CDX Section 5 Notices and Supports User Guide Primary Support


Section 5 Notices and Supports
User Guide - Primary Support

Environmental Protection Agency

Office of Pollution Prevention and Toxics

Manage Toxic Substances

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

Version 1.0
December 17, 2014

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Table of Contents

Table of Contents	i

List of Exhibits	v

1	Introduction	1

2	System Requirements	2

2.1	Supported Browsers	2

2.2	Screen Resolution	2

3	Primary 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	10

3.5	Navigation Tree	11

3.6	Action Bar	22

3.7	Attach Documents	23

3.8	Search Substance Registry Services (SRS)	27

3.9	Add Facility	31

4	Edit Premanufacture Notice (PMN)	35

4.1	Edit PMN Form	35

4.2	General Form Information	35

4.3	User Fees Certification	40

4.4	Agent Information	41

4.4.1 Add Agent	43

4.5	Technical Contact Information	45

4.5.1 Add Technical Contact	47

4.6	Additional Submission Information	49

4.7	Joint Submitter Information	54

4.8	Joint Submission Information	55

4.8.1 Notify Joint Submitter of Joint Submission Information	58

4.9	Letter of Support Submitter Information	60

4.10	Letter of Support Submission Information	61

4.10.1 Notify Secondary Submitter of Letter of Support Information	64

4.11	Chemical Identification	66

4.12	Class 1 or 2 Chemical Substances	67

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4.13	Class 2 Substances	72

4.14	Additional Chemical Information	75

4.15	Polymer Identification Information	81

4.16	Monomers and Other Reactants	85

4.17	Production Volume and Hazard/Safety Information	90

4.18	Use Information	93

4.19	Physical and Chemical Properties Worksheet	99

4.20	Physical and Chemical Properties Worksheet - Continued (Optional)	107

4.20.1 Physical and Chemical Properties Worksheet - Continued (Optional) Attach

Documents	108

4.21	Site Information	112

4.22	Sites Controlled By Others	113

4.23	Submitter Operation Information	115

4.24	Occupational Exposures	121

4.25	Environmental Releases	125

4.26	Industrial Sites Controlled By Others	130

4.27	Exposures/Releases	133

4.28	Byproduct Information	138

4.29	Optional Pollution Prevention	139

4.30	Additional Attachments	142

4.31	Attachment Summary	144

4.32	Optional Cover Letter	145

4.33	Upload XML	147

5 Edit a Biotechnology Form	149

5.1	Edit Biotechnology Form	149

5.2	General Form Information	149

5.3	Joint Submitter Information	152

5.4	Joint Submission Information	153

5.4.1 Notify Secondary Submitter of Joint Submission Information	155

5.5	Letter of Support Submitter Information	157

5.6	Letter of Support Submission Information	158

5.6.1 Notify Secondary Submitter of Letter of Support Information	160

5.7	Technical Contact Information	163

5.7.1 Add Technical Contact	164

5.8	Optional Cover Letter	166

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6	Edit Notice of Commencement (NOC) Form	168

6.1	Edit NOC Form	168

6.2	General Form Information	168

6.3	Technical Contact Information	169

6.4	Chemical Information	172

6.5	Site Information	176

6.6	CBI Substantiation Part 1	177

6.7	CBI Substantiation Part 2	180

6.8	CBI Substantiation Part 3	183

6.9	Optional Cover Letter	186

7	Edit Support Form	188

7.1	Edit Support Form	188

7.2	General Form Information	188

7.3	Original Submitter Information	191

8	Edit Bona Fide Form	194

8.1	Edit Bona Fide Form	194

8.2	General Document Information	194

8.3	Primary Contact Information	197

8.4	Technical Contact Information	200

8.5	Statement of Intent	202

8.6	Letter of Support Submitter Information	204

8.7	Letter of Support Submission Information	206

8.7.1 Notify Secondary Submitter of Letter of Support Information	208

8.8	Chemical Identification Information	211

8.9	Class 1 or 2/Biotechnology Chemical Substances	212

8.10	Class 2/Biotechnology Substances	216

8.11	Polymer Identification Information	218

8.12	Monomers and Other Reactants	221

8.13	Use Information	224

8.14	Submitter Site Identification	225

8.15	Document Management	227

8.16	Optional Cover Letter	229

9	Edit Alternative Control Measures (ACM) Form	230

9.1	Edit ACM Form	230

9.2	Contact Information	230

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9.2.1 Add Contact	231

9.3 Attachments	233

10	Preview	236

11	Validate	241

12	Resources	243

Appendix A	246

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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	10

Exhibit 3-5: Enter Passphrase Screen	11

Exhibit 3-6: Navigation Prompt	12

Exhibit 3-7: Premanufacture Notice Navigation Tree (Scroll 1)	14

Exhibit 3-8: Premanufacture Notice Navigation Tree (Scroll 2)	15

Exhibit 3-9: Premanufacture Notice Navigation Tree (Scroll 3)	16

Exhibit 3-10: Premanufacture Notice Navigation Tree (Scroll 4)	17

Exhibit 3-11: Biotechnology Navigation Tree	18

Exhibit 3-12: Notice of Commencement (NOC) Navigation Tree	19

Exhibit 3-13: Support Navigation Tree	19

Exhibit 3-14: Bona Fide Navigation Tree (Class 2 Substance)	20

Exhibit 3-15: Bona Fide Navigation Tree (Polymer)	21

Exhibit 3-16: Alternative Control Measures Navigation Tree	22

Exhibit 3-17: Action Bar-Validate	22

Exhibit 3-18: Action Bar - Save	23

Exhibit 3-19: Action Bar - Preview	23

Exhibit 3-20: Action Bar - Help Links	23

Exhibit 3-21: Attach Documents Pop-Up Window	26

Exhibit 3-22: Search Substance Registry Services Pop-Up Window	28

Exhibit 3-23: Chemical Not Found In Substance Registry Services Pop-Up Window	30

Exhibit 3-24: Add Facility Message Pop-Up Window	32

Exhibit 3-25: Add Facility Pop-Up Window	33

Exhibit 4-1: General Form Information Screen (Scroll 1)	38

Exhibit 4-2: General Form Information Screen (Scroll 2)	39

Exhibit 4-3: User Fees Certification Screen	41

Exhibit 4-4: Agent Information Screen	43

Exhibit 4-5: Add Agent Pop-Up Window	45

Exhibit 4-6: Technical Contact Information Screen	47

Exhibit 4-7: Add Technical Contact Pop-Up Window	49

Exhibit 4-8: Additional Submission Information Screen	53

Exhibit 4-9: Joint Submitter Information Screen	55

Exhibit 4-10: Joint Submission Information Screen	57

Exhibit 4-11: Unique Identifier Notification Pop-Up Window	59

Exhibit 4-12: Letter of Support Submitter Information Screen	61

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Exhibit 4-13: Letter of Support Submission Information Screen	63

Exhibit 4-14: Unique Identifier Notification Pop-Up Window	65

Exhibit 4-15: Chemical Identification Screen	67

Exhibit 4-16: Class 1 or2 Chemical Substances Screen (Scroll 1)	71

Exhibit 4-17: Class 1 or2 Chemical Substances Screen (Scroll 2)	72

Exhibit 4-18: Class 2 Substances Screen (Scroll 1)	74

Exhibit 4-19: Class 2 Substances Screen (Scroll 2)	75

Exhibit 4-20: Additional Chemical Information Screen (Scroll 1)	79

Exhibit 4-21: Additional Chemical Information Screen (Scroll 2)	80

Exhibit 4-22: Polymer Identification Information Screen (Scroll 1)	84

Exhibit 4-23: Polymer Identification Information Screen (Scroll 2)	85

Exhibit 4-24: Monomers and Other Reactants Screen (Scroll 1)	89

Exhibit 4-25: Monomers and Other Reactants Screen (Scroll 2)	90

Exhibit 4-26: Production Volume and Hazard/Safety Information Screen	93

Exhibit 4-27: Use Information Screen (Scroll 1)	97

Exhibit 4-28: Use Information Screen (Scroll 2)	98

Exhibit 4-29: Physical and Chemical Properties Worksheet Screen (Scroll 1)	105

Exhibit 4-30: Physical and Chemical Properties Worksheet Screen (Scroll 2)	106

Exhibit 4-31: Physical and Chemical Properties Worksheet - Continued (Optional) Screen....108

Exhibit 4-32: Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents Pop-Up Window (Scroll 1)	110

Exhibit 4-33: Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents Pop-Up Window (Scroll 2)	111

Exhibit 4-34: Site Information Screen	113

Exhibit 4-35: Sites Controlled By Others Screen	115

Exhibit 4-36: Submitter Operation Information Screen (Scroll 1)	119

Exhibit 4-37: Submitter Operation Information Screen (Scroll 2)	120

Exhibit 4-38: Occupational Exposures Screen (Scroll 1)	123

Exhibit 4-39: Occupational Exposures Screen (Scroll 2)	124

Exhibit 4-40: Environmental Releases Screen (Scroll 1)	128

Exhibit 4-41: Environmental Releases Screen (Scroll 2)	129

Exhibit 4-42: Industrial Sites Controlled By Others Screen	132

Exhibit 4-43: Exposures/Releases Screen (Scroll 1)	135

Exhibit 4-44: Exposures/Releases Screen (Scroll 2)	137

Exhibit 4-45: Byproduct Information Screen	139

Exhibit 4-46: Optional Pollution Prevention Screen	142

Exhibit 4-47: Additional Attachments Screen	144

Exhibit 4-48: Attachment Summary Screen	145

Exhibit 4-49: Optional Cover Letter Screen	146

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Exhibit 4-50: Upload XML Screen	148

Exhibit 5-1: General Form Information Screen (Biotechnology)	151

Exhibit 5-2: Joint Submitter Information Screen	153

Exhibit 5-3: Joint Submission Information Screen	154

Exhibit 5-4: Unique Identifier Notification Pop-Up Window	156

Exhibit 5-5: Letter of Support Submitter Information Screen	158

Exhibit 5-6: Letter of Support Submission Information Screen	160

Exhibit 5-7: Unique Identifier Notification Pop-Up Window	162

Exhibit 5-8: Technical Contact Information Screen	164

Exhibit 5-9: Add Technical Contact Pop-Up Window	166

Exhibit 5-10: Optional Cover Letter Screen	167

Exhibit 6-1: General Form Information Screen	169

Exhibit 6-2: Technical Contact Information Screen	170

Exhibit 6-3: Add Technical Contact Pop-Up Window	172

Exhibit 6-4: Chemical Information Screen (Scroll 1)	175

Exhibit 6-5: Chemical Information Screen (Scroll 2)	176

Exhibit 6-6: Site Information Screen	177

Exhibit 6-7: CBI Substantiation Part 1 Screen (Scroll 1)	179

Exhibit 6-8: CBI Substantiation Part 1 Screen (Scroll 2)	180

Exhibit 6-9: CBI Substantiation Part 2 Screen (Scroll 1)	182

Exhibit 6-10: CBI Substantiation Part 2 Screen (Scroll 2)	183

Exhibit 6-11: CBI Substantiation Part 3 Screen (Scroll 1)	185

Exhibit 6-12: CBI Substantiation Part 3 Screen (Scroll 2)	186

Exhibit 6-13: Optional Cover Letter Screen	187

Exhibit 7-1: General Form Information Screen (Scroll 1)	190

Exhibit 7-2: General Form Information Screen (Scroll 2)	191

Exhibit 7-3: Original Submitter Information Screen	193

Exhibit 8-1: General Document Information Screen (Scroll 1)	196

Exhibit 8-2: General Document Information Screen (Scroll 2)	197

Exhibit 8-3: Primary Contact Information Screen	199

Exhibit 8-4: Technical Contact Information Screen (Scroll 1)	201

Exhibit 8-5: Technical Contact Information Screen (Scroll 2)	202

Exhibit 8-6: Statement of Intent Screen	204

Exhibit 8-7: Letter of Support Submitter Information Screen	206

Exhibit 8-8: Letter of Support Submission Information Screen	208

Exhibit 8-9: Unique Identifier Notification Pop-Up Window	210

Exhibit 8-10: Chemical Identification Information Screen (Class 1 or 2 Chemical Substance) .212

Exhibit 8-11: Class 1 or 2 Chemical/Biotechnology Chemical Substances Screen	215

Exhibit 8-12: Class 2/Biotechnology Substances Screen (Scroll 1)	217

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Exhibit 8-13: Class 2/Biotechnology Substances Screen (Scroll 2)	218

Exhibit 8-14: Polymer Identification Information Screen	221

Exhibit 8-15: Monomers and Other Reactants Screen	224

Exhibit 8-16: Use Information Screen	225

Exhibit 8-17: Submitter Site Identification Screen	227

Exhibit 8-18: Document Management Screen	228

Exhibit 8-19: Optional Cover Letter Screen	229

Exhibit 9-1: Contact Information Screen	231

Exhibit 9-2: Add Contact Pop-Up Window	233

Exhibit 9-3: Attachments Screen	235

Exhibit 10-1: Preview Biotechnology Form Screen	237

Exhibit 10-2: Preview Biotechnology Form PDF	238

Exhibit 10-3: Preview NOC Form PDF	239

Exhibit 10-4: Preview Support Form PDF	240

Exhibit 11-1: Section 5 Notices and Supports Validation Pop-Up Window	242

Exhibit 12-1: Resources Screen (Scroll 1)	244

Exhibit 12-2: Resources Screen (Scroll 2)	245

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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

12/17/14

1.0

Final Section 5 Notices and Supports
Primary Support User Guide

Incorporated OPPT comments given
on 11/07/2013

Incorporated Release 1.00
enhancements, other OPPT
comments

C. Yeh

J. Bronick

12/17/14

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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 Primary 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 Environmental Protection Agency (EPA) for the submission of Section 5 Notices and
Supports data. As a Primary Support, you can modify a Section 5 Notices and Supports form that
a Primary 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. appl e. com/kb/dl 8 7 7

•	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 Primary 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 forms - Premanufacture Notice (PMN),
Biotechnology, Notice of Commencement (NOC), Support, Bona Fide, and Alternative
Control Measures (ACM) 721.30

• Upload an Extensible Markup Language (XML) file

The Primary Support is designated by a Primary AO to provide supporting information on behalf
of a company. A Primary Support may either work on behalf of a United States (U.S.)-based
company or non-U. S. based company. Examples of a Primary 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.
Primary Supports do not have the ability to sign the certification statement required for a form,
but they may enter or modify data for a form for which they have access. The Primary Support
does not have access rights to create or submit a form.

Once the Primary AO creates a new form, the Primary AO will provide the Primary Support with
the passphrase to access the form and complete all sections of the form. The Primary Support can
edit a form that is created by the Primary AO. The Primary Support can only access forms to
which the Primary AO has granted access.

The system will allow the Primary 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
Primary Support completes a form, the Primary 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

Legend

X=Can Perform Function

/

~

y

s/

J"
/

>

J

<5*

*/

~
/

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 SuddoiIforms

X

X

X

X

















Submit amendment for older cases and
other support forms

X

X

X

X

















Unlock Support and ACM forms

X

X

X

X

















Edit unlocked Support and ACM forms

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 Joint forms













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 'Primary 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

P



*¦ Logged in as: Jane Doe, Primary Support

Log Out

CHEMICAL INFORMATION SUBMISSION SYSTEM

T3CA Section 5 Notices and Supports - ePMN

OK

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 S300-14 (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 'TSCA Section
5 Notices and Supports - ePMN' from the submission type 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 Section 5 Notices and Supports forms 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 12.

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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

¦ Logged in as: Jane Doe, Primary 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) tor 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, Pvlodifications for LVEs and LoREX submissions; Biotechnology
Notice form (EPA Form 6300-14) should be used to submit MCANs. TERAs. Tier I 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.

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, which helps differentiate
between 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 3.4 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 Form Information' screen within a
PMN, Biotechnology, NOC, or Support form; the 'General Document Information' screen
within a Bona Fide Notice; or 'Contact Information' screen within an ACM 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: 'Primary PMN,' 'Biotechnology,' 'Support,'
'NOC,' 'Bona Fide,' or'ACM.'

•	Subtype: Displays the form subtype pertaining to the form type for the reported chemical
substance or mixture.

-	This column contains one of the following values for a PMN form:

'MOCK SUBMISSION,' 'LOREXMODIFIC ATION,' (Low Release/Low Exposure
Exemption Modification) 'LVEMODIFIC ATION,' (Low Volume Exemption
Modification) 'LOREX,' 'LVE,' 'TMEA,' (Test Marketing Exemption Application)
'SNUN,' (Significant New Use Notice) or 'PMN.'

-	This column contains the following values for a Biotechnology form: 'MCAN,' (Microbial
Commercial Activity Notice) 'TERA,' (TSCA Experimental Release Application)

'TIER1,' 'TIER2,' or'Biotechnology TME' (Biotechnology Test Market Exemption).

-	This column contains the following values for a Support form: 'Amendment,' 'TestData,'
'TransferOfOwnership,' 'WithdrawalRequest,' 'SuspensionRequest,' or

' OtherC orrespondence.'

-	NOC forms, ACM forms, and Bona Fide Notices do not have subtypes.

•	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.

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-	A PMN submission can have the following case number formats: P-XX-XXXX for PMN,
SN-XX-XXXX for SNUN, L-XX-XXXX for LVE, LM-XX-XXXX for LVE
Modifications, X-XX-XXXX for LOREX, XM-XX-XXXX for LOREX Modifications, T-
XX-XXXX for TMEA, and I-XX-XXXX for Mock PMN notice types.

-	A Biotechnology form can have the following case number formats: J-XX-XXXX for
MC AN, R-XX-XXXX for TERA, G-XX-XXXX for Tier I Exemption, and H-XX-XXXX
for Tier II.

-	Bona Fide forms will have a case number format of BF-XX-XXXX.

-	ACM forms will have a case number format of ACM-XX-XXXX.

-	NOC and Support forms will display user-specified case numbers.

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

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

•	Submission Date: Displays the date 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 y Forms f Resources

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.

¦fi- Logged in as: Jane Doe, Primary Support

Log Out

6 items found.

Page 1 of 1

Items Per Page:

Alias t

Type

Subtype Case Number

Status £

Modify Date Submission Date

ACM-20130520-16:42:43 EDT

ACM



In Progress

06/17/2013

Biotecl mology-20130619-10:05:49 EDT

Biotechnology



In Progress

06/19/2013

Bona Fide-20130502-13:16:43 EDT

Bona Fide



In Progress

06/18/2013

NOC-20130619-10:06:58 EDT

NOC



In Progress

06/19/2013

Primary PMN-20130619-10:03:48 EDT

Primary PMN

LVE_MODIFICATION

In Progress

06/19/2013

Support-20130619-10:07:32 EDT

Support

SuspensionRequest

In Progress

06/19/2013

Export options: CSV 13 Excel 143 XML | S PDF

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

Navigation: Click the alias link in the 'Alias' column of an 'In Progress' form to navigate to the
'Enter Passphrase' screen.

3.4 Enter Passphrase

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 supplied by the Primary AO that was originally
associated with the form.

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

Exhibit 3-5: Enter Passphrase Screen

A Logged in as: Jane Doe, Primary 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.

Cancel

Navigation: Enter the passphrase that the Primary AO originally created and associated with the
form and click the 'Next' button to navigate to the 'General Form Information' screen in a PMN,
Biotechnology, NOC, or Support form. Click the 'Next' button to navigate to the 'General
Document Information' screen in a Bona Fide form. Click the 'Next' button to navigate to the
'Contact Information' screen in an ACM 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.

• 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

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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, NOC, Support, Bona Fide Notice, or ACM forms, and is
unavailable when amending a PMN form.

• 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, NOC, Support, Bona Fide, or ACM
forms, and is unavailable when amending a PMN form.

• Delete 'Submitter Controlled Operations' or 'Operations Controlled By Others'
folders: Click the 'Delete' icon ( *) that displays at the bottom of each 'Submitter
Controlled 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

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Others' folder. This delete functionality is not applicable to the Biotechnology, NOC,
Support, Bona Fide Notices, or ACM forms.

• Upload XML: The system displays an 'Upload XML' button in the navigation tree to allow
a user to upload an XML file into a PMN form or joint PMN form, or to export an existing
PMN form into an XML file format. A user may also upload eTSCA thick client files into a
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 4.33.

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 capture of the PMN navigation tree (Scroll 1):

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

Premanufacture Notice ^

Pr imary Support

General Form Information A

User Fees Certification

!""[ Agent Information

Technical Contact Information

Additional Submission
Information

Joiirt Submission

: B . Joint Submission 1

l ;""|3]Joint Submitter
i i j Information

Joint Submission
j	Information

:""SC Remove

'"EglAdd Joint Submission

Letter of Support

j S^Brown

Letter of Support

Submitter

Information

Letter of Support
| i I Submission
Information

	L[=jAdd Letter of Support

Chemicals

El Chemical 3715

Chemical
j ! Identification

j	jjClass 1 or 2

j | Chemical
I j	Substances

I j !""[% Class 2 Substances

j""2 Additional Chemical v

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Exhibit 3-8 shows a screen capture of the PMN navigation tree (Scroll 2):

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

Premanufacture Notice ^

Primary Support

j B A Chemical 2715	A

Chemical
Identification

| I i""|"~~lClass 1 or 2
j ; j Chemical
I j j Substances

Class 2 Substances

| ! j""2 Additional Chemical

Information	pi

~ Production Volume
j !	and Hazard/Safety

l j | Information

! !""[=_ Use Information

$ ^Physical &

Chemical
Properties

!	j	r"|_|Physical and

I	I I	[ Chemical

j	j 1	| Properties

|	M	; Worksheet

| j } 	[^Physical and

Chemical
Properties
Worksheet -
Continued
(Optional)

.,-4 Remove

| i Hi Copy

S Chemical 2718

Chemical
j j ! Identification

j ; j""[ "iPolymer
j ! Identification
i ; j Information

j""| Monomers and

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Exhibit 3-9 shows a screen capture of the PMN navigation tree (Scroll 3):

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

Premanufacture Notice ^

Primary Sii|>|>oit
j M A Chemical 2718	a

Chemical
;	Identification

I |""(5 |Polymer

Identification
Information

[^Monomers and
Other Reactants

Additional Chemical
Information

Production Volume
and Hazard/Safety
Information

Use Information

Physical &

Chemical
Properties

Physical and
Chemical
Properties
Worksheet

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

"JCRemove

Si Copy

A Add Consolidated
Chemical

Site Information

Submitter Controlled Site
Information

Sites Controlled By Others ^

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Exhibit 3-10 shows a screen capture of the PMN navigation tree (Scroll 4):

Exhibit 3-10: Premanufacture Notice Navigation Tree (Scroll 4)

Premanufacture Notice ^

Primary Support

A Add Consolidated	A

Chemical

Site Information

Submitter Controlled Site
Information

!	Sites Controlled By Others

B Submitter Conti oiled
Operations

~ HTlsite Alias 1

Submitter Operation
l !	Information

!""[ Occupational
i i	Exposures

Environmental
l ! ! Releases

,^ Remove

:'"EjjlAdd Operation

Operations Controlled by
Others

" [JjAlias A

| j'"t Industrial Sites
i i	Controlled By

I ! | Others

i""|W ExposuresjReleases

| ;""h|By product
I ; I Information

Remove
®-u=iAdd Operation
Optional Pollution Prevention
Additional Attachments
I"" Attachment Summary
Optional Cover Letter

v

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Exhibit 3-11 shows a screen capture of the Biotechnology navigation tree:

Exhibit 3-11: Biotechnology Navigation Tree

Biotechnology
Primary Support	^

Biotechnology-20130619-
10:05:49 EDT
General Form Information
? Joint Submission
~ 2 Joint Submission 1

Joint Submitter
i	Information

Joint Submission
information

:""K Remove

'^Add Joint Submission

Letter Of Support

~ .^Letter of Support 1

' Letter of Support
I | j Submitter
! I | Information

Letter of Support
Submission
| | l information

;-x Remove

:""Ej=|Add Letter Of Support

Technical Contact Information

Optional Cover Letter

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Exhibit 3-12 shows a screen capture of the NOC navigation tree:

Exhibit 3-12: Notice of Commencement (NOC) Navigation Tree

Notice of Commencement
Primary Support	^

NOC-20130619-10:06:58 EDT
j"'[^General Form Information

{""[^Technical Contact Information
j""[5]Chemical Information
j""[S]Submitter Site Information
CBI Substantiation

! "[J CBI Substantiation Part 1
rlpCBI Substantiation Part 2
;..„g)CB| Substantiation Part 3
"•"[^Optional Cover Letter

Exhibit 3-13 shows a screen capture of the Support navigation tree:

Exhibit 3-13: Support Navigation Tree

Support
Primary Support

Support-20130619-10:07:32 EDT
i""(^General Form Information

:""[S]Original Submitter Information

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Exhibit 3-14 shows a screen capture of the Bona Fide navigation tree (Class 2 Substance):
Exhibit 3-14: Bona Fide Navigation Tree (Class 2 Substance)

Bona Fide
Primary Support	^

i'"[j General Document
Information

jffiJPrimary Contact Information

|""[=]Technical Contact Information

restatement of Intent

~ "F ILetter of Support

i"'fflLetter of Support
Submitter Information

:....g|Letter of Support

Submission Information

Chemical

l""[W|Chemical Identification
Information

^Chemical 2678

|"'U]Class 1 or 2
Chemical
Substances

h j®Class 2
Substances

: [S)Use Information

Site Information

:""[W|Submitter Site
Identification

!""g]Document Management
"'"[^Optional Cover Letter

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Exhibit 3-15 shows a screen capture of the Bona Fide navigation tree (Polymer):
Exhibit 3-15: Bona Fide Navigation Tree (Polymer)

Bona Fide
Primary Support	^

!""{j General Document
Information

Primary Contact Information
Technical Contact Information
Statement of Intent
Letter of Support

j j~5 Letter of Support

Submitter Information

Letter of Support
Submission Information

Chemical

Chemical Identification
! Information

" Chemical 3063

!""[] Polymer
; ! Identification
; j Information

l ^ Monomers and
Other Reactants

Use Information

Site Information

; '""[^[Submitter Site
Identification

P Document Management
Optional Cover Letter

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Exhibit 3-16 shows a screen capture of the ACM navigation tree:

Exhibit 3-16: Alternative Control Measures Navigation Tree

ACM

Primary Support ^

ACM-20130520-16:42:43 EDT
!" "Qcoiitact Information

"'"[^Attachments

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 11 for more information on validating a
form.

The following exhibits, Exhibit 3-17, Exhibit 3-18, and Exhibit 3-19 show screen captures for
the action bar:

Exhibit 3-17: 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.

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Exhibit 3-18: 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 3-19: 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.

- 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 3-20 shows a screen capture of the action bar 'Help' links:

Exhibit 3-20: 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.

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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.

• 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.

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•	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 3-21 shows a screen capture of the 'Attach Documents' pop-up window:

Exhibit 3-21: Attach Documents Pop-Up Window





ATTACH DOCUMENTS

Type and Subtype Type:

Select the type and subtype Aquatic Ecotoxicity

of the attachment

Subtype:

Attachment

Select the file to attach

File:

Browse

Description

Provide a description of the
attachment

**Please do not include any
CBf infomiation in trie
description of trie file
infomation.

Number of Pages

pages

CBI

Check to claim the attachment as CBI 0

Sanitized Attachment File

Selectthe sanitized file to	Browse

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

not containing any CBI data.

Cancel

R

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 CASRN of the chemical. 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: Click the 'Search' 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 display the 'Chemical
Not Found In Substance Registry Services' pop-up window.

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Exhibit 3-22 shows a screen capture of the 'Search Substance Registry Services' pop-up
window:

Exhibit 3-22: 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:

2.	CA Index Name or Other Synonym:

Matches exactly
Matches Exactly -

Search SRS

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
'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'

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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 3-23 shows a screen capture of the 'Chemical Not Found In Substance Registry Services'
pop-up window:

Exhibit 3-23: Chemical Not Found In Substance Registry Services Pop-Up Window

Q

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 fulfilled.

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

Chemical ID

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-hand corner to close the pop-up window
and navigate back to the screen from which the SRS search was initiated.

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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 PMN form. This button also displays on
the 'Site Information' screen within aNOC form and the 'Submitter Site Identification' screen
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 user's 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 site 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 3-24 shows a screen capture of the 'Add Facility' pop-up window:
Exhibit 3-24: Add Facility Message Pop-Up Window

CSPP

m

ADD FACILITY

All available sites you are currently registered to within CDX have been added.
If you wish to identity and add additional sites to this form, please add these
sites within your CDX registration profile.

Cancel

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Exhibit 3-25 shows a screen capture of the 'Add Facility' pop-up window:

ADD FACILITY

Select a site from the drop-down menu below:

1 -

Alias:

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

State:

Postal Code:

Exhibit 3-25: Add Facility Pop-Up Window



Add Facility Cancel

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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 Premanufacture Notice (PMN)

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 PMN Form

To edit a PMN form, 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 3.4 for additional details regarding the enter passphrase process.

4.2 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 application contains the following functionality and may generate additional screens for a
PMN form based on the type of notice selected from the 'Type of Notice' drop-down menu on
the 'General Form Information' screen:

• If you select 'Premanufacture Notice (PMN)' or 'Significant New Use Notice (SNUN)' from
the 'Type of Notice' drop-down menu, the 'Payment ID' and the 'TS Number' fields are
required. Click the 'Next' button to navigate to the 'User Fees Certification' screen.

• If you select 'SNUN' from the 'Type of Notice' drop-down menu, it is recommended that a
cover letter be provided. Otherwise, a warning message will display during validation of the
form.

• If you are not filing a PMN or SNUN, click the 'Next' button to navigate to the 'Agent
Information' screen.

• If 'Low Volume Exemption (LVE) @ 40 CFR 723.50(c)(1)' or 'LVE Modification' is
selected from the 'Type of Notice' drop-down menu, a 'LVE Certification' screen generates
and displays during the submission process. The 'LVE Modification' form type requires only
identification of a technical contact, and selection of a 'Manufacture' or 'Import' option.

• If 'Low Release/Low Exposure Exemption (LOREX) @ 40 CFR 723.50(c)(2)' or 'LOREX
Modification' is selected from the 'Type of Notice' drop-down menu, a 'LOREX
Certification' screen generates and displays during the submission process. The 'LOREX
Modification' form type requires only identification of a technical contact, and selection of a
'Manufacture' or 'Import' option.

• If 'Test Marketing Exemption Application (TMEA)' is selected from the 'Type of Notice'
drop-down menu, click the 'Next' button to navigate to the 'Agent Information' screen. The

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'TMEA' form type requires only identification of a technical contact, and selection of a
'Manufacture' or 'Import' option.

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 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 'Payment ID' is a user supplied alphanumeric value that corresponds to the method of
payment used to submit the user fee (e.g. a check number, a wire transfer number, or a Pay.gov
transaction number). The 'Payment ID' is a required field when you are filing a PMN or SNUN.

The 'Test Data' section provides checkboxes to identify data that is included in the notice
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
requirements of §720.50 of the Premanufacture Notification Rule (40 Code of Federal
Regulations (CFR) Part 720).

The 'Identify whether any of the below options apply' section provides checkboxes for you to
indicate how interactions with other companies occur within the form. If the company is filing a
Joint Submission, a 'Joint Submission' folder generates within the navigation tree for you to
enter information concerning the Joint Submission. A unique identification number will be
generated and sent to the joint submitter by the primary submitter and will link the two forms
together. You will also be able to indicate that a Letter of Support submitted by a Secondary AO
is expected with the original PMN form. You will also be able to indicate that a Letter of Support
is expected with the PMN form. The Letter of Support will be submitted by a Secondary AO,
with a unique identification number linking the forms.

• Form Alias: Displays the form alias created by the Primary AO. This is an editable field that
can be modified if necessary. This is a required field.

• Type of Notice: Select a value to indicate the type of notice for the PMN form. Valid values
include: 'Premanufacture Notice (PMN),' 'Significant New Use Notice (SNUN),' 'Test
Marketing Exemption Application (TMEA),' 'Low Volume Exemption (LVE) @ 40 CFR

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723.50 (c)(1),' 'Low Release/Low Exposure Exemption (LOREX) @ 40 CFR 723.50(c)(2),'
'LVE Modification,' 'LOREX Modification,' and 'Mock Submission.' Select 'PMN' if the
application is for a standard, fine-product new chemical substance for placement on the
TSCA inventory. Select 'Significant New Use Notice' for any notice that is marked in
accordance with a Significant New Use Rule (SNUR). Select 'TMEA' for any notice
submitted in accordance with the criteria listed in 40 CFR §720.38. A 'Mock Submission' is
an enforcement case where the chemical was manufactured/imported in the past and is not
currently being manufactured/imported by the company. 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.

• Payment ID: The 'Payment ID' can be entered as free text, but refers to a check number,
wire transfer number, or a Pay.gov transaction number used to electronically transmit a fee.
This field is required if either '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.

• Check here if you are filing a joint PMN: Check the 'Check here if you are filing a joint
PMN' checkbox to indicate that the form is pending a joint PMN form. A 'Joint Submission'
folder generates within the navigation tree upon clicking the ' Save' icon located at the
bottom of the screen within the action bar or by clicking the 'Next' button on the 'General
Form Information' screen.

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• Check here if you have a Letter of Support pending: Check the 'Check here if you have a
Letter of Support pending' checkbox to indicate that the form is pending a Letter of Support.
A 'Letter of Support' folder displays within the navigation tree upon clicking the 'Save' icon
located at the bottom of the screen within the action bar or by clicking the 'Next' button on
the 'General Form Information' screen.

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

T

T

*• Logged in as: Jane Doe, Primary Support

Log Out

Premanufacture Notice
Primary Support

General Form Information

User Fees Certification

Agent Information

2 Technical Contact Information

Additional Submission
Information

=! Joint Submission

~ Joint Submission 1

Joint Submitter
Information

Joint Submission
Information

" "X Remove

0=}Add Joint Submission

Letter of Support

? ^Letter of Support 1

Letter of Support
Submitter
Information

Letter of Support
Submission
Information

X Remove

Add Letter of Support

Chemicals

Chemical 2715

Chemical
Identification

iCtass 1 or 2
Chemical
Substances

'i ' Class 2 Substances

Additional Chemical
Information

Preinaniifacture Notice (Primary PMN-20130619-10:03:48 E D I) > 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
make 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 anytime.

I

Form Alias:
Type of Notice

Primary PMN-20130619-10:03:48 EC

Select the Type of Notice for the type of form you wish to file.

Premanufacture Notice (PMN)	w

PMN Identification

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

TS Number:
Payment ID:

L

Test Data

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

Environmental fate data:
Health effects data:
Environmental effects data:
Physical/Chemical properties:

~
~
~
~

Risk assessments:
Structure/Activity
relationships:
Other data:

~
~

~

Test data not in the possession or control of the ~
submitter:

I Hp ntifty whpfhpr an\/ nf thP hp





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CDX Homepage |

I MyCDX Homepage |

EPA Homepage I Terms and Conditions |

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CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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Exhibit 4-2 shows a screen capture of the 'General Form Information' screen (Scroll 2):
Exhibit 4-2: General Form Information Screen (Scroll 2)

Premanufacture Notice
Primary Support	^

General Form Information

"Quser Fees Certification

jAgent Information

Technical Contact Information

Additional Submission
} Information

B"i Joint Submission

-i Joint Submission 1

Joint Submitter
Information

Joint Submission
Information

Remove

|=|Add Joint Submission

Letter of Support

$ ^IjifLetter of Support 1

"| " Letter of Support
Submitter
Information

"I Letter of Support
Submission
Information

JCRemove

:""L?i=)Add Letter of Support

Chemicals

$ & Chemical 2715

Chemical
| Identification

Class 1 or 2
Chemical
Substances

Class 2 Substances

Additional Chemical

Home y Forms y Resources

date it was created. The form alias may be changed at any time.

•£• Logged in as: Jane Doe, Primary Support

Log Out

Primary PMN-20130619-10:03:48 EC

Form Alias:

Type of Notice

Select the Type of Notice for the type of form you wish to file.

Premanufacture Notice (PMN)	| *

PMN Identification

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

TS Number:
Payment ID:

Test Data

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

Environmental fate data:	~

Health effects data:	~

Environmental effects data:	~

Physical/Chemical properties:	~

Test data not in the possession or control of the	~
submitter:

Identify whether any of the below options apply.

Check here if you are filing a joint PMN:	0

Check here if have a Letter of Support pending:	0

Risk assessments:
Structure/Activity
relationships:
Other data:

~
~

~





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4.3 User Fees Certification

You can access the 'User Fees Certification' screen by selecting 'Premanufacture Notice (PMN)'
or 'Significant New Use Notice (SNUN)' from the 'Type of Notice' drop-down menu and by
clicking the 'Next' button from the 'General Form Information' screen. You can also access this
screen by clicking the 'User Fees Certification' link within the navigation tree.

The purpose of the 'User Fees Certification' screen is to inform EPA of how the user fees were
paid. You will have three (3) options to select from to notify EPA which user fee was selected. A
company will indicate whether '$100' was submitted for a small business, '$1,000' was
submitted for an intermediate PMN, or '$2,500' was submitted for a large business. You can find
the specifics of which category to file under by reviewing 40 Code of Federal Regulations (CFR)
Section 700.

•	The Company named in Part 1, Section A has remitted the fee of $2,500 specified in 40
CFR 700.45(b): Select this radio button to indicate that you have submitted a user fee in the
amount of $2,500. One of the three user fee options must be selected.

•	The Company named in Part 1, Section A has remitted the fee of $1,000 for
Intermediate PMN (defined @ 40 CFR 700.43) in accordance with 40 CFR 700.45(b):

Select this radio button to indicate that you have submitted a user fee in the amount of
$1,000. One of the three user fee options must be selected.

•	The Company named in Part 1, Section A is a small business concern under 40 CFR
700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b): Select this
radio button to indicate that you have submitted a user fee in the amount of $100. One of the
three user fee options must be selected.

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Exhibit 4-3 shows a screen capture of the 'User Fees Certification' screen:

Exhibit 4-3: User Fees Certification Screen

Premanufacture Notice
Primary Support

General Form Information
User Fees Certification

Agent Information

i'"PlTechnical Contact Information

Additional Submission
Information

Pi. Joint Submission

" Joint Submission 1

Joint Submitter
| Information

i""h Joint Submission
i Information

X Remove

:""Lr(k)Add Joint Submission

Letter of Support

$ ^Letter of Support 1

Letter of Support
Submitter
Information

Letter of Support
Submission
Information

X Remove

'^Add Letter of Support

Chemicals

f i Chemical 2715

Logged in as: Jane Doe, Primary' Support
Log Out

Premanufacture Notice (Primary PMN-20130619-10:03:48 EDT) > User Fees Certification

USER FEES CERTIFICATION

If a user is submitting a PMN or SNUN, select the user fee certification statement that applies.

If you select Option 2 please note the following statement: Notice(s) for chemical intermediates submitted
together in sequence with a final PMN are eligible for a reduced review fee of $1,000 for each intermediate
notice-

User Fees Certification



Select the following user fee certification statement that applies:

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

The Company named in Part I, Section A has remitted the fee of $1000 for Intermediate PMN
(defined @ 40 CFR 700.43) in accordance with 40 CFR 700.45(b).

The Company named in Part 1, Section A is a small business concern under 40 CFR 700.43
and has remitted a fee of $100 In accordance with 40 CFR 700.45(b).

Previous

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CDX Homepage | MyCDX Homepage I EPA Homepage I 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 Inforaiation' link within the navigation tree.

4.4 Agent Information

You can access the 'Agent Information' screen by clicking the 'Next' button from the 'General
Form Information' screen if you are not filing a 'PMN' or 'SNUN.' You can also navigate to this
screen by clicking the 'Next' button from the 'User Fees Certification' screen if you are filing a
'PMN' or 'SNUN.' Click the 'Agent Information' link within the navigation tree to access this
screen.

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

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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 this button to display the 'Add Agent' pop-up window, which provides
fields for you to enter agent contact information.

•	Last Name: Displays the last name of the reported agent. Click the last name link to edit the
agent information.

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

•	Address: Displays the 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.

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

Exhibit 4-4: Agent Information Screen

T

* Logged in as: Jane Doe, Primary Support

Log Out

Premanufacture Notice
Primary Support

General Form Information
" jUser Fees Certification
Agent fnform Agent Information

AGENT INFORMATION

To add a new Agent click the Add Agent button. Add Agent

Last Name	First Name	Address

'&

CBI

Actions





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~













Validate Save

Preview



CDX Homepage |

| MyCDX Homepage |

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

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.

4.4.1 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.

• 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. To claim agent information as confidential, check the 'CBI'
checkbox after importing CDX registration information.

•	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.

•	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.

•	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.

•	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.

•	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. This is a required field.

•	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.

•	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.

•	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 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 the 'Country' field is set to 'United States.'

•	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.

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Exhibit 4-5 shows a screen capture of the 'Add Agent' pop-up window:

Exhibit 4-5: Add Agent Pop-Up Window

rej

dicspp

ADD AGENT

Please enter the information for the agents who will be responsible for supporting the information on the
form. Chech 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:

Mailing Address 2

City:

State:

Postal Code:
Country:

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

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.

4.5 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.

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The technical contact should be able to answer, or obtain answers to, questions related to the
chemical submitted to EPA within the PMN form. 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 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 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.

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Exhibit 4-6 shows a screen capture of the 'Technical Contact Information' screen:
Exhibit 4-6: Technical Contact Information Screen

A Logged in as: Jane Doe, Primary Support

Log Out

Premanufacture Notice
Primaiy Suppoit

General Form Information

"| ' jUser Fees Certification

"l^lAgent Information

[^Technical Contact
Information

Additional Submission
Information

S Joint Submission

5 l^Joint Submission 1

Qjoint Submitter
Information

'jjjJoint Submission
Information

"X Remove

^"'^Add Joint Submission

S" Letter of Support

S'lMfirown

Letter of Support
Submitter
Information
Letter of Support
Submission
Information

X Remove
_,Add Letter of Support

4, Premanufacture Notice (Primaiy PMN-20130619-10:03:48 ECU) > Technical Contact Information

TECHNICAL CONTACT INFORMATION

CBI

To add a new Technical Contact click the Add Technical Contact button |jAdd Technical Contact
Last Name	First Name	Address

Previous

Actions





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CDXr

•	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 4-7 shows a screen capture of the 'Add Technical Contact' pop-up window:
Exhibit 4-7: Add Technical Contact Pop-Up Window

¦Sj

c^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 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:

Mailing Address 2:

City:

State:

Postal Code:
Country:

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

Apartment, suite, etc.

United States

Cancel

OK

Navigation: Click the 'Cancel' button or 'X' icon at the top left-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.

4.6 Additional Submission Information

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

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The 'Additional Submission Information' screen gathers information concerning the PMN form
that references generic information allowing EPA to set a base point for the project.

The 'Prenotice Communication Number' is a number given to a user during past communication
with EPA. The 'Prenotice Communication Number' is required if you are filing a consolidated
PMN. EPA must approve all consolidated PMN forms prior to submission. The system will
require that you either enter a number into the text field or check the 'None' checkbox. You may
declare the number confidential by checking the 'CBI' checkbox.

EPA uses the 'Previously Submitted Notice Number' to link past, current, and future forms. This
number allows EPA to associate previous renditions of the current submission in the PMN
process. The system will require that you either enter a case number into the text field or check
the 'None' checkbox. You may declare the number confidential by checking the 'CBI'
checkbox.

The 'Bona Fide Intent Notice Number' is listed to show the company previously contacted EPA
to determine whether the chemical in question was previously listed on the TSCA inventory. The
system will require that you either enter a number into the text field or check the 'None'
checkbox. You may declare the number confidential by checking the 'CBI' checkbox.

On this screen, a company must also declare whether the newly registered chemical will be
manufactured or imported. You will have the option to select 'Manufacture' and/or 'Import' and
depending on whether the company only intends to do one of the available options, the system
provides 'Binding' checkboxes to indicate a binding option. If the 'Manufacture' checkbox is
checked, the screens within the 'Submitter Controlled Operations' folder automatically
generates.

The binding option demonstrates that you intend to only do the one option selected and would be
willing to legally bind to that situation if EPA chooses to regulate that chemical. The purpose of
the binding option is to enable EPA (if necessary) to efficiently negotiate with a PMN submitter
the development of §5(e) consent orders and promulgate SNUR for those new chemical
substances that the Agency determines may present an unreasonable risk if certain control
actions are not implemented. This option is intended to reduce delays that can slow the
development of consent orders. At one time, SNUR were limited to environmental release
activities and certain industrial, commercial, or consumer activities, but now they can include
other important activities, such as protection in the workplace and hazard communications.
Control measures instituted by the submitter to reduce exposures and/or releases of the substance
may have a direct bearing on the Agency's conclusions regarding risk. Therefore, you may wish
to indicate your willingness to be bound to certain submitted information on the form, which
relates to the issue of potential risk such as use, production volume, protective equipment,
engineering controls, and/or process description. By indicating your willingness to make these
commitments, you would be indicating an interest in future negotiations if EPA deems them
necessary.

Please note that in IE 7, leaving an identification number field blank and clicking the 'Save' icon
associated with an identification number does not cause the empty field to turn yellow. In
addition, entering identification numbers with incorrect formats into the 'Previously Submitted
Notice Number' field does not cause the field to turn yellow.

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•	Prenotice Communication Number - None: Check the 'None' checkbox for the 'Prenotice
Communication Number' to indicate that there is no prenotice communication number.
Checking the 'None' checkbox removes the 'Prenotice Communication Number' fields and
associated actions. Un-check the 'None' checkbox to re-generate a 'Prenotice
Communication Number' field and enter a value.

•	Prenotice Communication Number: Enter the prenotice communication number to
associate with a previous contact with EPA. Click the 'Save' icon (0) to save an individual
entry. Click the 'Form' icon (0) that displays after saving to edit an individual entry. Click
the 'Delete' icon ( *) to delete individual entries. Click the 'Add' icon ( ) to generate blank
text fields to provide additional entries. This field is required if a form is a consolidated
submission, regardless of whether the 'None' checkbox is checked.

•	Prenotice Communication Number - CBI: Check the 'CBI' checkbox to claim all
identified prenotice communication numbers as confidential.

•	Previously Submitted Notice Number - None: Check the 'None' checkbox for the
'Previously Submitted Notice Number' to indicate that there is no previously submitted
notice number. Checking the 'None' checkbox removes the 'Previously Submitted Notice
Number' fields and associated actions. Un-check the 'None' checkbox to re-generate a
'Previously Submitted Notice Number' field and enter a value.

•	Previously Submitted Notice Number: Enter the previously submitted notice number to
associate with a previous contact with EPA. Enter this number in a case number format; this
value accepts alphanumeric characters and dashes. Click the 'Save' icon (H) to save an
individual entry. Click the 'Form' icon (Hi) that displays after saving to edit an individual
entry. Click the 'Delete' icon ( *) to delete individual entries. Click the 'Add' icon ( ) to
generate blank text fields to provide additional entries. This field is required, or the 'None'
checkbox must be checked.

•	Previously Submitted Notice Number - CBI: Check the 'CBI' checkbox to claim all
identified previously submitted notice numbers as confidential.

•	Bona Fide Intent Notice Number - None: Check the 'None' checkbox for the 'Bona Fide
Intent Notice Number' to indicate that there is no bona fide intent notice number. Checking
the 'None' checkbox removes the 'Bona Fide Intent Notice Number' fields and associated
actions. Un-check the 'None' checkbox to re-generate a 'Bona Fide Intent Notice Number'
field and enter a value.

•	Bona Fide Intent Notice Number: Enter the bona fide intent notice number to associate
with a previous contact with EPA. Click the 'Save' icon (H) to save an individual entry.
Click the 'Form' icon (Hi) that displays after saving to edit an individual entry. Click the
'Delete' icon ( ¦¦*) to delete individual entries. Click the 'Add' icon ( ) to generate blank
text fields to provide additional entries. This field is required, or the 'None' checkbox must
be checked.

•	Bona Fide Intent Notice Number - CBI: Check the 'CBI' checkbox to claim all identified
bona fide intent notice numbers as confidential.

•	Manufacture: Check the 'Manufacture' checkbox to claim the intent to manufacture. The
screens within the 'Submitter Controlled Operations' folder automatically generate when the
'Manufacture' checkbox is checked.

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

•	Import: Check the 'Import' checkbox to claim the intent to import.

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

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Exhibit 4-8 shows a screen capture of the 'Additional Submission Information' screen:
Exhibit 4-8: Additional Submission Information Screen



Pr©manufacture Notice
Pi Unary Support

Genera* Form Informal ton '

User Fees Certification

Agent Information

Techntcal Contact Information

Additional Submission
Information

- Joirrt Submission

3	Submission 1

Joint S&Mr&tu
taformadjon

Joint Subrnfcss»n
Information

X Remove

Add Joint Submission

Letter of Support

E3 .^tetter of support 1

x Letter ol Support
Subntfter
Information

Letter ol Support

Subrnssion

Irrformabon

XRemove

Add Letter of Support

3 Chemicals

B ^chemicilins

Chemical
htentiUcation

Class 1 or 2

Chemical

Substances

Class 2 Substances

Addllcoat Chemical
Information

Logged in as Jane Doe, Primary Support
Log Out

Home J Fomre y He sources
Pium Aiiaitloii.ilSubmission HiToiitialIon

ADDITIONAL SUBMISSION INFORMATION

Please enter identification numbers EPA has provided in past communication pertaining to this form. This
allows EPA to link the torm with previously submitted Information.

3. Prenotlce Communication Number:

None

i CBI

Prenotice
Communication =

Actions

yx+

4. Previously Submitted Notice Number

None

Previously submitted

Actions

CBI

Notice #







ax#

5. Bona Fide Intent Notice Number:

None

Bona Fide intent

Actions



- CBI

Notice #



six#

Manufacture or Import Options

Please select whether you intend to manufacture and/or import the chemical(s). Check tne Binding option
if you are willing to submit to being regulated on the option(s) specified

Manufacture:
Import

Binding:
Binding:

Previous

| Next |





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Validate Save

Preview



COX Homepage I

I MvCDX Homepage

| EPA Homepage \ Terms and Conditions |

Privacy Notice |

CDXHelpdesk (888) 890-1995

Navigation: If you are not filing a Joint PMN or Letter of Support submission, click the 'Next'
button to navigate to the 'Chemical Identification' screen. You can also access this screen by
clicking the 'Chemical Identification' link within the navigation tree. If you are submitting a
Joint Submission, click the 'Next' button to navigate to the 'Joint Submitter Information' screen.
You can also navigate to this screen by clicking the 'Joint Submitter Information' link within the
navigation tree. If you have a Letter of Support pending and are not submitting a joint
submission, click the 'Next' button to navigate to the 'Letter of Support Submitter Information'

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screen. You can also navigate to this screen by clicking the 'Letter of Support Submitter
Information' link within the navigation tree.

4.7 Joint Submitter Information

You can access the 'Joint Submitter Information' screen by clicking the 'Next' button from the
'Additional Submission Information' screen. You can also access this screen by clicking the
'Joint Submitter Information' link within the navigation tree. Click the 'Add Joint Submission'
link within the navigation tree to add an additional joint submitter; a maximum of two joint
submitters may be listed in a PMN form.

The 'Joint Submitter Information' screen is used to enter contact information regarding the joint
submitter that will be submitting separate information regarding the PMN form. The joint
submitter will be sent the unique identification number by the Primary AO. The provided email
address will be used to send the joint submitter the unique identification number.

•	Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim the joint submitter contact information as
confidential.

•	First Name: Enter the joint submitter's first name. This is a required field.

•	Last Name: Enter the joint submitter's last name. This is a required field.

•	Position: Enter the joint submitter's job title.

•	Company Name: Enter the joint submitter's company name. This is a required field.

•	Phone Number: Enter the joint submitter's daytime phone number; U.S. or international.
This field does not accept dashes. This is a required field.

•	Phone Extension: Enter the joint submitter's U.S. phone number extension if applicable.

•	Email Address: Enter the joint submitter's email address. The email address must follow the
standard email address format: John.Doe@abc.com. This is not a required field, but is
suggested for this contact.

•	Mailing Address 1: Enter the first line of the joint submitter's mailing address. This is a
required field.

•	Mailing Address 2: Enter the second line of the joint submitter's mailing address.

•	City: Enter the city of the joint submitter's mailing address. This is a required field.

•	State: Select the state of the joint submitter's mailing address from the drop-down menu.

This is a required field.

•	Postal Code: Enter the postal code of the joint submitter's mailing address. This is a required
field.

•	Country: Displays 'United States.'

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Exhibit 4-9 shows a screen capture of the 'Joint Submitter Information' screen:

Exhibit 4-9: Joint Submitter Information Screen

Pr#manufacture Notice
PrliiuMySuppoft

C«eo*r«f Form inJorrrwtiefi *

User fees Certiflealien

Aoert mfonnabon

Tectvacal Cert ad ki(ormal»n

Addtiooal Sutxrfssicn
lrDrtSu6fl*5!»aO
InfcrffcfltiQrv

AcfcJJort SubmfcMfi

Letter of Support

£ fflettef of Suppoit 1

LeG» of SMSport

SubmBer

InKsowitjQrt

Lcttdnr of Support

SUber&gOC

thforifiatiorv

X*««r»0ve

Add Letter of Stfjpcrt
Ch«mkiit
- il hrn.Kjl ??)S

Chemeal	,

Jane Doe. Primary Support
Log Out

PfMfiaiiUtocltit Notice (PvmwyPMN 2013061910c03:4$ EDT) > Joint Sutmtfnei Inform.* ion

JOINT SUBMITTER INFORMATION

Please enter contact information for the joint submitter who will Be responsible for providing EPA with PMN
information not provided by the man submitter Check to claim information as CBI

Check nere to claim this Information as CBI ;

First Name:

Last Name.

Position.

Company Name:

Phone Number

[Do not wtar »ny d»*h« (-> In PNe-r* ffemb^r fi«kf

Phone Extension:

Email Address:

Mailing Address 1:

Mailing Address 2:

City-
state.

Postal Code
Country.

5to«t	P.O. to*. e&mp»rry rum*, «fcc.

Apartment. *t«.

United States
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CDX Homepage

I MyCDX Homepage

I 6PA Homepage | Terms and Conditions |

Pwaty Notice I

CDX Helpdeik <81

38) 890-1995

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

4.8 Joint Submission Information

You can access the 'Joint Submission Information' screen by clicking the 'Next' button from the
'Joint Submitter Information' screen. You can also access this screen by clicking the 'Joint
Submission Information' link within the navigation tree.

The 'Joint Submission Information' screen is used as a communication point between two
companies. The 'Joint Submission Information' screen displays fields that capture information
that will be passed on to the joint submitter. A text box is used by the Primary AO or Primary

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Agent/Consultant to send information to the joint submitter in an unencrypted email. A 'Unique
Identifier for Joint Submissions' box will also display on this screen. The unique identification
number displays when a user declares a joint submission is being established.

Joint Submission Process: When a Primary AO, Primary Agent/Consultant, or Primary Support
designates that a joint submission is being filed, you will be asked to enter contact information
for a joint submitter. When the Primary AO or Primary Agent/Consultant navigates to the 'Joint
Submission Information' screen, the Primary AO or Primary Agent/Consultant can choose to
send an email to the joint submitter identified on the 'Joint Submitter Information' screen. The
email will contain the unique identification number that will link the two forms.

When the joint submitter (Secondary AO or Secondary Agent/Consultant) accesses the 'Section
5 Notices and Supports Forms' screen and creates a new form, the joint submitter will be
prompted to enter the unique identification number on the 'Create Passphrase' screen. Once the
unique identification number has been entered, the system will link the primary and joint forms.
The original notice will not undergo a review process until all forms are received.

•	Joint Submission Information Instructions: Enter the information that the primary
submitter is sending to the joint submitter.

•	Joint Submission Informational Text: Displays instructional text provided by OPPT, the
unique identification number automatically generated for the form, and provides functionality
to email the unique identification number to the joint submitter by clicking the 'Notify the
Secondary Submitter of the Joint Submission' link.

•	Unique Identification Number: The unique identification number is a random, auto-
generated number that must be provided to the joint submitter to create a joint submission.

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Exhibit 4-10 shows a screen capture of the 'Joint Submission Information' screen:
Exhibit 4-10: Joint Submission Information Screen

¦ Logged in as: Jane Doe, Primary Support
Log Out

Premanufacture Notice
Primary Support

"iGeneral Form Information A

User Fees Certification
mAgent Information

Technical Contact Information
!"" Additional Submission

Information
5" Joint Submission
@'ljj|fjoint Submission 1
Joint Submitter

Joint Submission
Information

: ' ^Add Joint Submission

S Letter of Support

S IStj^Letter of Support 1

Letter of Support
Submitter
Information

Letter of Support
Submission
Information

: 'XRemove

: L[=jAdd Letter of Support

S Chemicals

Pi emanufactui e Notice (Primary PMN-20130619-10:03:48 EDT) > Joint Submission Infoimation

JOINT SUBMISSION INFORMATION

Please include instructions you wish the joint submitter to see. Clicking the link
below will relay the information in this text box to your joint submitter via
unencrypted e-mail

$ & Chemical 2715

Chemical
¦ Identification

Class 1 or 2
: Chemical
Substances
Class 2 Substances

p Additional Chemical [^]

Unique Identifier for Joint Submission: 07455dec-e2fa-413d-9674-8d2eb1 b241 c5

This is the unique identification number for your joint submitter. Notify the
Secondare Submitter of the Joint Submission.

The Secondary1 Submitter will need this identification number to complete the
form. It is your responsibility to ensure that your secondary submitter
understands how to complete the PMN form and sends the information to EPA.
The information collected in the primary and secondary form(s) will be linked by
the unique identifier. The original notice will not undergo a review process until all
forms have been received.

jjtextJ



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Preview

CDX Homepage

MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (888) 890-1095

Navigation: Click the 'Notify the Secondary Submitter of the Joint Submission' link to access
the unique identifier notification pop-up window. Click the 'Next' button to navigate to the
'Chemical Identification' screen if you are not filing a Letter of Support. You can also access
this screen by clicking the 'Add Consolidated Chemical' link within the navigation tree. Click
the 'Next' button to navigate to the 'Letter of Support Submitter Information' screen if you are
submitting a Letter of Support. You can also access this screen by clicking the 'Letter of Support
Submitter Information' link within the navigation tree. A warning generates on this screen after

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clicking the 'Next' or 'Previous' button if you have not sent an email notification to the Joint
Submitter.

4.8.1 Notify Joint Submitter of Joint Submission Information

You can access the unique identifier notification window by clicking the 'Notify the Secondary
Submitter of the Joint Submission' link from the 'Joint Submission Information' screen.

The unique identifier notification window is used to provide the unique identification number to
the joint submitter. The unique identifier notification window displays a 'CC' field for you to
add other email addresses to the notification (including the original submitter), a 'To' field, and
an 'Additional Comments' text box.

•	Chemical Checkbox (es): The chemical(s) identified within a form displays on the unique
identifier notification pop-up window. Check the checkbox (es) for the chemical(s) identified
within the form for which the secondary submitter should provide supporting information.

•	From: Displays the email address of the user that created the form.

•	CC: This editable field automatically populates with the email address of the user that
created the original form and the email address(es) of the technical contact(s) identified
within the form.

•	To: Contains instructional text for you to enter multiple email addresses. Contains the
editable email address of the joint submitter specified on the 'Joint Submitter Information'
screen; this email address will be pre-populated upon navigating to the window. Enter any
additional email addresses to which the email should be sent.

•	Subject: Displays ' YYYY Primary PMN.'

•	Message: Contains a pre-determined message that will display in the email sent to a joint
submitter.

•	Additional Comments: Enter any other additional comments or instructions that should be
passed onto the joint submitter.

•	Send: Click the 'Send' button to generate and send the email to the email addresses
identified in the 'CC' and 'To' fields.

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Exhibit 4-11 shows a screen capture of the 'Unique Identifier Notification' pop-up window:
Exhibit 4-11: Unique Identifier Notification Pop-Up Window

Select the chemicals you want to notify the Secondary Submitter with:

Chemical 1

From:

CC:

To:

Jane.Doe@test.com

jane, doe @te st.com





A

jane.doe@test.com





A

Subject:	2014 Primary PMN

Message:	As the Authorized Official of TESTORGCGI1,1 have

identified you as a Secondary Submitter of a joint
submission for this 2014 Premanufacture Notice (PMN)
form. Please use the Section 5 Notices and Supports
application to provide the correct information for the
necessary items in this form. See the instructions
below for accessing the Section 5 Notices and
Supports application. You will need to use the unique
identification number to access and complete the
Premanufacture Notice (PMN) form for the joint
submission.

Unique Identifier ae7e4637-d900-403a-bb79-
11c156366112

Information about the Section 5 programs, how to
access the Section 5 Notices and Supports application,
and instructions for reporting under the Section 5 rule
are available at www.epa.oov/oppbnewchems/. For
additional information or if you believe you have
received this email in error, please contact me.

Additional Comments:

Navigation: Click the 'Send' button to send the email to the joint submitter and navigate back to
the 'Joint Submission Information' screen. Click the 'X' icon in the upper right-hand corner to

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exit the screen without sending the email and navigate back to the 'Joint Submission
Information' screen.

4.9 Letter of Support Submitter Information

Click the 'Next' button from the 'Joint Submission Information' screen to access the 'Letter of
Support Submitter Information' screen if a Letter of Support is pending. You can also access this
screen by clicking the 'Letter of Support Submitter Information' link within the navigation tree.
If you are only filing a Letter of Support, click the 'Next' button from the 'Additional
Submission Information' screen to navigate to the 'Letter of Support Submitter Information'
screen. Click the 'Add Letter of Support' link within the navigation tree to add extra Letters of
Support.

The 'Letter of Support Submitter Information' screen is used to enter contact information for the
Letter of Support submitter who will enter separate information for the PMN form. The unique
identification number will be sent to the Letter of Support submitter via the email address
provided.

An unlimited number of Letters of Support can be identified for each form.

•	Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim the Letter of Support submitter contact information as
confidential.

•	First Name: Enter the Letter of Support submitter's first name. This is a required field.

•	Last Name: Enter the Letter of Support submitter's last name. This is a required field.

•	Position: Enter the Letter of Support submitter's job title.

•	Company Name: Enter the Letter of Support submitter's company name. This is a required
field.

•	Phone Number: Enter the Letter of Support submitter's daytime phone number; U.S. or
international. This field does not accept dashes. This is a required field.

•	Phone Extension: Enter the Letter of Support submitter's phone number extension if
applicable.

•	Email Address: Enter the Letter of Support submitter's email address. The email address
must follow the standard email address format: John.Doe@abc.com. This is not a required
field, but is suggested for this contact.

•	Mailing Address 1: Enter the first line of the Letter of Support submitter's mailing address.
This is a required field.

•	Mailing Address 2: Enter the second line of the Letter of Support submitter's mailing
address.

•	City: Enter the city of the Letter of Support submitter's mailing address. This is a required
field.

•	State: Select the state of the Letter of Support submitter's mailing address from the drop-
down menu. This is a required field if 'United States' is selected from the 'Country' drop-
down menu.

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*	Postal Code: Enter the postal code of the Letter of Support submitter's mailing address. This
is a required field if the 'Country' field is set to 'United States.'

•	Country: Select the country of the Letter of Support submitter's mailing address from the
drop-down menu. This is a required field.

Exhibit 4-12 shows a screen capture of the 'Letter of Support Submitter Information' screen:
Exhibit 4-12: Letter of Support Submitter Information Screen

Premanufacture Notice
Prlmaiy Siippoif

CenettJ Form Information *

U$w Fees Certification

Agwt Inlofmatton

Technical Contact Information

Adtibonal Sitonteson
Information

Joint Submission

Joint StibmtMtOfl 1

Joint Submtter
Information

Joint Submis sion
InlormaUon

X Remove

Add Joint Submission

Letter of Support

r- ^Letter of support 1

Letlci of Support

Submitter

Information

Letter ot Support

Submission

Intormadion

Add Letter of St^iport

Chemicals

- JLCheniiciimS

Chewieai

Home y Forms j Resources

• Logged in as: Jane Doe. Primary Support
Log Out

PreuictiiUfactiire Notice  Letter of Support Submitlei lnfoinunion

LETTER OF SUPPORT SUBMITTER INFORMATION

Please enter the contact Information (or trie letter of support submitter who will be responsible for providing
supporting information to the main pmm submission, check to claim information as CBI.

Check here to claim this information as CBI:

First Name:

Last Name
Position

Company Name
Phone Number

(Do cat *nt*r tny dashes <•) in Phone Ptomber field above.)

Phone Extension
Email Address
Mailing Address t:

Mailing Address 2'

City
Stale

Postal Code
Cauntrv

5tr*et addr«s, P.O. box, company name, etc.

Apartment, suit*, etc.

Previous





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Preview



CDX Homepage |

MyCDX Homepage

I EPA Homepage 1 Terms and ConUiSons 1

Privacy Notice |

CDX Helpdesk. (88?) 890-1995

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

4.10 Letter of Support Submission Information

You can navigate to the 'Letter of Support Submission Inforaiation' screen by clicking the
'Next' button from the 'Letter of Support Submitter Information' screen. You can also access
this screen by clicking the 'Letter of Support Submission Information' link within the navigation
tree.

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The 'Letter of Support Submission Information' screen is used as a communication point
between two companies. The 'Letter of Support Submission Information' screen displays fields
that capture information to pass onto the Letter of Support submitter. A text box is used to send
information to the Letter of Support submitter in an email sent by the Primary AO. A 'Unique
Identifier for Letter of Support Submissions' box will also display on this screen. The unique
identification number generates when you declare a Letter of Support is being established.

Letter of Support Submission Process: When you designate that a Letter of Support is
pending, you will be asked to enter all the information within the 'Letter of Support' folder.

When the primary submitter chooses to, the system will send an email to the Letter of Support
submitter designated on the 'Letter of Support Submitter Information' screen. The email will
contain the unique identification number that will link the two forms.

When the Letter of Support submitter accesses the 'Section 5 Notices and Supports Forms'
screen and clicks the 'Start New Form' button, the Letter of Support submitter will be prompted
to enter the unique identification number on the 'Create Passphrase' screen. Once the unique
identification number has been entered, the system will link the primary form and Letters of
Support. Click the 'Add Letter of Support' link within the navigation tree to add extra Letters of
Support as needed.

•	Letter of Support Submission Information Instructions: Enter the information that the
primary submitter is sending to the Letter of Support submitter.

•	Letter of Support Submission Informational Text: Displays instructional text provided by
EPA, the unique identification number generated for the form, and provides functionality to
email the unique identification number to the Letter of Support submitter by clicking the
'Notify the Secondary Submitter of the letter of support submission' link.

•	Unique Identification Number: The unique identification number is a random number auto-
generated to pass on to the Letter of Support submitter to create a Letter of Support.

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Exhibit 4-13 shows a screen capture of the 'Letter of Support Submission Information' screen:
Exhibit 4-13: Letter of Support Submission Information Screen

* Logged in as Jane Doe, Primary Support

Log Out

Pre manufacture Notice
Pr tmaiy Support

General Form Information '

User Fees Certification

Agent Information

Technical Contact information

Adctfoonal Submission
Information

Joint Submission

E '^Jolnt Submission 1

H] Joint SUxntfer
Inlormotion

Joint Submission
InJormaiion

XRwnove

_Add ,foint Submission

^ Letter of Support

" .^Letter of Support t

Letter of Support
Submit er
Information

Letter of Support
Submission
Irrfor motion

1 u Add Letter of Supped

& Chemicals

- & Chemical ?71S

Chemical
Identification

~}J Class 1 or 2
Cheir»cal
Substances

Class 2 Substances

Addiiooai Cheir > Lettei of Support Submission lufotni^tioti

LETTER OF SUPPORT SUBMISSION INFORMATION

Please include Instructions you wish the Letter of Support submitter to see.
Clicking the link Below will relay die Information in ttils text Cox to your Letter ot
Support submitter via unencrypted e-mail.

Unique Identifier for Letter of Support Submission Qfe6dQcc-4e$9-422b-b223-
93a4154ae467

Tms is the unique identification number for your Letter of Support submitter
Notify ihe Secondary Submitter of the letser of support submission

The Secondary Submitter will need this Identification number to complete the
form It is your responsibility to ensure mat your secondary submitter
understands how to send the information to EPA The information collected in
Ihe primary and secondary forms(s) will be linked Oy Ihe unique identifier The
original notice will not undergo a review process until all forms have been
received

Previous

j^NextJ



¦

¦

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Preview

CDXHomepaje I MyCDXHorrrepage | EPA Homepage | Terms and Conditions I PrimyNolice | CDXHelpdesk (888)890-1995

Navigation: Click the 'Notify the Secondary Submitter of the letter of support submission' link
to navigate to the unique identifier notification window. Click the 'Add Letter of Support' link to
file two or more Letters of Support. Click the 'Next' button to navigate to the 'Letter of Support
Submitter Information' screen if additional Letters of Support are identified. A warning
generates on this screen after clicking the 'Next' or 'Previous' button (which may be present
depending on the presence of multiple Letters of Support) if you have not sent an email
notification to the Letter of Support submitter.

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4.10.1 Notify Secondary Submitter of Letter of Support Information

You can access the unique identifier notification window by clicking the 'Notify the Secondary
Submitter of the letter of support submission' link from the 'Letter of Support Submission
Information' screen.

The unique identifier notification window is used to notify the Letter of Support submitter of the
unique identification number. The unique identifier notification window displays a 'CC' field for
you to add other email addresses to the notification (including the original submitter), a 'To'
field, and an 'Additional Comments' text box.

•	Chemical Checkbox(es): The chemical(s) identified within a form displays on the unique
identifier notification pop-up window. Check the checkbox(es) for the chemical(s) identified
within the form for which the secondary submitter should provide supporting information.

•	From: Displays the email address of the logged in user that created the form.

•	CC: This field automatically populates with the email address of the logged in user that
created the form and the email address (es) of the technical contact(s).

•	To: This field contains instructional text for you to enter multiple email addresses. Contains
the editable email address of the Letter of Support submitter specified on the 'Letter of
Support Submitter' screen; this field is pre-populated with an email address upon navigating
to the unique identifier notification window.

•	Subject: Displays ' YYYY Primary PMN.'

•	Message: Displays a pre-determined message in the email sent to a Letter of Support
submitter.

•	Additional Comments: Enter any other additional comments or instructions to pass onto the
Letter of Support submitter.

•	Send: Click the 'Send' button to generate and send the email to the email addresses
identified in the 'CC' and 'To' fields.

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Exhibit 4-14 shows a screen capture of the 'Unique Identifier Notification' pop-up window:
Exhibit 4-14: Unique Identifier Notification Pop-Up Window

Select the chemicals you want to notify the Secondary Submitter with:

60 Chemical 1

From:

CC:

To:

2014 Primary PMN

As the Authorized Official of TESTORGCGI1,1 have
identified you as a Secondary Submitter of a letter of
support submission for this 2014 Premanufacture
Notice (PMN) form. Please use the Section 5 Notices
and Supports application to provide the correct
information for the necessary items in this form. See
the instructions below for accessing the Section 5
Notices and Supports application. You will need to use
the unique identification number to access and
complete the Premanufacture Notice (PMN) form for
the letter of support submission.

Unique Identifier 16630013-d64c-4c 17-90f7-
8000e4af3899

Information about the Section 5 programs, how to
access the Section 5 Notices and Supports application,
and instructions for reporting under the Section 5 rule
are available at www.eDa.gov/oppfr'newchems/. For
additional information or if you believe you have
received this email in error, please contact me.

Navigation: Click the 'Send' button to send the email to the Letter of Support Submitter and
navigate back to the 'Letter of Support Submission Information' screen. Click the 'X' icon to
exit the screen without sending the email and navigate back to the 'Letter of Support Submission
Information' screen.

Jane.Doe@test.com

ja ne .doe pjtest.com

jane.doe@test.com





A

Subject:
Message:

Additional Comments:

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4.11 Chemical Identification

You can navigate to the 'Chemical Identification' screen by clicking the 'Next' button from the
'Additional Submission Information' screen if you have not identified a joint submitter and/or
Letter of Support submitter. You can access this screen by clicking the 'Next' button from the
'Joint Submission Information' screen if you have identified a joint submitter. You can navigate
to this screen by clicking the 'Next' button from the 'Letter of Support Submission Information'
screen if you have identified a Letter of Support submitter. You can also navigate to this screen
by clicking the 'Add Consolidated Chemical' link within the navigation tree.

The 'Chemical Identification' screen identifies the type of chemical the submitter will be
entering into the application. You will be able to file a 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 if the form is pending a Joint Submission or a Letter of Support.

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Exhibit 4-15 shows a screen capture of the 'Chemical Identification' screen:

Exhibit 4-15: Chemical Identification Screen

Premanufacture Notice
Pi Imaiy Support

:""i-i3)Add Letter of Support

@"i_ Chemicals

j f & Chemical 2715

Chemical
Identification

j MClass 1 or 2
I Chemical
Substances

Class 2 Substances
'Additional Chemical
Information
"[^Production Volume
and Hazard/Safety
Information

"[fjUse Information

&ftfPhysical &

Chemical
Properties

Physical and
| j Chemical
Properties
Worksheet

Physical and
Chemical
Properties

0

Logged in as: Jane Doe, Primary Support
Log Out

PieinaiHifacture Notice (Primary PMN-20130619-10:03:48 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.

Class 1 or 2 Chemical Substance ®

Polymer	Q

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 navigation tree after you
have selected 'Class 1 or 2 Chemical Substance' or 'Polymer' above and then selected 'Next' below.

|^NextJ



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Preview

CDX Homepage | MyCDX Homepage | EPA Homepage I Terms and Conditions I Privacy Notice I CDX Helpdesk: (888) 890-1985

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 access this screen by clicking the 'Polymer
Identification Information' link within the navigation tree.

4.12 Class 1 or 2 Chemical Substances

You can access this 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
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.

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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:

1)	List the immediate precursor substances with their respective CASRN.

2)	Describe the nature of the reaction or process.

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

4)	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 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.

•	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. You may claim the chemical
substance class as confidential by checking the 'CBI' checkbox. 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 3.8 for further 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; this
generates the 'Generic Chemical Name' 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.' This is a
required field when displayed.

•	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. A
single response option in the 'B.l.c. ID Method' section is required.

•	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. A single response option in the 'B.l.c. ID
Method' section is required.

•	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.

•	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. This is a required field.

•	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 3.7 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

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

Exhibit 4-16 shows a screen capture of the 'Class 1 or 2 Chemical Substances' screen (Scroll 1):
Exhibit 4-16: Class 1 or 2 Chemical Substances Screen (Scroll 1)

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Pi ii nary Support

General Form Information

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Premanufacture Notice (Primary PMN-20130619-10:03:48 EDT} > Class 1 or 2 Chemical Substances
CLASS 1 OR 2 CHEMICAL SUBSTANCES

Expand Alii| 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 Setvices (SRS) for the desired chemical.
Search SRS

CASRN:

Chemical Name:

CBI:	0

B.6. Generic Chemical Name:

B.1 .c. ID Method

® Method 1 (CAS Inventory Expert Service) O Method 2 (Other Method)

IES Order#:	|	]

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

B.1 ,d. Molecular Formula:

CBI: ~

B.1 ,e. Chemical Structure Diagram:

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

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TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 4-17 shows a screen capture of the 'Class 1 or 2 Chemical Substances' screen (Scroll 2):
Exhibit 4-17: Class 1 or 2 Chemical Substances Screen (Scroll 2)

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IES Order #:

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8.1 .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 CBl Actions

Save

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

•Coniohdited chemicals are entered by clicking tha 'Add Consolidated Chemical' link within the navigation tree on the
left

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'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.'

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 3.9 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.

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•	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 (3 ) to delete the entire document row permanently from the
system; a warning message displays to confirm the deletion.

Exhibit 4-18 shows a screen capture of the 'Class 2 Substances' screen (Scroll 1):
Exhibit 4-18: Class 2 Substances Screen (Scroll 1)

T

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General Form Information

"Quser Fees Certification

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!""[D Class 2 Substances

CLASS 2 SUBSTANCES

Class 2 Substance Details

In the fields below for a 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.I.e.l. Precursor Substances CBI: ~

search srs Click the 'Search SRS' button to search EPA's Substance Registry 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.1 ,e.2. Nature of Reaction CBI: ~

CASRN

Actions

B.1 .e.3. Range of Composition CBI: ~

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I EPA Homepage | Terms and Conditions |

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CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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Exhibit 4-19 shows a screen capture of the 'Class 2 Substances' screen (Scroll 2):
Exhibit 4-19: Class 2 Substances Screen (Scroll 2)

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Primary Support

General Form Information

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1 ~ |Agent Information

[^Technical Contact Information

"h|Additional Submission
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precursor supstance or to manually enter the Chemical Name and CASRN (if applicable) if it is not found in
SRS.

Chemical Name

B.1 .e.2. Nature of Reaction CBI: ~

CASRN

Actions

B.1 .e.3. Range of Composition CBI: ~

Attachments

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

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CDX Homepage

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i 890-1995

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.

4.14 Additional Chemical Information

You can navigate to the 'Additional Chemical Information' screen by selecting the 'Class V
radio button on the 'Class 1 or 2 Chemical Substances' screen and clicking the 'Next' button, by

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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.

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.

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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.

•	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 3.8 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

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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.

•	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. 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 (0) to save a chemical synonym. Click the
'Form' icon (0) to edit a chemical synonym. 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.'

•	Attach Document: Click the 'Attach Document' button to display the 'Attach Documents'
pop-up window. Refer to Section 3.7 for further details regarding the attach document
functionality.

•	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 4-20 shows a screen capture of the 'Additional Chemical Information' screen (Scroll 1):
Exhibit 4-20: Additional Chemical Information Screen (Scroll 1)

T

T

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Log Out

Premanufacture Notice
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Epi Chemicals

! Chemical 2715

"(f\Chemical
Identification

"(f7 Class 1 or 2
Chemical
Substances

Class 2 Substances

Additional
Chemical
Information

Production Volume
and Hazard/Safety
Information

hHuse Information
B l^physical &

Chemical
Properties

Physical and
Chemical
Properties
Worksheet

"h Physical and
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Properties
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Continued
(Optional)

$ & Chemical 2718

|p Chemical
Identification

"'[§ Polymer
Identification
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Monomers and
Other Reactants

Additional Chemical

Information

0

Premanufacture Notice (Primary PMN-20130619-10:03:48 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 %.

Click the Search SRS button on the right to search SRS or to manually enter an impurity, search srs
Impurity	CASRN	Maximums	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.

B.5. Trade Identification

Synonym

CBI: ~

Actions

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Privacy Notice |

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TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 4-21 shows a screen capture of the 'Additional Chemical Information' screen (Scroll 2):
Exhibit 4-21: Additional Chemical Information Screen (Scroll 2)



Premanufacture Notice
Primary Support

@ Chemicals

Chemical 2715

"Qchemical
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substance. Provide the CAS Registry Number if available.

Logged in as: Jane Doe, Primary Support
Log Out

Infnrmatinn

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

B.5. Trade Identification CBI: ~

List trade names for the new chemical substance.

Trade Name

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

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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.

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4.15 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.

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.

To reference a monomer cleared with an LVE, comments should be included in an attachment
(for example, on a reaction scheme).

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.

•	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.

•	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.

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•	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
3.8 for additional details regarding the search SRS functionality.

•	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.

•	Generic chemical name: Enter the generic name to associate with a chemical. This field
displays when 'Chemical Name' and 'CASRN' are claimed CBI. This is a required field if
there is no pending Letter of Support or Joint Submission for the form.

•	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. A single response option in the 'ID Method' section is required if there is no
pending Letter of Support or Joint Submission for the form.

•	IES Order #: Select the 'Method 1 (CAS Inventory Expert Service)' radio button to generate
this field. Enter the IES order number. This is a required field if there is no pending Letter of
Support or Joint Submission for the form.

•	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.' A single response option in
the 'ID Method' section is required if there is no pending Letter of Support or Joint
Submission for the form.

•	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.' It is required that a document be attached for the ID Method if
there is no pending Letter of Support or Joint Submission for the form.

•	Attach Document: Click the button to generate the 'Attach Documents' pop-up window.
Refer to Section 3.7 for additional details regarding the attach document functionality.

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

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•	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.

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

Exhibit 4-22 shows a screen capture of the 'Polymer Identification Information' screen (Scroll

1):

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 4-22: Polymer Identification Information Screen (Scroll 1)

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Premanufacture Notice
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Production Volume
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POLYMER IDENTIFICATION INFORMATION

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Cancel X

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

CASRN:

Chemical Name:

CBI:	0

B.6. Generic chemical name:

B.1.C. ID Method

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

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Exhibit 4-23 shows a screen capture of the 'Polymer Identification Information' screen (Scroll
2):

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

Primary

Support

December 17, 2014
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Exhibit 4-23: Polymer Identification Information Screen (Scroll 2)

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B.l.C. ID Method

© Method I (CAS Inventory Expert Service) O Memod 2 (Otner Method)
IES Order #.

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B.t.e. Chemical Structure Diagram:

Include an attachment for the chemical structure diagram below
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Add Mew Chemical

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CDX Helpdesk (868)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.

4.16 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.

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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December 17, 2014
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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.

•	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. This is a
required field if there is no pending Letter of Support or Joint Submission for the form.

•	Specify other method of measure: 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.
This is a required field if there is no pending Letter of Support or Joint Submission.

•	(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. This is a required field if there are no pending Joint
Submissions or Letters of Support. Please note that in IE 7, the % symbols might be slightly
misaligned.

•	(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. This is a required field if there are no pending Joint
Submissions or Letters of Support. Please note that in IE 7, the % symbols might be slightly
misaligned.

•	Add Monomer: Click the 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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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'Cancel' link is displayed when the 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 the
expandable/collapsible field set to modify the information entered in the fields. The 'Edit'
link is displayed 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 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 'Search SRS' button to generate the 'Search Substance Registry
Services' pop-up window. Refer to Section 3.8 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

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maximum weight; do not use ppm units (1 ppm = 0.0001 wt%). The value entered must be a
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.

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

•	Attach Document: Click the 'Attach Document' button to generate 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 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Exhibit 4-24 shows a screen capture of the 'Monomers and Other Reactants' screen (Scroll 1):
Exhibit 4-24: Monomers and Other Reactants Screen (Scroll 1)

Home y Forms J Resources

-&> Logged in as: Jane Doe, Primary Support

Log Out

Premanufacture Notice
Primary Support

j P ^Physical &

Chemical
Properties

j | f^lPhysical and
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Properties
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If & Chemical 2718

1 IChemical
Identification

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Monomers and
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Production Volume
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« Preiminnfactuie Notice IPrimaiy PFvlN-20130619-10:03:48 EDT> > Monomers ami Other Reactfints

MONOMERS AND OTHER REACTANTS
B.2.a. Polymer Weight Information CBI: ~

Indicate the method of measurement in which the polymer weight was recorded.
Method of Measurement: O GPC ® Other(Specify)

Q

Specify other method of
measure

Indicate the number-average weight of the lowest molecular weight composition of the polymer you intend
to manufacture. Indicate maximum weight percent of low molecular weight species (not including residual
monomers, reactants, or solvents) below 500 and below 1,000 absolute molecular weight of that
composition.

%
%

(i)	lowest number avg. molecular weight:

(ii)	max. weight % below 500 molecular weight:

(iii)	max. weight % below 1000 molecular weight:

B.2.b. Monomers and Other Reactants

Enter a percent value less than or egual 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.

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

Composition Total:0.0%

Attachments
Attach Document





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Exhibit 4-25 shows a screen capture of the 'Monomers and Other Reactants' screen (Scroll 2):
Exhibit 4-25: Monomers and Other Reactants Screen (Scroll 2)

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Primary Support

i ? IjjffPhysical &

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

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Expand All | Collapse All

Cancel

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

Search SRS

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

Chemical Name:

Typical Composition:

Maximum Residual:

cbio

CBlO

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Save

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

Composition Total:0.0%

Attachments
Attach Document

File Name

Description

Pages
| Next |

CBI

Actions







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CDXr

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 and are creating an LVE or LVE
modification submission. 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

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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.

•	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.'

•	Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window. Refer to Section 3.7 for additional details regarding the attach document
functionality.

•	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 4-26 shows a screen capture of the 'Production Volume and Hazard/Safety Information'
screen:

Exhibit 4-26: Production Volume and Hazard/Safety Information Screen

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a

Premanufacture Notice
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^(Remove

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$ & Chemical 2718

I |-~jl chemical
I Identification

I j [J Polymer

Pi emanufacture Notice (Primary PMN-20130619-10:03:48 EDT) > Production Volume and Hazard/Safety Information

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.



Identification
Information

f->

Monomers and
Other Reactants
Additional Chemical
| Information

Production
Volume and
Hazard/Safety
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C.1. Production Volume

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

CBI: ~ Binding: ~

kg/yr
kg.tyr

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

0Copy

Previous

| Next |

JJjAdd Consolidated
Chemical

Site Information

Submitter Controlled Site





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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.

4.18 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.

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The 'Use Information' screen is used to capture 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 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 will open and display
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,
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.

•	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.

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

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

•	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 is displayed 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). 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.

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•	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 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.

•	Attach Document: Click the 'Attach Document' button to generate 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 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.

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

•	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 4-27 shows a screen capture of the 'Use Information' screen (Scroll 1):

Exhibit 4-27: Use Information Screen (Scroll 1)



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Premanufacture Notice
Primary Support

—Add Letter of Support

B Chemicals

- £ Chemical 2715

"Qchemical
Identification

Class 1 or 2
Chemical
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Premanufacture Notice (Primary PMN-20130619-10:03:48 EOT) > Use Information

USE INFORMATION

Expand All | Collapse All
Cancel X

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
'Category of Use1 to hide details. (Click on it again to show those details).

Category of Use:	CBlO 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:

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% of substance expected per use:

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CDX Homepage |

| MyCDX Homepage |

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CDX Helpdesk: (888;

) 890-1995

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 4-28 shows a screen capture of the 'Use Information' screen (Scroll 2):

Exhibit 4-28: Use Information Screen (Scroll 2)





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Premanufacture Notice
Primary Support

: " Lii=]Add Letter of Support

9" Chemicals

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4.19 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. The chemical properties are used by EPA to
determine 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 will
expand and display 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.

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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'
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 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 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

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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.

•	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.

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•	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.

•	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.

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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.

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.

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•	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.

•	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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Exhibit 4-29 shows a screen capture of the 'Physical and Chemical Properties Worksheet' screen
(Scroll 1):

Exhibit 4-29: Physical and Chemical Properties Worksheet Screen (Scroll 1)

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Premanufacture Notice
Primary Support

Chemical 2715

:

: ¦ iTT-,

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4; Premanufacture Notice (Primaiy PMN-20130619-10:03:48 EDT) > Physical and Chemical Properties Worksheet

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET

#

To assist EPA's review of physical and chemical properties data, please complete the following worksheet for data you
provide and include it in the notice. Identify the property measured, the value of the property, the units in which the
property is measured (as necessary), and whether or not the property is claimed as confidential. 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

V

~

Adsorption Coefficient

Edit

X

~

Boiling/sublimation tempeiature @ 15 to it pressure

Edit

X

~

Density relative density

Edit

X

~

Dissociation constant

Edit

X

~

Explodability

Edit

X

~

Flammability

Edit

X

~

Henry's Law constant

Edit

X

~

Melting Temperatuie

Edit

x

~

Octanol water partition coefficient

Edit

X

~

Particle size distiibution

Edit

X

~

Physical state of neat substance

Edit

X

~

pH @ concentiation test value

Edit

X

~

Solubility ^temperature 15°C solvent

Edit

X

~

Solubility in Water @ tempeiature 15°C

Edit

X

~

Spectra

Edit

X

~

Vapoi Pressure @ temperature 11°C

Edit

X





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CDX Homepage

I MyCDX Homepage

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
Primary Support

December 17, 2014
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Exhibit 4-30 shows a screen capture of the 'Physical and Chemical Properties Worksheet' screen
(Scroll 2):

Exhibit 4-30: Physical arid Chemical Properties Worksheet Screen (Scroll 2)

Rremanufacture Notice
Primaiy Support

$ & Chemical 2715

r'5 Chemical
Identification

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Additional Chemical
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submission of test data.

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a I an temperature 11°C

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~ Volatilization from water

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~ Volatilization from soil

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CDX Homepage

MyCDX Homepage

I EPA Homepage

| Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8i

38) 890-1995

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

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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'Physical and Chemical Properties Worksheet - Continued (Optional)' link within the navigation
tree.

4.20 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
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.

•	Attach Document: Click the 'Attach Document' button to generate 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 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 the 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 4-31 shows a screen capture of the 'Physical and Chemical Properties Worksheet -
Continued (Optional)' screen:

Exhibit 4-31: Physical and Chemical Properties Worksheet - Continued (Optional) Screen

il&
Chemical
Properties

Physical and
Chemical
Properties
Worksheet

"I: Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

Qcopy
B Jk Chemical 2718

0

Premanufacture Notice
Primary Suppoit
S' Chemicals

@ & Chemical 2715

H~%lChemical
Identification

Class 1 or 2
Chemical
Substances

Additional Chemical
Information

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Production Volume
and Hazard/Safety
I Information
Use Information

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4 Pi ©manufacture Notice (Primary PMN-20130619-10:03:48 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 Docuinei it

File Name

Properties

Description

Pages

CBI

Actions

Pievious

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CDX Homepage | MyCDX Homepage

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

Navigation: Click the 'Next' button to navigate to the 'Submitter Controlled Site Information'
screen if you have not identified another chemical. You can also access this screen by clicking
the 'Submitter Controlled 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.

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

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

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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When attaching a document, all 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.

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
previous 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.

•	Number of 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 4-32 shows a screen capture of the 'Physical and Chemical Properties Worksheet -
Continued (Optional) Attach Documents' pop-up window (Scroll 1):

Exhibit 4-32: Physical and Chemical Properties Worksheet - Continued (Optional) Attach

Documents Pop-Up Window (Scroll 1)

ATTACH DOCUMENTS

Type and Subtype Type:

Select the type and subtype Aquatic Ecotoxicity

of the attachment

Subtype:

Chemical Properties

Adsorption/ Coefficient

Boiling/ sublimation temperature @

Density/ relative density

Dissociation constant

Explodability

Flammabiiity

Henry's Law constant

Melting Temperature

O eta no I/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	' lle

Select the file to attach	Browse

Description

Provide a description of the
attachment

0

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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CDY~

Exhibit 4-33 shows a screen capture of the 'Physical and Chemical Properties Worksheet -
Continued (Optional) Attach Documents' pop-up window (Scroll 2):

Exhibit 4-33: Physical and Chemical Properties Worksheet - Continued (Optional) Attach

Documents Pop-Up Window (Scroll 2)

Sanitized Attachment File
Select the sanitized file to

attach

Browse

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

"ok I

| Cancel |

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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December 17, 2014
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information and navigate back to the 'Physical and Chemical Properties Worksheet - Continued
(Optional)' screen.

4.21 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 generates 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 PMN 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 PMN 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Exhibit 4-34 shows a screen capture of the 'Site Information' screen:

Exhibit 4-34: Site Information Screen

Logged in as: Jane Doe. Primary Support
Log Out

- M

Premanufacture Notice
Primary Support

use mionnaaion ^

Physical &

Chcniic.il
Pi opeities

Physical and
Cherr«c$l

Properties

Wort Sheet

Physical and

Chemcal

Properties

Worksheet •

Continued

(Opbomal)

XRemove

^ICopv

&Add Consolidated
Che*niesi

Site Information

Subnwttei Coiiti oiled
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SubfNHer Operation
information

PietiwiHif-icfitfe Noiice iPuin.irv PMM 20130610-10:03:48 EOT) > Sulmiittei Controlled Site Information

SITE INFORMATION

1. Do you have siles controlled by the submitter'?

O Yes no

2 Do you have sites controlled by others?

O Yes No

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CDX Homepage | MyCDX Homepage I EPA Homepage | Terms and Conditions I Privacy Notic e | CDX Helpdesk: (888) 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.

4.22 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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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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
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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Exhibit 4-35 shows a screen capture of the 'Sites Controlled By Others' screen:

Exhibit 4-35: Sites Controlled By Others Screen

Logged in as Jane Doe, Pnmary Support
Log Out

Premanutacture Notice
Prlithiiy Sii|>poi1

Wcrtshed -

Cortmued

(Optional)

XRwtove

—I Copy

& Add CortsoMaied
Chejttcal

Sitelnfoimalion

Submitter Condoled Sue
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Sites Contioiled By
Other®

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Others

4 Pfeiii.Mii(f,ictiif6 Notice (Pirn wiy PMN 20130619-10:03:48 ED1> > Sites ContiolleiJ By Others

SITES CONTROLLED BY OTHERS

00 you have any sites controlled t>y others tor which you have information to repoif

#	Yes No

B.l.a. Operation description

Do you have site-specific information''

® Yes No

The '# ol Unknown Sites' field is required. Enter '0' If none.

#	of unknown srtes	I	I	CBIJJ

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CDX Homepage | MvCDX Homepage ,| ERA Homepage | Terms and Conditions | PrivacyNolice | CDXHelpdestc (888)890-1995

Navigation: Click the 'Next' button to navigate to the 'Optional Pollution Prevention' screen if
the submitter controlled operations screens have not been generated. You can access the
'Submitter Operation Information' screen by clicking the 'Submitter Operation Information' link
under the 'Submitter Controlled Operations' folder within the navigation tree.

4.23 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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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responses, information will display to fill out a series of fields about 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 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. Refer to
Section 3.9 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.

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•	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.

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

•	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

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chemical conversions. Include interim storage and transport containers (specify - e.g., 5-
gallon pails, 55-gallon drum, rail car, tank truck, etc.). (2) Provide the identity, the
approximate weight (by kg/day or kg/batch on a 100% new chemical substance basis), and
entry point of all starting materials and feedstocks (including reactants, solvents, catalysts,
etc.), and of all products, recycle streams, and wastes. Include cleaning chemicals (note
frequency if not used daily or per batch). (3) Identify by number the points of release,
including small or intermittent releases, to the environment of the new chemical substance. If
releasing to two media at the same step, assign a second release number for the second
medium. Either this field is required or a document must be attached.

•	Attach Document: Click the 'Attach Document' button to generate 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 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 4-36 shows a screen capture of the 'Submitter Operation Information' screen (Scroll 1):
Exhibit 4-36: Submitter Operation Information Screen (Scroll 1)

Premanutacture Notice
Pr un.n y Support

Bcopy	-

j^Add Coracidaled
Chemical

Site liifoi motion

Subjwttef Cortroled Site
tniofmation

Sles Controled By Others
Submrttei Coirti oiled

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~ nrutus a

Industrial S*C5
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Others

Exposur es-fteteases

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• i .Add Operation

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Adcttonal Attachments

AMachitient $urrurw*Y

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PmnmicMcTiire Notice tPtimoiy PMM-20130619-10:03:48 EDI I > Snlniiitt^i Operation Mot motion

SUBMITTER OPERATION INFORMATION

Operation Alias:

The operation alias Is an optional field that changes tne 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:

Add Facility
Site Name

Address City State	Postal Code

The information on this page refers to consolidated etiemicai(s):

~	chemical 1

~	Chemical 2

A. 1 .b 0 pe ratio n Type CBI ~

Please select the type of operations present at this site.

Manufacturing ~

Processing: 0
use: ~

A.I.e. Operation Description

Actions

Amount and Duration (Complete 1 or 2 as appropnate)
Is it batch or continuous'

Ol Batth ®2. Continuous
max kg/day:

CBI ~

hours/day:
days/year

(100% new chemical substance)





s/

validate

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Preview



CDX Homepage

| MyCDX Homepage

I EPA Homepage | Terms and Conditions I

Privacy Notice I

CDXHelpdesk (888) 890-1995

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
Primary Support

December 17, 2014
119

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Exhibit 4-37 shows a screen capture of the 'Submitter Operation Information' screen (Scroll 2):
Exhibit 4-37: Submitter Operation Information Screen (Scroll 2)





Logged in as Jane Doe, Primary Support



r Foiiiis T Re sowtes

Log Out

Premanufacture Notice
Primary Support

' Bow	S

&Add ConscMsted
CherrtCdl

Site Information

Sutortter Corttoled Sie

Wormeiton

Sites Cortxoled By Other s

Subiitmei Controlled
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^formation
X Remove
Add Operation
Optional Polution FVevenboo
Addtiooai Attachments
Attachment SurvtHSry
Optional Cover Letter

A,1,b Operation Type CBI:D

Please select the type of operations present at this site.
Manufacturing: ~

Processing El
Use: ~

A.l.c. Operation Descnption

Amount and Duration (Complete 1 or 2 as appropriate)
is it catch or continuous?

• 1 Batch 2 Continuous
max kg/batch

(100^ new chemical substanca)

hours/bate h
batches/year

A.i.o Process Description

CBl: a

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C8I

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File Name

Descnption	Pages

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CDXHomepase I

I MyCDX Homepage I

EPA Homepage I Terms and Conditions J

Privacy Nolice I

CDXHelpdesk (888)890-1995

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.

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4.24 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
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 is displayed when the 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 the
expandable/collapsible field set to modify the information entered in the fields. The 'Edit'
link is displayed 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. The 'Delete' icon ( ¦*) is displayed when the user has clicked the 'Add'
button.

•	Expand All: Click the 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 link located at the upper right-hand corner 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.

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•	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.

•	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) and percentage of new chemical substance (if part of a
mixture) 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 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 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 'CBI' 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 'CBI' checkbox to claim the maximum duration values as confidential.

•	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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide	December 17, 2014

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to navigate away from the screen using the 'Previous' and 'Next' buttons. Refer to Section
3.6 for more information regarding the save functionality in an expandable/collapsible field
set.

Exhibit 4-38 shows a screen capture of the 'Occupational Exposures' screen (Scroll 1):
Exhibit 4-38: Occupational Exposures Screen (Scroll 1)

• i ogged in 35 Jane Doe, Primary Support
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Pre manufacture Notice
Pthm.ny Suppoit

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< Ptenianufacture Notice  > Occupational Exposures

OCCUPATIONAL EXPOSURES
A.2 Occupational Exposure - Submitter Controlled Sites

Lxp.intl AJI | Collapse All
Cancel X

Worker Category (t):
loading into Transport corrtainerswessels

worker AttMly (1):

Protective Equipment'Engineering Controls (3):

CBI

~

Binding

~

Physical Form(s) (5);
% New Substance (5):
# Workers Exposed (8):

Maximum Duration
Hours/Day (10):

Day&/

1









Validate

Save

Preview



CDX Homepage

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EPA Homepage I Terms and Condillons |

Privacy Nolice |

CDX Helpdesk (888) 890-1995

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
Primary Support

December 17, 2014
123

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CDY~

Exhibit 4-39 shows a screen capture of the 'Occupational Exposures' screen (Scroll 2):
Exhibit 4-39: Occupational Exposures Screen (Scroll 2)

Pre manufacture Notice
Piimaiy Support

<&Add Consolidated
Chemeal

Site biToinuljon

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brfofmabon

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= [Jjsitc Alias 1

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worker category (1):

Loading into Transport Coritairief$Atessei$

Worker Activity (t):

Protective Equipment/ Engineering Controls (3):

Physical Form(s) (5):	r

% New Substance (5):	I

# Workers Exposed (8):

Maximum Duration
Hours/Day (10):

Days/Year (11):

Save

Cfick the Add button to add an occupational exposure Atw

Pi evioiis

%

¦ Logged in si Jane Doe, Primary Support
Log Out

Exii.ilitl All [ Collapse All
Cancel X

CBI Binding

~

~

~

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~

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~

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CDX Homepage I

I MyCDK Homepage

EPA Homepage I Terms and Conditions |

Privacy Notice I

CDX Helpdesk- (89B) 890-1995

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

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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Support

December 17, 2014
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4.25 Environmental Releases

You can navigate to the 'Environmental Releases' screen by clicking the 'Next' button from the
'Occupational Exposures' screen. You can also access this screen by clicking the 'Environmental
Releases' link within the navigation tree.

The 'Environmental Releases' screen captures information about the environmental release and
disposal status of a particular site. The information on exposure and environmental release is
related to the flow diagram/process description on the 'Submitter Operation Information' screen.
This page is duplicated and populated for each flow diagram supplied in the PMN
(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 '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 is displayed when the 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 the
expandable/collapsible field set to modify the information entered in the fields. The 'Edit'
link is displayed 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. The 'Delete' icon ( ») is displayed when the user has clicked the 'Add'
button.

•	Expand All: Click the 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 link located at the upper right-hand corner 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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•	Amount of new substance released to Environment (2a): Enter the amount of new
substance released to environment. Release estimates should be consistent with the release
levels shown on the preceding flow diagram. 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.

•	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. 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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•	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.

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

•	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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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December 17, 2014
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Exhibit 4-40 shows a screen capture of the 'Environmental Releases' screen (Scroll 1):
Exhibit 4-40: Environmental Releases Screen (Scroll 1)



Premanufacture Notice
Prln my Support

Physic*l«xl
CheirtCdl
Properties
Worksheet

- Physical and
Cherricel
Properties
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Continued
(Optional)

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J Copy

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Subrriter Cortroled Sle
information

-C SEiivttoiiiiieiital Releases

ENVIRONMENTAL RELEASES
A.3, Environmental Release and Disposal - Submitter Controlled Sites

Release Number (1): I

Amount of new substance released
O to Environment (2a):

Oto Control Technology (20)

Media of Release (4):

Control Technology Description (5a)

Kg/Day Kg/Batch

Kg/Day Kg/Batch

Release after control Technology (5b):

| Save |

Click the Add button to add an environmental release and disposal Ad/ S

Validate Save

m

Preview



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CDX Helpdesk (888) 890-1995

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Support

December 17, 2014
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-------
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Exhibit 4-41 shows a screen capture of the 'Environmental Releases' screen (Scroll 2):
Exhibit 4-41: Environmental Releases Screen (Scroll 2)

jbm®

Premanufacture Notice
Primary Support

Physical or»d
ChemcoJ
Proswrlies
Worksheet

Physical arwl

Chetracal

Preterites

Wcrtsfteel-

Continued

(OpttarwO

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Release Number (1):

Amount of new substance released
O to Environment (2a):

O to Control Technology (2b)

Media of Release (4)

Control Technology Description (5a):

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Log Out

CB! Binding

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Kg/Day Kg/Batcft

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CDX Homepage I

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Privacy Notice I

C DX Helpdesk; (888) 890-1S95

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'

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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.

4.26 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
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 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 3.9 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.'

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•	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 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.

•	Attach Document: Click the 'Attach Document' button to generate 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 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 4-42 shows a screen capture of the 'Industrial Sites Controlled By Others' screen:
Exhibit 4-42: Industrial Sites Controlled By Others Screen

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Premanutacture Notice
Primary Support

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The 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:

Add Facility

Site Name Address	City	State Postal Code

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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.

4.27 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.

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 '# 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.

•	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 is displayed when the 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 the
expandable/collapsible field set to modify the information entered in the fields. The 'Edit'
link is displayed 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 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 link located at the upper right-hand corner 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.

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•	# 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.

•	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 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.

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

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Exhibit 4-43 shows a screen capture of the 'Exposures/Releases' screen (Scroll 1):
Exhibit 4-43: Exposures/Releases Screen (Scroll 1)

Jaoe Doe. Primary Support
Log Out

Pre manufacture Notice
Plhii.wy Su|i|hhI

4 Premaoufacture Nonce [Primary PMN 20141201-11:36:29 E ST) > Exposures Releases

EXPOSURE SfRELEASES

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• Add: Click the 'Add' button to generate the 'Environmental Disposal'
expandable/collapsible field set.

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•	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.

•	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.

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

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Exhibit 4-44 shows a screen capture of the 'Exposures/Releases' screen (Scroll 2):
Exhibit 4-44: Exposures/Releases Screen (Scroll 2)

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Pre manufacture Notice

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Contowned

Site Information

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Terms and Conditions

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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.

4.28 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
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.

Please note in IE 7, the right side of the 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 (0) to save an entered byproduct. Click the 'Delete' icon ( *)
to delete a byproduct. Click the 'Add' icon ( ) to add a byproduct. Click the 'Form' icon
(0) to edit a saved byproduct.

Exhibit 4-45 shows a screen capture of the 'Byproduct Information' screen:

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Exhibit 4-45: Byproduct Information Screen

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Log Out

Premanufacture Notice Premamifacture Notice (Primary PMN-20130619-10:03:48 EDT) > Byproduct Information
¦ Primary Support	BYPRODUCT INFORMATION

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

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.

4.29 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.

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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. 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

(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

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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?

(5)	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.

•	Attach Document: Click the 'Attach Document' button to generate 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 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.

•	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.

Exhibit 4-46 shows a screen capture of the 'Optional Pollution Prevention' screen:

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 4-46: Optional Pollution Prevention Screen

Rremanutacture Notice
Primaiy Support

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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 CBl: p

Attach lioci in lent

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I CDX Helpdesfc (888) 890-1995

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.

4.30 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.

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.

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•	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 view, open, or make edits to
the 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.

Exhibit 4-47 shows a screen capture of the 'Additional Attachments' screen:

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 4-47: Additional Attachments Screen

Premanufacture Notice
Primaiy Support
Operations	a

~ T^lsite Alias 1

Submitter Operation
Information

"F Occupational
Exposures

| MP Environmental
Releases

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: i^elAdd Operation

3"|_ Operations Controlled l>y
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Byproduct
Information

:""3C Remove
: " LrgjAdd Operation
Optional Pollution Prevention
Additional Attachments
Attachment Summary
Optional Cover Letter

Logged in as: Jane Doe, Primary Support
Log Out

4 Pi emannfactiii e Notice (Primary PMN-20130619-10:03:48 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 Pe attached.

Attach Document

File Name

Description

Pi evious

Pages

Date

CBI

Action

>/

a

f	1



Validate

Save

Preview

CDX Homepage

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

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.

4.31 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.

•	Section: Displays the section of the PMN form with which the attached document is
associated.

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

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•	Description: Displays the description of a document that was uploaded on the 'Attach
Documents' pop-up window.

•	Pages: Displays the number of pages in a document that was uploaded on the 'Attach
Documents' pop-up window.

•	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 4-48 shows a screen capture of the 'Attachment Summary' screen:

Exhibit 4-48: Attachment Summary Screen

* ms.BB	

T Forms T

Premanufacture Notice < premanllfact,ire Notice (Primary PMN-20130619-10:03:48 EDT) > Attachment Summary
Primary Support	ATTACHMENT SUMMARY

Operations
~~ rpSite Alias 1

!""(^'Submitter Operation

•*> Logged in as: Jane Doe, Primary Support

Log Out

&

Information

I j-Qoccupstional
Exposures

i" ^Environmental
Releases

XRemove

"" ^Add Operation

Operations Controlled by
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Optional Pollution Prevention

iAdditional Attachments

Attachment Summary

Optional Cover Letter

The documents included in the form are listed below

Section

File Name

Description

Pages

Date

CBI



a

i	|

¦



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Preview

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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.

4.32 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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The 'Optional Cover Letter' screen is used to communicate information to 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 'Check 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 4-49 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 4-49: Optional Cover Letter Screen

Home y Forms j Resources

A Logged in as: Jane Doe, Primary' Support

Log Out

Premanufacture Notice
Primary Support
Operations	a

— HiTsite Alias 1

Submitter Operation
Information

!"" Occupational
Exposures

Environmental
Releases

X Remove

Hj=|Add Operation

0" Operations Controlled by
Others

$ ®Uias A

i"'V Industrial Sites
Controlled By
Others

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Information
| "'"X Remove
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Optional Pollution Prevention
Additional Attachments
~Attachment Summary

< Pi einamifacture Notice (Primary PMN-20130619-10:03:48 EDT) > Optional Cover Letter

OPTIONAL COVER LETTER

If you would like to include a cover letter, please use the space below.

Click here to claim this information as CBI: ~

Previous







«/ ¦













Validate Save

Preview





CDX Homepage

I MyCDX Homepage

| EPA Homepage

| Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8£

38) 890-1995

Navigation: Click the 'Validate icon c ) located in the bottom action bar to validate the form.
Click the 'Save' icon (i ) located in the bottom action bar to perforai a global save on the form.
Click the 'Preview' icon m located in the bottom action bar to view a PDF preview of the
form.

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4.33 Upload XML

You can access the 'Upload XML' screen by clicking the 'Upload XML' button within the
lower-left 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 PMN
form for PMN forms with numerous chemicals. You also have the option to export a current
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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 4-50 shows a screen capture of the 'Upload XML' screen:

Exhibit 4-50: Upload XML Screen

A Logged in as: Jane Doe, Primary' Support

Log Out

Premanufacture Notice
Piinuiiy Support
Operations
SfXIsite Alias 1

| i "[% Submitter Operation
Information

j; f"[5 Occupational
Exposures

j !""[= Environmental
Releases

'XRemove

"'^Aeld Operation

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Information

:"X Remove
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iOptional Pollution Prevention
Additional Attachments
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0

UPLOAD XML

Click the Upload XML File Putton Pelow and select the ZIP archive file you have populated with PMN information. This
archive must contain your form XML in a file labeled 'formdata .xml1.

Upload archive file

Warning: When importing an XML file into the current form, if XML validation is passed, all form contents will be
overwritten with the information stored within the imported XML file.

Export Xml





>/

S











Validate

Save

Preview





CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice i

CDX Helpdesk: (888;

) 890-1995

Navigation: Click the 'Validate' icon < ) 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 a 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),'
'TSCA 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 Biotechnology Form

To edit a Biotechnology form, navigate to the 'Section 5 Notices and Supports Forms' screen,
and click the alias link in the 'Alias' column of a 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 3.4 for additional details regarding the enter passphrase process.

5.2	General Form Information

You can access the 'General Form Information' screen by clicking the alias link in the 'Alias'
column of an 'In Progress' form and entering a passphrase on the 'Enter Passphrase' screen.

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 will auto-generate a default
alias in the following format: .

Select the submission type from the 'Type of Submission' drop-down menu. The 'Type of
Submission' drop-down menu displays the following values:

•	MCAN (Microbial Commercial Activity Notice)

•	TERA (TSCA Experimental Release Application)

•	Tier I Exemption

•	Tier II Exemption

•	Biotechnology TME (Text Market Exemption)

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 must 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 numeric series are not recommended.

The 'Text/Comments' text box is required when an attachment is not provided. A 'CBI'
checkbox is displayed above the 'Text/Comments' text box to claim the information as
confidential.

The 'General Form Information' screen displays the option to attach a document by clicking the
'Attach Document' button.

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•	Form Alias: Enter the form alias. 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).'

•	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, 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 3.7 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.

•	Check here if you are filing a consolidated Biotechnology form: Check the 'Check here if
you are filing a consolidated Biotechnology form' checkbox to indicate you will be
submitting a consolidated form. This field is required if a value is entered in the 'Number of
Microorganisms' text field. This field is non-editable when creating a Biotechnology
amendment.

•	Number of Microorganisms: Enter the number of microorganisms in a consolidated
submission; this number should be a value from two (2) through twenty (20). This field is
required if the 'Check here if you are filing a consolidated Biotechnology form' checkbox is
checked. This field is non-editable when creating a Biotechnology amendment.

•	Check here if you are filing a joint Biotechnology form: Check the 'Check here if you are

filing a joint Biotechnology form' checkbox to indicate you will be submitting a joint form.

•	Check here if you have a Letter of Support pending: Check the 'Check here if you have a
Letter of Support pending' checkbox to indicate the form is pending a Letter of Support.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Exhibit 5-1 shows a screen capture of the 'General Form Information' screen:

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

Home y Forms J Resources

-&> Logged in as: Jane Doe, Primary Support

Log Out

Biotechnology
Primary Support
Biotechnology-
20130619-10:05:49 EDT
l "!= General Form Information
B" _ Joint Submission
~ Joint Submission 1

Joint Submitter
Information

Joint Submission
Information

^Remove

j Add Joint Submission

$ _ Letter Of Suppoit

$ ^Letter of Support 1

'"[^jLetter of Support
Submitter
Information

l""0Letter of Support
Submission
Information

: XRemove

"%)Add Letter Of Support

Technical Contact Information

iOptional Cover Letter

« Biotechnolotjy (Biotec I inolo Geneial Form Infoi mat ion

GENERAL FORM INFORMATION

You may enter an alias for easier form identification or the system will provide a time stamp.
Form Alias:	Biotechnology-20130619-10:05:49 E

III. Type of Submission:

Tier I Exemption
TS Number:

IV. Text Comments CBlO

Please describe the submission and/or attachment.

Attach Document

File Name

Description

Pages

CBI

Actions

Check here if you are filing a consolidated ~ Number of Microorganisms:	(2-20)

Biotechnology form:

Check here if you are filing a joint	0

Biotechnology form:

Check here if you have a Letter of Support 0
pending:

>/

B

¦

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

Navigation: If you are filing a joint Biotechnology form, click the 'Next' button to navigate to
the 'Joint Submitter Information' screen. You can also access this screen by clicking the 'Joint
Submitter Information' link within the navigation tree. If you are filing a Letter of Support and
not a joint Biotechnology form, click the 'Next' button to navigate to the 'Letter of Support
Submitter Information' screen. You can also access this screen by clicking the 'Letter of Support
Submitter Information' link within the navigation tree. If you are not filing either a Letter of
Support or a Joint Biotechnology form, 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.

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5.3 Joint Submitter Information

You can access the 'Joint Submitter Information' screen by clicking the 'Next' button from the
'General Form Information' screen if you indicate that a joint Biotechnology form is pending.
You can also access this screen by clicking the 'Joint Submitter Information' link within the
navigation tree. You may add a maximum of two (2) Joint Submissions by clicking the 'Add
Joint Submission' link within the navigation tree. Click the 'Remove' link ( *) within the
navigation tree to remove a Joint Submission.

The 'Joint Submitter Information' screen presents a list of text fields and drop-down menus used
to enter contact information for the joint submitter who will be submitting separate information
for the Biotechnology form. The provided email address will be used to send the joint submitter
the unique identification number.

•	Check here to claim this information as CBI: Check the 'CBI' checkbox to claim the joint
submitter information as confidential. When you claim CBI, you are stating that the
information is confidential and should not be released to the public.

•	First Name: Enter the joint submitter's first name. This is a required field.

•	Last Name: Enter the joint submitter's last name. This is a required field.

•	Position: Enter the joint submitter's job title.

•	Company Name: Enter the joint submitter's company name. This is a required field.

•	Phone Number: Enter the joint submitter's U.S. phone number. This is a required field.

•	Phone Extension: Enter the joint submitter's U.S. phone number extension if applicable.

•	Email Address: Enter the joint submitter's email address. The email address must follow the
standard email address format: John.Doe@abc.com.

•	Mailing Address 1: Enter the first line mailing address of the joint submitter. This is a
required field.

•	Mailing Address 2: Enter the second line of the mailing address of the joint submitter.

•	City: Enter the U.S. city of the mailing address of the joint submitter. This is a required field.

•	State: Enter the state of the mailing address of the joint submitter. This is a required field.

•	Postal Code: Enter the postal code of the mailing address of the joint submitter. This is a
required field.

•	Country: Displays 'United States.'

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Exhibit 5-2 shows a screen capture of the 'Joint Submitter Information' screen:

Exhibit 5-2: Joint Submitter Information Screen



Biotechnology
Prui i,ii y support
Biotechnology-20130619-
10:05:49 EDT

Q&mti Fc«m fcformotwn

Joint Submission

^Joinf Submission 1

Joint Submitter
Irtf or matron

~\2 JoW Submission
Inlonwition

XR«fiove

Add JOW Sutomis-sion

Letter Of Support

~ ^Letter of Support 1

Letter o< Support

Suferrttter

Information

l: Letter o 1 Support
Subfflteston
lniorm«tion

XRemove

Add Lefte* 01 Sifiport
Techmcai Contact Information
Qpbonai Cover Letter

Home y Forms y Resources

* Logged in as Jane Doe, Primary Support

Log Out

BhrteclmoloBy  Joan Submitter Msttiiatioti

JOINT SUBMITTER INFORMATION

Please enter me information for me joint suemitter vvno will Be responsfflie for
supporting the information on the form Check to claim information as CBi

Check here to claim this information as CBI.	i

First Name
Last Name
Position

Company fiame
Phone Number:

(Do not enter »rty dssh*t (-) ir» Ph««o Number field abevt.)

Phone Extension
Email Address
Mailing Address 1

Street sddrets, P.O. box. coimotny namo, etc.

Mailing Address 2

City
State

Postal Code
Country

A&srtmont, suit*. etc.

United states

Previous





Validate

e

save

Preview



CDX Homepage |

I MyCDX Homepage I

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Privacy Notice I

CDX Helpdesfc (8&8) 890-1995

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

5.4 Joint Submission Information

You can access the 'Joint Submission Information' screen by clicking the 'Next' button from the
'Joint Submitter Information' screen. You can also access this screen by clicking the 'Joint
Submission Information' link within the navigation tree.

The 'Joint Submission Information' screen is used as a communication point between two
companies. The 'Joint Submission Information' screen displays fields that capture information to
pass to the joint submitter. A text box is used to send information to the joint submitter in an
unencrypted email sent by the primary submitter. A 'Unique Identifier for Joint Submissions'
box will also display on this screen. The unique identification number auto-generates when a
user declares a joint submission is being established.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Joint Submission Process: A 'Special Information' field will be used to send information to the
joint submitter in an email sent by the primary submitter.

When the secondary submitter accesses the 'Section 5 Notices and Supports Forms' screen and
creates a new form, the secondary submitter will be prompted to enter the unique identification
number on the 'Create Passphrase' screen.

•	Joint Submission Information Instructions: Enter the information that the primary
submitter is sending to the joint submitter.

•	Joint Submission Informational Text: Displays instructional text provided by OPPT, the
unique identification number automatically generated for the form, and provides functionality
to email the unique identification number to the joint submitter by clicking the 'Notify the
Secondary Submitter of the Joint Submission' link.

•	Unique Identification Number: The unique identification number is a random number auto-
generated to pass on to the joint submitter to create a joint submission.

Exhibit 5-3 shows a screen capture of the 'Joint Submission Information' screen:
Exhibit 5-3: Joint Submission Information Screen



Biotechnology
Pi imaiy Support
Bioteclmoloyy-
20130619-10:05:49 EDT

General Form Information
S Joint Submission
" Joint Submission 1

j -[Joint Submitter
Information

"Qjoint Submission
Information

"X Remove
I L^Add Joint Submission

S	Letter Of Support

S ^Letter of Support 1

i""| 3 Letter of Support
Submitter
Information
Letter of Support
Submission
Information

' XRemove
"^Add Letter Of Support
Technical Contact Information
Optional Cover Letter

•*> Logged in as" Jane Doe, Primary Support

Log Out

Bioteclinolo Joint Submission Information
JOINT SUBMISSION INFORMATION

Please include instructions you wish the joint submitter to see. Clicking the link below
will relay the information in this text box to your joint submitter via unencrypted e-mail

Unique Identifier for Joint Submission: 3bb40ce9-0dda-4a2f-9b06-e76a500f898e

This is the unique identification number for your joint submitter. Notify1 the
Secondare Submitter of the Joint Submission.

The Secondary Submitter will need this identification number to complete the
form It is your responsibility to ensure that your secondary submitter
understands how to complete the Biotechnology form and sends the information
to EPA by the end of the submission period. The information collected in the
primary1 and secondary1 form(s) will be linked by the unique identifier. The form
will not undergo a review process until all forms have been received.

Previous

l^jexTj





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m

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Support

December 17, 2014
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Navigation: Click the 'Notify the Secondary Submitter of the Joint Submission' link to access
the unique identifier notification window. If you are filing a Letter of Support, click the 'Next'
button to navigate to the 'Letter of Support Submitter Information' screen. You can also access
this screen by clicking the 'Letter of Support Submitter Information' link within the navigation
tree. If you are not filing a Letter of Support, 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.

5.4.1 Notify Secondary Submitter of Joint Submission Information

You can access the unique identifier notification pop-up window by clicking the 'Notify the
Secondary Submitter of the Joint Submission' link from the 'Joint Submission Information'
screen.

The unique identifier notification pop-up window is used to notify the secondary submitter of the
unique identification number. The unique identifier notification window displays a 'CC' field to
add other email addresses to the notification (including the original submitter), a 'To' field, and
an 'Additional Comments' text box.

•	From: Displays the email address of the Primary AO who created the form.

•	CC: Contains the email address of the Primary AO populated from CDX registration
information, and the email address of the technical contact. This is an editable field and
additional email addresses may be added if necessary.

•	To: Contains instructional text to enter multiple email addresses. Contains the editable email
address of the joint submitter specified on the 'Joint Submitter Information' screen; this
email address will be automatically populated upon navigating to the unique identifier
notification window. Enter any additional email addresses that the email should be sent to.

•	Subject: Displays 'YYYY Biotechnology.'

•	Message: Displays a pre-determined message that will be contained in the email sent to a
secondary submitter.

•	Additional Comments: Enter any other additional comments or instructions that should be
passed onto the secondary submitter.

•	Send: Click the button to generate and send an email to the email addresses identified in the
'CC' and 'To' fields.

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Exhibit 5-4 shows a screen capture of the 'Unique Identifier Notification' pop-up window.
Exhibit 5-4: Unique Identifier Notification Pop-Up Window

C^CSPP

From:

CC:

To:

Jane.Doe@te5t.com

iane.doe@test.com





/,

Enter email addresses separated by semicolons (;} or
commas (,). Click in this box to start entering email
addresses.

Subject:	2014 Biotechnology

Message:	As the Authorized Official of TESTORGCGI1,1 have

identified you as a Secondary Submitter of a joint
submission for this 2014 Biotechnology form. Please
use the Section 5 Notices and Supports application to
provide the correct information for the necessary items
in this form. See the instructions below for accessing
the Section 5 Notices and Supports application. You
will need to use the unique identification number to
access and complete the Biotechnology form for the
joint submission.

Unique Identifier f4e0f809-c35e-4ea1-9daf-
b8c22f9d0ac9

Information about the Section 5 programs, how to
access the Section 5 Notices and Supports application,
and instructions for reporting under the Section 5 rule
are available at www.epa.aov/oppt.'newchems/. For
additional information or if you believe you have
received this email in error, please contact me.

Additional Comments:

Send

Navigation: Click the 'Send' button to send the email to the Joint Submitter and navigate back
to the 'Joint Submission Information' screen. Click the 'X' button in the upper right-hand corner
to cancel the process of notifying a Joint Submitter and navigate back to the 'Joint Submission
Information' screen.

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5.5 Letter of Support Submitter Information

You can access the 'Letter of Support Submitter Information' screen by clicking the 'Next'
button from the 'General Form Information' screen if you are not filing a Joint Submission. You
can also access this screen by clicking the 'Next' button from the 'Joint Submission Information'
screen if you identified that a Joint Submission would be filed. You can also access this screen
by clicking the 'Letter of Support Submitter Information' link within the navigation tree when
you have indicated that a Letter of Support form will be filed. Click the 'Add Letter of Support'
link within the navigation tree to add a Letter of Support. The system will allow an unlimited
number of Letters of Support to be filed. Remove a Letter of Support by clicking the 'Remove'
link (¦¦*) within the navigation tree.

The 'Letter of Support Submitter Information' screen presents a list of text fields and drop-down
menus used to enter contact information for the Letter of Support submitter who will be
submitting separate information for the Biotechnology form. The provided email address will be
used to send the Letter of Support submitter the unique identification number to create the Letter
of Support at the discretion of the primary submitter.

•	Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim the Letter of Support submitter information as
confidential. When you claim the Letter of Support submitter contact information as CBI,
you are stating that the information is confidential and should not be released to the public.

•	First Name: Enter the Letter of Support submitter's first name. This is a required field.

•	Last Name: Enter the Letter of Support submitter's last name. This is a required field.

•	Position: Enter the Letter of Support submitter's job title.

•	Company Name: Enter the Letter of Support submitter's company name. This is a required
field.

•	Phone Number: Enter the Letter of Support submitter's phone number. This is a required
field.

•	Phone Extension: Enter the Letter of Support submitter's phone number extension if
applicable.

•	Email Address: Enter the Letter of Support submitter's email address. The email address
must follow the standard email address format: John.Doe@abc.com.

•	Mailing Address 1: Enter the first line of the Letter of Support submitter's mailing address.
This is a required field.

•	Mailing Address 2: Enter the second line of the Letter of Support submitter's mailing
address.

•	City: Enter the city of the mailing address of the Letter of Support submitter. This is a
required field.

•	State: Enter the state of the mailing address of the Letter of Support submitter. This is a
required field if the 'Country' field is set to 'United States.'

•	Postal Code: Enter the postal code of the mailing address for the Letter of Support submitter.

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• Country: Select the country of the mailing address for the Letter of Support submitter. This
is a required field.

Exhibit 5-5 shows a screen capture of the 'Letter of Support Submitter Information' screen:
Exhibit 5-5: Letter of Support Submitter Information Screen

* Loggeo in as Jane Doe, Primaiy Support

Log Out

^ Bjoteclmotow Letter «1 Support Siilimrrtei liiTrxinatloii

LETTER OF SUPPORT SUBMITTER INFORMATION

Please enter the information for the letter of support submitter who will be responsible
for supporting ihe information on the form. Check to claim information as CSl

Check here to claim this information as CBI
First Name
Last Name
Position

Company Name
Phone Number:

Biotechnology
Primary Support
Bk>tectaiolo/

s

¦

Validate

Sawe

Preview

CDX Homepage | ktyCDX Homepage | EPAHomepage I Terms and Conditions I PrrvacyNotice | CDXHelpdesk: (888)89tM995

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

5.6 Letter of Support Submission Information

You can navigate to the 'Letter of Support Submission Information' screen by clicking the
'Next' button from the 'Letter of Support Submitter Information' screen. You can also access
this screen by clicking the 'Letter of Support Submission Information' link within the navigation
tree.

The 'Letter of Support Submission Information' screen is used as a communication point
between two companies. The 'Letter of Support Submission Information' screen presents fields
to enter information to pass to the secondary submitter. A text box is used to send information in

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an email to the secondary submitter. A 'Unique Identifier for Letter of Support Submissions' box
will also display on this screen. The unique identifier will auto-generate when a Letter of Support
submission is being established.

Letter of Support Submission Process: A field titled 'Special Information' will be used to send
information to the Joint Submitter in an email sent at the discretion of the primary submitter.

When the secondary submitter accesses the 'Section 5 Notices and Supports Forms' screen and
creates a new form, the secondary submitter will be prompted to enter the unique identifier on
the 'Create Passphrase' screen. Once the unique identifier has been entered, the application will
tie the two forms together.

•	Letter of Support Submission Information Instructions: Enter the information that the
primary submitter is sending to the Letter of Support submitter.

•	Letter of Support Submission Informational Text: Displays instructional text provided by
EPA, the unique identification number generated for the form, and provides functionality to
email the unique identification number to the Letter of Support submitter by clicking the
'Notify the Secondary Submitter of the letter of support submission' link.

•	Unique Identification Number: The unique identification number is a random number auto-
generated to pass on to the Letter of Support submitter to create a Letter of Support.

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Exhibit 5-6 shows a screen capture of the 'Letter of Support Submission Information' screen:
Exhibit 5-6: Letter of Support Submission Information Screen



Biotechnology
Pt y Supp-oit
Blofeclinology-
20130619 10:05:49 EOT

General Form Informatics

® John Submission

S1 -,*5 Joint Submission 1

Joint Submitter
information

Joint Sti*niss«x>
Informal ion

XRemove

1; Add Join! Sufcwiission

© Letter 01 Support

^Lettei of Support 1

Letter ot Support

Subfwtter

Inlofmabon

Lettei ot Suppoit
Submission
InTot maftion

XRefwve

Add Letter Ot Support
Technical Contact Information
C^tionei Cover Letter

T

* Logged in as. jane Doe, Primary Support

Log Out

4 Biotechnology iBtotediii«]<»jy-2013£l6t9.10;05,.4Si EOT) > LMtei ol Support Submission liifoiiiiiHioii

LETTER OF SUPPORT SUBMISSION INFORMATION

Please include Instructions you wish the joint submitter to see. Clicking the link below
will relay the information in this text box to your joint suDmltter via unencrypted e-mail

Unique Identifier for Letter of Support Submission f8172400-dSc 1-414 3-a700-
eiedbeSiiel7

This is the unique identification number tor your Letter of Support submitter The
Secondary Submitter will need this identification number to complete the form
r.fqii^ite5g^nteaSMte[nei^uti^ieagraf.SMBEgis^[r!ss;an

it is your responsibility to ensure inat your secondary submitter understands how
to complete the Biotechnology form and sends the information to EPA by the end
of the submission period The information collected in the primary and secondary
form(s) win be linked by the unique identifier The form will not undergo a review
process until all forms have been received

Pievioiis

|^NextJ





Validate

m

Save

¦

Preview



CDX Homepage

I MyCDX Homepase

I EPA Homepage | Terms and Conditions I

Prwacy Notice I

CDX Helpdesk: (80S) 890-1995

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.

5.6.1 Notify Secondary Submitter of Letter of Support information

You can access the unique identifier notification pop-up window by clicking the 'Notify the
Secondary Submitter of the Letter of Support Submission' link from the 'Letter of Support
Submission Information' screen.

The unique identifier notification pop-up window is used to notify the secondary submitter of the
unique identification number. The unique identifier notification window displays a 'CC' field to

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add other email addresses to the notification (including the original submitter), a 'To' field, and
an 'Additional Comments' text box.

•	From: Displays the email address of the Primary AO that created the form.

•	CC: This automatically populates with the email address of the Primary AO that created the
form and the email address of the technical contact. This is an editable field.

•	To: Contains instructional text to enter multiple email addresses. Contains the editable email
address of the joint submitter specified on the 'Joint Submitter Information' screen; this
email address will be automatically populated upon navigating to the window.

•	Subject: Displays 'YYYYBiotechnology.'

•	Message: Displays a pre-determined message that will display in the email sent to a
secondary submitter.

•	Additional Comments: Enter any other additional comments or instructions that can be
passed onto the secondary submitter.

•	Send: Click the button to generate and send the email to the email addresses identified in the
'CC' and 'To' fields.

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Exhibit 5-7 shows a screen capture of the 'Unique Identifier Notification' pop-up window:
Exhibit 5-7: Unique Identifier Notification Pop-Up Window

t^CSPP

From:

CC:

To:

2014 Biotechnology

As the Authorized Official of TESTORGCGI1.1 have
identified you as a Secondary Submitter of a letter of
support submission for this 2014 Biotechnology form.
Please use the Section 5 Notices and Supports
application to provide the correct information for the
necessary items in this form. See the instructions
below for accessing the Section 5 Notices and
Supports application. You will need to use the unique
identification number to access and complete the
Biotechnology form for the letter of support submission.
Unique Identifier f8ad312f-ae02-4cac-8bb9-
557Scf729b1b

Information about the Section 5 programs, how to
access the Section 5 Notices and Supports application,
and instructions for reporting under the Section 5 rule
are available at www.epa.oov/oppt/newchems/. For
additional information or if you believe you have
received this email in error, please contact me.

4

Navigation: Click the 'Send' button to send the email to the Letter of Support submitter and
navigate back to the 'Letter of Support Submission Information' screen. Click the 'X' icon in the
upper right-hand corner to exit the screen without sending the email and navigate back to the
'Letter of Support Submission Information' screen.

Jane.Doe@test.com

{a ne.d oe @te st.com





/,

Enter email addresses separated by semicolons (;) or
commas (,). Click in this box to startentering email
addresses.

Subject:
Message:

Additional Comments:

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5.7 Technical Contact Information

You can access the 'Technical Contact Information' screen by clicking the 'Next' button from
the 'General Form Information' screen if you are not filing a Joint Submission or Letter of
Support. You can also access this screen by clicking the 'Next' button from the 'Joint
Submission Information' screen if you are not filing a Letter of Support. You can navigate to the
'Letter of Support Submission Information' screen by clicking the 'Next' button if you are not
filing a Joint Submission. You can be directed 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
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 last name of the reported technical contact.

•	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 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.

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Exhibit 5-8 shows a screen capture of the 'Technical Contact Information' screen:
Exhibit 5-8: Technical Contact Information Screen

Biotechnology
Primary Support
Bioteelmoloyy-
20130619-10:05:49 EOT

General Form Information

B Joint Submission

Joint Submission 1

Joint Submitter
Information

"•(f Joint Submission
Information

:""X Remove

:" "%)Add Joint Submission

$ _ Letter Of Support

i ^Letter of Support 1

j r"p {Letter of Support
Submitter
Information
Letter of Support
! j | Submission
Information

j j '""X Remove

'%)Add Letter Of Support

Technical Contact
Information

"1 ~ Optional Cover Letter

Logged in as' Jane Doe, Primary Support
Log Out

4, Biotechnology (Biotechnology-20130619-10:05:49 EDT) > Technical Contact information

TECHNICAL CONTACT INFORMATION

0

To add a new Technical Contact click the Add Technical Contact button. :A/

B

¦

Validate

Save

Preview

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

Navigation: Click the 'Next' button from the 'Technical Contact Information' screen 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.

5.7.1 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.

•	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. If you have clicked the 'Copy CDX
Registration' button, the fields populate with information entered during CDX registration.
This is a required field.

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•	Last Name: Enter the technical contact's last name. If you have clicked the 'Copy CDX
Registration' button, the fields populate 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. If you have clicked the
'Copy CDX Registration' button, the fields populate with information entered during CDX
registration. This is a required field.

•	Phone Number: Enter the daytime U.S. phone number of the technical contact; this must be
at least 10 characters long and does not accept dashes. If you have clicked the 'Copy CDX
Registration' button, the fields populate 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. If you have clicked the 'Copy CDX
Registration' button, the fields populate with information entered during CDX registration.

•	Mailing Address 1: Enter the first line of the technical contact's mailing address. If you
have clicked the 'Copy CDX Registration' button, the fields populate 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. If you
have clicked the 'Copy CDX Registration' button, the fields populate with information
entered during CDX registration.

•	City: Enter the city of the technical contact's mailing address. If you have clicked the 'Copy
CDX Registration' button, the fields populate with information entered during CDX
registration. This is a required field.

•	State: Select the state of the technical contact's mailing address. If you have clicked the
'Copy CDX Registration' button, the fields populate with information entered during CDX
registration. This is a required field.

•	Postal Code: Enter the postal code of the technical contact's mailing address. If you have
clicked the 'Copy CDX Registration' button, the fields populate with information entered
during CDX registration. This is a required field.

•	Country: Displays 'United States.'

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Exhibit 5-9 shows a screen capture of the 'Add Technical Contact' pop-up window:
Exhibit 5-9: 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 CB! 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:

Phone Extension:
Email Address:
Mailing Address 1

Mailing Address 2

City:

State:

Postal Code:
Country:

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

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

Apartment, suite, etc.

United States

Cancel	I OK

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.

5.8 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.

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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regarding the application; enter any necessary instructions into the blank text field. 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 5-10 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 5-10: Optional Cover Letter Screen

Biotechnology
Primary Support
Biotechnology-20130619-
10:05:49 EDT

General Form Information
9" Joint Submission

B

Logged in as: Jane Doe, Primary Support
Log Out

^ Biotechnology (Biotechnology-20130619-10:05:49 EDT) > 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: ~

Submission 1

"P Joint Submitter
Information

Joint Submission
Information

: XRemove

|=jAdd Joint Submission

Letter Of Support

B l^Letter of Support 1

Letter of Support

Submitter

Information

Letter of Support
\ Submission
Information

XRemove

j=jAdd Letter Of Support

[^Technical Contact Information

(WjOptional Cover Letter

>/

s

*

Validate

Save

Preview

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

Navigation: Click the 'Validate' icon (V) 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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6 Edit Notice of Commencement (NOC) Form

The Notice of Commencement (NOC) form allows industry users to notify EPA when a new
chemical or microorganism, submitted under a Biotechnology or PMN form, has already started
manufacture or import. A NOC form cannot be submitted before the chemical or microorganism
has gone through the review period by EPA. The NOC must be submitted within thirty (30) days
after the start date of the first manufacture or import.

6.1	Edit NOC Form

To edit a NOC form, navigate to the ' Section 5 Notices and Supports Forms' screen and click the
alias link in the 'Alias' column of a NOC 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 3.4 for additional details regarding the enter passphrase process.

6.2	General Form Information

You can access the 'General Form Information' screen by clicking the alias link in the 'Alias'
column of an 'In Progress' form and entering a passphrase on the 'Enter Passphrase' screen. This
screen provides fields to identify information that notifies EPA of the form alias, case number,
and manufacture or import information.

The 'General Form Information' screen presents a list of text fields and drop-down menus to
input information about the originally filed form. The 'Manufacture/Import Information' field
presents radio buttons for you to state whether the company intends to manufacture or import the
new chemical substance. When a manufacture/import radio button is selected, a calendar widget
appears for you to enter the date of commencement.

•	Form Alias: Enter a custom form alias, if applicable. Upon navigating to the screen, the
system auto-generates an editable form alias in the following format: . This is a required field.

•	Case Number: Enter the case number pertaining to the reported chemical substance or
mixture. The case number must be in the following format: P-XX-0999 for Premanufacture
Notice cases or J-XX-0999 for MCAN Biotechnology cases where 'XX' indicates the fiscal
year in which the case number is generated, and the leading '0' is required. This is a required
field.

•	First Commercial Manufacture: Enter the date for the first commercial manufacture. A
calendar widget appears when the radio button is selected to select the appropriate date. If
you select a future date past the current date, an error displays when navigating away from
the screen. Either the 'First Commercial Manufacture' radio button or the 'First Commercial
Importation' field is required.

•	First Commercial Importation: Enter the date for the first commercial importation. A
calendar widget appears when the radio button is selected to select the appropriate date. If
you select a future date past the current date, an error displays when navigating away from
the screen. Either the 'First Commercial Manufacture' or the 'First Commercial Importation'
field is required.

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Exhibit 6-1 shows a screen capture of the 'General Form Information' screen:

Exhibit 6-1: General Form Information Screen

Logged in as Jane Doe, Primary Support
Log Out

Notice of Commencement
Primary Support	*

HOC 20130619 10:06:58 EDT
General Form Information

Technical Contact Information
~l2 Chemical Information
-|2 Submitter Sfle formation
B CBI Subsl.niti.rt ion

CBI S*iKtanlw(k5n Part 1
Ca Sitestarliation Part 2
"(5 CBI SUbstertialicn Port 3
Optional Cover Letter

Home J Forms J Resources
Notice of Commencement  > General Form Infoririatiori

GENERAL FORM INFORMATION

You may enter an alias tor easier form Identification or the system will provide a time stamp

Form Alias.

NOC-20140408-11:19:27 EDT

Part II ¦ Premanufacture Notice (PMN) 'P* or Microbial Commercial Activity Notice (MCAN) 'J' Case
Number

Case Number

PLaas® «nt#r the oh numb«r in !h« following format! 2-XX-0399 wA. • r« 'XX' Indicates th« in v^Hch the case
number Is g«nerBt*d, and tHi leading '0' it

Manufacture/Import Information

Please provide me following information. Date of commencement Is the date of completion of non-exempt
manufacture of the first amount (bath, drum, etc.) For importees, me date of commencement is the date
that the new chemical substance clears U.S. Customs.

First Commercial Manufacture
First Commercial Importation



m



Validate

Save

Preview

CDX Homepage t MyCDX Homepage | EPA Homepage | Terms and Conditions I Prr/acy Notice | CDX Helpdesk: (888) 890-1995

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.

6.3 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 access this 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 technical contact information into the list of text fields. Click the 'Copy CDX Registration'
button to populate the text fields with your contact information entered during CDX registration.
Check the 'Check here to claim this information as CBI' checkbox to claim the technical contact
information as confidential to indicate that the information will not be released to the public.

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•	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 technical contact's CBI status by displaying either a 'Y' or an 'N.'

•	Actions: Click the 'Delete' icon ( *) to delete the technical contact. A warning message
displays to confirm the deletion of the technical contact.

Exhibit 6-2 shows a screen capture of the 'Technical Contact Information' screen:
Exhibit 6-2: Technical Contact Information Screen

A Logged in as: Jane Doe, Primary Support

Log Out

Notice of Commencement
Primary Support	^

NOC-20130619-10:06:58 EDT

j""| [General Form Information

!""[S]Technical Contact
Information

Alchemical Information

I ~~ [Submitter Site Information

5 CBI Substantiation

!""[=)CBI Substantiation Part 1
i |""|W|CBI Substantiation Part 2
:""[=]CBI Substantiation Part 3
'^Optional Cover Letter

Notice of Commencement (NOC-20130619-10:06:58 EDT) > Technical Contact Information

TECHNICAL CONTACT INFORMATION

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

Q>

Last Name

First Name

Address

CBI

Actions

m n

Validate	Save	Preview

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

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

6.3.1 Add Technical Contact

Click the 'Add Technical Contact' button to begin the process of adding technical contacts.

You will enter the contact information for each technical contact within the 'Add Technical
Contact' window. The 'Add Technical Contact' pop-up window displays the fields for you to
input the information for a technical contact. The system provides functionality to enter multiple
technical contacts. If you are the technical contact, click the 'Copy CDX Registration' button to
populate the technical contact information with your user information entered during CDX
registration. The system provides you with the option to claim the technical contact information
as confidential by checking the 'CBI' checkbox. Each technical contact will have an individual

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CBI claim. After entering the information for a technical contact, click the 'OK' button which
will populate the technical contacts table located on the 'Technical Contact Information' screen.

•	Copy CDX Registration: Click the 'Copy CDX Registration' button to import contact
information from CDX registration; a confirmation will display.

•	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. If you have clicked the 'Copy CDX
Registration' button, the fields populate with information entered during CDX registration.
This is a required field.

•	Last Name: Enter the technical contact's last name. If you have clicked the 'Copy CDX
Registration' button, the fields populate with information entered during CDX registration.
This is a required field.

•	Company Name: Enter the technical contact's company name. If you have clicked the
'Copy CDX Registration' button, the fields populate 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. If you have clicked the 'Copy CDX
Registration' button, the fields populate 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@abc.com. If you have clicked the 'Copy CDX
Registration' button, the fields populate with information entered during CDX registration.

•	Mailing Address 1: Enter the first line of the technical contact's mailing address. If you
have clicked the 'Copy CDX Registration' button, the fields populate 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. If you
have clicked the 'Copy CDX Registration' button, the fields populate with information
entered during CDX registration.

•	City: Enter the city of the technical contact's mailing address. If you have clicked the 'Copy
CDX Registration' button, the fields populate 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. If
you have clicked the 'Copy CDX Registration' button, the fields populate with information
entered during CDX registration. This is a required field.

•	Postal Code: Enter the postal code of the technical contact's mailing address. If you have
clicked the 'Copy CDX Registration' button, the fields populate with information entered
during CDX registration. This is a required field.

•	Country: Displays 'United States.'

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Exhibit 6-3 shows a screen capture of the 'Add Technical Contact' pop-up window:
Exhibit 6-3: Add Technical Contact Pop-Up Window

¦a

c^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
Company Name
Phone Number:

Phone Extension:
Email Address:
Mailing Address 1

Mailing Address 2

City:

State:

Postal Code:
Country:

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

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

Apartment, suite, etc.

United States

Cancel

OK

Navigation: Click the 'Cancel' button or 'X' icon at the top left-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 the entered technical contact information and return
to the 'Technical Contact Information' screen.

6.4 Chemical Information

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

The 'Chemical Information' screen provides fields to identify the chemical the submitter has
begun to manufacture or import. The 'Specific Chemical Identity' section provides fields to input
information describing the chemical for which the NOC is to be filed. This screen outlines the
unique chemical properties and displays the name and CASRN of the chemical. Most of the

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chemicals submitted under aNOC will not be found in the 'Search Substance Registry Services'
window, and a new chemical will have to be created. To create a new chemical, click the 'Search
SRS' button, found in the 'Chemical Information' screen, and then the 'Create New Chemical'
button to generate the 'Chemical Not Found In Substance Registry Services' pop-up window.

If you claim a chemical as CBI, the 'Generic Chemical Name' text box generates. A 'CBI
Substantiation' folder displays within the navigation tree upon navigating away from the screen.

If you claim chemical identity as confidential, you must provide a generic chemical name for
your substance that reveals the specific chemical identity of the new chemical substance to the
maximum extent possible. Please note that EPA will be closely assessing the generic name at this
time; please make sure that your generic name is a good generic name that only hides the
proprietary parts of the chemical information.

•	Add New Chemical: Click the 'Add New Chemical' button to generate the 'Specific Chemical
Identity' expandable/collapsible field set. At least one chemical is required.

•	Search SRS: Click the 'Search SRS' button to generate the 'Search SRS' window. Refer to
Section 3.8 for additional details regarding the search SRS functionality.

•	CASRN: Displays the CASRN of the chemical being reported, if applicable.

•	Chemical Name: Displays the chemical name of the substance being reported.

•	CBI: Check the 'CBI' checkbox to claim the 'Specific Chemical Identity' information as
confidential and generate the 'Generic Chemical Name' text box. If you claim the chemical as
confidential, a 'CBI Substantiation' folder displays within the navigation tree after clicking the
'Next' button from the 'Chemical Information' screen.

•	Generic Chemical Name: Enter the generic name to associate with a chemical. This field
displays only when the 'Specific Chemical Identity' is claimed CBI.

•	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
for more information regarding the save functionality in an 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 is displayed when the 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 the expandable/collapsible
field set to modify the information entered in the fields. The 'Edit' link is displayed 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. The 'Delete' icon ( ¦*) is displayed when the user has clicked the 'Add
New Chemical' button.

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

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

•	Substance Identity Confidentiality Status: You will only be able to select a single radio
button. If you claim the chemical as CBI, after clicking the 'Save' button in the 'Specific
Chemical Identity' expandable/collapsible field set, the system will enable the first radio button
and disable the second and third radio buttons. If you do not claim the chemical as CBI, after
clicking the 'Save' button in the 'Specific Chemical Identity' expandable/collapsible field set,
the system will disable the first radio button and enable the second and third radio button
options. This section displays the following options:

o I wish to claim the substance identity confidential and the substantiation to support this
claim is attached. Failure to submit the required substantiation in accordance with 40
CFR 720.85(b) will result in waiver of your claim.

0	I previously claimed the substance identity as confidential and hereby relinquish that
claim.

01	did not claim the substance identity as confidential in my original PMN submission.

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Exhibit 6-4 shows a screen capture of the 'Chemical Information' screen (Scroll 1):
Exhibit 6-4: Chemical Information Screen (Scroll 1)

Notice of Commencement
Primary Support
NOC-20130619 10:06:58 EDT

General Form information
jt2 Technical Contact Information
Chemical Information
Submitter Ste Information
R Cfil SubstAiitijtioii

OS Svtostan(i Chemical Infoi motion

CHEMICAL INFORMATION

Part V - Specific Chemical Identity

CASRN:

• Logged in as Jane Doe, Primary Support
Log Out

&

tx|Kiii/

validate

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Preview



CDX Homepage |

I MyCDX Homepage |

I EPA Homepage | Terms and Conditions I

Privacy Notice |

CDXHelpdesfc (888)890-1995

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 6-5 shows a screen capture of the 'Chemical Information' screen (Scroll 2):

Exhibit 6-5: Chemical Information Screen (Scroll 2)



Notice of Commencement 4
Prwik.ii y Support
NOC-20130619-10:06:58 EOT

General Form Information
Technical Contact Inlornwibon
C hemic .hi Information
_ Sutwtfter sue information
B C EM Substantiation

-Q CBI Substantiation Port 1
CBI Substantiation Part 2
CBi Substantial ton Part 3
Opltonal Cover Letter

' CASRN:

* Logged in as Jane Doe. Primary Support

Log Out

Exp
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CDX?

the 'Add Site' button. You must select a site before moving on to the 'CBI Substantiation Part 1'
screen or to the 'Optional Cover Letter' screen.

•	Add Site: Click the 'Add Site' button to generate the 'Add Site' pop-up window. Refer to
Section 3.9 for additional details regarding the add site functionality.

•	Registry ID: Displays the EPA registry ID of the site

•	Site Name: Displays the site name associated with a site.

•	Address: Displays the site address of a site.

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

•	Actions: Click the 'Delete' icon ) to delete the site row permanently from the system. A
confirmation prompt displays to confirm the deletion.

Exhibit 6-6 shows a screen capture of the 'Site Information' screen:

Exhibit 6-6: Site Information Screen

Logged in as Jane Doe, Primary Support
Log Out

Notice of Commencement
Primary Suppoil	*

NOC 20130619 10:06:58 EDT

Gerierai Form Information
Tecftrrai Contact Informal ten
Cbamical Infcfmsfcon
Submittal Site Information
- CSI Substantiation

CBI l&festartlalian Part 1
09 Substantiation Part 2
CBI Sttostartlation Part 3
Oj#icc»at Cover Letter

NoJice of Commencement  > Submittal Site Irtfotrti^lon

SITE INFORMATION

Part IV • Manufacturing Plant Slte[s) or Importing Site(s)

Importers, provide street address of destination
Click to add a new site Add sue

Registry ID

Site Name

Address

CBI

| next |

Actions





Validate

¦

Save

Preview



CDX Homepage I

I MyCDX Homepage

I EPA Homepage | Terms and Conditions |

Pwacy Notice I

CDX Helpdesk: (888) 890-1995

Navigation: If you claimed a chemical CBI, click the 'Next' button to navigate to the 'CBI
Substantiation Part 1' screen. You can also access this screen by clicking the 'CBI Substantiation
Part 1' link within the navigation tree. If you did not claim a chemical as CBI, 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 to access this screen.

6.6 CBI Substantiation Part 1

You can access the 'CBI Substantiation Part 1' screen by clicking the 'Next' button from the
'Site Information' screen if a chemical was claimed CBI on the 'Chemical Information' screen.

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You can also access this screen by clicking the 'CBI Substantiation Part 1' link within the
navigation tree.

The 'CBI Substantiation Part 1' screen presents substantiation questions that require you to
provide answers into the text fields as free text or enter 'N/A' if the question does not apply. The
'CBI Substantiation Part 1' screen consists of questions A through D, which read as follows:

•	(A) What harmful effects to your competitive position, if any, do you think would result
if EPA publishes on the Inventory the identity of the chemical substance? How could a
competitor use such information given the fact that the identity of the substance
otherwise would appear on the Inventory of chemical substances with no link between
the substance and your company or industry? How substantial would the harmful
effects of disclosure be? What is the causal relationship between the disclosure and the
harmful effects?: Enter the answer to substantiation question A. This is a required field.

•	(B) For what period of time should confidential treatment be given? Until a specific
date, the occurrence of a specific event, or permanently? Why?: Enter the answer to
substantiation question B. This is a required field.

•	(C) Has the chemical substance been patented? If so, have you granted licenses to others
with respect to the patent as it applies to the chemical substance? If the chemical
substance has been patented and therefore disclosed through the patent, why should it
be treated as confidential for purposes of the Inventory?: Enter the answer to
substantiation question C. This is a required field.

•	(D) Has the identity of the chemical substance been kept confidential to the extent that
your competitors do not know it is being manufactured or imported for a commercial
purpose by anyone?: Enter the answer to substantiation question D. This is a required field.

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Exhibit 6-7 shows a screen capture of the 'CBI Substantiation Part 1' screen (Scroll 1):
Exhibit 6-7: CBI Substantiation Part 1 Screen (Scroll 1)

Notice of Commencement
Primary Support	4

NOC-20130619-10:06:58 EDT

General Form Information

Technical Contact Information

"|3jChemical Information

Submitter Site Information

CBI Substantiation

I""£CBI Substantiation Part
1

[CBI Substantiation Part 2

	QiCBI Substantiation Part 3

•(^Optional Cover Letter

•*> Logged in as: Jane Doe, Primary Support

Log Out

Notice of Commencement (NOC-20130619-10:06:58 EDT) > CBI Substantiation Part 1

CBI SUBSTANTIATION PART 1

Substantiate confidentiality of claims if you mark the substance identity (Part V) as CBI by answering the
following questions. Please enter N/A if the question does not apply.

(A) What harmful effects to your competitive position, if any, do you think would result if EPA publishes on
the Inventory the identity of the chemical substance? How could a competitor use such information given
the fact that the identity of the substance otherwise would appear on the Inventory of chemical substances
with no link between the substance and your company or industry? How substantial would the harmful
effects of disclosure be? What is the causal relationship between the disclosure and the harmful effects?

(B) Forwhat period of time should confidential treatment be given? Until a specific date, the occurrence of
a specific event, or permanently? Why?

(C) Has the chemical substance been patented? If so, have you granted licenses to others with respect to
the patent as it applies to the chemical substance? If the chemical substance has been patented and
therefore disclosed through the patent, why should it be treated as confidential for purposes of the
Inventory?

>/

a

¦

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Save

Preview

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 6-8 shows a screen capture of the 'CBI Substantiation Part 1' screen (Scroll 2):
Exhibit 6-8: CBI Substantiation Part 1 Screen (Scroll 2)

Notice of Commencement
Primary Support	4

NOC-20130619-10:06:58 EDT

f"1 ~ [General Form Information

!""U Technical Contact Information

i" IChemical Information

Submitter Site Information

CBI Substantiation

j" "I^ICBI Substantiation Part
1

! iglCBI Substantiation Part 2
-R^l Substantiation Part 3
'Optional Cover Letter

¦*> Logged in as: Jane Doe, Primary' Support

Log Out

(B) For what period of time should confidential treatment be given? Until a specific date, the occurrence of
a specific event, or permanently? Why?

(C) Has the chemical substance been patented? If so, have you granted licenses to others with respect to
the patent as it applies to the chemical substance? If the chemical substance has been patented and
therefore disclosed through the patent, why should it be treated as confidential for purposes of the
Inventory?

(D) Has the identity of the chemical substance been kept confidential to the extent that your competitors
do not know it is being manufactured or imported for a commercial purpose by anyone?







•y¦

Validate Save

Preview



CDX Homepage |

| MyCDX Homepage |

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button to navigate to the 'CBI Substantiation Part 2' screen. You
can also access this screen by clicking the 'CBI Substantiation Part 2' link within the navigation
tree.

6.7 CBI Substantiation Part 2

You can access the 'CBI Substantiation Part 2' screen by clicking the 'Next' button from the
'CBI Substantiation Part V screen. You can also access this screen by clicking the 'CBI
Substantiation Part 2' link within the navigation tree.

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The 'CBI Substantiation Part 2' screen presents substantiation questions that require answers to
be entered into the text fields as free text or enter 'N/A' if the question does not apply. The 'CBI
Substantiation Part 2' screen consists of questions E through H, which read as follows:

•	(E) Is the fact that someone is manufacturing or importing this chemical substance for
commercial purposes available to the public, e.g. in technical journals or other
publications; in libraries; or in State, local or Federal agency public files?: Enter the
answer to substantiation question E. This is a required field.

•	(F) What measures have you taken to prevent undesired disclosure of the fact that you
are manufacturing or importing this substance for a commercial purpose?: Enter the
answer to substantiation question F. This is a required field.

•	(G) To what extent has the fact that you are manufacturing or importing this chemical
substance for a commercial purpose been disclosed to others? What precautions have
you taken in regard to these disclosures? Has this information been disclosed to the
public, or to competitors?: Enter the answer to substantiation question G. This is a required
field.

•	(H) In what form does this particular chemical substance leave the site of manufacture,
e.g. as part of a product, in effluent or emission stream? If so, what measures have you
taken to guard against discovery of its identity?: Enter the answer to substantiation
question H. This is a required field.

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Exhibit 6-9 shows a screen capture of the 'CBI Substantiation Part 2' screen (Scroll 1):
Exhibit 6-9: CBI Substantiation Part 2 Screen (Scroll 1)

T

¦*> Logged in as" Jane Doe, Primary Support

Log Out

Notice of Commencement
Primary Support	'

NOC-20130619-10:06:58 EDT

General Form Information
; " Technical Contact Information
'"^Chemical Information
I'QlSubmitter Site Information
$ CBI Substantiation

ICBI Substantiation Part 1
CBI Substantiation Part

2

CBI Substantiation Part 3
Optional Cover Letter

Notice of Commencement (NOC-20130619-10:06:58 EDT) > CBI Substantiation Part 2

CBI SUBSTANTIATION PART 2

Substantiate confidentiality of claims if you mark the substance identity (Part V) as CBI by answering the
following questions. Please enter N/A if the question does not apply.

(E) Is the fact that someone is manufacturing or importing this chemical substance for commercial
purposes available to the public, e.g. in technical journals or other publications; in libraries; or in State,
local, or Federal agency public files?

(F) What measures have you taken to prevent undesired disclosure of the fact that you are manufacturing
or importing this substance for a commercial purpose?

(G) To what extent has the fact that you are manufacturing or importing this chemical substance for a
commercial purpose been disclosed to others? What precautions have you taken in regard to these
disclosures? Has this information been disclosed to the public or to competitors?

(H) In what form does this particular chemical substance leave the site of manufacture, e.g., as part of a
product; in effluent or emission stream? If so, what measures have you taken to guard against discovery of





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CDX?

Exhibit 6-10 shows a screen capture of the 'CBI Substantiation Part 2' screen (Scroll 2):
Exhibit 6-10: CBI Substantiation Part 2 Screen (Scroll 2)

Notice of Commencement
Primary Support	*

NOC-20130619-10:06:58 EDT

General Form Information

'[| iTechnical Contact Information

Chemical Information

Submitter Site Information

$ CBI Substantiation

CBI Substantiation Part 1

j""( ^jCBI Substantiation Part
2

•| rifiiCBI Substantiation Part 3
' jOptional Cover Letter

Logged in as: Jane Doe, Primary Support
Log Out

(F) What measures have you taken to prevent undesired disclosure of the fact that you are manufacturing
or importing this substance for a commercial purpose?

(G) To what extent has the fact that you are manufacturing or importing this chemical substance for a
commercial purpose been disclosed to others? What precautions have you taken in regard to these
disclosures? Has this information been disclosed to the public or to competitors?

(H) In what form does this particular chemical substance leave the site of manufacture, e.g., as part of a
product; in effluent or emission stream? If so, what measures have you taken to guard against discovery of
its identity?





-¦

Validate Save

Preview



CDX Homepage |

| MyCDX Homepage

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button to navigate to the 'CBI Substantiation Part 3' screen. You
can also access this screen by clicking the 'CBI Substantiation Part 3' link within the navigation
tree.

6.8 CBI Substantiation Part 3

You can access the 'CBI Substantiation Part 3* screen by clicking the 'Next' button from the
'CBI Substantiation Part 2' screen. You can also access this screen by clicking the 'CBI
Substantiation Part 3' link within the navigation tree.

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The 'CBI Substantiation Part 3' screen presents substantiation questions that require answers to
be entered into the text fields as free text or enter 'N/A' if the question does not apply. The 'CBI
Substantiation Part 3' screen consists of questions I through L, which read as follows:

•	(I) If the chemical substance leaves the site of manufacture in a product that is available
to either the public or your competitors, can they identify the substance by analyzing
the product?: Enter the answer to substantiation question I. This is a required field.

•	(J) For what purpose do you manufacture or import the substance?: Enter the answer to
substantiation question J. This is a required field.

•	(K) Has EPA, another Federal agency, or any Federal court made any persistent
confidentiality determinations regarding this chemical substance? If so, copies of such
determinations must be included in the substantiation.: Enter the answer to substantiation
question K. This is a required field.

•	Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window and attach supporting documentation for substantiation question K. 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 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 of the document.

•	(L) If the notice includes a health and safety study concerning the new chemical
substance, the submitter must also answer the question in 40 CFR 720.90(b)(2). Persons
must answer this question if a health and safety study was provided at any time in the
new chemical process.: Enter the answer to substantiation question L. This is a required
field.

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Exhibit 6-11 shows a screen capture of the 'CBI Substantiation Part 3' screen (Scroll 1):
Exhibit 6-11: CBI Substantiation Part 3 Screen (Scroll 1)

T

T

Logged in as: Jane Doe, Primary Support
Log Out

Notice of Commencement
Primary Support	*

NOC-20130619-10:06:58 EDT

iGeneral Form Information
[Technical Contact Information

I	^Chemical Information

Submitter Site Information
$ _ CBI Substantiation

"byCBI Substantiation Part 1
""[fjCBI Substantiation Part 2

""I |CBI Substantiation Part

3

iOptional Cover Letter

Notice of Commencemeiiit (NOC-20130619-10:06:58 EDT) > CBI Substantiation Part 3

CBI SUBSTANTIATION PART 3

Substantiate confidentiality of claims if you mark the substance identity (Part V) as CBI by answering the
following questions. Please enter N/A if the question does not apply.

(I) If the chemical substance leaves the site of manufacture in a product that is available to either the
public or your competitors, can they identify the substance by analyzing the product?

#

(J) For what purpose do you manufacture or import the substance?

(K) Has EPA, another Federal agency, or any Federal court made any persistent confidentiality
determinations regarding this chemical substance? If so, copies of such determinations must be included
in the substantiation.

Attach Document

File Name	Description	Pages	CBI	Actions

>/

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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December 17, 2014
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Exhibit 6-12 shows a screen capture of the 'CBI Substantiation Part 3' screen (Scroll 2):
Exhibit 6-12: CBI Substantiation Part 3 Screen (Scroll 2)

Notice of Commencement
Primary Support	4

NOC-20130619-10:06:58 EDT

1^ General Form Information
Technical Contact Information
IChemical Information
Submitter Site Information
$' CBI Substantiation

j""RcBl Substantiation Part 1
-E CBI Substantiation Part 2

p CBI Substantiation Part

3

Home y Forms y Resources

(J) For what purpose do you manufacture or import the substance?

•S- Logged in as: Jane Doe, Primary Support

Log Out

Optional Cover Letter

(K) Has EPA, another Federal agency, or any Federal court made any persistent confidentiality
determinations regarding this chemical substance? If so, copies of such determinations must be included
in the substantiation.

Attach Document

File Name

Description

Pages

CBI

Actions

(L) If the notice includes a health and safety study concerning the new chemical substance, the submitter
must also answer the questions in 40 CFR 720.90(b)(2). (Persons must answer this question if a health
and safety study was provided at anytime in the new chemical process.)







•y¦

Validate Save

Preview



CDX Homepage |

| MyCDX Homepage |

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button from the 'Site Information' screen if a chemical was not
claimed CBI, or the 'CBI Substantiation Part 3' screen 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.

6.9 Optional Cover Letter

If you are not claiming a chemical as CBI on the 'Chemical Information' screen, click the 'Next'
button from the 'Site Information' screen to navigate to the 'Optional Cover Letter' screen. If
you did claim a chemical as CBI on the 'Chemical Information' screen, click the 'Next' button

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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from the 'CBI Substantiation Part 3' screen 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.

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 and 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 as confidential

•	Cover Letter: Enter any additional information or special instructions associated with the
form.

Exhibit 6-13 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 6-13: Optional Cover Letter Screen

Notice of Commencement
Primary Support	^

NOC-20130619-10:06:58 EDT

r| General Form Information
l~= [Technical Contact Information
Chemical Information
Submitter Site Information
CBI Substantiation
j-gJCBI Substantiation Part 1
" CBI Substantiation Part 2
" iCBI Substantiation Part 3
Optional Cower Letter

line y Forms J Resour
Notice of Commencement (NOC-20130619-10:06:58 EDT) > 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: ~

• Logged in as: Jane Doe, Primary Support
Log Out

Previous





V

Validate Save

Preview





CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8£

38) 890-1995

Navigation: Click the 'Validate' icon (l ) located in the bottom action bar to validate the Form.
Click the 'Save' icon ( ) 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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7 Edit Support Form

The Section 5 Notices and Supports application allows support forms to be submitted such as
'Amendment,' 'Other Correspondence,' 'Suspension Request,' 'Transfer of Ownership,'
'Withdrawal Requests,' and 'Test Data.' Support forms are filed separately from PMN forms due
to access restrictions and/or to provide information not included in the original PMN. The
Support form is used to supplement the original PMN by providing additional data that was not
provided originally, withdraw a PMN application, or provide data that was requested later.

7.1	Edit Support Form

To edit a Support form, 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 3.4 for additional details regarding the enter passphrase process.

7.2	General Form Information

You can access the 'General Form Information' screen by entering a passphrase on the 'Enter
Passphrase' screen or creating a passphrase on the 'Create Passphrase' screen.

The 'General Form Information' screen provides a list of text fields and drop-down menus for
you to input information about the originally filed form.

Please note that if you are using IE 7, the action bar icons may be misaligned and hovering over
the 'Next' button on this screen causes the button to move. In addition, the calendar widget next
to the 'Original Submission Date' text field will be misaligned.

•	Form Alias: Enter the form alias. Upon navigating to the screen, the system auto-generates
an editable form alias comprised of .
This is a required field.

•	Case Number: Enter the case number that connects to the original submission in the system.
This is a type-ahead field that displays the forms that have been submitted under the same
organization. If the case number is in the application, the remaining fields on the 'General
Form Information' screen will populate. The 'Original Submitter Information' screen will
also populate for forms created within the thin client. In the case of legacy submissions, case
numbers must be manually entered. The case number must be in one of the following
formats: P-XX-XXXX for PMN, SN-XX-XXXX for SNUN, L-XX-XXXX for LVE, LM-
XX-XXXX for LVE Modifications, X-XX-XXXX for LOREX, XM-XX-XXXX for LOREX
Modifications, T-XX-XXXX for TMEA, I-XX-XXXX for Mock PMN, J-XX-XXXX for
MCAN, R-XX-XXXX for TERA, G-XX-XXXX for Tier-I, H-XX-XXXX for Tier-II, or BF-
XX-XXXX for Bona Fide. This field does not accept -0000 as a case number suffix. This is a
required field.

•	TS Number: Enter the TS number; this field accepts any six (6) character alphanumeric
combination. This value is determined by the company in order to identify the form for both
payments and connecting related submissions (Letters of Support, Joint Submissions and
corrections). The TS number should include two (2), three (3), or four (4) letters. Company
names, recognizable words, and numeric series are not recommended.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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•	Type of Support: Select the type of support from the drop-down menu. This field contains
the following values: 'Amendment,' 'Suspension Request,' 'Test Data,' 'Transfer of
Ownership,' 'Withdrawal Request,' and 'Other Correspondence.' The 'Amendment' type is
unavailable when creating an amendment. This is a required field.

•	Check if requested by EPA/Contractor: Check the 'Check if requested by
EPA/Contractor' checkbox to display fields to enter information to identify the requestor that
asked you to submit support information.

•	Last Name: Enter the requestor's last name. This field displays if the 'Check if requested by
EPA/Contractor' checkbox is checked and is required if displayed.

•	First Name: Enter the requestor's first name. This field displays if the 'Check if requested
by EPA/Contractor' checkbox is checked and is required if displayed.

•	EPA/Contractor: Select a value from the drop-down menu to identify whether the requestor
is an EPA official, a contractor, or unknown. This drop-down menu contains the following
options: 'EPA,' 'Contractor,' and 'Unknown.'

•	Actions: Click the 'Save' icon (H) to save an individual EPA/contractor entry. Click the
'Form' icon (El) to edit an individual EPA/contractor entry. Click the 'Delete' icon (¦¦-*) to
delete an individual EPA/contractor entry. Click the 'Add' icon ( ) to add another entry to
enter EPA/contractor information.

•	CBI: Check the 'CBF checkbox to claim the support description or explanation of support as
confidential.

•	Description or Explanation of Support: Enter the support description or explanation of
support. Either the 'Description or Explanation of Support' field is required, or an attached
document is required.

•	Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window and attach documents describing the Support form. Attachments that are
uploaded include individual toxicity studies, GPC data, spectra, exposure monitoring
evaluations, physical and chemical properties data, SAR modeling, test samples
characterization data, explanatory comments, etc. Analytical tests should be provided with
their complete data set. For example, provide a GPC test report with time interval data and all
graphs. For ease of review, group attachments by type of data, e.g., physical/chemical
properties, fate information. Refer to Section 3.7 for additional details regarding the attach
document functionality.

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

•	Description: Displays the description of a file that is uploaded on the 'Attach Documents'
pop-up window.

•	Subtype: Displays the subtype 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 (K) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 7-1 shows a screen capture of the 'General Form Information' screen (Scroll 1):
Exhibit 7-1: General Form Information Screen (Scroll 1)



* Logged in as Jane Doe, Primary Support

Log Out

Support
Pi Hilary Support

Support.20141202-08:48:56 EST

General Form Information

Original Submtter Information

< Support  General Form Information

GENERAL FORM INFORMATION

Trie form alias is an optional flew that changes the form name on the Forms screen its purpose is to
make it easier to distinguish between multiple forms If an alias Is not selected, trie field will default to the
date II was created The form atlas may be changed at any time

Form Alias

Susport-201412D2-08:J9:56 EST

I. Original Notice Submission Information

Case Number:

TS Number

IV, Type of Support

Check If requested by EPA/Contractor
Last Name	First Name

EPA'Contractor

Actions

3X4>

V. Description or Explanation of Support GBI

*/ u b m

Valid ale	Save	Preview	Submit

COX Homepage | MyCDX Homepage | EPA Homepage I Terms and Commons | privacy Notice 1 CDX Belpdesk. (858)890-1995

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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Support

December 17, 2014
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Exhibit 7-2 shows a screen capture of the 'General Form Information' screen (Scroll 2):
Exhibit 7-2: General Form Information Screen (Scroll 2)



Support
PiiiiMiy Supp-OTl

Support-2014120248:48:56 EST
GmwK Form lnform«»on

Cr^raf Sutxnttef If!or ma&on

Hwm y foims y Resources

I. Original Notice Submission Infonrution

Case Number
TS Number

rv. Type of Support

* Logged in as Jane Doe. Pnmary Support

Log Out

Check If requested try EPA/ConSractor *
Last Name	First Name

EPA/Contractor

Actions
HX+

V. Description or Explanation of Support

C0l

Attach Document



File Name Description

Subtype

Pages

CBI

Actions















Validate

5

Save

=

Preview

¦

Submit



CDX Homepage !

1 MyCOX Homepage | epa Homepage | Terms ana COMSfcMis

1 Privacy Nonce

1 COX HeJpPesK

(888)890-1995

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

7.3 Original Submitter Information

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

The 'Original Submitter Information' screen provides a list of text fields to enter the contact
information of the Authorized Official who submitted the original PMN form for whom you are
filing the Support form.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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•	Click here to copy your information from CDX Registration: Click the 'Copy CDX
Registration' button to import your CDX registration information. A prompt will generate to
confirm the import of registration information.

•	Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim the original submitter contact information as
confidential.

•	First Name: Enter the Authorized Official's first name. This is a required field.

•	Last Name: Enter the Authorized Official's last name. This is a required field.

•	Position: Enter the Authorized Official's job title.

•	Company Name: Enter the Authorized Official's company name. This is a required field.

•	Phone Number: Enter the Authorized Official's daytime phone number. This field does not
allow dashes. This is a required field.

•	Phone Extension: Enter the Authorized Official's phone number extension, if applicable.

•	Email Address: Enter the Authorized Official'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 Authorized Official's mailing address. This is a
required field.

•	Mailing Address 2: Enter the second line of the Authorized Official's mailing address.

•	City: Enter the city of the Authorized Official's mailing address. This is a required field.

•	State: Enter the state of the Authorized Official's mailing address. This is a required field if
the 'Country' field is set to 'United States.'

•	Postal Code: Enter the postal code of the Authorized Official's mailing address. This is a
required field.

•	Country: Displays 'United States.'

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Exhibit 7-3 shows a screen capture of the 'Original Submitter Information' screen:
Exhibit 7-3: Original Submitter Information Screen

Support

Primary Support

Support 201404Q8 11:18:40 EDT

H ~ General Form Information

Original Submitter
Information

¦ Logged in as- Jane Doe, Primary Support
Log Out

4 Sup-port (Support-20140408 11:13:40 EDT) > Original submitter Information

ORIGINAL SUBMITTER INFORMATION

Please enter the information of the Authorized Official who submitted me ongmal PMN/Biotech/Bona Fide
form for which you are filing a Support document

ClicK here to copy your information from CDX Registration
Check here to claim this information as CBI

Copy CDX Registration

First Name
Last Name
Position
Company flame
Phone Number

(Do not enter any dashes (•) in Phone fiumber field above.)

Phone Extension
Email Address
Mailing Address 1

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

Mailing Address 2

Apartment. su>te, etc.

City

State	! *

Postal Code

Country	Unlled S,ates

Previous







>/

Validate

5

Save

=

Preview

¦

submit

COX Homepage

I MyCDX Homepage I

\ epa Homepage I

Terms and ContWons

J Piwacy Notice

I COXHeipdesk (888)890-1995

Navigation: Click the 'Validate' icon (' ) located in the bottom action bar to validate the form.
Click the 'Save' icon ( B) 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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8 Edit 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.

8.1	Edit Bona Fide Form

To edit a Bona Fide form, navigate to the 'Section 5 Notices and Supports Forms' screen and
click the alias link in the 'Alias' column of a 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 3.4 for additional details regarding the enter passphrase process.

8.2	General Document Information

You can access the 'General Document Information' screen by accessing a Section 5 Notices and
Supports Bona Fide form that is 'In Progress' and entering the passphrase associated with the
selected form.

The 'General Document Information' screen presents text fields and checkboxes for you to input
identifying information for the specific form. You will have the option to assign a 'Form Alias'
by which the form can be identified. The form alias is helpful when you or the company has
multiple forms and/or when you must differentiate between forms to the help desk. If a form
alias is not entered, the system will provide an editable default alias in the following format:
.

You can claim the entirety of the submission as CBI. The entire submission will be claimed as
CBI if you check the 'I claim the entirety of the submission as CBI' checkbox. The entire
submission 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 form. The application will display a 'Technical
Contact Information' screen when you check the 'Technical Contact' checkbox.

You can indicate that a Letter of Support is expected to be filed by a secondary submitter by
checking the 'Letter of Support' checkbox. The Letter of Support shall be submitted by a
Secondary Authorized Official. They will have a unique identification number that will link the
submissions. The unique identification number will be sent to the Letter of Support submitter,
via email, and the unique identifier will link the two forms together.

You can indicate that you are submitting on behalf of another company by checking the
'Submitting on Behalf of Company' checkbox. The 'Submitting on Behalf of Company' screen
presents a list of text fields for you to input contact information for the company on whose behalf
the submission is being made when submitting on behalf of another company. The application
will display a 'Submitting on Behalf of Company' screen during the submission process when
you check the ' Submitting on Behalf of Company' checkbox.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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•	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: . This is a required field.

•	I claim the entirety of the submission as CBI: Check the 'I claim the entirety of the
submission as CBI' checkbox to flag all data contained within the form as confidential.

•	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.

•	Letter of Support: Check the 'Letter of Support' checkbox to indicate that the form is
pending a Letter of Support and to display the 'Letter of Support' folder within the
navigation tree. The 'Letter of Support' folder contains the following screens: 'Letter of
Support Submitter Information' and 'Letter of Support Submission Information.'

•	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 'Submitting on Behalf of Company' screen will display during the submission
process for you to enter information pertaining to the company you are submitting on behalf
of that will manufacture or import the chemical substance.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 8-1 shows a screen capture of the 'General Document Information' screen (Scroll 1):
Exhibit 8-1: General Document Information Screen (Scroll 1)

Bona Fide
Primary Support

General Document
Information

Primary Contact Information

Technical Contact Information

Statement of Intent

?" Letter of Support

j""hjl_etter of Support
Submitter Information

""ijliLetter of Support

Submission Information

Chemical

{"" 'Chemical Identification
Information

& & Chemical 3063

-gpoiymer
Identification
Information

Monomers and
Other Reactants

""'[i^Use information

9 Site Information

Submitter Site
Identification

Document Management
Optional Cover Letter

-&> Logged in as: Jane Doe, Primary Support

Log Out

« Bona Fide (Bona Fide-20130502-13:16:43 EOT) > General Document Infoimation

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 alias may be changed at anytime.

Form Alias:

Bona Fide-20130502-13:16:43 EDT

Please check all applicable checkboxes below:

I claim the entirety of the submission as CBI. 0

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 physically 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 checkthe 'Technical Contact' checkbox below to identify a
technical contact for your submission.

Technical Contact: 0

The 'Letter of Support' screen is used to enter contact information regarding the Letter of Support
submitter who will submit information separately for the Bona Fide The email address will be used to send
the secondary submitter the unique identification number to tie the Letter of Support, completed by the
secondary submitter, to the primary Bona Fide completed by the primary submitter. Please check the
'Letter of Support' checkbox below to identify a Letter of Support submitter.

Letter of Support: 0

The 'Submitting on Behalf of Company' screen allows users to submit a Bona Fide on behalf of another



v ¦

H









Validate Save

Preview



CDX Homepage

I MyCDX Homepage | EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

Primary

Support

December 17, 2014
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CDX?

Exhibit 8-2 shows a screen capture of the 'General Document Information' screen (Scroll 2):
Exhibit 8-2: General Document Information Screen (Scroll 2)

-&> Logged in as: Jane Doe, Primary Support

Log Out

Bona Fide
Primary Support

General Document
Information

Primary Contact Information
Technical Contact Information
Statement of Intent
?" Letter of Support

i-hlLetter 0f support

Submitter Information

""ijliLetter of Support

Submission Information

Chemical

i " ": 'Chemical Identification
Information

& & Chemical 3063

-gpoiymer
Identification
Information

'"(WjMonomers and
Other Reactants

I ^ )Use Information

S Site Imfoi m.ition

Submitter Site
Identification

Document Management

' [=IOptionaI Cover Letter

Home y Foims * Resouices
Please check all applicable checkboxes below:

I claim the entirety of the submission as CBI. 0

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 physically 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 checkthe 'Technical Contact' checkbox below to identify a
technical contact for your submission.

Technical Contact: 0

The 'Letter of Support' screen is used to enter contact information regarding the Letter of Support
submitter who will submit information separately for the Bona Fide. The email address will be used to send
the secondary submitter the unique identification number to tie the Letter of Support, completed by the
secondary submitter, to the primary Bona Fide completed by the primary submitter. Please check the
'Letter of Support' checkbox below to identify a Letter of Support submitter.

Letter of Support: 0

The 'Submitting on Behalf of Company' screen allows users to submit a Bona Fide on behalf of another
company. The 'Submitting on Behalf of Company' screen presents a list of text fields which allow the input
of contact information for the company on whose behalf the submission is being made. The submitter
information entered on the 'Submitting on Behalf of Company' screen pertains to the company that will
manufacture or import the substance. Please checkthe 'Submitting on Behalf of Company' checkbox
below to identify if you are submitting on behalf of another company.

Submitting on Behalf of Company: 0

|^Ne*tJ





B

¦

¦

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Save

Preview

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions ! Privacy Notice | CDX Helpdesk: (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.

8.3 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.

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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updates. The 'Title' field on this screen is not pre-populated from CDX registration and you are
required to enter a value for this 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 will be flagged as CBI.

The following fields are captured and displayed from the primary submitter's CDX registration
information:

•	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.

•	Phone Number: Enter the primary contact's daytime U.S. phone number; dashes are not
allowed. This is a required field.

•	Phone Extension: Enter the extension to the primary contact's daytime U.S. 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.

•	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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Exhibit 8-3 shows a screen capture of the 'Primary Contact Information' screen:

Exhibit 8-3: Primary Contact Information Screen



Bona Fide

Pi jimmy Support
Bona Fide 20141205 13:19:43
EST

General Document WcrmKiofl

Primary Contact Information

Technicnl Contact Information

j"(j Statement of i«e«

8 Letter of Support

hp Lette* of Support
Sufcmtter Infermaftfefi

~|J Lena* of Support

Submission Information

S j Chemical

Chemc al IdenMlk a tor
Information

B site information

Submitter Sic
Identfc afon

Doc ument Management

OpOxiol Cover Letter

*¦ Logged in a;. Jane Doe, Primary Support

Log Out

Home J Foiitis * Resources
Bona Fide (Bona Fide-20141205-13:19:43 E ST) > Primary Contact Information

'	PRIMARY CONTACT INFORMATION

The 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 1

Mailing Address 2

City
State,

Postal Code
Country

Mrs | T

yane	'

£

Doe
Test

Test Company
1234567890

(Do rot enter »n> dashes (•) in Phone Number field above,}

jane.clb8@test.coni

123 Main Sireel	\

Street address, P.O. company nam*, etc.

Apartment, suit*, «tc»

Main

Alabama	) *

12345

United States

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CDX Homepage

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Terms and Conditions

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I CDX Helpdes* 4888)890-1995

Navigation: Click the 'Next' button to navigate to the 'Technical Contact Information' screen if
you checked the 'Technical Contact' checkbox on the 'General Document Information' screen.
You can also access this screen by clicking the 'Technical Contact Information' link within the
navigation tree. Click the 'Next' button to navigate to the 'Statement of Intent' screen if you left
the 'Technical Contact' checkbox unchecked on the 'General Document Information' screen.
You can also access this screen by clicking the 'Statement of Intent' link within the navigation
tree.

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8.4 Technical Contact Information

If you indicated on the 'General Document Information' screen that technical contact
information would be provided, then you can navigate to the 'Technical Contact Information'
screen by clicking the 'Next' button from the 'Primary Contact Information' screen. You can
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.'

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Exhibit 8-4 shows a screen capture of the 'Technical Contact Information' screen (Scroll 1):
Exhibit 8-4: Technical Contact Information Screen (Scroll 1)



Bona Fide

Primary Support
Bona Ftfe 20140515 10.10:10
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Logged in as Jane Doe, Primary Support
Log Out

4 Bona Fide (Bona Fide-2014051S 10:10:10 EOT) > Techn>caf Contact Information

TECHNICAL CONTACT INFORMATION

Please enter the information for the technical contact wtio will be responsible for providing additional
information it required

Prefix	|	1 .

First Name
Middle initial
last flame

Suffix	~| _

Title

Company Name
Phone Number

(Do not enter anv d*iH«i {-) in Phone Numb-a' fteW above.)

Phone Extension
Email Address
Mailing Address 1

Mailing Address 2

City

Street add<«*j. P.O. Pox, comae ny n»m«, etc.

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TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 8-5 shows a screen capture of the 'Technical Contact Information' screen (Scroll 2):
Exhibit 8-5: Technical Contact Information Screen (Scroll 2)

Bona Fide
Pi Hilary Support

Bona FW®-20140515-1Grl 0:10
EOT

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Last flame
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Title

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Phone Number

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Phone Extension
Email Address
Mailing Address 1

t.laiimg Address 2

Crty
State

Postal Code
Country

(D© nOt	»ny d»fh«f (-) In P*»©n# P<^mb«r abov«-,'l

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COX Homepage I MyCOXHomepage I EPA Homepage | Terms and CdriSiOons | Prvacy NGSce I CDXHelpdesk {888)890-1995

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

8.5 Statement of Intent

You can access the 'Statement of Intent' screen by clicking the 'Next' button from the 'Primary
Contact Information' if you left the 'Technical Contact' checkbox unchecked on the 'General
Document Information' screen or by clicking the 'Next' button on the 'Technical Contact
Information' screen if you checked the 'Technical Contact' checkbox on the 'General Document
Information' screen. You can also access this screen by clicking the 'Statement of Intent' link
within the navigation tree.

The 'Statement of Intent' screen requires you to indicate whether your intent is to manufacture or
import the chemical substance for which you are requesting a TSCA inventory determination
from EPA. You must indicate the activities of 'Manufacture' and/or 'Import' by checking the

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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provided checkboxes. If you indicate that you intend to manufacture the chemical substance, a
prompt to identify the 'Site of Manufacture' after clicking the 'Add Site' button on the
'Submitter Site Identification' screen will display. Similarly, if you indicate that you intend to
import the chemical substance, a prompt to identify a 'Port of Entry' after clicking the 'Add Site'
button on the 'Submitter Site Identification' screen will display.

On this screen, you are required to enter the date you expect to submit a Section 5 notification if
the result is that the chemical is not found on the inventory.

If you checked the 'I claim the entirety of the submission as CBI' checkbox on the 'General
Document Information' screen, all information entered on the 'Statement of Intent' screen will
be flagged as CBI.

•	Manufacture: Check the 'Manufacture' checkbox to indicate the chemical substance
will be manufactured. Either the 'Manufacture' or 'Import' checkbox is required to be
checked.

•	Import: Check the 'Import' checkbox to indicate the chemical substance will be
imported. Either the 'Manufacture' or 'Import' checkbox is required to be checked.

•	Date of expected Section 5 notification if the result is that the chemical is not on the
inventory: Enter the date when you are expecting to submit a Section 5 notification if the
result is that the chemical is not found on the inventory. This data can be entered in any
format (e.g. 'Quarter 1 of 2014,' '10/01/14'). This is a required field.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 8-6 shows a screen capture of the 'Statement of Intent' screen:

Exhibit 8-6: Statement of Intent Screen

Bona Fide
Primaiy Support

General Document Information

Primary Contact Information

f"[5 Technical Contact Information

jQstatement of Intent

5 _ Lettei of Suppoit

i"" Letter of Support
Submitter Information

Letter of Support
Submission Information

B" _ Chemical

;..„[^|Chemical Identification

Information
$ & Chemical 3063

I r^\

| Ml ^ [Polymer

| | Identification

Information
I :p|f"lMonomers and
Other Reactants

I '""P^IUse Information

01	iSile Information

Submitter Site
Identification

'[fflDocument Management

Optional Cover Letter

Home J Forms * Resources
4 Bona Fide (Bona FKIe-20130502-13:16:43 EDT) > Statement of Intent

•*- Logged in as: Jane Doe, Primary Support

Log Out



STATEMENT OF INTENT

Please select whether you intend to manufacture and/or import the chemical.

Manufacture: ~

Import:	~

Date of expected Section 5 notification if the result is that the chemical is not on the inventory.

|^NextJ



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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 'Letter of Support Submitter Information'
screen if you checked the 'Letter of Support' checkbox on the 'General Document Information'
screen. You can also access this screen by clicking the 'Letter of Support Submitter Information'
link within the navigation tree.

8.6 Letter of Support Submitter Information

You can access the 'Letter of Support Submitter Information' screen by clicking the 'Next'
button from the ' Statement of Intent' screen if you selected the 'Letter of Support' checkbox on
the 'General Document Information' screen. You can also access this screen by clicking the
'Letter of Support Submitter Information' link within the navigation tree.

The 'Letter of Support Submitter Information' screen is used to enter contact information
regarding the Letter of Support submitter who will provide additional, separate information
regarding the Bona Fide form. The email address provided for the Letter of Support submitter

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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will be used to send the unique identification number, which is used to link the primary and
secondary submissions, to the Letter of Support submitter.

If you checked the 'I claim the entirety of the submission as CBI' checkbox on the 'General
Document Information' screen, all information entered on the 'Letter of Support Submitter
Information' screen will be flagged as CBI.

•	Prefix: Select the Letter of Support submitter's prefix from the drop-down menu.

•	First Name: Enter the Letter of Support submitter's first name. This is a required field.

•	Middle Initial: Enter the Letter of Support submitter's middle initial.

•	Last Name: Enter the Letter of Support submitter's last name. This is a required field.

•	Suffix: Select the Letter of Support submitter's suffix from the drop-down menu.

•	Title: Enter the Letter of Support submitter's job title.

•	Company Name: Enter the Letter of Support submitter's company name. This is a required
field.

•	Phone Number: Enter the Letter of Support submitter's U.S. or international daytime phone
number; dashes are not allowed. This is a required field.

•	Phone Extension: Enter the Letter of Support submitter's U.S. or international daytime
phone number extension.

•	Email Address: Enter the Letter of Support submitter'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 Letter of Support submitter's mailing address.
This is a required field.

•	Mailing Address 2: Enter the second line of the Letter of Support submitter's mailing
address.

•	City: Enter the city of the Letter of Support submitter's mailing address. This is a required
field.

•	State: Select the state of the Letter of Support submitter's mailing address from the drop-
down menu. This is a required field when the 'Country' field is identified as 'United States.'

•	Postal Code: Enter the postal code of the Letter of Support submitter's mailing address. This
is a required field.

•	Country: Select the country of the Letter of Support submitter's mailing address from the
drop-down menu. This is a required field.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 8-7 shows a screen capture of the 'Letter of Support Submitter Information' screen:
Exhibit 8-7: Letter of Support Submitter information Screen

Bona Fide

Primary Author tied Official

Bona FkJe-2014120248:57:56
EST

|p J G«walOocurrtentlflfOfmiBtoft

hp Prlnwy Contact information

Technical Cofflact Information

|Hj SiaEement of intent

S Letter of Support

letter of Support
Submitter Information

4_ Letterof Support

SubmisBen Information

S _ Chemical

ChemeaJ Identic a ton
hiformstcr;

S Site Information

Submitter See
toentlfieajiwi

Document Management
Qfrttonal Cover Letter

Lagged In as Jane Doe, Primary Support
Log Out

Hmne y Forms ™ Resources
Borva Fjcte (Bona Fide.201412024>8:57:56 EST) > Letter of Support Submitter information

LETTER OF SUPPORT SUBMITTER INFORMATION

Please enter (tie contact information for the Letter of Support submitter who will be completing the Letter
of Support.

Prefix	I I "

First Name:

Middle initial
Last Name:

Suffix:	I I r

Title:

Company Name
Phone Number-

(Oo not enter iny	(-) fcn Phcr* Number field above.)

Phone Extension.

Email Address
Mailing Address 1.

Mailing Address 2:

City
State:

Postal Code
Country:

Street addrus* P.O. box. p*nY neme. ete.

Apartment- lu-ite etc.

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CDX Horoepase | MyCDX Homepage i EPAHomeeaje | Terms ana Conditions | Prtvscy Notice | CDXH«iptlesk (388) 890-1995

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

8.7 Letter of Support Submission Information

You can access the 'Letter of Support Submission Information' screen by clicking the 'Next'
button from the 'Letter of Support Submitter Information' screen. You can also access this
screen by clicking the 'Letter of Support Submission Information' link within the navigation
tree.

The 'Letter of Support Submission Information' screen is used as a communication point
between two companies. The 'Letter of Support Submission Information' screen displays a
comment box for you to enter information that will be passed on to the Letter of Support

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submitter. A text field will be used to send information to the Letter of Support submitter in an
email sent by the primary submitter. A 'Unique Identification Number for Letter of Support
Submissions' box will also display on this screen. The unique identification number is generated
when you declare a Letter of Support submission is being established.

Letter of Support Submission Process: When you designate that a Letter of Support
submission is being filed, you will be asked to enter all the information within the 'Letter of
Support Submission' folder. The forms from the primary submitter will be linked, but not
combined by the system.

When the primary submitter chooses to notify the Letter of Support submitter of the unique
identification number, the system will send an email to the Letter of Support submitter
designated on the 'Letter of Support Submitter Information' screen. The email will contain the
'Unique Identifier Number' that will link the two forms.

When the Letter of Support submitter accesses the 'Section 5 Notices and Supports Forms'
screen and creates a form to be filed, the user will be prompted to enter the unique identification
number on the 'Create Passphrase' screen. Once the unique identification number has been
entered, the system will link the primary and Letter of Support forms. You may add additional
Letters of Supports by clicking the 'Add Letter of Support' link within the navigation tree.

•	Letter of Support Submission Information Instructions: Enter the information that the
Primary AO is sending to the Letter of Support submitter.

•	Letter of Support Submission Informational Text: Displays instructional text provided by
OPPT, the unique identifier number generated for the form, and allows you to email the
unique identifier number to the Letter of Support submitter by clicking the 'Notify the
Secondary Submitter of the letter of support submission' link.

•	Unique Identification Number: The unique identification number is a random number auto-
generated to pass on to the Letter of Support submitter to create a Letter of Support
submission.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 8-8 shows a screen capture of the 'Letter of Support Submission Information' screen:
Exhibit 8-8: Letter of Support Submission Information Screen

Logged in as: Jarie Doe, Primary Support
Log Out

Bona Fide
Piinmiy Support

General Document Information

'"byPrimary Contact Information

"Technical Contact Information

Statement of Intent

Letter of Support

< Bona Fide (Bona Fide-20130502-13:16:43 EOT) > Letter of Support Submission Information

LETTER OF SUPPORT SUBMISSION INFORMATION

Please include instructions you wish the Letter of Support submitter to see.
Clicking the link below will relay the information in this text box to your Letter of
Support submitter via unencrypted e-mail

Letter of Support
Submitter Information

IjjLetter of Support
Submission
Information

B Chemical

Chemical Identification
Information

$ JLChemical 3063

'"[f iPolymer
Identification
Information

M? iMonomers and
Other Reactants

''ffJUse Information

Site lufoi niation

Submitter Site
Identification

Document Management

Optional Cover Letter

Unique Identifier for Letter of Support Submission: 8b2ec120-ccfa-4c5d-
94c4-8ac7fda566f9

This is the unique identification number for your joint submitter. Notify the
Secondary Submitter of the letter of support submission.

The Secondary Submitter will need this identification number to complete the
form. It is your responsibility to ensure that your secondary submitter
understands how to complete the Bona Fide form and sends the information to
EPA by the end of the submission period. The information collected in the
primary and secondary form(s) will be linked by the unique identifier. The form
will not undergo a review process until all forms have been received.

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Navigation: Click the 'Notify the Secondary Submitter of the letter of support submission' link
to access the 'Unique Identifier Notification' pop-up window. Click the 'Next' button to navigate
to the 'Chemical Identification Information' screen. You can also access the 'Chemical
Identification' screen by clicking the 'Chemical Identification' link within the navigation tree.

8.7.1 Notify Secondary Submitter of Letter of Support Information

You can access the 'Unique Identifier Notification' window by clicking the 'Notify the
Secondary Submitter of the letter of support submission' link from the 'Letter of Support
Submission Information' screen.

The ' Unique Identifier Notification' window is used to notify the Secondary Submitter of the
'Unique Identifier Number.' The 'Unique Identifier Notification' screen displays a 'CC' field for

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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you to add other email addresses to the notification (including the original submitter), a 'To'
field, and an 'Additional Comments' text box.

•	From: Displays the email address of the Primary AO that created the form.

•	CC: Contains instructional text for a user to enter multiple email addresses. This will
automatically populate with the email address of the Primary AO, and the email address of
the technical contact.

•	To: Contains the editable email address of the Letter of Support submitter specified on the
'Letter of Support Submitter Information' screen; this email address will be automatically
populated upon navigating to the window.

•	Subject: Displays 'YYYYBona Fide.'

•	Message: Displays a pre-determined message in the email sent to a Letter of Support
submitter.

•	Additional Comments: Enter any other additional comments or instructions to be passed
onto the Letter of Support submitter.

•	Send: Click the 'Send' button to generate and send the email to the email addresses
identified in the 'CC' and 'To' fields.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 8-9 shows a screen capture of the 'Unique Identifier Notification' pop-up window:
Exhibit 8-9: Unique Identifier Notification Pop-Up Window

c^CSPP

From:

CC:

To:

Jane.Doe@test.com

{ane.doe@test.com





/,

Enter email addresses separated by semicolons (;) or
commas (.). Click in this box to start entering email
addresses.

Subject:	2014 Bona Fide

Message:	As the Authorized Official of TESTORGCGI1.1 have

identified you as a Secondary Submitter of a letter of
support submission for this 2014 Bona Fide form.
Please use the Section 5 Notices and Supports
application to provide the correct information for the
necessary items in this form. See the instructions
below for accessing the Section 5 Notices and
Supports application. You will need to use the unique
identification number to access and complete the Bona
Fide form for the letter of support submission.

Unique Identifier a89f9a97-f706-4aa1-a3bc-
69ad4967786d

Information about the Section 5 programs, how to
access the Section 5 Notices and Supports application,
and instructions for reporting under the Section 5 rule
are available at www.epa.aov/oppt/newchems/. For
additional information or if you believe you have
received this email in error, please contact me.

Additional Comments:

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Navigation: Click the 'Send' button to send the email to the Letter of Support submitter and
navigate back to the 'Letter of Support Submission Information' screen. Click the 'X' button in
the upper right-hand corner to cancel the unique identifier notification process.

8.8 Chemical Identification Information

You can access the 'Chemical Identification Information' screen by clicking the 'Next' button
from the 'Statement of Intent' screen if you left the 'Letter of Support' checkbox unchecked on
the 'General Document Information' screen. You can also access the 'Chemical Identification
Information' screen from the 'Letter of Support Submission Information' screen if you checked
the 'Letter of Support' checkbox on the 'General Document 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 be entering into the application. You will be able to file a Bona Fide form for a class 1 or
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. The
chemical alias is required if a Letter of Support is being filed.

•	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 a notification
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 a notification 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. This is a required
field only if a Letter of Support is being filed.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 8-10 shows a screen capture of the 'Chemical Identification Information' screen (Class 1
or 2 Chemical Substance):

Exhibit 8-10: Chemical Identification Information Screen (Class 1 or 2 Chemical

Substance)

¦ Logged in as: Jane Doe, Primary Support
Log Out

Bona Fide
Pi imaiy Support

General Document Information

Primary Contact Information

[j Technical Contact Information

[Statement of Intent

@"i_ Letter of Support

i "1 ^ [Letter of Support
! Submitter Information

i ""1=[Letter of Support

Submission Information

B" Chemical

j"U Chemical Identification
Information
&Chemical 41435

rf^JCIass 1 or 2
Chemical
Substances
Use Information
S'	Site Information

"'2 Submitter Site
Identification

"pjDocument Management

JOptional Cover Letter

4 Bona Fide (Bona Fkle-20130502-13:16:43 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.

#

® Class 1 or 2 Chemical Substance

Chemical Alias:

O Polymer

The chemical alias is an optional field that changes the folder name in the navigation tree on the left-hand
side of the screen.

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Navigation: If you selected the 'Class 1 or 2/Biotechnology Chemical Substance' radio button,
click the 'Next' button to navigate to the 'Class 1 or 2/Biotechnology Chemical Substances'
screen. If you selected the 'Polymer' radio button, click the 'Next' button to navigate to the
'Polymer Identification Information' screen.

8.9 Class 1 or 2/Biotechnology Chemical Substances

If you selected the 'Class 1 or 2/Biotechnology Chemical Substance' radio button, click the
'Next' button to navigate to the 'Class 1 or 2/Biotechnology Chemical Substances' screen.

The 'Class 1 or 2/Biotechnology Chemical Substances' screen provides fields for you to enter
information describing the chemical for the Bona Fide which is to be filed, including its name,
composition, and structure.

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You can add a chemical component by clicking the 'Add New Chemical' button. Upon clicking
the 'Add New Chemical' button, an expandable/collapsible field set generates that contains
numerous fields to identify the chemical in question. You will be able to enter multiple chemical
substances, each with unique information, by clicking the 'Add New Chemical' button for each
chemical substance you wish to identify.

After the document(s) is/are attached and you have clicked the 'OK' button, the 'Attach
Chemical Structure' pop-up window closes and the document information will be displayed in a
table format on the 'Class 1 or 2/Biotechnology Chemical Substances' screen. The attachment
table displays the file name of the document and user-provided description of the document. The
system allows you to delete unwanted documents by clicking the 'Delete' icon ( *) located
under the 'Actions' column. To access or edit previously attached documents, click the
appropriate file name of the document within the 'File Name' column of the attachment table.

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.

•	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.

•	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 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 link located at the upper right-hand corner 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 a '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

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selected chemical by clicking the 'OK' button located at the bottom of the 'Add Chemical ID'
window.

•	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.

•	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
will close and the document information will be displayed 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 (K) 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.

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

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Exhibit 8-11 shows a screen capture of the 'Class 1 or 2/Biotechnology Chemical Substances'
screen:

Exhibit 8-11: Class 1 or 2 Chemical/Biotechnology Chemical Substances Screen

* Logged in as Jane Doe, Primary Support

Log Out

4 Bona Fide (Bona Fide-20141128-14:19:27 EST) > Class 1 or 2'Bioiechnolooy Chemical Substances

CLASS 1 OR 2/BIOTECHNOLOGY CHEMICAL SUBSTANCES

Bona Fide
Primary Support

General Document information

Primary Ccriad frrf«mat»o

Technical Cortact IntonrwHion

S1 sterner* oi Wert

Letter of Support

Letter or Sc^>po«1
Submitter information

Letter or Support
SufcwrissiDn information

Class 1 or 2/Biotechnology Chemical Substances
Chemical Identification Information

Expand All | Collapse All
Cancel X

Class of Substance

Class i Class 2/Biotechnology

Click the button below to search EPA's Substance Registry Services (SRS) for the desired chemical
Add Chemical ID

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CASRN

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ID Method

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Method 2 (Other Method)

Attach IES Report

File Name	Description

Molecular Formula (optional)

Chemical Structure Diagram (optional)
include an attachment for the chemical structure diagram below
Attach Chemical Structure

Actions

File Name

Description

Actions

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



Previous



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Submit

CDXHomeoaoe I MyCDX Horoepaoe I EPAHomepaae I Terms and Conditions I Privacy Notice I CDXBelodesk (888) 890-1995

Navigation: If you selected the 'Class 1' radio button, 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. If you selected 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.

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8.10 Class 2/Biotechnology Substances

You can navigate to the 'Class 2/Biotechnology Substances' screen by clicking the 'Next' button
from the 'Class 1 or 2/Biotechnology Chemical Substances' screen when you select the 'Class
2/Biotechnology' radio button. You can also access this screen by clicking the 'Save' icon ( )
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 3.7 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 8-12 shows a screen capture of the 'Class 2/Biotechnology Substances' screen (Scroll 1):
Exhibit 8-12: Class 2/Biotechnology Substances Screen (Scroll 1)

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Bona Fide
Priii wi y Support

General Oocumert Information

Primary Contact Information

Technical Cortaet yrfOrtMBon

Statement o» mtert

Lettei of Support

Letter of Support
Siismitter Infer mabon

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< Bona Fl Class 2 Substances

CLASS 2/BIOTECHNOLOGY SUBSTANCES
Class 2'Biotechnology Substance Details

Fill In below for a class biotechnology substance, (1) List me Immediate precursor substances 'Aim ifteir
respective cas Regisiry numbers (2) Describe the nature of me reaction or process (3) indicate me
range of composition (where appropriate)

Precursor Substances

jseaichSRS; Click the Search SRS button on the left to search or enter a precursor substance
Chemical Name	CASRN	Actions

Nature of Reaction

Range of Composition (Optional)

Optional Attachments
Attoclk Document





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Exhibit 8-13 shows a screen capture of the 'Class 2/Biotechnology Substances' screen (Scroll 2):
Exhibit 8-13: Class 2/Biotechnology Substances Screen (Scroll 2)

Bona Fide
Primary Support

General Document Information

"{§ 'Primary Contact Information

Technical Contact Information

Statement of Intent

_ Letter of Support

i""Fjl_etter of Support
Submitter Information

""'[^Letter of Support

Submission Information

Chemical Identification
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composition and the typical composition (where appropriate).

Precursor Substances

A Logged in as: Jane Doe, Primary Support

Log Out

Search SRSi Click the Search SRS button on the left to search or enter a precursor substance.

Chemical Name

CASRN

Actions

Nature of Reaction

Range of Composition (Optional!

Optional Attachments
Attach Document

File Name

Description

Actions

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CDX Homepage |

| MyCDX Homepage |

| EPA Homepage | Terms and Conditions |

Privacy Notice |

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.

8.11 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.

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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
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.

•	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.

•	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-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.

•	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.

•	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

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chemical substance using the 'Add Chemical ID' search or manually enter the chemical
information in the 'Add Chemical ID' pop-up.

•	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.

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

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 8-14 shows a screen capture of the 'Polymer Identification Information' screen:
Exhibit 8-14: Polymer Identification Information Screen



Bona Fide

Primaiy Support

General Document Inlormation

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< Bona FM« (Bona Rde-20130502-1 J;(6:43 EDTi > Polymei Mentifie.itl«n Information

POLYMER IDENTIFICATION INFORMATION

Click the button befowto add a substance to this document
Add Chemical ID

CASRN;

Chemical Name:

ID Method

© Method 1 (CAS inventory Expert Service)
Attach [ES Report

File Name

O Method 2 (Other Method)

Description

Chemical Structure Diagram (optional):

include an attachment tor the chemical structure diagram below.

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CDX Homepage

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EPA Homepage | Terms and Conditions |

Privacy Notice I

CDX Helpdesk (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.

8.12 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 'Monomers and Other Reactants' screen has an 'Add
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.

•	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.

•	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-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.

•	Search SRS: Click the 'Search SRS' button to generate the 'Search Substance Registry
Services' pop-up window. Refer to Section 3.8 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.

•	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

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to navigate away from the screen using the 'Previous' and 'Next' buttons. Refer to Section
3.6 for more information regarding the save functionality in an expandable/collapsible field
set.

•	Attach Document: Click the 'Attach Document' button to generate 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 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.

•	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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 8-15 shows a screen capture of the 'Monomers and Other Reactants' screen:
Exhibit 8-15: Monomers and Other Reactants Screen

Home y Forms y Resources

Logged in as Jane Doe, Primary Support
Log Out

Bona Fide
Primary Support

General Document Information

JPrimary Contact Information

Technical Contact Information

Statement of Intent

B"i	(Letter of Support

M,Letter of Support
Submitter Information

'"I ^Letter of Support
Submission Information

E! Chemical

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Optional Cover Letter

4 Bona Fide (Bona Fide-20130502-13:16:43 EOT) > Monomers and Other Reactants

MONOMERS AND OTHER REACTANTS

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

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

Typical Composition:

~

Save

Click to add a monomer |Add Monomer

Composition Total:0.0%

Optional Attachments
Attach Document

File Name

Description

Actions



Upload XML



Validate

Save

Preview

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | 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.

8.13 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 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 8-16 shows a screen capture of the 'Use Information' screen:

Exhibit 8-16: Use Information Screen

Bona Fide
Primary Support

j""l General Document Information

Primary Contact Information

I " j ^ [Technical Contact Information

^Statement of Intent

B Letter of Support

Letter of Support
Submitter Information

Letter of Support
Submission Information

S"i Chemical

Chemical Identification
Information
$ & Chemical 41490

I Polymer
Identification
Information
"I Monomers and
Other Reactants
Use Information
0 Site Information

Submitter Site
Identification

Document Management

Optional Cover Letter

Home y Forms y Resources
« Bona Fide (Bona Fide-20130502-13:16:43 EDT) > Use Information

USE INFORMATION

How will the substance be used?

Logged in as: Jane Doe, Primary Support
Log Out

Previous

j^NexJ



Si

	]

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Preview

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

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

8.14 Submitter Site Identification

You can navigate to the 'Submitter Site Identification' screen by clicking the 'Next' button from
the 'Use Information' screen. You can also access this screen by clicking the 'Submitter Site
Identification' link within the navigation tree.

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The 'Submitter Site Identification' screen captures information about the identification of the
sites of manufacture and/or the port of entry. A screen captures specific data for the site of
manufacture and/or port of entry by allowing you to identify sites based on sites with which you
are registered. The system requires you to select from the 'Site of Manufacture or Import' drop-
down menu when both the 'Manufacture' and 'Import' checkboxes are checked on the
'Statement of Intent' screen. List all of the sites of manufacture and/or the ports of entry that are
controlled by the submitter on this screen; at least one site is required.

•	Add Site: Click the 'Add Site' button to display the 'Add Site' pop-up window. Refer to
Section 3.11 for additional details regarding the add site functionality.

•	EPA Registry ID: Displays the EPA Registry ID of the site and/or port.

•	Site of Manufacture or Port of Entry: Displays the site of manufacture or port of entry
depending on the checkbox (es) the user checks on the 'Statement of Intent' screen. This is a
required field if the checkboxes were checked.

•	Site Name: Displays the site name of the site or port. This is a required field.

•	Address: Displays the address of the site or port. This is a required field.

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

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Exhibit 8-17 shows a screen capture of the 'Submitter Site Identification' screen:
Exhibit 8-17: Submitter Site Identification Screen



Bona Fide
Primary Support

General Document inlormation

Primary Contact Womtaban

Technical Contact informatics

Statement o» Intent

Letter ot Support

Letter of Support
Submitter iniormalton

Letter of Supped
Siixntssaon hformabon

B chemical

Chemical Wertrftcatoon
informofikxi

S &Chemicdi 4149*

Polymer
Wertiftcatien
Informalton
MorwmerSflod
Other Re-aetarts
Us# intormation
Site liifoi rnation

SiilniMttei Site
ktentifkatiorv

Document Manegemert

Oattonal'Cover Letter

. Logged In as: Jane Doe. Primary Support

Log Out

4 BoiiaFMo (Bona Fiile-20130502 13:16:43 EOT SiilHniltei Site Ideiilitic.ition

SUBMITTER SITE IDENTIFICATION

Site of Manufacture or Port of Entry:

Please identify a site for reporting or port of entry.

Add site

List of Submitter Sites

EPA Registry 10 Site of

Site Name

Address

Actions

Manufacture







or Port of Entry







Previous

| Next |



5

in



Validate

Save

Preview

CDXHomepage | MyCOXHomepage | EPAHomepage I Teims and Conditions I PmracyNotice | CDXHelpdesk:<88S)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.

8.15 Document Management

You can navigate to the 'Document Management' screen by clicking the 'Next' button from the
'Submitter Site Identification' 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
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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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•	Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window to upload documents. Refer to Section 3.7 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.

Exhibit 8-18 shows a screen capture of the 'Document Management' screen:

Exhibit 8-18: Document Management Screen

ms.RB	

~ Forms T

Bona Fide	< Bona Fide (Bona Fitle-20130502-13:16:43EDT)> Document Management

DOCUMENT MANAGEMENT

General Document lnformatior|Aj
Primary Contact Information
Technical Contact Information

•*> Logged in as: Jane Doe, Primary Support

Log Out

B

Please attach at least one of each of the following documents:

"^ Statement of Intent
Letter of Support

[Letter of Support
Submitter Information
Letter of Support
Submission Information

B Chemical

ri=[Chemical Identification
Information

5 & Chemical 41490

"F"|Folymer
Identification
Information

Monomers and
Other Reactants

""Qllse Information

? _ Site Information

'"[fjSubmitter Site
Identification

[~Document
Management

[Optional Cover Letter

•	Spectrum of Substance: Infrared spectrum or alternative spectra or other data which identify the
substance.

•	Statement of Commercialization: 1) A brief statement indicating how long the substance has been in
commercial use outside of the United States. 2) The name of a country in which it has been commercially
used. 3) Whether the importer believes that the substance has already been used commercially, in any
country, for the same purpose or application that 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 documents.

Attach Document

Document Name

Document Type

Action

j^NexJ

>/

Q

~

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Preview

CDX Homepage

MyCDX Homepage

EPA Homepage | Terms and Conditions | 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.

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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8.16 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.

• Optional Cover Letter: Enter any additional special instructions regarding the form.
Exhibit 8-19 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 8-19: Optional Cover Letter Screen

T

* Logged in as: Jane Doe, Primary Support

Log Out

Bona Fide
Primary Support

j""[f iGeneral Document Information

r-r Primary Contact Information

j""p Technical Contact Information

!""[ 7 [Statement of Intent

If" Lettei of Support

Letter of Support
i Submitter Information

Letter of Support
Submission Information

El _ Chemical

|""l5 iChemical Identification
Information

$ & Chemical 41490

Polymer
Identification
Information
ffi[i Monomers and
Other Reactants
Use Information
?"i	;Site Information

'"[f Submitter Site
Identification

j""[^|Document Management

Optional Cover Lettei

4 Bona Fide (Bona Fi(le-20130502-13:16:43 EDT) > Optional Cover Letter

OPTIONAL COVER LETTER

If you would like to include a cover letter, please use the space below.

Previous



B

i	j

¦



Validate

Save

Preview

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

Navigation: Click the 'Validate icon e ) located in the bottom action bar to validate the form.
Click the 'Save' icon ( Q) located in the bottom action bar to save the overall form. Click the
'Preview' icon ( ) located in the bottom action bar to view a PDF preview of the form.

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9 Edit Alternative Control Measures (ACM) Form

The Section 5 Notices and Supports application allows alternative control measures (ACM)
forms to be submitted. The ACM form is used to report proposed Alternative Control Measures
for published significant new use rules (SNURs).

9.1	Edit ACM Form

To edit an ACM form, navigate to the 'Section 5 Notices and Supports Forms' screen and click
the alias link in the 'Alias' column of an ACM 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 3.4 for additional details regarding the enter passphrase process.

9.2	Contact Information

You can access the 'Contact Information' screen by entering a passphrase in the 'Enter
Passphrase' screen.

The 'Contact Information' screen provides an 'Add Contact' button and a contact information
table for you to identify a point of contact who is working for a U.S. based company.

Please note that if you using IE 7 to view this screen, the 'Form Alias' text field label is
displayed within the form alias at the top of the screen.

•	Form Alias: Enter a custom alias to differentiate the ACM 721.30 form, if applicable. The
system auto-generates a default alias consisting of the form type and date stamp in the
following format: . The form alias is
an editable field that may be changed at any time. This is a required field.

•	Add Contact: Click the button to display the 'Add Contact' window, for you to enter
information for a point of contact. At least one contact is required.

•	Last Name: Displays the last name of the contact identified on the 'Add Contact' pop-up
window.

•	First Name: Displays the first name of the contact identified on the 'Add Contact' pop-up
window.

•	Address: Displays the mailing address of the contact identified on the 'Add Contact' pop-up
window.

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

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

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Exhibit 9-1 shows a screen capture of the 'Contact Information' screen:

Exhibit 9-1: Contact Information Screen

Home ~ Forms T Resources

A Logged in as: Jane Doe, Primary Support

Log Out

ACM
Primary Support
ACM-20130520-16:42:43 EDT
! {^Contact Information

""[^1 Attachments

ACM (ACM-20130520-16:42:43 EDT) > Contact Information

CONTACT INFORMATION

You may enter an alias for easier form identification or the system will provide a time stamp.
Form Alias:	ACM-20130520-1 6:42:43 EDT

0

To add a new Contact clickthe Add Contact button. Add Contact

Last Name

First Name

Address	CBI	Actions

Next





-/ a

Validate Save

Preview





CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8?

58) 890-1995

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

9.2.1 Add Contact

You can access the 'Add Contact' pop-up window by clicking the 'Add Contact' button on the
'Contact Information' screen.

The 'Add Contact' pop-up window displays fields for you to enter information regarding the
point of contact.

Please note that if you are using IE 7 to view this pop-up window, the 'Copy CDX Registration'
button and 'Help' button are misaligned.

•	Click here to copy your information from 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.

•	Check here to claim this information as CBI: Check the 'CBI' checkbox to claim the
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 screen after copying CDX registration information. To claim a contact
as confidential, check the 'CBI' checkbox after importing CDX registration information.

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•	First Name: Enter the contact's first name. If you have clicked the 'Copy CDX Registration'
button, the fields populate with information entered during CDX registration. This is a
required field.

•	Last Name: Enter the contact's last name. If you have clicked the 'Copy CDX Registration'
button, the fields populate with information entered during CDX registration. This is a
required field.

•	Company Name: Enter the contact's company name. If you have clicked the 'Copy CDX
Registration' button, the fields populate with information entered during CDX registration.
This is a required field.

•	Phone Number: Enter the contact's daytime phone number; dashes are not allowed. If you
have clicked the 'Copy CDX Registration' button, the fields populate with information
entered during CDX registration. This is a required field.

•	Phone Extension: Enter the contact's phone number extension, if applicable.

•	Email Address: Enter the contact's email address. The email address must follow the
standard email address format: John.Doe@abc.com. If you have clicked the 'Copy CDX
Registration' button, the fields populate with information entered during CDX registration.
This is a required field.

•	Mailing Address 1: Enter the first line of the contact's mailing address. If you have clicked
the 'Copy CDX Registration' button, the fields populate with information entered during
CDX registration. This is a required field.

•	Mailing Address 2: Enter the second line of the contact's mailing address. If you have
clicked the 'Copy CDX Registration' button, the fields populate with information entered
during CDX registration.

•	City: Enter the contact's U.S. city of the mailing address. If you have clicked the 'Copy
CDX Registration' button, the fields populate with information entered during CDX
registration. This is a required field.

•	State: Select the state of the contact's mailing address from the drop-down menu. If you
have clicked the 'Copy CDX Registration' button, the fields populate with information
entered during CDX registration. This is a required field.

•	Postal Code: Enter the postal code of the contact's mailing address. If you have clicked the
'Copy CDX Registration' button, the fields populate with information entered during CDX
registration. This is a required field.

•	Country: Displays 'United States.'

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Exhibit 9-2 shows a screen capture of the 'Add Contact' pop-up window:

Exhibit 9-2: Add Contact Pop-Up Window

£ CSPP

»®

ADD CONTACT

Please enter the information for the contacts who will be responsible for supporting the information on
the form. For multiple contacts, click the Add Contact button to populate a table with multiple contacts.
Check to claim information as CBI or to populate from CDX (if applicable).

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

First Name
Last Name
Company Name:
Phone Number:

Phone Extension:
Email Address
Mailing Address 1:

Mailing Address 2.

City:

State:

Postal Code.
Country:

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

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

Apartment, suite, etc.

United States

Cancel

Navigation: Click the 'Cancel' button or the 'X' icon to stop populating contact information.
Click the 'OK' button to save the entered contact information and navigate back to the 'Contact
Information' screen.

9.3 Attachments

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

The 'Attachments' screen provides an 'Attach Document' button for you to upload
documentation that fulfills the specified requirements, and a text field to provide the 40 CFR 721
citation to which the documentation refers.

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•	Attach Document: Click the 'Attach Document' button to attach documents that fulfill the
outlined requirements in the instructional text. At least one document is required. Refer to
Section 3.7 for additional information regarding the attach document functionality.

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

•	Description: Displays the description of a document uploaded on the 'Attach Documents'
pop-up window.

•	Pages: Displays the number of pages a document uploaded on the 'Attach Documents' pop-
up window contains.

•	Date: Displays the date that a document was uploaded on the 'Attach Documents' pop-up
window.

•	CBI: Indicates the CBI status of a document uploaded on the 'Attach Documents' pop-up
window by displaying either a ' Y' or an 'N.'

•	Action: Click the 'Delete' icon ( *£) to remove the attached document row. A warning
message displays to confirm deletion of the document.

•	ACM Citation at 40 CFR 721: Enter the ACM citation reference that the uploaded
documents support. This field allows up to seven (7) numeric characters; letters or other
characters are not allowed. This is a required field.

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Exhibit 9-3 shows a screen capture of the 'Attachments' screen:

Exhibit 9-3: Attachments Screen

ACM
Primary Support

ACM-20130520-16:42:43 EDT

Contact Information
'""V Attachments

Home y Forms J Resources
ACM {ACM-20130520-16:42:43 EDT) > Attachments

••• Logged In as. Jane Doe, Primary Support

Log Out

ATTACHMENTS

Please remember to upload documentation that fulfills the following requirements:
1) The specific chemical identity of the substance.



2) A detailed description of the activities involved.

3) The specifications of the alternative worker exposure control measures or environmental release control
measures.

4)	An analysis justifying why such alternative control measures provide substantially the same degree of
protection as the specific control measures identified which pertain to the substance for which the request
is being submitted.

5)	The data and information described in 720.50 (a) and (b) of this chapter unless such data and
information have already been submitted to the Office of Pollution Prevention and Toxics, EPA.

Attach Document

File Name	Description	Pages	Date CBi Action

Please provide the specific section in subpart E to which the proposed Alternative Control Measure refers.
ACM Citation at 40 CFR 721:

Previous







Validate

a

Save

Preview



CDX Homepage !

| MyCDX Homepage ]

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Validate icon e ) in the bottom action bar to validate the form. Click
the 'Save' icon ( ) located in the bottom action bar to save the overall form. Click the
'Preview' icon ( ) located in the bottom action bar to view a PDF preview of the form.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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10 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide

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Exhibit 10-1 shows a screen capture for the 'Preview' of the Biotechnology form:
Exhibit 10-1: Preview Biotechnology Form Screen

Biotechnology

Primary Support
Biotechnology- 20130114

General Form InfOrmflticri

S John Submission

£ Joint Submission 1

Jont Sutsralta
Information

Joint Sufc*niss«r*
Srtfofmation

Xffcmove

Add JoW Submission

~ Lettei Of Support

-^iLetter o* Support 1

letter ot Support

Submtler

Information

Letter ot Support

Submission

Infonmaton

X Remove

Add Letter Ot Support
Technical Contact Wowrtten
Opl tonal Cover Letter

Home J Fomis j Resouices

* Logged in as Jane Doe, Primary Support

Log Out

PREVIEW EPMN FORM

Please choose a Regular or Sanitized PDF

FuB Version Sanrti zed Version

Note: it you maKe no CBI claims me two versions win be me same

•V ¦ B

Validate Save Preview

CDXHomepage [ MyCDXHomepage | EPA Homepage | Terms arid Conditions | P rivscy Nottc e | CDX Helpdesk: (888)890-1995

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide
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Exhibit 10-2 shows a screen capture for the 'Preview' of the Biotechnology form:

Exhibit 10-2: Preview Biotechnology Form PDF

niwiiiiiiiiiiiiiiii

B:O20'.4P1

BI02D14P1

Form Approved. O.M.B. Nos. 2D70-0D12 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)

TDD 9.21 OPPT MTS Section 5 Notices arid Supports User Guide

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Exhibit 10-3 shows a screen capture for the 'Preview' of the NOC form:

Exhibit 10-3: Preview NOC Form PDF

Form Approved. O.M.6. No. 207D-0012

CBI SUBMISSION

U.S. Environmental Protection Agency
CD A NOTICE OF COMMENCEMENT OF
t rn MANUFACTURE OR IMPORT (40CFR67M.1C2)

Report Number

Part I - SUBMITTER IDENTIFICATION

Doaasent Control 3:

Manu-
facturer/
Importer

(in U.S.)

Name of Authorized Official

Mailing Address {number and street)

CBI*

(first) (last)



Company Name

City

State

Zip











Technical
Contact
(in U.S.)

Name

Telephone Number



{first) (last)



Part II - Premanufacture Notice (PMN) "P" Case Number:

Part III - Check the appropriate box and provide the exact date of manufacture or importation:

First Commercial Manufacture*

First Commercial Importation"

Date:

Date:

"Date of commencement Is tfe date of corrpieSton of non-exempt manufacture of "tie first amount ibatfc, drum, etc.)
"Tor Irnportees, trie date of commencement is the date tfta* the new chemical Budstance clears U.S. eussoois.

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





Part V - Specific Chemical Identity: {For Consolidated sufcm ssions, each substance must have a separate NOC form wth the specify

identity of eg0Mithei^^[su^bnce.)



	



Part VI - Generic Chemical Name (if shem-cai ^entity is claimed cbi"):

	

Part VII - Substance Identity Confidentiality Status:

5 wish to continue to claim the substance identity confidential and the substantiation to support th;s claim is attached. Failure to submit
the re
-------
CDY~

Exhibit 10-4 shows a screen capture for the 'Preview' of the Support form:

Exhibit 10-4: Preview Support Form PDF

SUP2D14P1

NON-CBI SUBMISSION

Form Approved. O.M.B, No. 2070-0173.

EPA Support Form

Support Form Report Number

Mark (X) if anything is CBI

~

1 ORIGINAL NOTICE SUBMISSION IDENTIFICATION

Report Number

TS

Number

Case
Number

Original Submission Date

Original Submission Media Type

II. ORIGINAL NOTICE SUBMITTER IDENTIFICATION

CBI ~

Authorized Official
Name

Position

Mailing Address
(Number & Street)

(first)

Company Nairn

City

e-mail

State

m. CURRENT SUPPORT DOCUMENT IDENTIFICATION INFORMATION

	

CBI

~

Name

(first)

=

(last)

Position

Company Name

Mailing Address
(Number & Street)

City



State

Postal Code

Province

Country

e-mail

Telephone
(include area code)

IV. TYPE OF SUPPORT (Check One)

Transfer of Ownership

~
~

Suspension Request

Withdrawal Request

~

Other Correspondence

~

TEST DATA (Health/Eco/Fate)

~

Amendment (Changes made to PMN pages 1-13, MSDS or Physical/Chemical

Check if requested by EPA' contrac tor

~

EPA person/contractor

Submitter Signature

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11 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 top right-hand corner of the window.

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Exhibit 11-1 shows a screen capture for the 'Section 5 Notices and Supports Validation' pop-up
window:

Exhibit 11-1: Section 5 Notices arid Supports Validation Pop-Up Window

SECTION 5 NOTICES AND SUPPORTS VALIDATION
Errors:

•	Technical Contact Information

® Contact is reauired.

•	Additional Submission Information

'© Values are required.

•	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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12 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.

The FRS generally includes such core data elements as name, address, affiliated
organizations and contacts, and industrial classifications. When using this query to search
for facilities, use any combination of facility name, geographic location, facility industrial
classification, affiliated organization and contact, program category, and national systems
information. Enter in as many fields as possible, otherwise the system will return a results
list too big to display.

To search for a specific facility, search by Facility Name, Registry ID, Zip Code, and State
for an accurate list of results. Search by City Name, Zip Code, and State to return a
truncated list of results within a geographic region.

•	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.

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• 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.

Exhibit 12-1 shows a screen capture of the 'Resources' screen (Scroll 1):

Exhibit 12-1: Resources Screen (Scroll 1)

Home y Forms J Resources

Logged in as. Jane Doe, Primary 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 Regulator/ Impact Analysis for the Regulation of Microbial Products of

Biotechnology: Government Costs.

Regulatory Impact Analysis for the Regulation of Microbial Products of Biotechnology: Government Costs

Click the link provided below to access additional information related to TSCA Biotechnology Regulations.

Microbial Products of Biotechnology: Final Rule f£2 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

Click the link provided below to access additional information related to the Central Data Exchange (CDX).

CDX Homeoaoe

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 fFRSl

Clickthe link provided below to access additional information related to Inventory Expert Services.

PAQ Inv/pntnrv Fvnprt CJpr\/irp<;

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

Exhibit 12-2 shows a screen capture of the 'Resources' screen (Scroll 2):

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Exhibit 12-2: Resources Screen (Scroll 2)





Logged in as: Jane Doe, Primary Support



r Forms ~ Resources

Log Out

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 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

Clickthe link provided below to access additional information related to the National Pollutant Discharge Elimination System.

National Pollutant Discharge Elimination System fNPDESI

Clickthe link provided below to access additional information related to the New Chemicals Program.

New Chemicals Program Homepage

Clickthe 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@epamail.eba.gov.

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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

AO

Authorized Official

BCF/BAF

Bioconcentration Factors/Bioaccumulation Factors

CBI

Confidential Business Information

CA

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

FR

Federal Regulation

FRS

Facility Registry System

GPC

Gel-permeation Chromatography

ID

Identification

IE

Internet Explorer

IES

Inventory Expert Service

IH

Industrial Hygienist

IR

Infrared

KG

Kilogram

LOREX

Low Release/Low Exposure Exemption

LOS

Letter of Support

LVE

Low Volume Exemption

MCAN

Microbial Commercial Activity Notice

MS

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

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OPPT

Office of Pollution Prevention and Toxics

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

TS

Toxic Substances

TSCA

Toxic Substances Control Act

UV

Ultraviolet

XML

Extensible Markup Language

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