functionality.

• Site Name: Displays the site name.

• Address: Displays the site address.

• City: Displays the site city.

• State: Displays the site state.

• Postal Code: Displays the site postal code.

• CBI: Indicates the CBI status of the site by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete a site from the table. A warning message
confirming deletion of the site displays.

• Select the chemical(s) that this submission pertains to: Displays all consolidated chemicals
in a PMN form.

• Operation Description: Enter the operation process description. Cover the following items:
(1) Diagram the major unit operation steps and chemical conversions, including interim storage

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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, provide the identity, the approximate weight (by kg/day or
kg/batch, on a 100% new chemical substance basis), entry point of all feedstocks (including
reactants, solvents and catalysts, etc.), 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, identify by number the points of release, including small or intermittent
releases, to the environment of the new chemical substance. Either this field is required or a
document must be attached.

• CBI: Check the 'CBI' checkbox to claim the operation description as confidential.

• File Name: Displays the file name and file extension of the document that was uploaded on the
'Attach Documents' pop-up window.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete the entire attached document row permanently
from the system. A warning message displays to confirm deletion of the document.

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Exhibit 4-32 shows a screen capture of the 'Industrial Sites Controlled By Others' screen:
Exhibit 4-32: Industrial Sites Controlled By Others Screen

¦ Logged m as. Jane Doe, secondary support

Log Out

Premanufacture Notice

Secondary Support

XRemcwe G

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Pi-'iiMiiiff.ictiHe Notice (Joint PMN 20130502-14:0^:03 EDI) > hiiltisli i.il Sites Ccrnlioiled By Oflieis

INDUSTRIAL SITES CONTROLLED BY OTHERS

Operation AJIas:

The operation alias is an optional field that changes the folder name In Hie navigation tree on the left. Its
purpose is to make it easier to distinguish between operations when there Is more than one. The operation
alias is required if a letter of support and/or joint submission is pending.

Please select the site to report operations on:

Ackl Facility

Site Name Address City State Postal Code CBI

The Information do this page refers to consolidated chemlcal(s):

Actions

~ Chemical Information 0

~ Chemical Information 1

Operation Description

B 1 b. Please describe the attached process/operation (optional)

CBI: ~

Attdcli Dociime-rtt
File Name

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validate

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Preview

CDX Homepage | MyCDX Homepage I EPA Homepage | Terms and Conditions I Privacy Notice | CDXHelpdesk (988) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Exposures/Releases' screen. You can
also access this screen by clicking the 'Exposures/Releases' link within the navigation tree.

4.1.21 Exposures/Releases

You can navigate to the 'Exposures/Releases' screen by clicking the 'Next' button from the
'Industrial Sites Controlled By Others' screen. You can also access this screen by clicking the
'Exposures/Releases' link within the navigation tree under the 'Operations Controlled By
Others' folder.

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The screen provides buttons to add expandable/collapsible field sets for worker exposure release
information and environmental disposal information. The screen displays fields in the worker
exposure expandable/collapsible field set to enter information for 'Letter of Activity (1),' '#
Workers Exposed (2),' 'Duration of Exposure Hours/Day (4a),' 'Duration of Exposure
Days/Year (4b),' 'Protective Equipment/Engineering Controls (6),' 'Physical Form (6),' '%New
Substance (6),' and '% in Formulation (7).' The screen displays fields in the environmental
release expandable/collapsible field set to enter information for 'Release Number (9),' the
amount of the new substance released directly 'to environment (10a),' the amount of new
substance released 'into control technology (10b),' 'Media of Release (12),' and 'Control
Technology (12).'

Information entered into the 'Duration of Exposure Hours/Day (4a)' and 'Duration of Exposure
Days/Year (4b)' fields must be a positive whole number or decimal. The system does not allow
special characters to be saved in these fields. If further explanation is required regarding duration
of exposure, please provide this in an attachment.

• Add: Click the 'Add' button to generate the 'Worker Exposure' expandable/collapsible field
set.

• Expand All: Click the 'Expand All' link located at the upper-right of the
expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the 'Collapse All' link located at the upper-right of the
expandable/collapsible field sets to collapse a series of field sets.

• Letter of Activity (1): Indicate the activities in which workers may be exposed to the specified
substance.

• CBI: Check the 'CBI' checkbox to claim the letter of activity as confidential.

• # Workers Exposed (2): Enter an estimate of the number of workers exposed for all sites
combined.

• CBI: Check the 'CBI' checkbox to claim the number of workers exposed as confidential.

• Duration of Exposure Hours/Day (4a): Enter an estimate of the typical duration of exposure
per worker in hours/day. This field allows decimal values.

• Duration of Exposure Days/Year (4b): Enter an estimate of the typical duration of exposure
per worker in days/year. This field allows decimal values.

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• CBI: Check the 'CBI' checkbox to claim the duration of exposure hours/day and days/year as
confidential.

• Protective Equipment/Engineering Controls (6): Enter a description of any protective
equipment and engineering controls, if any, used to protect workers. Please pay particular
attention to the information within if this field is populated via XML file. The information
contained within the 'Protective Equipment/Engineering Controls/Physical Forms' field in the
thick client separates into two (2) separate fields, the 'Protective Equipment/Engineering
Controls' and 'Physical Forms' field when these fields are populated via an XML file
generated from the ePMN thick client.

• CBI: Check the 'CBI' checkbox to claim the protective equipment/engineering controls
information as confidential.

• Physical Form (6): Enter a description of physical forms of exposure. Please pay particular
attention to the information populated in this field if this field is populated via XML file. The
information contained within the 'Protective Equipment/Engineering Controls/Physical forms'
field in the thick client separates into two (2) separate fields, the 'Protective
Equipment/Engineering Controls' and 'Physical Forms' field when these fields are populated
via an XML file generated from the ePMN thick client.

• % New Substance (6): Describe percentage of new chemical substance (if in mixture).

• % in Formulation (7): Estimate the percent of the new substance as formulated when
packaged or used as a final product.

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Exhibit 4-33 shows a screen capture of the 'Exposures/Releases' screen (Scroll 1):
Exhibit 4-33: Exposures/Releases Screen (Scroll 1)

Home J Fohiis j Resouces

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Second.* y S«f or motion

Suttfiutter Conlroled Sle
Infcrmatoon

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EXPOSURES/RELEASES

B.2, Worker Exposure Environmental Release - Sites Controlled by Others

worker Category (1):

Loading into Transport ContairrersWBssels

Worker Activity (1):

# Workers Exposed (2)

Duration of Exposure
Hours/Day (4a):

Days/Year (4b); I |

Protective Equipment/ Engineering controls (6):

Physical Forms (6):
% New Substance (6):
% In Formulation (7):

| Save J

Click Add to acffl a worker exposurelAtwJ
Click Add to add an environmental disposal am

Expviml All | Course All
Cancel X

CBI

validate

Save

Preview

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• Add: Click the 'Add' button to generate the 'Environmental Disposal' expandable/collapsible
field set.

• Release Number (9): Enter the number of each release point from the process diagram
previously entered.

• CBI: Check the 'CBI' checkbox to claim the release number information as confidential.

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• Amt New Substance Released Directly into Environment (10a): Enter an estimate of the
amount of the new substance released directly to the environment in Kg/day or Kg/batch.

• Amt New Substance Released Directly into Environment Kg/Day: Select the 'Kg/Day'
radio button to indicate that the amount of substance released into environment measures in
kilograms per day.

• Amt New Substance Released Directly into Environment Kg/Batch: Select the 'Kg/Batch'
radio button to indicate that the amount of substance released into environment measures in
kilograms per batch.

• Amt New Substance Released Directly into Control Technology (10b): Estimate the
amount of the new substance released into control technology in Kg/Day or Kg/Batch.

• Amt New Substance Released Directly into Control Technology Kg/Day: Select the
'Kg/Day' radio button to indicate that the amount of substance released into control technology
measures in kilograms per day.

• Amt New Substance Released Directly into Control Technology Kg/Batch: Select the
'Kg/Batch' radio button to indicate that the amount of substance released into control
technology measures in kilograms per batch.

• Media of Release (12): Select a value from the drop-down menu to capture the media of
release. The 'Media of Release' drop-down menu contains the following values: 'Fugitive Air,'
'Off-Site Incineration,' 'On-site Incineration,' 'On-site WWT,' 'POTW,' 'Stack Air,' 'Surface
Water,' and 'Other,' that will be used to limit the release of the new substance to the
environment. Please pay particular attention to the information within if this field is populated
via XML file. The information contained within the 'Media of Release & Control Technology'
field in the thick client separates into two (2) separate fields, the 'Media of Release' drop-down
menu and 'Control Technology' field when these fields are populated via an XML file
generated from the ePMN thick client.

• If Other, specify: Enter the other media of release.

• CBI: Check the 'CBI' checkbox to claim the media of release as confidential.

• Control Technology (12): Enter the control technology, if any, which will be used to limit the
release of the new substance to the environment. Please pay particular attention to the
information within if this field is populated via XML file. The information contained within the
'Media of Release & Control Technology' field in the thick client separates into two (2)
separate fields, the 'Media of Release' drop-down menu and 'Control Technology' field when
these fields are populated via an XML file generated from the ePMN thick client.

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Exhibit 4-34 shows a screen capture of the 'Exposures/Releases' screen (Scroll 2):
Exhibit 4-34: Exposures/Releases Screen (Scroll 2)

Pre manufacture Notice

Secondary Support

ID copy

&Add Conscfciaied
Chemical

Site Infoun4lion

Submit# Contuoled Sde
Information

Sies Controftsd By Others

Submittal Controlled
Operations

* Logged in as: jane Doe, Secondary Support

Log Out

Save

Click Add to add a worker exposure ![ari .Mton 1

Subirdjer Operation
Information
Occupational
Exposes
Environmental
Retewses
XRemove
Add Operation

Opeutions Coirti oiled by
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Attachment Summary

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Release Number (9):

Amt New Substance Released Directly into Environment (1 Oa):
O Kg/Day O Kg/Batch

Amt New Substance Released Directly into Control Technology (tOb)
O Kg/Day O Kg/Batch

Media of Release (12):

Control Technology (12):

f xji.iiiil All | Collapse All

Cancel X |

CBI

Save

Click Add to add an environmental disposal a/

Validate

Save

Preview

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Navigation: Click the 'Next' button to navigate to the 'Byproduct Information' screen. You can
also access this screen by clicking the 'Byproduct Information' link within the navigation tree.

4.1.22 Byproduct Information

• You can navigate to the 'Byproduct Information' screen by clicking the 'Next' button from the
'Exposures/Releases' screen. You can also access this screen by clicking the 'Byproduct

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Information' link under the 'Operations Controlled By Others' folder within the navigation
tree.

• The 'Byproduct Information' screen captures byproducts resulting from a particular site. The
system displays fields to enter byproducts.

• Note that in IE 7, the right side of the 'Byproduct' text box may be cut off.

• CBI: Check the 'CBI' checkbox to claim all byproducts as confidential .

• Byproduct: Enter byproducts that may result from the operation.

• Actions: Click the 'Save' icon (5 ) to save an entered byproduct. Click the 'Delete' icon (5 )
to delete a byproduct. Click the 'Add' icon ( ) to add a byproduct. Click the 'Form' icon (H )
to edit a saved byproduct.

Exhibit 4-35 shows a screen capture of the 'Byproduct Information' screen:

Exhibit 4-35: Byproduct Information Screen

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Pre manufacture Notice

Secondary Support

Submitter Corrti oiled
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Optional Cover Letter

¦ Logged in as Jane Doe, Secondary Support

Log Out

4 Pr ©manufacture Nolice (Joint PMH 20130502-14:00:03 EOT) > BypiodiKi lufoimation

BYPRODUCT INFORMATION

Identify byproducts that may result from the operation. Check the CBI checkbox if the Information is
confidential

B.2.14. Byproducts CBI:

Byproduct

Actions

ax#

Validate

Save

Preview

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Navigation: Click the 'Next' button to navigate to the 'Optional Pollution Prevention' screen.
You can also access this screen by clicking the 'Optional Pollution Prevention' link within the
navigation tree.

4.1.23 Optional Pollution Prevention

You can navigate to the 'Optional Pollution Prevention' screen by clicking the 'Next' button
from the 'Byproduct Information' screen. You can also access this screen by clicking the
'Optional Pollution Prevention' link within the navigation tree.

The 'Optional Pollution Prevention' screen provides fields for companies to enter data about
their pollution prevention efforts. The company has the option of entering information as a free
text field or as an attachment. The company can claim the information as confidential by
checking the 'CBI' checkbox.

The system allows an uploaded document to be claimed as CBI. If a document is claimed as
CBI, the system requires the sanitized version of the attached document to be uploaded. To
access or edit previously attached documents, click the appropriate file name of the document
within the 'File Name' column of the document table.

The attachment table displays the file name and file extension of the document, the document
description, the number of pages the document contains, and the CBI status of the document.
Click the 'Delete' icon ( ¦¦*) located within the 'Actions' column to delete unwanted documents.

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 on the 'Optional Pollution Prevention'
screen. 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. 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 non-environmental 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

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(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.

EPA strongly encourages submitters to provide pollution prevention data in their notices, as this
information assists the Agency in balancing the benefits of a PMN substance against its unique
risks.

While Agency staffers frequently receive information on the benefits of the PMN substance with
respect to its use(s), data on pollution prevention effects are rarely included. This section should
be utilized to indicate to EPA benefits in terms of the raw materials incorporated, the
manufacturing process, emission reductions, less toxic waste byproducts, or lower risks upon end
use and disposal. You should consider the entire life cycle of the PMN substance in your
evaluation.

Also consider opportunities for product stewardship or other risk management controls that could
significantly reduce risk characteristics of the new substance (e.g., disposal techniques that can
be easily implemented and substantially reduce waste toxicity).

Initiatives in the New Chemicals Program such as Environmental Technology Initiative (ETI) for
Chemicals, and the Pollution Prevention Recognition Project, are geared towards incorporating
this type of information into the Agency's risk management decision making and recognizing
innovative chemical design or technological innovation that shows potential for environmental
and human health benefits.

Describe any pollution prevention benefits here, and indicate if this information is confidential
business information. Attempt to quantify the expected benefits to the extent possible and avoid
exaggeration and highly speculative statements. The following questions can be used to assess
pollution prevention benefits:

(1) Are there pollution prevention benefits associated with the new PMN chemical?

(2) Does it allow reduction of elimination of (more) toxic solvents?

(3) Does it reduce disposal to land, or in safer forms, compared to the chemistry it replaces?

(4) Can it be recycled more easily than existing materials?

Does your manufacturing process eliminate or reduce the use/release of hazardous substances?

• Please click here to review additional information that should be included on this page:

Click the link to display additional information regarding the pollution information.

• Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim the pollution prevention information as confidential.

• Optional Pollution Prevention text box: Enter information about pollution prevention in this
field.

• File Name: Displays the file name and file extension of a document that is uploaded on the
'Attach Documents' pop-up window. Click the file name link to navigate to the 'Attach
Documents' pop-up window to make any edits to an attached document.

• Description: Displays the description associated with a document.

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• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon (S- ) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

Exhibit 4-36 shows a screen capture of the 'Optional Pollution Prevention' screen:
Exhibit 4-36: Optional Pollution Prevention Screen

A Logged in as: Jane Doe, Secondary Support

Log Out

Premanufacture Notice
Secondary Support

~| (Operation 1

| §""( Submitter Operation
Information

"|_ Occupational
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Environmental
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4 Premanufacture Notice (Joint PMN-20130502-14:09:03 EDT) > Optional Pollution Prevention

OPTIONAL POLLUTION PREVENTION

In this section you may provide information not reported elsewhere in this form regarding your efforts to
reduce or minimize potential risk associated with activities surrounding manufacturing, processing, use,
and disposal of the chemical substance.

Please click here to review additional information that should be included on this page.

Check here to claim this information as CBI: ~

Attach Document

File Name

Description

Pages CBI Actions

j^NextJ

V ¦

Validate Save

Preview

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Navigation: Click the 'Next' button to navigate to the 'Additional Attachments' screen. You can
also access this screen by clicking the 'Additional Attachments' link within the navigation tree.

4.1.24

Additional Attachments

You can navigate to the 'Additional Attachments' screen by clicking the 'Next' button from the
'Optional Pollution Prevention' screen. You can also access this screen by clicking the
'Additional Attachments' link within the navigation tree.

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• The 'Additional Attachments' screen provides a table for you to add additional attachments
that have not been incorporated into the form. This screen allows documents that did not have a
suitable place in the application to be uploaded.

• Please click here to view a list of commonly attached documents and where they should
be attached: Click the link to display a list of documents and where they should be attached.

• Attach Document: Click the 'Attach Document' button to display the 'Attach Documents'
pop-up window. Refer to Section 3.7 for additional details regarding the attach document
functionality.

• File Name: Displays the file name and file extension of the file that is uploaded through the
'Attach Documents' pop-up window. Click the file name link in the 'File Name' column to
view and/or edit an attached document.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains.

• Date: Displays the date a document was uploaded.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Action: Click the 'Delete' icon ( ¦*) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

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Exhibit 4-37 shows a screen capture of the 'Additional Attachments' screen:

Exhibit 4-37: Additional Attachments Screen

Logged in as: Jane Doe, Secondary Support

Log Out

Premanufacture Notice
Secondary Support
Operations
SfjfToperation I

Submitter Operation
Information

|""J] Occupational
Exposures

Environmental

Premanufacture Notice (Joint PMN-20130502-14:09:03 EDT> > Additional Attachments

ADDITIONAL ATTACHMENTS

Please use this page to attach documents that are not listed on other parts of the form (test data, EPA
correspondence, etc). Please click here to view a list of commonly attached documents and where they
should be attached.

Attach Document

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File Name

Description

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Preview

CDX Homepage

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CDX Helpdesk: (8E

38) 890-1 995

Navigation: Click the 'Next' button to navigate to the 'Attachment Summary' screen. You can
also access this screen by clicking the 'Attachment Summary' link within the navigation tree.

4.1.25 Attachment Summary

You can navigate to the 'Attachment Summary' screen by clicking the 'Next' button from the
'Additional Attachments' screen. You can also access this screen by clicking the 'Attachment
Summary' link within the navigation tree.

The 'Attachment Summary' screen displays a summary of the documents attached to the PMN
form. The attachment table displays the section of the form a document is associated with, file
name and file extension of a document, the document description, number of pages in a
document, date attached, and whether the document is CBI.

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• Section: Displays the section of the PAIN form that the attached document is associated.

• File Name: Displays the file name and file extension of a document that is uploaded on the
'Attach Documents' pop-up window.

• Description: Displays the description of a document that was uploaded on the 'Attach
Documents' pop-up window.

• Pages: Displays the number of pages a document contains.

• Date: Displays the upload date of a document that was uploaded on the 'Attach Documents'
pop-up window.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

Exhibit 4-38 shows a screen capture of the 'Attachment Summary' screen:

Exhibit 4-38: Attachment Summary Screen

Premanutacture Notice

Secondary Support
Operations

^ 1

Submiter Operation
InJormartion

¦H Occupational
Exposures

Environmental
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« Pi ef Manufacture Notice (Joint PMN-20130502-14:09jQ3 EDT> > Attachment Suminaiy

ATTACHMENT SUMMARY

The documents included in the form are listed below The attachments displayed are for viewing
purposes only, edits can he made by navigating bach to the original page where they were uploaded

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4.1.26 Optional Cover Letter

You can navigate to the 'Optional Cover Letter' screen by clicking the 'Next' button from the
'Attachment Summary' screen. You can also access this screen by clicking the 'Optional Cover
Letter' link within the navigation tree.

The 'Optional Cover Letter' screen is used to communicate information with EPA that is not
collected elsewhere in the form. The cover letter is used to give OPPT resources and special
instructions regarding the application.

• Click here to claim this information as CBI: Check the 'Click here to claim this information
as CBI' checkbox to claim the information as confidential.

• Optional Cover Letter: Enter the description and any additional special instructions regarding
the form.

Exhibit 4-39 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 4-39: Optional Cover Letter Screen

Homo J Forms Y ReswHiices

• Logged in as: Jane Doe, Secondary Support

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Pre manufacture Notice
Secondary Support
Opei atlons *

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< PieniaiKifacliiie Notice < Jolail PMN-20130502-14:09:03 EDTi > Optional Covei Letter

OPTIONAL COVER LETTER

If you would like to include a cover letter, please use toe space below.

Check here to claim this information as cbi.

Pilous

validate

Save

Preview

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Navigation: Click the 'Validate' icon (* ) located in the bottom action bar to validate the form.
Click the 'Save' iron ( ) located in the bottom action bar to save the overall form. Click the
'Preview' icon ( ) located in the bottom action bar to view a preview of the PMN PDF.

4.1.27 Upload XML

You can access the 'Upload XML' screen by clicking the 'Upload XML' button within the lower
left-hand side of the bottom action bar.

The 'Upload XML' screen is used to upload a PMN XML file (created from the PMN thick
client with a file type of .pmntsca or the ZIP file generated from a CoR) into a current joint
PMN form for joint PMN forms with numerous chemicals. You also have the option to export a
current joint PMN form into an XML file using the 'Export XML' link. The upload XML
functionality is only available for a PMN form.

If you upload an XML file into a pre-populated form, the XML file overwrites the contents of the
pre-populated form. In addition, uploading any file removes the attached documents within a
form, which must be re-attached. You must also add any sites identified within the form to your
CDX registration profile.

After uploading a file, click the 'Preview' icon ( ) located in the bottom action bar to view a
PDF preview of the form ensuring that all the data has populated correctly and any other
information is displayed accurately. In particular, ensure that the 'Letter of Activity (1),'
'Protective Equipment/Engineering Controls,' 'Physical Form,' 'Media of Release,' 'Control
Technology,' and '%New Substance' fields of entry have been populated correctly.

Please note that in IE 7, if an upload fails, the action bar at the bottom of the screen might be
misaligned when the 'Upload XML' screen reloads.

• Upload archive file: Click the button to generate the 'File Upload' window to search for the
ZIP copy of record archive file populated with PMN information. The copy of record archive
file must contain the XML form in a file labeled 'formdata.xml.' The application processes the
ZIP copy of record archive file and displays any applicable error messages.

• Export XML: Click the button to generate the XML file of the current PMN form that a user
can download.

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Exhibit 4-40 shows a screen capture of the 'Upload XML' screen:

Exhibit 4-40: Upload XML Screen

Premanufacture Notice 4

Secondary Support

Operations a

? [^Operation 1

Submitter Operation
Information

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Exposures

Environmental
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Additional Attachments
Attachment Summary
Optional Cover Letter [*

* Logged in as: Jane Doe, Secondary Support

Log Out

•&

UPLOAD XML

Click the Upload XML File button below and select the ZIP archive file you have populated with PMN information. This
archive must contain your form XML in a file labeled 'formdata.xmr.

Upload archive file

Warning: When importing an XML file into the current form, if XML validation is passed, all form contents *
overwritten with the information stored within the imported XML file

Export Xml

I be

ValidatE

Save

PreviEW

CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Validate icon o ) located in the bottom action bar to validate the form.
Click the 'Save' icon (E ) located in the bottom action bar to perform a global save on the form.
Click the 'Preview' icon ( ) located in the bottom action bar to view a PDF preview of the

form.

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5 Edit Joint Biotechnology Form

The Biotechnology form is used to collect information about "intergeneric" microorganisms that
will be manufactured or imported into the United States. EPA collects the information provided
in a Biotechnology form through a free text box and attachments. The Biotechnology form does
not have a structured data format, but there are several types of Biotechnology notices that can
be filed. The different types are as follows: Microbial Commercial Activity Notice (MCAN),
TSC A Experimental Release Application (TERA), Tier I Exemption, Tier II Exemption, and
Biotechnology Test Market Exemption (TME) forms. All the forms have the same upload
requirements and EPA will retain responsibility for verifying the correct information is received.

5.1 Edit Joint/Letter of Support Biotechnology Form

To edit a Joint Biotechnology form, navigate to the 'Section 5 Notices and Supports Forms'
screen, and click the alias link in the 'Alias' column of a Joint Biotechnology form with a status
of 'In Progress.' Refer to Section 3.3 for additional details regarding the 'Section 5 Notices and
Supports Forms' screen.

Refer to Section 0 for additional details regarding the enter passphrase process.
5.1.1 General Form Information

You can access the 'General Form Information' screen by entering a passphrase on the 'Enter
Passphrase' screen for the selected Joint Biotechnology form with a status of 'In Progress.'

The 'General Form Information' screen presents a list of text fields and drop-down menus for
you to input identifying information for the specific form. You will have the option to assign a
'Form Alias' to help you identify the form. A form alias is helpful when a user or company has
multiple forms and/or when you must differentiate between forms to the help desk. Upon
navigating to the 'General Form Information' screen, the system auto-generates a default alias in
the following format: .

The system will provide a 'TS number' field for you to enter a TS number to tie support forms or
Joint Submissions to the original Biotechnology form. The TS number can be a six (6) character
alphanumeric combination. The TS number should include two (2), three (3), or four (4) letters.
Company names, recognizable words, and numerical series are not recommended.

The 'Text/Comments' text box is required when an attachment is not provided. A 'CBI'
checkbox is displayed next to the 'Text/Comments' text box to claim the information as
confidential.

The 'General Form Information' screen also enables you to attach a document by clicking the
'Attach Document' button. For more information regarding the attach document functionality,
please refer to Section 3.7.

• Form Alias: Enter a custom form alias, if applicable. Upon navigating to the screen, the
system auto-generates an editable alias comprised of . This is a required field.

• Type of Submission: Select the submission type from the drop-down menu. This drop-down
menu contains the following values: 'MCAN (Microbial Commercial Activity Notice),'

'TERA (TSCA Experimental Release Application),' 'Tier I Exemption,' 'Tier II Exemption,'
and 'Biotechnology TME (Test Market Exemption).'

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• TS Number: Enter the TS number. The TS number can be any six (6) character alphanumeric
combination and should include two (2), three (3), or four (4) letters. Company names,
recognizable words, and numeric series are not recommended. This field is required if
'MCAN' is selected from the 'Type of Submission' drop-down menu, but is also required
regardless of the submission type if a Letter of Support is pending, and/or if a joint
Biotechnology form is being filed.

• Text/Comments: Enter a description of the form and/or attachment.

• CBI: Check the 'CBI' checkbox to claim the 'Text/Comments' information as confidential.

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window. Upload attachments including published literature, regulations and
certifications, ID data, construct data, effects data, MSDS, manufacturing details, use details,
inactivation data, and/or other types of documents. At least one document is required even if a
Letter of Support or Joint Submission is claimed. Please refer to Section Error! Reference
source not found, for additional details regarding the attach document process.

• File Name: Displays the file name and file extension of a document that is uploaded on the
'Attach Documents' pop-up window.

• Description: Displays the description of a document.

• Pages: Displays the number of pages a document contains.

• CBI: Indicates the CBI status of a document by displaying either a 'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( ¦¦*) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

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Exhibit 5-1 shows a screen capture of the 'General Form Information' screen (Joint
Biotechnology):

Exhibit 5-1: General Form information Screen (Joint Biotechnology)

Home J Forms J Resources

¦ Logged in as: Jane Doe, Secondary' Support

Log Out

Biotechnology
Secondary Support
Joint Biotechnology-
20130502-14:07:12 EOT
General Form liifoi m.ition
Technical Contact Information
Optional Cover Letter

< Biotechnology (Joint Bioteclmology-20130502-14:07:12 EOT) > General Form Information

GENERAL FORM INFORMATION

You may enter an alias for easier form identification or the system will provide a time stamp.
Form Alias: Joint Biotechnology-20130502-14:07

III. Type of Submission:

TS Number:

IV. Text Comments CBlO

Please describe the submission and/or attachment.

¦&

Attach Document

File Name

Description

Pages

CBI Actions

|^NexiJ

Validate

Save

Preview

CDX Homepage |

| MyCDX Homepage | EPA Homepage

| Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 800-1995

Navigation: Click the 'Next' button to navigate to the 'Technical Contact Information' screen.
You can also access this screen by clicking the 'Technical Contact Information' link within the
navigation tree.

5.1.2 Technical Contact Information

You can access the 'Technical Contact Information' screen by clicking the 'Next' button from
the 'General Form Information' screen. You can also navigate to the 'Technical Contact
Information' screen by clicking the 'Technical Contact Information' link within the navigation
tree.

The 'Technical Contact Information' screen displays an 'Add Technical Contact' button. Click
the 'Add Technical Contact' button to generate an 'Add Technical Contact' pop-up window to
enter information into the text fields. Click the 'Copy CDX Registration' button to populate the
text fields using your CDX registration information. Check the 'Check here to claim this

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information as CBI' checkbox to indicate that the information is confidential and will not be
released to the public.

• Add Technical Contact: Click the 'Add Technical Contact' button to generate the 'Add
Technical Contact' pop-up window.

• Last Name: Displays the technical contact's last name.

• First Name: Displays the technical contact's first name.

• Address: Displays the technical contact's address.

• CBI: Indicates the CBI status of the reported technical contact information by displaying either
a'Y' or an 'N.'

• Actions: Click the 'Delete' icon ( *) to delete the technical contact information from the table.
A warning message displays to confirm the deletion.

Exhibit 5-2 shows a screen capture of the 'Technical Contact Information' screen (Joint
Biotechnology):

Exhibit 5-2: Technical Contact Information Screen (Joint Biotechnology)

•*> Logged in as: Jane Doe, Secondary Support

Log Out

Biotechnology
Secondary Support
Joint Bioteclmolo Technical Contact Information ^

TECHNICAL CONTACT INFORMATION

To add a new Technical Contact click the Add Technical Contact button. Add Technical Contact

Last Name First Name

Address CBI Actions

|Optional Cover Letter

| Hext |

>/ ¦

Validate Save

Preview

CDX Homepage |

MyCDX Homepage | EPA Homepage | Terms and Conditions

I Privacy Notice | CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Optional Cover Letter' screen. You can
also access this screen by clicking the 'Optional Cover Letter' link within the navigation tree.

5.1.2.1 Add Technical Contact

You can access the 'Add Technical Contact' pop-up window by clicking the 'Add Technical
Contact' button on the 'Technical Contact Information' screen.

• Copy CDX Registration: Click the 'Copy CDX Registration' button to copy your information
from CDX registration; a message displays confirming the import of CDX registration
information.

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• Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim the technical contact information as confidential.

• First Name: Enter the technical contact's first name. Click the 'Copy CDX Registration'
button to populate the fields with information entered during CDX registration. This is a
required field.

• Last Name: Enter the technical contact's last name. Click the 'Copy CDX Registration' button
to populate the fields with information entered during CDX registration. This is a required
field.

• Position: Enter the technical contact's job title.

• Company Name: Enter the technical contact's company name. Click the 'Copy CDX
Registration' button to populate the fields with information entered during CDX registration.
This is a required field.

• Phone Number: Enter the technical contact's daytime U.S. phone number; this must be at
least 10 characters long and does not accept dashes. Click the 'Copy CDX Registration' button
to populate the fields with information entered during CDX registration. This is a required
field.

• Phone Extension: Enter the technical contact's phone number extension if applicable.

• Email Address: Enter the technical contact's email address. The email address must follow the
standard email address format: John.Doe@domain. Click the 'Copy CDX Registration' button
to populate the fields with information entered during CDX registration.

• Mailing Address 1: Enter the first line of the technical contact's mailing address. Click the
'Copy CDX Registration' button to populate the fields with information entered during CDX
registration. This is a required field.

• Mailing Address 2: Enter the second line of the technical contact's mailing address. Click the
'Copy CDX Registration' button to populate the fields with information entered during CDX
registration.

• City: Enter the city of the technical contact's mailing address. Click the 'Copy CDX
Registration' button to populate the fields with information entered during CDX registration.
This is a required field.

• State: Select the state of the technical contact's mailing address from the drop-down menu.
Click the 'Copy CDX Registration' button to populate the fields with information entered
during CDX registration. This is a required field.

• Postal Code: Enter the postal code of the technical contact's mailing address. Click the 'Copy
CDX Registration' button to populate the fields with information entered during CDX
registration. This is a required field.

• Country: Displays 'United States.'

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Exhibit 5-3 shows a screen capture of the 'Add Technical Contact' pop-up window (Joint
Biotechnology):

Exhibit 5-3: Add Technical Contact Pop-Up Window (Joint Biotechnology)

First Name:

Last Name:
Position:

Company Name:
Phone Number:

Phone Extension:
Email Address:
Mailing Address 1

Mailing Address 2

City:

State:

Postal Code:
Country:

United States

Cancel

Navigation: Click the 'Cancel' button to stop populating technical contact information and
navigate back to the 'Technical Contact Information' screen. Click the 'OK' button to save and
populate the entered technical contact information and navigate back to the 'Technical Contact
Information' screen.

5.1.3 Optional Cover Letter

You can access the 'Optional Cover Letter' screen by clicking the 'Next' button from the
'Technical Contact Information' screen. You can also access this screen by clicking the
'Optional Cover Letter' link within the navigation tree.

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The 'Optional Cover Letter' screen is used to communicate information to EPA not collected
elsewhere in the form. The cover letter is used to give OPPT resources and special instructions
regarding the application. The cover letter should be either fully CBI or non-CBI to eliminate
user error to promote transparency between the company and EPA.

• Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim the cover letter information as confidential.

• Optional Cover Letter: Enter the description and any additional special instructions regarding
the form.

Exhibit 5-4 shows a screen capture of the 'Optional Cover Letter' screen (Joint Biotechnology):
Exhibit 5-4: Optional Cover Letter Screen (Joint Biotechnology)

A Logged in as: Jane Doe, Secondary Support

Log Out

Biotechnology
Secondary Support
Joint Biotechnolotjy-
20130502-14:07:12 EDT

General Form Information
Technical Contact Information
Optional Covei Letter

< Biotechnology (Joint Biotechnolo Optional Cover Letter

OPTIONAL COVER LETTER

If you would like to include a cover letter, write it here.

Check here to claim this information as CBI: ~

Validate

Save

Preview

CDX Homepage |

I MyCDX Homepage

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Validate' icon C ) located in the bottom action bar to validate the form.
Click the 'Save' icon (E ) located in the bottom action bar to perform a global save of the form.
Click the 'Preview' icon (^) located in the bottom action bar to view a PDF preview of the
form.

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6 Edit Letter of Support Bona Fide Form

The purpose of the Bona Fide module is to receive an official determination from EPA as to
whether a substance is on the TSCA inventory. Submitters may attempt to avoid submitting a
PMN by completing a Bona Fide form to establish that the chemical already exists on the
inventory. The Bona Fide process is covered in a thirty (30) day period.

6.1 Edit Letter of Support Bona Fide Form

To edit a Letter of Support Bona Fide form, navigate to the 'Section 5 Notices and Supports
Forms' screen and click the alias link in the 'Alias' column of a Letter of Support Bona Fide
form with a status of 'In Progress.' Refer to Section 3.3 for additional details regarding the
'Section 5 Notices and Supports Forms' screen.

Refer to Section 0 for additional details regarding the enter passphrase process.
6.1.1 General Document Information

You can access the 'General Document Information' screen by entering the passphrase on the
'Enter Passphrase' screen for a selected Letter of Support Bona Fide form with a status of 'In
Progress.' The 'General Document Information' screen allows you to identify information that is
specific to the form type selected from the 'Section 5 Notices and Supports Forms' screen.

The 'General Document Information' screen presents text fields and checkboxes that allow you
to input identifying information for the specific form. You will have the option to edit a 'Form
Alias' by which you will identify the form. A form alias is helpful when you or your company
has multiple forms and/or when you must differentiate between forms to the help desk. Upon
navigating to the 'General Document Information' screen, the system will have already auto-
generated an editable default alias comprised of a form type, date stamp and time stamp for the
AO in the following format: .

You can claim the entirety of the form as CBI. The entire form will be claimed as CBI if you
check the 'I claim the entirety of the submission as CBI' checkbox. The entire form will be
considered non-CBI if you leave the 'I claim the entirety of the submission as CBI' checkbox
unchecked.

You can indicate that a technical contact will be identified by checking the 'Technical Contact'
checkbox. The technical contact must possess sufficient knowledge to answer any questions EPA
may have about the chemical reported in the submission. The application will generate a
'Technical Contact Information' screen when you check the 'Technical Contact' checkbox.

• Form Alias: Edit the form alias if necessary. Upon navigating to the screen, the screen will
auto-generate an editable form alias in the following format: .

• I claim the entirety of the submission as CBI: By checking the 'I claim the entirety of the
submission as CBI' checkbox, all data contained within the submission is flagged as CBI.

• Technical Contact: Check the 'Technical Contact' checkbox to display a 'Technical Contact
Information' screen for you to enter contact information about the technical contact associated
with the reported chemical.

• Submitting on Behalf of Company: Check the 'Submitting on Behalf of Company' checkbox
to indicate that you will be submitting a Bona Fide form on behalf of another company. A

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'Submitting on Behalf of Company' screen will display during the submission process for you
to enter information pertaining to the company that will manufacture or import the chemical
substance, on whose behalf you are submitting a Bona Fide form.

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Exhibit 6-1 shows a screen capture of the 'General Document Information' screen (Letter of
Support Submission):

Exhibit 6-1: General Document Information Screen (Letter of Support Submission)

Bona Fide ^

Secondary Support

General Document
Information

Pww*y Contact Information

Technical Contact Information

Chemical

Ctvemi»l Idefitrfcaboo
Infocmitioa

Docy-tnent

Optonal Cover Letter

> Logged n as, Jane Doe. Secondary Support
LogOut

Bona Fide {Joint Bona Fide-20130920-13:00:54 EOT) > General Document Information

GENERAL DOCUMENT INFORMATION

The form alias is a required field that allows the user to give the Bona Fide a name to be displayed in the
'Alias' field on the Section 5 Notices and Supports Forms screen Its purpose is to make It easier for you
to distinguish between multiple forms, if an alias is not selected, the field will default to the date and time
the Bona Fide was created. The form anas may be changed at any time-

Form Alias: Joint Bona Ficte-2014*t205-T.i:52.46

Please check all applicable checkboxes below

This Bona Fide Notice can be claimed entirely as Confidential Business Information (CB1) Please check
the "l claim the entirety of the submission as OBI' checkbox to claim your entire submission as OBI

I claim the entirety of the submission as CBi:

The technical contact is a subject matter expert (SME) who is capable of answering questions related to
the chemical within the Bona Fide The technical contact does not have to physical work at the site
reported but must possess extensive knowledge on the chemical reported In order to answer EPA's
questions pertaining to the submission. Please check me Technical Contact' checkbox below to identify a
technical contact for your submission.

Technical Contact:

VakJate

Save

Preview

CDX Homepage i

| MyCDX Homepage |

EPA Homepage | Terms and Conditions |

| Privacy Mottoe i

I CDX Helpdest (888) 890-1995

Navigation: Click the 'Next' button to navigate to the ' Primary Contact Information' screen.
You can also access this screen by clicking the 'Primary Contact Information' link within the
navigation tree.

6.1.2 Primary Contact Information

You can access the 'Primary Contact Information' screen by clicking the 'Next' button from the
'General Document Information' screen. You can also access this screen by clicking the
'Primary Contact Information' link within the navigation tree.

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The data fields on the 'Primary Contact Information' screen are pre-populated based on
information entered during CDX registration. All fields are editable allowing for necessary
updates. The 'Job Title' field on this screen is not pre-populated from CDX registration and is a
required field.

If you checked the 'I claim the entirety of the submission as CBI' checkbox on the 'General
Document Information' screen, all entered primary contact information is flagged as CBI.

The following fields are displayed for the primary contact:

• Prefix: Select the primary contact's prefix from the drop-down menu.

• First Name: Enter the primary contact's first name. This is a required field.

• Middle Initial: Enter the primary contact's middle initial.

• Last Name: Enter the primary contact's last name. This is a required field.

• Suffix: Select the primary contact's suffix from the drop-down menu.

• Title: Enter the primary contact's job title. This is a required field.

• Company Name: Enter the primary contact's company name. This is a required field.

• Phone Number: Enter the primary contact's daytime phone number; dashes are not allowed.
This is a required field.

• Phone Extension: Enter the extension to the primary contact's daytime phone number.

• Email Address: Enter the primary contact's email address. The email address must follow the
standard email address format: John.Doe@ABC.com. This is a required field.

• Mailing Address 1: Enter the first line of the primary contact's mailing address. This is a
required field.

• Mailing Address 2: Enter the second line of the primary contact's mailing address.

• City: Enter the city of the primary contact's mailing address. This is a required field.

• State: Select the state of the primary contact's mailing address from the drop-down menu. The
state field is required if the user selects 'United States' from the 'Country' drop-down menu.

• Postal Code: Enter the postal code of the primary contact's mailing address. This is a required
field.

• Country: Select the country of the primary contact's mailing address. This is a required field.

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Exhibit 6-2 shows a screen capture of the ' Primary Contact Information' screen:

Exhibit 6-2: Primary Contact Information Screen

* Logged in as Jane Doe Secondary Support

Log Out

Bona Fide

Secondary Support

General Docvneat to formation
Primary Contact Information
Teciwcal Contact tofOnttafcon
Chemical

tfentificaton

Cocumant Uanav«>n«flt
Cptonai Covar Matter

< Bona f(d<* (Joint Bona fi Primary Contact Information
PRIMARY CONTACT INFORMATION

Th€ primary contact fields have been pre-populated based on the information you provided during CDX
registration but may be edited if necessary The 'Job Title' field is required

Prefix
First Name
Middle initial
Last Name
Suffix
Title

Company Name.
Phone Number

Phone Extension
Email Address
Mailing Address t

Mailing Address 2:

City
State

Postal Code
Country

Mrs

TESTORGCGI1
7032577445

(Do net «nt*f any OiriJh«i (-} in Phcin# Ncmb*r frtld »bov*.)

Jeffrey &ronicK@cgife
-------
CDXr

also access this screen by clicking the 'Technical Contact Information' link within the navigation
tree.

The technical contact is a subject matter expert (SME) who is capable of answering questions
related to the chemical submitted to EPA within the Bona Fide form. The technical contact does
not have to work at the port or site reported on the form but must possess sufficient knowledge to
answer EPA's questions pertaining to the chemical reported in the form.

The text fields on the 'Technical Contact Information' screen will be blank upon accessing the
screen. To add information, you will enter data into the blank text boxes for the listed text fields.
If you checked the 'I claim the entirety of the submission as CBI' checkbox on the 'General
Document Information' screen, all entered technical contact information will be flagged as CBI.

Please note that if you are using IE 7, there will be a spacing issue between the 'Suffix' drop-
down menu and the 'Title' text field.

• Prefix: Select the technical contact's prefix from the drop-down menu.

• First Name: Enter the technical contact's first name. This is a required field.

• Middle Initial: Enter the technical contact's middle initial.

• Last Name: Enter the technical contact's last name. This is a required field.

• Suffix: Select the technical contact's suffix from the drop-down menu.

• Title: Enter the technical contact's job title.

• Company Name: Enter the technical contact's company name.

• Phone Number: Enter the technical contact's daytime U.S. phone number; dashes are not
allowed. This is a required field.

• Phone Extension: Enter the technical contact's phone number extension.

• Email Address: Enter the technical contact's email address. The email address must follow the
standard email address format: John.Doe@ABC.com. This is a required field.

• Mailing Address 1: Enter the first line of the technical contact's mailing address.

• Mailing Address 2: Enter the second line of the technical contact's mailing address.

• City: Enter the city of the technical contact's mailing address.

• State: Select the state of the technical contact's mailing address from the drop-down menu.

• Postal Code: Enter the postal code of the technical contact's mailing address.

• Country: Displays 'United States.'

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Exhibit 6-3 shows a screen capture of the 'Technical Contact Information' screen:
Exhibit 6-3: Technical Contact Information Screen

Bona Fide

Secondary Support

Document In formation

Prmary Contact InformaJUon

' _ iTechnical Contact |
Information

S Chemical

Chfiflfccal kSentsftcaten
taiformabon

Document Management

Opteflal Cover Letter

* Logged in as Jane Doe, Secondary Support

Log Out

Home y Forms T User Management y Resources

< Bona Tide (Joint Bona F»de-20141205-14:52:48 ESTt»Teclmteal Contact Information

TECHNICAL CONTACT INFORMATION

Please enter the Information for the technical contact v.tio will be responsible for prodding additional
information rf required

Prefix:

First Name
Middle Initial:
last Name
Suffix:

Title

Company Name:
Phone Number

Phone Extension:
Email Address:
Mailing Address 1

Mailing Address 2

City
State

Postal code
Country:

Str««t #6&mM- P.O. box. company i%imt, *tc.

ApwtrrMi*. su ti. site.

United Spates

Previous I Next

Validate

Save

Preview

Submit

Navigation: Click the 'Next' button to navigate to the 'Chemical Identification Information'
screen. You can also access this screen by clicking the 'Chemical Identification Information' link
within the navigation tree.

6.1.4 Chemical Identification Information

You can navigate to the 'Chemical Identification Information' screen by clicking the 'Next'
button from the 'Chemical Identification Information' screen. You can also access this screen by
clicking the 'Chemical Identification Information' link within the navigation tree.

The 'Chemical Identification Information' screen identifies the type of chemical the submitter
will enter into the application. You will be able to file a Bona Fide form for a class 1 or

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2/Biotechnology chemical substance or a polymer. Based on your selection, the appropriate

screens for the respective chemical will appear.

This screen also provides a text field for you to identify an alias for the chemical substance.

• Class 1 or 2/Biotechnology Chemical Substance: Select the 'Class 1 or 2/Biotechnology
Chemical Substance' radio button to indicate that the chemical is a class 1 or 2/biotechnology
substance. If you select the 'Polymer' radio button after initially selecting the 'Class 1 or
2/Biotechnology Chemical Substance' radio button, the application generates an error message
warning you that you will lose all data for this chemical if the chemical type changes. The user
is required to select one of the two radio button options displayed in the 'Chemical Type'
section.

• Polymer: Select the 'Polymer' radio button to indicate that the chemical is a polymer. If you
select the 'Class 1 or 2/Biotechnology Chemical Substance' radio button after initially
selecting the 'Polymer' radio button, the application generates an error message warning you
that you will lose all data for this chemical if the chemical type changes. The user is required to
select one of the two radio button options displayed in the 'Chemical Type' section.

• Chemical Alias: Enter the chemical alias to associate with a chemical.

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Exhibit 6-4 shows a screen capture of the 'Chemical Identification Information' screen:
Exhibit 6-4: Chemical Identification Information Screen

Bona Fide

Secondary Support

General Document Information

Primary Contact Information

Technical Contact Information

E3- Chemical

i chemical Identification
Information

! " "|2:|Document Management
"•"[ jOptional Cover Letter

Logged in as: Jane Doe. Secondary Support

Log Out

4 Bona Fide (Joint Bona Fide-20130920-13:00:54 EDT) > Chemical Identification Information

CHEMICAL IDENTIFICATION INFORMATION

Chemical type

Complete either item 1 (Class 1 or 2 Chemical Substance) or 2 (Polymer) as appropriate. Indicate which
selection you intend to complete below.

C> Polymer

Chemical Alias:

The chemical alias is an optional field that changes the folder name In the navigation tree on the left-hand
side of the screen.

-------
CDXr

Click the 'Delete' icon ( *) located under the 'Actions' column to delete unwanted documents.

Click the appropriate file name of the document within the 'File Name' column of the

attachment table to access or edit previously attached documents.

Please note that if you are using IE 7, part of the content on this screen displays behind the Bona

Fide navigation tree and certain fields on this screen may display twice.

• Add New Chemical: Click the button to generate the class 1 or 2/Biotechnology chemical
substances field set.

• Expand All: Click the 'Expand All' link located at the upper-right of the
expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the 'Collapse All' link located at the upper-right of the
expandable/collapsible field sets to collapse a series of field sets.

• Class of Substance: In the section, 'Class of Substance,' you identify whether a 'Class 1' or
'Class 2/Biotechnology' chemical substance is being reported. When you select the 'Class
2/Biotechnology' chemical substance radio button, you are indicating that some portions of the
structure may not be known and an additional screen will appear within the navigation tree that
provides fields for you to enter information concerning how the chemical was created. If
multiple class 2 chemical substances are added, one 'Class 2/Biotechnology Substances' screen
will apply to all chemical substances.

• Add Chemical ID: You can access the 'Add Chemical ID' pop-up window by clicking the
'Add Chemical ID' button within the 'Chemical Identification Information' field set. You can
search for the reported chemical(s) either by the 'CASRN' or 'CA Index Name or Other
Synonym.' If you retrieve zero results, the system provides fields for you to enter the chemical
information by filling in the 'Chemical Name' and the 'Chemical Abstract Services Registry
Number' under the manual entry field set. The system provides functionality to enter the
selected chemical by clicking the 'OK' button located at the bottom of the 'Add Chemical ID'
window. Refer to Section 3.8 for further details regarding the search SRS functionality.

• Chemical Name: The system provides fields for you to identify the 'Chemical Name' and the
'CASRN' (if available). The system provides functionality for you to search for the chemical
substance using the 'Add Chemical ID' search or manually enter the chemical information in
the 'Add Chemical ID' pop up.

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• ID Method: The system shall require that you identify which ID method was used to
determine the chemical identity. If you select 'Method 1,' you are required to attach an IES
report. You can also select 'Method 2 (Other Method).'

• Attach IES Report: To access the 'Attach IES Report' pop-up window, click the 'Attach IES
Report' button that displays within the 'Chemical Identification Information' field set. After
you attach the document(s), and click the 'OK' button, the 'Attach IES Report' pop-up window
closes and the document information displays in a table format on the 'Class 1 or
2/Biotechnology Chemical Substances' screen. The document attachment table displays the file
name of the document(s) and the user-provided description of the document(s). Click the
'Delete' icon (¦ *) located under the 'Actions' column to delete unwanted documents. Click the
file name link under the 'File Name' column to access or edit previously attached documents.

• Molecular Formula: Enter a molecular formula in a text field using a free text format. This
field is optional.

• Chemical Structure Diagram: The system allows you to attach a chemical structure diagram.
This field is optional.

• Attach Chemical Structure: Click the 'Attach Chemical Structure' button within the
'Chemical Identification Information' field set to access the 'Attach Chemical Structure' pop-
up window. You can attach the file(s) and enter a description of the document regarding the
chemical structure.

• File Name: Displays the file name and file extension of the file that is uploaded on the 'Attach
Chemical Structure' window.

• Description: Displays the description of the chemical structure.

• Actions: Click the 'Delete' icon ( ¦¦*) to delete the entire attached chemical structure row
permanently from the system. A warning message displays to confirm the deletion of the
document.

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Exhibit 6-5 shows a screen capture of the 'Class 1 or 2/Biotechnology Chemical Substances'
screen:

Exhibit 6-5: Class 1 or 2/Biotechnology Chemical Substances Screen

* Logged m as Jane Doe. Secoodajy Support

Bona Fid* B'ona FM,e (J0**10ona FWe-2(H41205-14:52s48 EST) > Class 1 or 2,"Biotechnology Chemical Substances u

Secondary Support

CLASS 1 OR 2/810TECHN0L0GY CHEMICAL SUBSTANCES

Prtnwy Contact Information

Class 1 or 2.'Blot®chnology Chemical Substances
Chemical Identification Information

Expand All | Collapse Alt

3 Chemical

Cancel X

ChenrKail Wenlrfica!»n
Info

Class of substance O Class i @ Class 2/BJoiechnology

^Chemical 1402

Click the button below to search EPA's Substance Registry Services (SRS) for the desired chemical

Class 12

Add Chemical ID

Chemical

Substance*

CASRN

Use totormttoft

Chemical Name

; -p Oocumert Uanaseffient

10 Method

OptonaJ Cover Letter

Method 1 (CAS Inventory Expert Service) O Method 2 (Other Method)
Attach IES Report

File Name Description Actions

Molecular Formula: (optional)

Chemical Structure Diagram (optional)

include an attachment for the chemical structure diagram below

Attach Chemical Structure

File Name Description Actions

Save

Click tne Add New Chemical button to add chemical name and structural information for a new chemical

Ado New Chemical

Previous | Next |

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within the action bar and clicking the 'Class 2/Biotechnology Substances' link within the
navigation tree.

The 'Class 2/Biotechnology Substances' screen provides fields for you to enter in information
regarding a class 2/biotechnology chemical substance. A class 2/biotechnology chemical
substance is a substance that may not have a defined chemical structure that has been identified.
This screen provides fields for you to identify specific elements in the creation of the chemical
using the following fields: 'Precursor Substances,' 'Nature of Reaction,' and 'Range of
Composition (Optional).'

You will be able to enter precursor substances by searching SRS or by the manual entry fields
when the substance is not in SRS. The substances will display in a table listing the 'Chemical
Name' and CASRN.

The system provides fields for you to capture 'Nature of Reaction' and 'Range of Composition'
in text boxes. The text boxes for both 'Nature of Reaction' and 'Range of Composition' can be
claimed as CBI.

• Precursor Substances: This table captures the chemicals identified as immediate precursor
substances, along with the respective CASRNs.

• Search SRS: Click the 'Search SRS' button to display the 'Search Substance Registry
Services' pop-up window. Refer to Section 3.8 for further details regarding the search SRS
functionality.

• Chemical Name: Displays the chemical name associated with a precursor substance. Click the
'Chemical Name' link to navigate to the 'Search SRS' pop-up window for edits.

• CASRN: Displays the CASRN associated with a precursor substance.

• Action: Click the 'Delete' icon ( ¦*) to delete the entire chemical row permanently from the
system. A warning message will display to confirm the deletion of the chemical.

• Nature of Reaction: Enter the 'Nature of Reaction' description. This is a required field.

• Range of Composition: Enter the 'Range of Composition' description. This field is optional.

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window and upload a document. Refer to Section Error! Reference source not found,
for further details regarding the attach document functionality.

• File Name: Displays the file name and file extension of the file that is uploaded on the 'Attach
Documents' window.

• Description: Displays the description associated with a document.

• Actions: Click the 'Delete' icon (.¦¦*) to delete the entire document row permanently from the
system. A warning message displays to confirm the deletion.

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Exhibit 6-6 shows a screen capture of the 'Class 2/Biotechnology Substances' screen (Scroll 1):
Exhibit 6-6: Class 2/Biotechnology Substances Screen (Scroll 1)

Home j forms j Resources

A Logged in as Jane Doe. Secondary Support

Log Out

Bona Fide

Secondary Support

General Document information

Prvnary Contact In formation

Technical Contact Information

Chemical

Cherrreal WcnSificabon
h formation

JL Chemical 1402

Class 1 or 2

Chemical

Substances

Class 2
Substances

-(_ Use In formation

_ Document Management

Options Cover Letter

4 Bona Fide (Joint Bona Fwle-20130920-13:00:54 EOT) > Class 2 Substances

CLASS 2/BIOTECHNOLOGY SUBSTANCES
Class ^'Biotechnology Substance Details

Fill in below for a class 2 subsiance (1) List the immediate precursor substances with Iter respective CAS
Registry Numbers- (2) Descnbe the nature ot me reaction or process. (3) Indicate the range of
composition and me typical composition (where appropriate)

Precursor Substances

[search SRSj Click the Search SRS button on the iett to search or enter a precursor substance
Chemical Name CASRN Actions

Nature ot Reaction

Range of Composition (Optional)

Optional Attachments

Attach Document

validate

Save

Preview

COX Homepage | MjCDX Homepage I EPA Homepage | Terms and Conditions | Privacy Notice | CDX Heipdeslc (808)890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 6-7 shows a screen capture of the 'Class 2/Biotechnology Substances' screen (Scroll 2):
Exhibit 6-7: Class 2/Biotechnology Substances Screen (Scroll 2)

Bona Fide

Secondary Support

General Document Information

! J |Primary Contact Information

j'i ^[Technical Contact Information

B Chemical

Chemical Identification
Information

(2:, Chemical 1402

Class 1 or 2
Chemical
Substances

H - Class 2
Substances

""[JJUse Information

Document Management

"I ^ Optional Cover Letter

Kegisiry Numoers. (Z) uescrioe ine naiure or ine reacnon or process. [3J inaicaie me range ot
composition and the typical composition (where appropriate).

Precursor Substances

Search SRSi Click the Search SRS button on the left to search or enter a precursor substance.

Chemical Name

Nature of Reaction

CASRN

Actions

Range of Composition (Optional)

Optional Attachments

Attach Document

File Name

Description

Actions

j^NextJ

Validate

Save

Preview

Navigation: Click the 'Next' button to navigate to the 'Use Information' screen. You can also
access this screen by clicking the 'Use Information' link within the navigation tree.

6.1.7 Polymer Identification Information

You can navigate to the 'Polymer Identification Information' screen by clicking the 'Next'
button from the 'Chemical Identification Information' screen when you select the 'Polymer'
radio button. You can also access this screen by clicking the 'Polymer Identification
Information' link within the navigation tree.

Click the 'Add New Chemical' button to create a chemical substance. Upon clicking the 'Add
New Chemical' button, an expandable/collapsible field set generates that contains numerous

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fields that pertain to the particular polymer. The system provides numerous fields for you to
enter multiple chemical substances, each with unique information, by clicking the 'Add New
Chemical' button for each chemical you wish to identify.

For a single component submission, create the field set by clicking the 'Add New Chemical'
button. Upon clicking the 'Add New Chemical' button, the application generates a field set
containing numerous fields for you to enter information pertaining to that particular chemical.

For a multi-component submission, create individual field sets by clicking the 'Add New
Chemical' button. Multi-component chemical submissions occur when two or more chemicals
always generate together in a single pot and are never isolated. Upon clicking the 'Add New
Chemical' button, the application generates a field set containing numerous fields for you to
enter information pertaining to that particular chemical. Enter additional chemical components,
each with unique identifying information, by clicking the 'Add New Chemical' button for each
additional chemical that is part of the multi-component mixture. All multi-component chemicals
will reside in one chemical folder in the navigation tree.

• Add New Chemical: Click the button to generate the 'Polymer Identification Information'
field set.

• Expand All: Click the 'Expand All' link located at the upper-right of the
expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the Collapse All' link located at the upper-right of the
expandable/collapsible field sets to collapse a series of field sets.

• Add Chemical ID: Click the 'Add Chemical ID' button within the 'Polymer Identification
Information' field set to generate the 'Add Chemical ID' pop-up window. You can search for
the reported chemical(s) either by the 'CASRN' or 'CA Index Name or Other Synonym.' If
you retrieve zero results, the system provides fields for you to enter the chemical information
by filling in the 'Chemical Name' and the 'Chemical Abstract Services Registry Number'
(CASRN) under the manual entry field set. The system provides functionality for you to enter
the selected chemical by clicking the 'OK' button located at the bottom of the 'Add Chemical
ID' window. Refer to Section 3.8 for further details regarding the search SRS functionality.

• Chemical Name: The system provides fields for you to identify the 'Chemical Name' and the
CASRN (if available). The system provides functionality for you to search for the chemical
substance using the 'Add Chemical ID' search or manually enter the chemical information in
the 'Add Chemical ID' pop up.

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• ID Method: The system shall require that you identify which ID method was used to
determine the chemical identity. When you select 'Method 1 (CAS Inventory Expert Service),'
the system generates an 'Attach IES Report' button for you to attach an IES report. If you
select 'Method 1,' you are required to attach an IES report. You can also select 'Method 2
(Other Method).'

• Attach IES Report: To access the 'Attach IES Report' pop-up window, click the 'Attach IES
Report' button within the 'Polymer Identification Information' field set after selecting the
'Method 1 (CAS Inventory Expert Service)' radio button. After you attach the document(s),
and click the 'OK' button, the 'Attach IES Report' pop-up window will close and the
document information will be displayed in a table format on the 'Polymer Identification
Information' screen. The attachment table displays the file name of the document and the user-
provided description of the document. Click the 'Delete' icon ( ¦*) located under the 'Actions'
column to delete unwanted documents. Click the file name link under the 'File Name' column
to access or edit previously attached documents.

• Chemical Structure Diagram: The system allows you to attach a chemical structure diagram.
This field is optional.

• Attach Chemical Structure: Click the 'Attach Chemical Structure' button within the
'Polymer Identification Information' field set to access the 'Attach Chemical Structure' pop-up
window. You can attach the file(s) and enter a description of the document.

• File Name: Displays the file name and file extension of the document that is uploaded on the
'Attach Chemical Structure' window.

• Description: Displays the description of the chemical structure

• Actions: Click the 'Delete' icon ( -) to delete the entire attached chemical structure row
permanently from the system. A warning message displays to confirm the deletion.

After the document is attached and you click the 'OK' button, the 'Attach Chemical Structure'
pop-up window closes and the document information will be displayed in a table format on the
'Polymer Identification Information' screen. The attachment table displays the file name of the
document and provided description of the document. The system provides functionality for you
to delete unwanted documents by clicking the 'Delete' icon (K) located under the 'Actions'
column. Click the appropriate file name of the document within the 'File Name' column of the
attachment table to access or edit previously attached documents.

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Exhibit 6-8 shows a screen capture of the 'Polymer Identification Information' screen:
Exhibit 6-8: Polymer Identification Information Screen

Lagged in as Jane Doe. Secondary Support

Log Out

4 Bona Fide (Jolni Bona Fide-20130920-13:00:54 EOT) > Polymer identification Information a

POLYMER IDENTIFICATION INFORMATION

Expand All | Collapse All

* Cancel X

Click the button Deiow to add a substance to this document

Add Chemical ID

GASRN:

Chemical Name

Bona Fide

Secondary Support

General Document frifonmaton

Primary Contact Information

Technical Contact information

C hem teal

§* Ctvenscal Wentification
Information

E & Chemical 1««

Polymer

Identification

Information

"~ Monomers ami
Olher R«dar4s

Use Information

DocumenJ Management

1 : Optional Cover Letter

ID Method

« Method 1 (CAS inventory Expert Service)
Attach IES Report

File Name

i Method 2 (Other Method)

Description

Actions

Chemical Structure Diagram (optional)

Include an attachment tor the chemical structure diagram below

Attach Chemical Structure

File Name

Description

Actions

Save

Click me button to add a substance to this document. Atw New Chemical

I^NextJ

Validate Save Preview

CDX Homepage | MyCDX Homepage f EPA Homepage 1 Terms and Conditions | Ptivacy Notice | CDX Helpdesfc (888) 890-1995

6.1.8 Monomers and Other Reactants

The 'Monomers and Other Reactants' screen is used to identify the chemical measurements and
monomers that make up a polymer. The 'Monomers and Other Reactants' screen has an 'Add

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014

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Monomer' button that allows you to identify the monomer(s) that make up the polymer

composition.

• Add Monomer: Click the 'Add Monomer' button to generate an expandable/collapsible field
set.

• Expand All: Click the 'Expand All' link located at the upper-right of the
expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the 'Collapse All' link located at the upper-right of the
expandable/collapsible field sets to collapse a series of field sets.

• Search SRS: Click the 'Search SRS' button to generate the 'Search Substance Registry
Services' pop-up window. Refer to Section Error! Reference source not found, for

additional details regarding the search SRS functionality.

• CAS Registry Number: Displays the CASRN for the specified monomer; this field populates
based on information entered on the 'Search Substance Registry Services' pop-up window.

This is a required field.

• Monomer or Other Reactant: Displays the monomer or other reactant name; this field
populates based on information entered on the 'Search Substance Registry Services' pop-up
window. This is a required field.

• Include in Identity: Check the 'Include in Identity' checkbox to claim the value for 'Monomer
or Other Reactant' as part of the monomer identification.

• Typical Composition: Enter the 'Typical Composition' value that a monomer contributes to a
polymer; the value entered must be a positive numerical value greater than zero (0) and less
than or equal to 100 with up to three decimal points. If the value entered is less than or equal to
'2' a warning will be displayed in the global 'Validate' function or during the submission
process indicating that the 'Typical Composition' is a value that is less than or equal to 2% and
asking the user whether it should be included in the 'Chemical Identity.' This is a required
field.

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• Description: Displays the description associated with a document.

• Actions: Click the 'Delete' icon ( ¦¦*) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion of the document.

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Exhibit 6-9 shows a screen capture of the 'Monomers and Other Reactants' screen:
Exhibit 6-9: Monomers and Other Reactants Screen

Logged in as. Jane Doe, Secondary Support

Log Out

Bona Fide ^ Bona Fide (Joint Bona Fide-20130920-13:00:54 EDT} > Monomers and Other Reactants

Secondan, Support MONOMERS AND OTHER REACTANTS

]_)General Document Information
""[^|Primary Contact Information

Technical Contact information Select the Add Monomer button to add monomers that make up the polymer composition.

B Chemical

Chemical Identification
Information

9'& Chemical 1406

f*| =|Piriyroer
Identification
Information

Monomers and
Other Reactants

: "j =|Use Information
•^¦Document Management

Optional Cover Letter

Expand All | Collapse All

Cancel

Click the button below to search ERA'S Substance Registry Services (SRS) for the desired
chemical.

Search SRS

CAS Registry Number.
Monomer or other reactant:
Include in Identity:

Typical Composition:

Save

Click to add a monomer iAdd Monomer

Composition Total:0.0%

Optional Attachments

Attach Document

File Name

Description

Actions

-/ a n

Validate Save Preview

Navigation: Click the 'Next' button to navigate to the 'Use Information' screen. You can also
access this screen by clicking the 'Use Information' link within the navigation tree.

6.1.9 Use Information

You can navigate to the 'Use Information' screen by clicking the 'Next' button from the 'Class 1
or 2 Chemical Substances' screen, on the 'Class 2/Biotechnology Substances' screen, or on the
'Monomers and Other Reactants' screen, depending on the choice made on the 'Class 1 or 2
Chemical Substances' screen. You can also access this screen by clicking the 'Use Information'
link within the navigation tree.

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The 'Use Information' screen is used to capture data about the chemical substance's intended
use. When the user navigates to the screen, the screen contains a text box with instructional text
that reads, 'How will the substance be used?' Enter specific data for the chemical substance and
then advance to the next screen.

How will the substance be used?: Enter data regarding how the chemical substance is intended
to be used. This is a required field.

Exhibit 6-10 shows a screen capture of the 'Use Information' screen:

Exhibit 6-10: Use Information Screen

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Log Out

Bona Fide

Secondary Support

General Document Information

4 Bona Fide (Joint Bona Fide-20130920-13:00:54 EDT) > Use Information

USE INFORMATION

How will the substance be used?

Primary Contact Information

Technical Contact Information

El" Chemical

¦ rfSlChemical Identification
Information

Chemical 1406

Polymer
Identification
Information

Monomers and
Other Reactants

""1 -1 Use Information

Document Management
Optional Cover Letter

|^NextJ

Validate Save

Preview

CDX Homepage |

I MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Document Management' screen. You can
also access this screen by clicking the 'Document Management' link within the navigation tree.

6.1.10 Document Management

You can navigate to the 'Document Management' screen by clicking the 'Next' button from the
'Use Information' screen. You can also access this screen by clicking the 'Document
Management' link within the navigation tree.

The 'Document Management' screen is used to attach required documents to the electronic form.
The user must attach three required documents: 'Spectrum of Substance,' 'Statement of
Commercialization,' and 'Statement of Research and Development.' The application also allows
the user to attach 'Other' documents.

Please note that in IE 7, you must attach the three required documents before clicking the 'Next'
button and navigating to the next screen. If you click the 'Next' button with only one or two

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documents attached, you will be taken to an error screen. Navigate away from this screen using

the back button on your browser and ensure that the correct documents have been attached.

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window to upload documents. Refer to Section Error! Reference source not found,
for additional details regarding the attach document functionality.

• Document Name: Displays the document name and file extension of the document uploaded
on the 'Attach Documents' pop-up window.

• Document Type: Displays the document type associated with the uploaded document.

• Action: Click the 'Delete' icon ( ¦>) to delete the entire document row permanently from the
system. A warning message displays to confirm the deletion of the document.

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Exhibit 6-11 shows a screen capture of the 'Document Management' screen:

Exhibit 6-11: Document Management Screen

Logged in as Jane Doe, Secondary Support

Log Out

Bona Fide

Secondary Support

General Document In forma ton
Primary Contact Information
TechiMcal Contact Information
Chemical

~[ Ch*fn»cai Werttification
Information

B & ChemicaM+06

rQWyiwr
ttentificaton
Information

i ~p Monomers and
Other Reaetants

Use Information

Document
Management

^(3 Optional Cover Letter

< Bona Fide (Joint Bona Fide-20130920-13:00:54 EDI) > Document Management t

DOCUMENT MANAGEMENT

Please attach at least one ot each of the following documents

• Spectrum of Substance; Infrared spectrum or alternative spectra or other data which identify the
substance

• Statement of Commercialization: 1) A brief statement indicaling how long the substance has been in
commercial use oulslde of the United States 2} The name of a country in which it has Seen commercially
used 3) Whether the importer Believes that the substance has already been used commercially, in any
country, for the same purpose or application mat the importer Is intending.

• Statement of Research and Development: A brief description of the research and development
activities conducted to date related to the substance.

You can also attach other documetiis.

Attach Document

Document Name

Document type

Action

•y s

Validate S3ve

Preview

CDX Homepage I

M>C0X Homepage

I EPA Homepage I Terms ana Conditions I

Privacy Notice I

CDX Helpcfeslc (089) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Optional Cover Letter' screen. You can
also access this screen by clicking the 'Optional Cover Letter' link within the navigation tree.

6.1.11 Optional Cover Letter

You can navigate to the 'Optional Cover Letter' screen by clicking the 'Next' button from the
'Document Management' screen. You can also access this screen by clicking the 'Optional
Cover Letter' link within the navigation tree.

The 'Optional Cover Letter' screen is used to communicate information with EPA that is not
collected elsewhere in the form. The cover letter is used to give EPA resources and special
instructions regarding the application.

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Optional Cover Letter: Enter any additional special instructions regarding the form.

Exhibit 6-12 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 6-12: Optional Cover Letter Screen

Logged in as Jane Doe. Secondary Support

Log Out

Bona Fide

Secondary Support

General Document Information

Primary Contact Information

Technical Contact Information

S Chemical

j"" Chemical Identification
Information

f" ^Chemical 1406

'[5] Polymer
Identification
Information

Monomers and
Other Reactants

Use Information

M Document Management

[^Optional Cover Letter

4 Bona Fide (Joint Bona Fide-20130920-13:0(h54 EDT) > Optional Cover Letter

OPTIONAL COVER LETTER

If you would like to include a cover letter, please use the space below.

Validate Save

Preview

CDX Homepage

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Validate' icon < > located in the bottom action bar to validate the form.
Click the 'Save' icon (I ) located in the bottom action bar to perform a global save on the form.
Click the 'Preview' icon ( ) located in the bottom action bar to preview the Bona Fide PDF.

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Preview

The system provides the option to preview a form at any point during the submission process.
Click the 'Preview' icon ( -?), located within the bottom action bar, to see a PDF version of the
form. A screen will display for you to view either the 'Full' or the 'Sanitized' version of the PDF
differentiated by buttons. After you choose either the 'Full' or 'Sanitized' PDF, the application
generates a draft, watermarked PDF version of the form.

Please note in IE 7, the 'Preview EPMN FORM' screen text might be misaligned.

The watermark reads 'Not for Submission' and displays across each page in the background. The
form preview displays the entire form in a printable format. The preview functionality provides
the flexibility to track the status of the form and see the entire form in a single viewpoint.

Exhibit 7-1 shows a screen capture for the 'Preview' of the Biotechnology form:
Exhibit 7-1: Preview Biotechnology Form Screen

Biotechnology
Secondly Siippoit
Joint Bioteclinology-
20130502-14:07:12 EOT

JGeneral Form Information
"MTechnical Contact Information
Optional Cover Letter

Home J Forms J Resources

-*¦ Logged in as: Jane Doe, Secondary Support

Log Out

PREVIEW EPMN FORM

Please choose a Regular or Sanitized PDF.

Full Vei sioii i I Sanitized Vei sion

~ ¦

Validate Save

Preview

CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDXHelpdesk: (8S

38) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 7-2 shows a screen capture for the 'Preview' of the Biotechnology form:

Exhibit 7-2 Preview Biotechnology Form PDF

niwiiiiiiiiiiiiiiii

B:O20'.4P1

BI02D14P1

Form Approved. O.M.B. Nos. 2Q70-0Q12 and 2D7Q-O03fl

EPA Biotech Form

Biotech Form Report Number

Mark (X) if anything is CBI [

L SUBMITTER IDENTIFICATION INFORMATION

CBI ~

First Name

Last Name

Position

Company

Mailing Address
(Number & Street)

City

State

Postal Code

e-mail

Telephone

(include area code)

la. JOINT SUBMITTER — If1you are submitting this notice as part of a joint submission, marl (X) I I I CBI O

First Name

Last Name

Position

Company

Mailing Address
(Number & Street)

City

State

Postal Code

e-mail

Telephone
(include area code)

n. TECHNICAL CONTACT IDENTIFICATION INFORMATION

CBI ~

First. Name

Last Name

Position

Company

Mailing Address
(Number & Street)

City

State

Postal Code

e-mail

Telephone

(include area code)

m. TYPE OF SUBMISSION (Check One)

1 1 MCAN (Microbial Commercial Activity Notice)
1 I TERA (TSCA Experimental Release Application)

1 Tier I Exemption
1 I Tier II Exemption
1 I Biotech TME (Test Market Exemption)

IV. TEXT / COMMENTS

CBI ~

EPA Form Number 6300-17 (6-09)

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8 Validate

You can click the 'Validate' icon (*) at any stage of completing a Section 5 Notices and
Supports form. The 'Section 5 Notices and Supports Validation' pop-up window displays when
you click the 'Validate' icon ( ). The pop-up blocker within your internet browser must be
disabled to ensure that the window displays correctly. The 'Section 5 Notices and Supports
Validation' pop-up window displays a report of all validation errors and warning messages.
During the validation process, the application validates each screen of the Section 5 Notices and
Supports form to find missing and invalid data.

Please note in IE 7, the 'Help' button is aligned to the right side of the 'Section 5 Notices and
Supports Validation' pop-up window.

Validation Errors: Errors are denoted by an 'Error' icon ( U) and can be fixed by clicking the
error link. The links will display the Screen Title Name (e.g., Chemical Identification) and the
associated error. After you click a link, the main application screen will display the section
where the error occurred so you can easily fix the error. Once you have fixed the error(s), click
the 'Validate' icon ( ) again to refresh the 'Section 5 Notices and Supports Validation' pop-up
window. If the information you fixed passes validation, the error will be removed from the
'Section 5 Notices and Supports Validation' pop-up window.

Warning Messages: Warnings are denoted by a 'Warning' icon ( ) and can be fixed by
clicking the warning link. The links will display the Screen Title and the associated warning
After you click a link, the main application screen will display the section where the warning
occurred so you can easily fix the warning. Once you have fixed the warning(s), click the
'Validate' icon ( ) again to refresh the 'Section 5 Notices and Supports Validation' pop-up
window. If the information you fixed passes validation, the warning will be removed from the
'Section 5 Notices and Supports Validation' pop-up window.

You can close the 'Section 5 Notices and Supports Validation' pop-up window by clicking the
'X' button located at the upper right-hand corner of the window.

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Exhibit 8-1 shows a screen captures for the 'Section 5 Notices and Supports Validation' pop-up
window:

Exhibit 8-1: Section 5 Notices and Supports Validation Pop-Up Window

SECTION 5 NOTICES AND SUPPORTS VALIDATION
Errors:

• Technical Contact Information

® Contact is reauired.

• Additional Submission Information

• Site Information

® 'Do vou have sites controlled bv the submitter?' is required.

® 'Do vou have sites controlled bv others?' is required.

@ Do vou have sites controlled bv the submitter? must be answered with Yes since a Submitter Controlled Operation has been added.
Do vou have sites controlled bv others? must be answered with Yes since an Operation Controlled bv Others has been added.

• Submitter Controlled Operations
« Operation 1

¦ Submitter Operation Information

• Operations Controlled by Others
o Operation 1

• Industrial Sites Controlled By Others

# Alias is required.

Warnings:

• Joint Submission 1

« Joint Submission Information

: You did not notilv the Secondary Submitter of the joint submission.

• LOS Submission 1

o Letter of Support Submission Information

@ Operation Alias is required

: You did not notify the Secondary Submitter of the letter of support submission

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9 Resources

You can access the 'Resources' screen by clicking the 'Resources' tab located at the top of the
screen at any time during the submission process. You can also access the 'Resources' screen by
clicking the 'Resources' link from the Section 5 Notices and Supports 'Home' screen. The
'Resources' screen provides you with links to the appropriate Section 5 Notices and Supports
user guides as well as additional helpful links. Click the 'User Guide' link to access the Section 5
Notices and Supports user guide document.

• Regulatory Impact Analysis for the Regulation of Microbial Products of Biotechnology:
Government Costs: If you click this link, a new internet browser window will generate
displaying the 'Regulatory Impact Analysis for the Regulation of Microbial Products of
Biotechnology: Government Costs' screen.

• Microbial Products of Biotechnology: Final Rule (62 FR 17910): If you click this link, a
new internet browser window will generate displaying the 'Microbial Products of
Biotechnology: Final Rule (62 FR 17910)' screen.

• Points to Consider in the Preparation of TSCA Biotechnology Submissions for
Microorganisms: If you click this link, a new internet browser window will generate
displaying the 'Points to Consider in the Preparation of TSCA Biotechnology Submissions for
Microorganisms' PDF.

• CDX Homepage: If you click this link, a new internet browser window will generate
displaying the CDX Homepage.

• TSCA Chemical Substances Inventory: If you click this link, a new internet browser window
will generate displaying the 'TSCA Chemical Substances Inventory' screen.

• Substance Registry Services (SRS): If you click this link, a new internet browser window
will generate displaying the 'Substance Registry Services (SRS)' screen.

• Facility Registry System (FRS): If you click this link, a new internet browser window will
generate displaying the 'Facility Registry System (FRS)' screen.

• CAS Inventory Expert Services: If you click this link, a new internet browser window will
generate displaying the 'CAS Inventory Expert Services (IES)' screen.

• National Pollutant Discharge Elimination System (NPDES): If you click this link, a new
internet browser window will generate displaying the 'National Pollutant Discharge
Elimination System (NPDES)' screen.

• New Chemicals Program Homepage: If you click this link, a new internet browser window
will generate displaying the 'New Chemicals Program' screen.

• Status of Section 5 Notices: If you click this link, a new internet browser window will
generate displaying the 'Status of Section 5 Notices' screen.

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Exhibit 9-1 shows a screen capture of the 'Resources' screen (Scroll 1):

Exhibit 9-1 Resources Screen (Scroll 1)

Logged in as: Jane Doe, Secondary Support

Log Out

RESOURCES

Section 5 Notices and Supports User Guide
This guide describes each screen of the Section 5 Notices and Supports software and provides information on how to use the system to complete a
Section 5 Notices and Supports form. The guide also contains instructions for registering with CDX, submitting the Section 5 Notices and Supports
form, and amending a previous submission. You can download and print the guide for quick reference.

User Guide

Helpful Web Links

Click the link provided below to access additional information related to the Regulatory Impact Analysis for the Regulation of Microbial Products of

Biotechnology: Government Costs.

Regulators Impact Analysis for the Regulation of Microbial Products of Biotechnology: Government Costs

Clickthe link provided below to access additional information related to TSCA Biotechnology Regulations.

Microbial Products of Biotechnology: Final Rulef62 FR 179101

Click the link provided below to access additional information related to Points to Consider in the Preparation of TSCA Biotechnology Submissions for

Microorganisms.

Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms

Clickthe link provided below to access additional information related to the Central Data Exchange (CDX).

CDX Homepage

Click the link provided below to access additional information related to the Toxic Substances Control Act (TSCA) Chemical Substances Inventory.

TSCA Chemical Substances Inventory

Clickthe link provided below to access additional information related to Substance Registry Services.

Substance Registry Services fSRSI

Clickthe link provided below to access additional information related to the Facility Registry System.

Facility Registry System fFRSI

Clickthe link provided below to access additional information related to Inventory Expert Services.
CAS Inventory Expert Services

CDX Homepage | MyCDX Homepage | EPA Homepage I Terms and Conditions I Privacy Notice I CDX Helpdesk: (888) 890-1995

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Exhibit 9-2 shows a screen capture of the 'Resources' screen (Scroll 2):

Exhibit 9-2 Resources Screen (Scroll 2)

Home y Forms y Resources

Microbial Products of Biotechr

Logged in as: Jane Doe, Secondary Support

Log Out

Biotechnology: Hnal Rule lti'2 hN 1 /91ut

Click the link provided below to access additional information related to Points to Consider in the Preparation of TSCA Biotechnology Submissions for

Microorganisms.

Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms

Click the link provided below to access additional information related to the Central Data Exchange (CDX).

CDX Hornenage

Click the link provided below to access additional information related to the Toxic Substances Control Act (TSCA) Chemical Substances Inventory.

TSCA Chemical Substances Inventory

Click the link provided below to access additional information related to Substance Registry Services.

Substance Reoistrv Sen/ices fSRSl

Click the link provided below to access additional information related to the Facility Registry System.

Facility Reoistiv System fFRSl

Click the link provided below to access additional information related to Inventory Expert Services.

CAS Inventors Expert Services

Click the link provided below to access additional information related to the National Pollutant Discharge Elimination System.

National Pollutant Discharge Elimination System fNPDESI

Click the link provided below to access additional information related to the New Chemicals Program.

New Chemicals Prooram Homeoaae

Click the link provided below to access information related to the status of Section 5 Notices.

Status of Section 5 Notices

Fortechnical assistance, please call CDX helpdesk at (888) 890-1995. For assistance on how to fill out the forms (content) or for policy questions,
please call (202) 554-1404 Monday to Friday 8:30 a.m. - 5:00 p.m. EST or e-mail the TSCA Hotline at TSCA-Hotline@eoamail.eba.oov.

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions I Privacy Notice | CDX Helpdesk: (888) 890-1995

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10 Appendix A.

The following table displays all the definitions, acronyms, and abbreviations used in this
document and their full name.

Definitions, Acronyms, and Abbreviations

Acronym

Full Name

ACM

Alternative Control Measures

Authorized Official

BCF/BAF

Bioconcentration Factors/Bioaccumulation Factors

CBI

Confidential Business Information

Chemical Abstracts

CAS

Chemical Abstracts Service

CASRN

Chemical Abstracts Service Registry Number

CDX

Central Data Exchange

CFR

Code of Federal Regulations

CoR

Copy of Record

CROMERR

Cross-Media Electronic Reporting Regulation

CSPP

Chemical Safety and Pesticide Programs

CSV

Comma-Separated Values

DNA

Deoxyribonucleic Acid

EPA

Environmental Protection Agency

EST

Eastern Standard Time

ETI

Environmental Technology Initiative

Federal Regulation

FRS

Facility Registry System

GPC

Gel-permeation Chromatography

Identification

Internet Explorer

IES

Inventory Expert Service

Industrial Hygienist

Infrared

Kilogram

LOREX

Low Release/Low Exposure Exemption

LOS

Letter of Support

LVE

Low Volume Exemption

MCAN

Microbial Commercial Activity Notice

Mass Spectrometry

MSDS

Material Safety Data Sheet

NIOSH

National Institute for Occupational Safety and Health

NMR

Nuclear Magnetic Resonance

NOC

Notice of Commencement

NPDES

National Pollutant Discharge Elimination System

OPPT

Office of Pollution Prevention and Toxics

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PDF

Portable Document Format

PMN

Premanufacture Notice

POTW

Publicly Owned Treatment Works

PPE

Personal Protective Equipment

PPM

Parts Per Million

RCRA

Resource Conservation and Recovery Act

SAR

Structure-Activity Relationship

SDS

Safety Data Sheet

SME

Subject Matter Expert

SNUN

Significant New Use Notice

SNUR

Significant New Use Rule

SRS

Substance Registry Services

STN

Scientific and Technical Information Network

TERA

TSCA Experimental Release Application

TME

Test Market Exemption

TMEA

Test Marketing Exemption Application

Toxic Substances

TSCA

Toxic Substances Control Act

Ultraviolet

XML

Extensible Markup Language

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