CDX Section 5 Notices and Supports User Guide Primary Authorized Official


Section 5 Notices and Supports User
Guide - Primary Authorized Official

Environmental Protection Agency
Office of Pollution Prevention and Toxics

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

Version 1.0
December 15, 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 Authorized Official (AO) Functions	3

3.1	Log into Section 5 Notices and Supports Application	4

3.2	Home Screen Navigation	5

3.3	User Management	7

3.4	Section 5 Notices and Supports Forms	9

3.5	Create Passphrase	14

3.6	Attach Documents	15

3.7	Enter Passphrase	21

3.8	Navigation Tree	21

3.9	Action Bar	33

3.10	Search Substance Registry Services (SRS)	35

3.11	Add Facility	40

4	Create Premanufacture Notice (PMN) Form	44

4.1 Create PMN Form	44

4.1.1	General Form Information	44

4.1.2	User Fees Certification	49

4.1.3	Agent Information	50

4.1.3.1 Add Agent	53

4.1.4	Technical Contact Information	56

4.1.4.1 Add Technical Contact	58

4.1.5	Additional Submission Information	61

4.1.6	Chemical Identification	65

4.1.7	Class 1 or 2 Chemical Substances	67

4.1.8	Class 2 Substances	73

4.1.9	Additional Chemical Information	76

4.1.10	Polymer Identification Information	81

4.1.11	Monomers and Other Reactants	85

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4.1.12	Production Volume and Hazard/Safety Information	91

4.1.13	Use Information	94

4.1.14	Physical and Chemical Properties Worksheet	99

4.1.15	Physical and Chemical Properties Worksheet - Continued (Optional)	106

4.1.16	Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents	108

4.1.17	Site Information	112

4.1.18	Sites Controlled By Others	113

4.1.19	Submitter Operation Information	115

4.1.20	Occupational Exposures	121

4.1.21	Environmental Releases	125

4.1.22	Industrial Sites Controlled By Others	130

4.1.23	Exposures/Releases	134

4.1.24	Byproduct Information	139

4.1.25	Optional Pollution Prevention	141

4.1.26	Additional Attachments	143

4.1.27	Attachment Summary	145

4.1.28	Optional Cover Letter	147

4.1.29	Joint Submitter Information	149

4.1.30	Joint Submission Information	151

4.1.31	Notify Joint Submitter of Joint Submission Information	153

4.1.32	Letter of Support Submitter Information	156

4.1.33	Letter of Support Submission Information	158

4.1.34	Notify Secondary Submitter of Letter of Support Information	160

4.1.35	Upload XML	163

5 Create Biotechnology Form	165

5.1 Create Biotechnology Form	165

5.1.1	General Form Information	165

5.1.2	Joint Submitter Information	169

5.1.3	Joint Submission Information	170

5.1.4	Notify Secondary Submitter of Joint Submission Information	172

5.1.5	Letter of Support Submitter Information	173

5.1.6	Letter of Support Submission Information	175

5.1.7	Notify Secondary Submitter of Letter of Support Information	178

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5.1.8	Technical Contact Information	180

5.1.8.1 Add Technical Contact	181

5.1.9	Optional Cover Letter	184

6	Create Notice of Commencement (NOC) Form	186

6.1 Create NOC Form	186

6.1.1	General Form Information	186

6.1.2	Technical Contact Information	187

6.1.2.1 Add Technical Contact	188

6.1.3	Chemical Information	190

6.1.4	Site Information	194

6.1.5	CBI Substantiation Part 1	196

6.1.6	CBI Substantiation Part 2	199

6.1.7	CBI Substantiation Part 3	202

6.1.8	Optional Cover Letter	205

7	Create Support Form	207

7.1 Create Support Form	207

7.1.1	General Form Information	207

7.1.2	Original Submitter Information	210

8	Create Bona Fide Form	213

8.1 Create Bona Fide Form	213

8.1.1	General Document Information	213

8.1.2	Primary Contact Information	215

8.1.3	Technical Contact Information	218

8.1.4	Statement of Intent	220

8.1.5	Letter of Support Submitter Information	222

8.1.6	Letter of Support Submission Information	224

8.1.7	Notify Secondary Submitter of Letter of Support Information	227

8.1.8	Chemical Identification Information	230

8.1.9	Class 1 or 2/Biotechnology Chemical Substances	231

8.1.10	Class 2/Biotechnology Substances	235

8.1.11	Polymer Identification Information	237

8.1.12	Monomers and Other Reactants	240

8.1.13	Use Information	243

8.1.14	Submitter Site Identification	245

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8.1.15	Document Management	247

8.1.16	Optional Cover Letter	249

9	Create Alternative Control Measures (ACM) Form	251

9.1 Create Alternative Control Measures Form	251

9.1.1	Contact Information	251

9.1.1.1 Add Contact	252

9.1.2	Attachments	254

10	Preview	257

11	Validate	262

12	Submit to EPA via CDX	264

12.1	Submitting Official Information	264

12.2	LVE Certification	267

12.3	LOREX Certification	268

12.4	Submission Process: Validation	269

12.5	Cross-Media Electronic Reporting Regulation (CROMERR) Certification	271

12.6	Cross-Media Electronic Reporting Regulation (CROMERR) Login	272

12.7	Cross-Media Electronic Reporting Regulation (CROMERR) Security Question	273

12.8	Submit to CDX	274

12.9	Cross-Media Electronic Reporting Regulation (CROMERR) Submission	275

13	Download Copy of Record	276

14	Create An Amendment	279

15	Resources	282

Appendix A	285

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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: User Management Screen	9

Exhibit 3-5: Section 5 Notices and Supports Forms Screen	13

Exhibit 3-6: Create Passphrase Screen	15

Exhibit 3-7: Section 5 Document Types and Subtypes	17

Exhibit 3-8: Attach Documents Pop-Up Window	20

Exhibit 3-9: Enter Passphrase Screen	21

Exhibit 3-10: Navigation Prompt Pop-Up Window	22

Exhibit 3-11: Premanufacture Notice Navigation Tree (Scroll 1)	24

Exhibit 3-12: Premanufacture Notice Navigation Tree (Scroll 2)	25

Exhibit 3-13: Premanufacture Notice Navigation Tree (Scroll 3)	26

Exhibit 3-14: Premanufacture Notice Navigation Tree (Scroll 4)	27

Exhibit 3-15: Premanufacture Notice Navigation Tree (Scroll 5):	28

Exhibit 3-16: Biotechnology Navigation Tree	29

Exhibit 3-17: Notice of Commencement (NOC) Navigation Tree	30

Exhibit 3-18: Support Navigation Tree	30

Exhibit 3-19: Bona Fide Navigation Tree (Class 2 Substance)	31

Exhibit 3-20: Bona Fide Navigation Tree (Polymer)	32

Exhibit 3-21: Alternative Control Measures (ACM) Navigation Tree	33

Exhibit 3-22: Action Bar - Validate	33

Exhibit 3-23: Action Bar - Save	34

Exhibit 3-24: Action Bar - Preview	34

Exhibit 3-25: Action Bar - Submit	34

Exhibit 3-26: Action Bar - Help Links	35

Exhibit 3-27: Search Substance Registry Services Pop-Up Window	37

Exhibit 3-28: Chemical Not Found In Substance Registry Services Pop-Up Window	39

Exhibit 3-29: Add Facility Message Pop-Up Window	41

Exhibit 3-30: Add Facility Pop-Up Window	42

Exhibit 4-1: General Form Information Screen (Scroll 1)	47

Exhibit 4-2: General Form Information Screen (Scroll 2)	48

Exhibit 4-3: User Fees Certification Screen	50

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Exhibit 4-4: Agent Information Screen	52

Exhibit 4-5: Add Agent Pop-Up Window	56

Exhibit 4-6: Technical Contact Information Screen	58

Exhibit 4-7: Add Technical Contact Pop-Up Window	60

Exhibit 4-8: Additional Submission Information Screen	64

Exhibit 4-9: Chemical Identification Screen	66

Exhibit 4-10: Class 1 or2 Chemical Substances Screen (Scroll 1)	71

Exhibit 4-11: Class 1 or 2 Chemical Substances Screen (Scroll 2)	72

Exhibit 4-12: Class 2 Substances Screen (Scroll 1)	75

Exhibit 4-13: Class 2 Substances Screen (Scroll 2)	76

Exhibit 4-14: Additional Chemical Information Screen (Scroll 1)	80

Exhibit 4-15: Additional Chemical Information Screen (Scroll 2)	81

Exhibit 4-16: Polymer Identification Information Screen (Scroll 1)	84

Exhibit 4-17: Polymer Identification Information Screen (Scroll 2)	85

Exhibit 4-18: Monomers and Other Reactants Screen (Scroll 1)	89

Exhibit 4-19: Monomers and Other Reactants Screen (Scroll 2)	90

Exhibit 4-20: Production Volume and Hazard/Safety Information Screen	93

Exhibit 4-21: Use Information Screen (Scroll 1)	97

Exhibit 4-22: Use Information Screen (Scroll 2)	98

Exhibit 4-23: Physical and Chemical Properties Worksheet Screen (Scroll 1)	105

Exhibit 4-24: Physical and Chemical Properties Worksheet Screen (Scroll 2)	106

Exhibit 4-25: Physical and Chemical Properties Worksheet - Continued (Optional) Screen ....108

Exhibit 4-26: Physical and Chemical Properties Worksheet - Continued (Optional) Attach

Documents Pop-Up Window (Scroll 1)	110

Exhibit 4-27: Physical and Chemical Properties Worksheet - Continued (Optional) Attach

Documents Pop-Up Window (Scroll 2)	111

Exhibit 4-28: Site Information Screen	113

Exhibit 4-29: Sites Controlled By Others Screen	115

Exhibit 4-30: Submitter Operation Information Screen (Scroll 1)	119

Exhibit 4-31: Submitter Operation Information Screen (Scroll 2)	120

Exhibit 4-32: Occupational Exposures Screen (Scroll 1)	123

Exhibit 4-33: Occupational Exposures Screen (Scroll 2)	124

Exhibit 4-34: Environmental Releases Screen (Scroll 1)	128

Exhibit 4-35: Environmental Releases Screen (Scroll 2)	129

Exhibit 4-36: Industrial Sites Controlled By Others Screen (Scroll 1)	133

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Exhibit 4-37: Industrial Sites Controlled By Others Screen (Scroll 2)	134

Exhibit 4-38: Exposures/Releases Screen (Scroll 1)	137

Exhibit 4-39: Exposures/Releases Screen (Scroll 2)	139

Exhibit 4-40: Byproduct Information Screen	140

Exhibit 4-41: Optional Pollution Prevention Screen	143

Exhibit 4-42: Additional Attachments Screen	145

Exhibit 4-43: Attachment Summary Screen	146

Exhibit 4-44: Optional Cover Letter Screen	148

Exhibit 4-45: Joint Submitter Information Screen	150

Exhibit 4-46: Joint Submission Information Screen	152

Exhibit 4-47: Joint Submission Unique Identifier Notification Pop-Up Window (Scroll 1)	154

Exhibit 4-48: Joint Submission Unique Identifier Notification Pop-Up Window (Scroll 2)	155

Exhibit 4-49: Letter of Support Submitter Information Screen	157

Exhibit 4-50: Letter of Support Submission Information Screen	159

Exhibit 4-51: Letter of Support Unique Identifier Notification Pop-Up Window	162

Exhibit 4-52: Upload XML Screen	164

Exhibit 5-1: General Form Information Screen (Biotechnology) (Scroll 1)	167

Exhibit 5-2: General Form Information Screen (Biotechnology) (Scroll 2)	168

Exhibit 5-3: Joint Submitter Information Screen (Biotechnology)	170

Exhibit 5-4: Joint Submission Information Screen (Biotechnology)	171

Exhibit 5-5: Unique Identifier Notification Pop-Up Window	173

Exhibit 5-6: Letter of Support Submitter Information Screen (Biotechnology)	175

Exhibit 5-7: Letter of Support Submission Information Screen (Biotechnology)	177

Exhibit 5-8: Unique Identifier Notification Pop-Up Window	179

Exhibit 5-9: Technical Contact Information Screen (Biotechnology)	181

Exhibit 5-10: Add Technical Contact Pop-Up Window	183

Exhibit 5-11: Optional Cover Letter Screen	184

Exhibit 6-1: General Form Information Screen (NOC)	187

Exhibit 6-2: Technical Contact Information Screen (NOC)	188

Exhibit 6-3: Add Technical Contact Pop-Up Window (NOC)	190

Exhibit 6-4: Chemical Information Screen (Scroll 1) (NOC)	193

Exhibit 6-5: Chemical Information Screen (Scroll 2) (NOC)	194

Exhibit 6-6: Site Information Screen (NOC)	195

Exhibit 6-7: CBI Substantiation Part 1 Screen (Scroll 1)	197

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Exhibit 6-8: CBI Substantiation Part 1 Screen (Scroll 2)	198

Exhibit 6-9: CBI Substantiation Part 2 Screen (Scroll 1)	200

Exhibit 6-10: CBI Substantiation Part 2 Screen (Scroll 2)	201

Exhibit 6-11: CBI Substantiation Part 3 Screen (Scroll 1)	203

Exhibit 6-12: CBI Substantiation Part 3 Screen (Scroll 2)	204

Exhibit 6-13: Optional Cover Letter Screen (NOC)	205

Exhibit 7-1: General Form Information Screen (Scroll 1) (Support)	209

Exhibit 7-2: General Form Information Screen (Scroll 2) (Support)	210

Exhibit 7-3: Original Submitter Information Screen (Support)	212

Exhibit 8-1: General Document Information Screen (Scroll 1)	214

Exhibit 8-2: General Document Information Screen (Scroll 2)	215

Exhibit 8-3: Primary Contact Information Screen	217

Exhibit 8-4: Technical Contact Information Screen (Scroll 1)	219

Exhibit 8-5: Technical Contact Information Screen (Scroll 2)	220

Exhibit 8-6: Statement of Intent Screen	222

Exhibit 8-7: Letter of Support Submitter Information Screen	224

Exhibit 8-8: Letter of Support Submission Information Screen	226

Exhibit 8-9: Notify Letter of Support Submitter Pop-Up Window	229

Exhibit 8-10: Chemical Identification Information Screen	231

Exhibit 8-11: Class 1 or 2/Biotechnology Chemical Substances Screen (Scroll 1)	234

Exhibit 8-12: Class 2/Biotechnology Substances Screen (Scroll 1)	236

Exhibit 8-13: Class 2/Biotechnology Substances Screen (Scroll 2)	237

Exhibit 8-14: Polymer Identification Information Screen	240

Exhibit 8-15: Monomers and Other Reactants Screen	243

Exhibit 8-16: Use Information Screen	245

Exhibit 8-17: Submitter Site Identification Screen	247

Exhibit 8-18: Document Management Screen	249

Exhibit 8-19: Optional Cover Letter Screen	250

Exhibit 9-1: Contact Information Screen (ACM)	252

Exhibit 9-2: Add Contact Pop-Up Window (ACM)	254

Exhibit 9-3: Attachments Screen (ACM)	256

Exhibit 10-1: Preview EPMN Form Screen	257

Exhibit 10-2: Preview Biotechnology Form PDF	258

Exhibit 10-3: Preview NOC Form PDF	259

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Exhibit 10-4: Preview Support Form PDF	261

Exhibit 11-1: Section 5 Notices and Supports Validation Pop-Up Window	263

Exhibit 12-1: Submitting Official Information Screen	266

Exhibit 12-2: LVE Certification Screen	267

Exhibit 12-3: LOREX Certification Screen	268

Exhibit 12-4: Submission Process: Validation Screen	269

Exhibit 12-5: Submission Process: PDF Generation Screen	270

Exhibit 12-6: Cross-Media Electronic Reporting Regulation (CROMERR) Certification Screen271

Exhibit 12-7: Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen	272

Exhibit 12-8: Cross-Media Electronic Reporting Regulation (CROMERR) Security Question

Screen	273

Exhibit 12-9: Submit To CDX Screen	274

Exhibit 12-10: Cross-Media Electronic Reporting Regulation (CROMERR) Submission Screen275

Exhibit 13-1: Download Copy of Record Screen	277

Exhibit 13-2: Download Prompt Window	278

Exhibit 14-1: Section 5 Notices and Supports Forms Screen - Amendment	280

Exhibit 14-2: Unlock Prompt Message	281

Exhibit 15-1: Resources Screen (Scroll 1)	283

Exhibit 15-2: Resources Screen (Scroll 2)	284

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Revision Log

Date

Version
No.

Description



Author

Reviewer

Review
Date

| 09/20/13

| 0.01

Initial Draft of Section 5 Notices and
Supports Primary AO User Guide

C
J.

Yeh

DeRosa

| S. Mulvey
[ J. Ritchey

| 09/20/13

| 12/15/14

I 1.0

Final Draft of Section 5 Notices and
Supports Primary AO User Guide

Incorporated OPPT comments given on
11/07/2013

Incorporated Release 1.00
enhancements, other OPPT comments

C

Yeh

| J. Bronick

I 12/15/14

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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 application submission process. This document is the user guide
for the Primary Authorized Official (AO) user of the Section 5 Notices and Supports application.

The Section 5 Notices and Supports 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 AO, you can create, modify, and/or submit a Section 5 Notices and Supports
form. You can also delete Section 5 Notices and Supports forms, create amendments, and
download the Copy of Record (CoR).

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 77

•	Google Chrome

-	Go to the following link to download:
http://www.google.com/chrome

•	Opera

-	Go to the following link to download:
http ://www. opera, com/download

2.2	Screen Resolution

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

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3 Primary Authorized Official (AO) Functions

This section describes how to:

•	Access the application

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

•	Assign Supports to complete a form

•	Start and complete the Section 5 Notices and Supports forms - Premanufacture Notice
(PMN), Biotechnology, Notice of Commencement (NOC), Support, Bona Fide Notices, and
Alternative Control Measures (ACM) 721.30

•	Upload an extensible markup language (XML) file

•	Download a Copy of Record

•	Create an amendment

The Primary AO is responsible for the submission of original main forms, including PMN,
Biotechnology, NOC, Support, Bona Fide, or ACM forms. As a Primary AO, you can create a
new form. You are also responsible for submitting amendments, unlocking submissions, and
deleting forms. You can assign Supports (or other authorized individuals) to edit and complete a
form on your behalf. The Primary AO can be thought of as a primary company authorized
official, specifically in regards to any sponsored individuals.

You can save the form at any point during the data entry process. The save functionality allows
you to return to that same form at any point in the future. You can print the form at any point;
however, the 'Not for Submission' watermark will be placed on the form anytime the form is
printed prior to actual submission.

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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

/



\

\

\

~

4/

~
/

J& iS>

//



//
//

/J*
//

& r



US

non-US

us

non-US

us

non-US

us

non-US

us

non-US

us

non-US

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



Create all oriainal main forms

X

X

X

X

















Submit oriainal main forms

X























Submit oriainal ACM forms

X

X

X

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 forms



Create Support forms

X

X

X

X

















Submit oriainal Support forms

X

X

X

X

















Submit amendment for older cases and
other support forms

X

X

X

X

















Unlock supportforms

X

X

X

X

















Edit unlocked supportforms

X

X

X

X

X

X













Delete forms

X

X

X

X

















Assign Supports

X

X





















LOS submissions

























Create LOS for PMN, Biotechnology, or Bona
Fide













X

X

X

X





Submit original LOS for PMN, Biotechnology
or Bona Fide













X











Submit amendments to LOS submissions













X

X

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, click the 'Primary Authorized Official' link for the
Chemical Safety and Pesticide Programs (CSPP) data flow to navigate 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

ESBRJ

Logged in as: Jane Doe, Primary Authorized Official

Log Out

CHEMICAL INFORMATION SUBMISSION SYSTEM

| TSCA Section ;¦ Nonces and Supports - eFl.'N

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 (Le-
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.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").

Please note: The public reporting and recordkeeping burden for this collection of information is estimated to average 93
hours per response for PMN, SNUN. LVE, and LOREX applications (TMEA is estimated to average 88 hours per response),
including time for reviewing Instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. The public reporting and recordkeeping burden for this collection of
information is estimated to average 290 hours per response for MCAN applications and the NOC is estimated to average 0.8
hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden
estimates, and any suggested methods for minimizing respondent burden, Including through the use of automated collection
techniques to the Director, Collection Strategies Division. U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania
Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed
EPA Form 7710-25 (PMN) or Form 6300-14 (Biotechnology) or Form 7710-56 (NOC) to this address.

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

Navigation: To access the Section 5 Notices and Supports 'Home' screen, select '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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide	December 15, 2014

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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
Notices and Supports Forms,' 'User Management,' and 'Resources' screens. To navigate to
either of these screens, click the corresponding 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' tab or link to navigate to the 'Section 5 Notices and Supports
Forms' screen. You can create, modify, or delete a Section 5 Notices and Supports form
using the 'Section 5 Notices and Supports Forms' screen. For additional details about the
'Section 5 Notices and Supports Forms' screen, please refer to Section 3.4.

• User Management: Click the 'User Management' link or tab to navigate to the 'User
Management' screen. You can manage the access rights of Supports per form alias using the
'User Management' screen. For additional details about the 'User Management' 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 15.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 3-3 shows a screen capture of the Section 5 Notices and Supports 'Home' screen:
Exhibit 3-3: Section 5 Notices and Supports Home Screen



f *J */

Home Y Forms ^^UseiJ|1aiTagemen^J Resources

Logged in as: Jane Doe, Primary Authorized Official

Log Out

HOME

Forms

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

Use the following forms to report new chemicals to EPA: Premanufacture Notice form (EPA Form 7710-25) should be
used to submit PMNs, LVEs, SNUNs. LOREXs, TMEAs, Modifications for LVEs and LoREX submissions: Biotechnology
Notice form (EPA Form 6300-14) should be used to submit MCANs TERAs Tier 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 Notice1)

User Management

Manage the access rights of Support persons for each Section 5 Notices and Support document-

Resources

g,

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

Authorized Official

An Authorized Official has the ability to create delete, amend unlock, and submit all Section 5 Notices and
Support forms electronically to EPA. The Authorized Official also has the ability to assign Supports to individual

forms.

CDX Homepage I MvCDXHomeoaae I EPAHomepaae I Terms and Conditions I Privacy Notice I CDX Helodesk: (8881890-1995

Navigation: Click the 'User Management' link or tab to access the 'User Management' screen to
assign Supports or Primary Agents/Consultants (if applicable).

3.3 User Management

You can access the 'User Management' screen by clicking the 'User Management' link on the
Section 5 Notices and Supports 'Home' screen or by clicking the 'User Management' tab from
the application header.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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On the 'User Management' screen, you have the ability to assign one or more Supports or
Primary Agents/Consultants to have access to modify any of the Section 5 Notices and Support
forms you have created.

Form Alias: A form alias will not be available in this drop-down menu until one has been
created. Select a form alias from the drop-down menu to begin assigning Supports or Primary
Agents/Consultants. Once a form alias has been selected, the 'Assign Users' group box will
update to display only the Supports or Primary Agents/Consultants who have identified you as
their AO during CDX registration, or a user you have specified that is able to submit on your
behalf.

Form Information: This field set displays information pertaining to the form you selected from
the 'Form Alias' drop-down menu.

• Form Alias: Displays the form alias that a form is given.

• TS Number: Displays the toxic substances (TS) number that is entered for that specific form
(if applicable).

• Form Type/SubType: Displays the type of form, which may include 'Primary PMN,'
'Biotechnology,' 'NOC,' 'Support,' ' Bona Fide,' 'or'ACM.' This field also displays the
subtype of the form, if applicable. NOC, Bona Fide, and ACM forms do not have subtype
values.

• Last Modified: Displays the date and time the form was last modified.

Assign Users: This box shows all the Supports or Primary Agents/Consultants you can assign to
complete a Section 5 Notices and Supports form for the form alias selected. To move support
persons from the 'Unassigned' group box to the 'Assigned' group box, highlight an individual or
multiple Support(s) or Primary Agent(s)/Consultant(s) and click the 'add »' button.

• Unassigned: This box/field contains the registered Support(s) and/or Primary
Agent(s)/Consultant(s) associated with the AO who can potentially be assigned to access and
edit the selected form. To move support persons from the 'Unassigned' group box to the
'Assigned' group box, highlight an individual or multiple support persons and click the 'add
»' button. To highlight multiple support persons hold down the key on your
keyboard while clicking each Support and/or Primary Agent/Consultant. To highlight
multiple consecutive support persons, hold down the key on your keyboard while
clicking the first and last Support and/or Primary Agent/Consultant in the list.

• Assigned: This box/field contains the registered Support(s) and/or Primary
Agent(s)/Consultant(s) given permission, by the AO, to access and edit the selected form.
This group box shows all support persons assigned to complete the Section 5 Notices and
Supports form for a single form alias. To move Supports and/or Primary Agents/Consultants
from the 'Assigned' group box to the 'Unassigned' group box highlight individual or
multiple support persons and click the '« remove' button. To highlight multiple support
persons hold down the key on your keyboard while clicking each Support and/or
Primary Agent/Consultant. To highlight multiple consecutive support persons, hold down the
key on your keyboard while clicking the first and last Support and/or Primary
Agent/Consultant in the list.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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•	Add »: Click the button to move Supports and/or Primary Agents/Consultants from the
'Unassigned' box to the 'Assigned' box.

•	« Remove: Click the button to move Supports and/or Primary Agents/Consultants from the
'Assigned' box to the 'Unassigned' box.

When you have finished assigning the Supports and/or Primary Agents/Consultants, click the
'Save' button that displays after selecting a form to save the selection.

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

Exhibit 3-4: User Management Screen

^^Forms^J User Management J Resources

A Logged in as Jane Doe, Primary Authorized Official

Log Out

USER MANAGEMENT

The Authorized Official is responsible for restricting a Support's access to select forms by assigning or un-assigning them to each
form alias. The Support can access and edit only those documents for which the Authorized Official has granted access. Select the
form to manage from the drop-down menu and assign a Support to the form by highlighting the individual and clicking the add link
To un-assign a Support, highlight the individual and click the remove link To highlight and assign or un-assign multiple Supports,
hold down the Ctrl or Shift keys on the keyboard and click each Support before clicking the add>>' or '«remove' link. You must
click the 'Save7 button after each change in user assignment.

Form Alias.

Assign Users

Unassigned

Assigned

CDXHomeoaqe I MyCDX Homepaqe I EPAHomepaqe I Terms and Conditions I Privacy Notice I CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Forms' tab located within the application header to navigate to the
'Section 5 Notices and Supports Forms' screen.

3.4 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.

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

Start New Form: To create a new Section 5 Notices and Supports form, select one of the
following options from the 'Form Type' drop-down menu and click the 'Start New Form'
button: 'Premanufacture Notice (PMN),' 'Support,' 'Notice of Commencement (NOC),'
'Biotechnology,' 'Bona Fide,' or 'Alternative Control Measures (ACM).' You are required to
create a passphrase that will be associated with that particular form. Make sure to create a
passphrase that you will remember, as it cannot be retrieved or reset. Refer to Section 3.5 for
further instructions on creating a passphrase.

Edit an 'In Progress' Form: To modify an existing Section 5 Notices and Supports form, click
the 'Alias' link for a form with a status of 'In Progress.' You are required to enter the passphrase
associated with that particular form to access and edit the form. It is possible for more than one
user to modify a form simultaneously; the user that clicks the 'Save' button first will have his/her
changes saved. Refer to Section 14 for further instructions on viewing and modifying a form that
is 'In Progress.'

Amend a submitted form: To edit an already submitted Section 5 Notices and Supports form
(i.e., to create an amendment), you must first unlock the particular submission by clicking the
'Lock' icon (1 ¦ ) under the 'Action' column. You will be required to enter the passphrase
associated with that particular submission to gain access and continue amending the submission.
All further changes that are made will be submitted as an amendment. Refer to Section 14 for
further instructions on creating an amendment.

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

• Alias: Displays the form alias you 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 the '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. Click the form alias link to navigate to the
'Enter Passphrase' screen to access a form.

• 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

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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,' 'Test Data,'
'Transfer Of Ownership,' 'Withdrawal Request,' 'Suspension Request,' or'Other
Correspondence.'

- 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.

- 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
MCAN, R-XX-XXXX for TERA, G-XX-XXXX for Tier I Exemption, 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.

• Copy of Record: Click the 'Copy of Record' icon ( ) to navigate to the 'Enter Passphrase'
screen, then the 'Cross-Media Electronic Reporting Regulation (CROMERR) Login' screen
to continue to the 'Copy of Record' screen. The 'Copy of Record' icon ( ) displays only
after the form has been completed. Refer to Section 13 for further instructions on
downloading the copy of record. If you have just submitted via CDX, the 'Copy of Record'
icon ( ) may take 15-20 minutes to display. In addition, you must refresh the 'Section 5
Notices and Supports Forms' screen for the 'Copy of Record' icon ( ) to display.

• Action: Displays a 'Delete" icon (X) for all forms with a status of 'In Progress." Click the
'Delete' icon to delete a form. This column displays a 'Lock' icon ( ¦ ) for all forms that

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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have been submitted and are not 'In Progress.' Only an AO or Primary Agent/Consultant can
unlock a form by clicking the 'Lock' icon ( • ) and unlocking the form. The form will remain
unlocked and display the 'Unlocked' icon ( 1 ) until the form is resubmitted by the AO.

•	Items Per Page: Select a value ('25,' '50,' '75,' or '100') from this drop-down menu to
specify the number of forms to display on a single page.

•	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) file, XML file, or portable document format
(PDF). The export options section will not display until a form is created.

•	Form Type: Select the form type that you would like to create from the drop-down menu.
This drop-down menu contains the following values: 'Premanufacture Notice (PMN),'
'Support,' 'Notice of Commencement (NOC),' 'Biotechnology,' 'Bona Fide,' and
'Alternative Control Measures (ACM).' This drop-down menu is only available to Primary
Authorized Officials and Primary Agents/Consultants.

•	Start New Form: Click this button to start a new form after selecting a form type and
navigate to the 'Create Passphrase' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 3-5 shows a screen capture of the ' Section 5 Notices and Supports Forms' screen:
Exhibit 3-5: Section 5 Notices and Supports Forms Screen



Logged in as: Jane Doe, Primary Authorized Official



¦fl

Home J Forms y User Management Y Resources

SECTION 5 NOTICES AND SUPPORTS FORMS	©

•	If submitting a form for the first time in the Section 5 Notices and Supports application, select the form type from the drop-down menu and
click Start New Form,

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

•	To access and edit a form previously submitted through CDX. unlock the form by clicking the lock ( gj) icon and enter the passphrase
when prompted. All additional changes made to the form will be submitted as an amendment.

•	To download a copy of record for a submitted form, click the green arrow (•$•) icon and enter the passphrase when prompted.

•	You may delete any form that has not yet been submitted by clicking the delete (X) icon.

•	All columns may be sorted by clicking the column header.

Page 1 of 1

7 items found.	Items Per Page: 25 ~

Alias $ Type ±

Subtype Case Number

Status

Modify
Date

Submission
Date

Copy of
Record

Action

ACM-20141128-11:30:18 EST ACM



In Progress

11/28/2014





X

Biotechnology-20141128-11:36:12 Biotechnology

TIER1

In Progress

11/28/2014





X

EST













Biotechnology-20141128-11:37:23 Biotechnology

TERA R-15-0001. R-15-0002, R-15-

• In Progress

11/28/2014

11/28/2014

~

B

EST

0003











Bona Fide-20141128-11:31:55 EST Bona Fide

BF-15-0015

m

Submitted

11/28/2014

11/28/2014



S3

NOC-20141128-11:45:27 EST NOC

P-14-8743

In Progress

11/28/2014





X

Primary PMN-20141128-11:49:15 Primary PMN

PMN

In Progress

11/28/2014





X

EST













Support-20141128-11:46:06 EST Support

Amendment P-22-2222

&
Submitted

11/28/2014

11/28/2014

~

nil

Export options: -fl CSV [ ^ Excel |

XML | "3 PDF







Select the forrm^£e^ndjTen_click_S^
Form Type ! Premanufacture Notice (PMN)

Start New Form

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

Navigation: Select a form type from the 'Form Type' drop-down menu and click the 'Start New
Form' button to navigate to the 'Create Passphrase' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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3.5 Create Passphrase

To start a new Section 5 Notices and Supports form, select a form type from the 'Form Type'
drop-down menu, and click the 'Start New Form' button on the 'Section 5 Notices and Supports
Forms' screen to navigate to the 'Create Passphrase' screen, which allows you to create a
passphrase and associate that passphrase with your newly created form.

The application uses the passphrase as an encryption key to protect the contents of the form. You
are responsible for remembering the passphrase and distributing it to the appropriate individuals.

If you forget the passphrase, you will not have access to the form and will not be able to view,
print, submit, or make changes. If you lose or forget the passphrase, you must create a new form
and passphrase. For security reasons, the system administrator does not have access to the
passphrase and will not be able to retrieve it or reset it to a new one.

New Passphrase: To associate a passphrase with a form, enter a passphrase that is at least eight
(8) characters in length. To protect your account, your passphrase should contain a combination
of letters and numbers. The passphrase you create may include spaces, but should not contain
special characters (for example, +, ?, and *). You can associate the same passphrase with
multiple forms.

You will be responsible for remembering the passphrase and distributing it to only
authorized Supports for an individual form. If you forget the passphrase, you will not be
able to access the Section 5 Notices and Supports form to print, submit, or make changes.

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Exhibit 3-6 shows a screen capture of the 'Create Passphrase' screen for a Primary Authorized
Official:

Exhibit 3-6: Create Passphrase Screen

A Logged in as: Jane Doe, Primary Authorized Official

Log Out

New Passphrase:

Confirm New Passphrase:

[

CREATE PASSPHRASE

Please create a passphrase that is at least 8 characters in length. To better protect your form, your passphrase should contain a
combination of letters and numbers. Your passphrase may include spaces, but should not contain special characters (for example, +, and

*)¦

As an Authorized Official, you are responsible for remembering your passphrase and distributing it to only authorized individuals. Your
passphrase will be used as an encryption key to protect the contents of your data. As an Authorized Official, you are responsible for
remembering your passphrase and distributing it to only authorized Supports.

Note: If you lose or forget your passphrase, you will not be able to access your Section 5 Notices and Supports Form to
print, submit, or make changes. You will need to complete a new Section 5 Notices and Supports Form and create a new
passphrase for the form. For security reasons, the system administrator will not have access to your passphrase and will
not be able to retrieve it or reset it.

Navigation: Create a passphrase 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 Notice. Click the 'Next'
button to navigate to the 'Contact Information' screen in an ACM form.

3.6 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.
Click the 'Attach Document' button displayed on a screen to access the 'Attach Documents'
pop-up window. 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 15, 2014

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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 (X) 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 from the drop-down menu of the document that you upload.
For additional information regarding document types, refer to Exhibit 3-7. This is a required
field.

• Subtype: Select the document subtype from the drop-down menu of the document that you
upload. For additional information regarding document subtypes, refer to Exhibit 3-7. This is
a required field when displayed.

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

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

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

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

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

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

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

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Exhibit 3-7 displays a table of the document types and subtypes for each Section 5 Notices and
Supports form:

Exhibit 3-7: Section 5 Document Types and Subtypes
Form Type	Document Type	Document Subtypes

I PMN &
I Support

| Aquatic Ecotoxicity [

•	Algae Toxicity

•	Fish Acute Toxicity

•	Fish Chronic Toxicity

•	Invertebrate Acute Toxicity

•	Invertebrate Chronic Toxicity



| Chemical Structure Diagram |

• Not applicable (N/A)



| Correspondence [

• N/A



| Fate |

•	BCF/BAF (bioconcentration factors / bioaccumulation
factors)

•	Biodegradation

•	Fugacity

•	Hydrolysis

•	Monitoring data (e.g., air, water, soil, biota, human)

•	Partitioning (e.g., Koc, Kd, Kow, Koa, Henry's law
constant)

•	Photolysis



I GPC |

• N/A



| Genetic Toxicity I

•	Chromosomal Aberrations Assay

•	Genetic Mutation Assay

•	Unscheduled DNA (Deoxyribonucleic acid) Synthesis

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Form Type Document Type

Document Subtypes

, | Health Toxicity

•	Acute Toxicity

•	Carcinogenicity

•	Combined Repeated-
Dose/Developmental/Reproductive Toxicity

•	Dermal Irritation

•	Developmental Toxicity

•	Eye Irritation

•	Immunotoxicity

•	Neurotoxicity

•	Pharmacokinetics/Metabolism

•	Repeated-Dose Toxicity

•	Reproductive Toxicity

•	Sensitization

| | IES Report

• N/A

| | Other

• A free text field generates for a user to provide a
description of the document type

| | Process Diagram - Other

• N/A

| | Process Diagram - Submitter

• N/A

| | Safety Datasheet

•	MSDS/SDS (material safety data sheet / safety data
sheet)

•	Technical Datasheet

| | Terrestrial Ecotoxicity

•	Avian Toxicity

•	Invertebrate Toxicity

•	Plant Toxicity

I Biotechnology | Published Literature

• N/A

| | Regs and Certifications

• N/A

I I ID

•	Identification (ID) Sequence Data

•	Other ID Data

•	Strain History

[ | Construct

•	Construct Methodology

•	Construct Data

•	Gene Sequence Data

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Form Type

Document Type

Document Subtypes



| Effects

•	Human Health Effects

•	Environmental Effects

•	Pathogenicity Data

•	Antibiotic Resistance

•	Metabolism



| MSDS

• N/A



| Manufacturing Details

• N/A



| Use Details

• N/A



| Inactivation Data

• N/A



| Other

• A free text field generates for a user to provide a
description of the document type

| Bona Fide

| Spectrum of Substance

• N/A



| Statement of
[ Commercialization

• N/A



| Statement of Research and
| Development

• N/A



| Other

• A free text field generates for a user to provide a
description of the document type

| NOC

| CBI Substantiation K

• N/A

| ACM

| N/A

• N/A

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Exhibit 3-8 shows a screen capture of the 'Attach Documents' pop-up window that displays
within the majority of forms:

Exhibit 3-8: Attach Documents Pop-Up Window

"	^g,

ATTACH DOCUMENTS

Type and Subtype Type
Select the type and subtype
of the attachment

Attachment	File

Select the file to attach	Browse

Description

Provide a description of the
attachment

**Please do not include any
CBt infbmation in trie
description of trie file
infbmation.

Number of Pages	pages

CBI	Check to claim the attachment as CBIW

FilP

Sanitized Attachment r"c

Select the sanitized file to	Browse

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

not containing any CBI data.

| Cancel ]	EEI

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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3.7 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 that you originally created and associated with the
form.

Exhibit 3-9 shows a screen capture of the 'Enter Passphrase' screen:

Exhibit 3-9: Enter Passphrase Screen

Logged in as: Jane Doe, Primary Authorized Official

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 intend to import or manufacture.

Navigation: Enter the passphrase that you 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 Notice. Click the 'Next' button to navigate to the
'Contact Information' screen in an ACM form.

3.8 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

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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
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. A 'Form' icon ( )
denotes each section of a form. 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.' Click the 'OK' button to navigate to the
requested screen without saving any of the data in the previous screen. Click the 'Cancel'
button to close the prompt and remain on the current screen.

Exhibit 3-10 shows a screen capture of the navigation prompt pop-up window:

Exhibit 3-10: Navigation Prompt Pop-Up Window

Windows Internet Explorer

• Add Joint Submission: Click the 'Add Joint Submission' link located under the 'Joint
Submission' folder within the navigation tree to add a Joint Submission. A maximum of two
Joint Submissions can be added to a PMN form.

• Add Letter of Support: Click the 'Add Letter of Support' link located under the 'Letter of
Support' folder within the navigation tree to add a Letter of Support (LOS). An unlimited
number of Letters of Support can be added to a PMN form.

• Add Consolidated Chemical: Click the 'Add Consolidated Chemical' link within the
navigation tree to add a chemical within a consolidated submission and select the 'Class 1 or
2 Chemical Substance' or 'Polymer' radio button on the 'Chemical Identification' screen. A
maximum of six (6) separate chemical folders can be added to a PMN form. The ability to
add a consolidated chemical within a PMN form is unavailable when creating a PMN
amendment.

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• Delete chemical folders: Click the 'Delete" icon (X) that displays at the bottom of each
chemical folder within the navigation tree of a PMN form to delete specific chemical folders.
When a chemical folder is deleted, all information entered within the deleted chemical folder
is lost and cannot be retrieved. Click the 'Add Consolidated Chemical' link and fill in all
corresponding data to add a new chemical report. 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: Click the 'Copy' icon ( ) that displays at the bottom of each
chemical folder within the navigation tree of a PMN form to copy a specific chemical folder.
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 (X) 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. Click the 'Add Operation' link under the
appropriate operations folder and fill in all corresponding data to add a new ' Submitter
Controlled Operations' or 'Operation Controlled by Others' folder. The delete functionality
is not applicable while a user is navigating on a screen within the 'Operations Controlled by
Others' folder. This delete functionality is not applicable to the Biotechnology, 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 4.1.35,

Please note that in IE 7, the scroll bar within the navigation tree may freeze or portions of the
scroll 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 3-11 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 1):
Exhibit 3-11: Premanufacture Notice Navigation Tree (Scroll 1)

Premanufacture Notice 4

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

p General Form Information

{j; I User Fees Certification

[5]Agent Information

Technical Contact Information

Additional Submission
Information

S _jChemicaIs

l_- ^Class 2 Chemical
Substance

P Chemical
Identification

Q Class 1 or 2
Chemical
Substances

j_2 Class 2 Substances

|_2 Additional Chemical
Information

5 Production Volume
and Hazard/Safety
Information

'|3 Use Information

? l^Physical S.

Chemical
Properties

Physical and
Chemical
Properties
Worksheet

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 3-12 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 2):
Exhibit 3-12: Premanufacture Notice Navigation Tree (Scroll 2)

Premanufacture Notice 4

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

~ fij|fPhysical &

Chemical
Properties

5 Physical and
Chemical
Properties
Worksheet

[^Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

X Remove

B Copy

I? A Polymer Substance

"~11 Che mica I
Identification

"ij Polymer
Identification
Information

'QlMonomers and
Other Reactants

Additional Chemical
Information

"(jj ;Production Volume
and Hazard/Safety
Information

"[¥]Us.e Information

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 3-13 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 3):
Exhibit 3-13: Premanufacture Notice Navigation Tree (Scroll 3)

Premanufacture Notice 4

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

ij'flfphysical &

Chemical
Properties

PPhysical and
Chemical
Properties
Worksheet

0Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

"X Remove

® Copy

JjAdd Consolidated
Chemical

Site Information

| Site Information
IjySites Controlled By Others

Submitter Controlled
Operations

~ Ul^peration 1

Submitter Operation
Information

I Occupational
Exposures

( " Environmental

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Exhibit 3-14 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 4):
Exhibit 3-14: Premanufacture Notice Navigation Tree (Scroll 4)

Premanufacture Notice ^

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

[f Environmental ^

Releases

Remove

l-r[=|A
-------
CD)Sr

Exhibit 3-15 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 5):
Exhibit 3-15: Premanufacture Notice Navigation Tree (Scroll 5):

Premanufacture Notice ^

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDI

""p| Byproduct *

Information

"JC Remove

i^Add Operation

U Optional Pollution Prevention

'(5 Additional Attachments

'5 Attachment Summary

[^ Optional Cover Letter

Joint Submission

"I'f^fjoint Submission 1

"~JJoint Submitter
Information

Submission
Information

X Remove

l%)A(id Joint Submission

Letter of Support

0'Hf Letter of Support 1

pS]Letter of Support
Submitter
Information

Letter of Support
Submission
Information

X Remove

l%)Add Letter of Support

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 3-16 shows a screen capture of the Biotechnology navigation tree:

Exhibit 3-16: Biotechnology Navigation Tree

Biotechnology 4
Primary Authorized Official

Biotechnolouy-20140313-
10:38:43 EDT
j ^General Form Information

Joint Submission
I ^ Joint Submission 1

| J°int Submitter
Information

; i j""|=|Joint Submission
i i Information

:""X Remove

: [-*¦

i : -t[2)Add Joint Submission

Letter Of Support

I $ l^Letter of Support 1

j i""N Letter of Support
j Submitter

! Information

j j " "N Letter of Support
j j Submission
j j Information

""'XRemove

"" Eg]Add Letter Of Support

j""[S]Technical Contact Information

"•¦¦[S|optional Cover Letter

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Exhibit 3-17 shows a screen capture of the NOC navigation tree:

Exhibit 3-17: Notice of Commencement (NOC) Navigation Tree

Notice of Commencement ^

Primary Authorized Official

NOC-20140313-10:35:30 EDT
j""|j General Form Information

r-[^Technical Contact Information
j""[=]Chemical Information
i ""2]Submitter Site Information
CBI Substantiation
r-gCBI Substantiation Part 1
rj&CBI Substantiation Part 2
! substantiation par[ 3

:Optional Cover Letter

Exhibit 3-18 shows a screen capture of the Support navigation tree:

Exhibit 3-18: Support Navigation Tree

Support 4

Primary Authorized Official

Support-20140313-10:33:47 EDT
i ""^General Form Information

;""U)original Submitter Information

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 3-19 shows a screen capture of the Bona Fide navigation tree (Class 2 Substance):
Exhibit 3-19: Bona Fide Navigation Tree (Class 2 Substance)

Bona Fide ^

Primary Authorized Official

Bona Ficle-20140313-10:39:22
EDT

!""( General Document
Information

Primary Contact Information
Technical Contact information
j""H| Statement of Intent
Letter of Support

Letter of Support
j ! Submitter Information

Letter of Support
Submission Information

Chemical

Chemical Identification
I Information

- ;2>Class 2 Chemical
Substance

i !""| Class 1 or

2fiiotechnology
| Chemical

; Substances

| |-"-[S* ciaSS
! 2©iotechnology

! Substances

Use Information

Site Information

I •'¦ilgjsubmitter Site
Identification

Document Management
Optional Cover Letter

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Exhibit 3-20 shows a screen capture of the Bona Fide navigation tree (Polymer):

Exhibit 3-20: Bona Fide Navigation Tree (Polymer)

Bona Fide 4

Primary Authorized Official

Bona Ficle-20140313-10:39:22
EDT

General Document
Information

Primary Contact Information
Technical Contact Information
Statement of Intent
P" _ Letter of Support

Letter of Support
Submitter Information

Letter of Support
Submission Information

Chemical

Chemical Identification
j Information

~ Polymer Chemical
Substance

!""[ Polymer
] Identification

] Information

i i""(5 Monomers and
Other Reactants

Use Information

Site Information

Submitter Site
Identification

Document Management
Optional Cover Letter

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Exhibit 3-21 shows a screen capture of the ACM navigation tree:

Exhibit 3-21: Alternative Control Measures (ACM) Navigation Tree

ACM <

Primary Authorized Official

ACM-20140313-10:40:14 EDT
j""[j Contact Information

Attachments

3.9 Action Bar

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

• Validate: 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 3-22, Exhibit 3-23, Exhibit 3-24, and Exhibit 3-25 show screen
captures for the action bar:

Exhibit 3-22: Action Bar - Validate

Validate

Save

Preview

Submit

• 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 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

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within the expandable/collapsible field set to save the information entered before being able
to click the ' Save' icon ( ) located within the action bar or use the 'Previous' and 'Next'
buttons to navigate to another page. Click the 'Previous' and 'Next' buttons on a form to save
the data entered within a form. Click the 'X' button in the upper right-hand corner of the
form in your browser to close the form without saving.

Exhibit 3-23: Action Bar - Save

y a ~ m

Validate Save Preview Submit

• 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 3-24: Action Bar - Preview

y a ~ m

Validate Save Preview Submit

• Submit: You can click the 'Submit' icon ( ) to submit a Section 5 Notices and Supports
form after you and/or an assigned Support have completed all sections of a Section 5 Notices
and Supports form. After you click the ' Submit' icon ( ) a pop-up message displays to
confirm the submission process. The form validates during the submission process and
displays any applicable warning or error messages. Refer to Section 11 for further
instructions on validation errors. You can continue with the submission process only after
clearing all validation errors. Validation warnings will not prevent you from submitting a
form. Upon successful submission of the form, the application generates and sends an email
indicating the successful submission of the form to the submitter's email address. Refer to
Section 12 for more information on submitting a Section 5 Notices and Supports form.

Exhibit 3-25: Action Bar - Submit

Validate

Save

Preview

Submit

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

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• 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 3-26 shows a screen capture of the action bar 'Help' links:

Exhibit 3-26: Action Bar - Help Links

3.10 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' pop-up 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' pop-up 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. The application checks
chemicals 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.

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

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

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

• Search SRS: Click the 'Search' button to initiate the database search for the 'CASRN' or
'CA Index Name or Other Synonym' for the desired chemical. Refer to Section 3.10 for
additional details regarding the search SRS functionality.

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

Exhibit 3-27 shows a screen capture of the 'Search Substance Registry Services' pop-up
window:

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Exhibit 3-27: Search Substance Registry Services Pop-Up Window

c^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 I

ICreate New Chemical I

Navigation: Click the 'Search SRS' 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 radio button associated to a 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 'CB1' 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 CASRN, if available.

• Maximum Percent: Enter the maximum percentage for the impurity. This field displays
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' pop-up 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.

Exhibit 3-28 shows a screen capture of the 'Chemical Not Found In Substance Registry Services'
pop-up window:

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Exhibit 3-28: Chemical Not Found In Substance Registry Services Pop-Up Window

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

CBI:

Chemical Name

CASRN:

Maximum Percent:

Navigation: Click the 'OK' button to save the specified 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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3.11 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 Notice. The 'Add Facility' button is used to generate the 'Add Facility' pop-
up window and select the applicable sites for which you will be reporting. The 'Add Facility'
drop-down menu contains the sites that all AO users within the same organization are registered
for within CDX registration; additional facilities can be added within CDX to further populate
this drop-down menu.

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

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

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

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

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

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

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

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

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

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

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

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

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

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Exhibit 3-29 shows a screen capture of the 'Add Facility' pop-up window:

Exhibit 3-29: Add Facility Message Pop-Up Window

ADD FACILITY

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

Cancel

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 3-30 shows a screen capture of the 'Add Facility' pop-up window:

Exhibit 3-30: Add Facility Pop-Up Window

Select a site from the drop-down menu below:

CBI:

Alias:

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

State:

Postal Code:

ADD FACILITY

Add Facility Cancel

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 Create Premanufacture Notice (PMN) Form

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

4.1 Create PMN Form

To create a new PMN form, navigate to the 'Section 5 Notices and Supports Forms' screen and
select 'Premanufacture Notice (PMN)' from the 'Form Type' drop-down menu. Refer to Section
3.4 for additional details regarding the 'Section 5 Notices and Supports Forms' screen.

Refer to Section 3.5 for additional details regarding the create passphrase process.

4.1.1 General Form Information

You can navigate to the 'General Form Information' screen by clicking the 'Start New Form'
button and creating a new passphrase, or 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.

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• 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
'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 payments and connecting
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 numerical 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.

• Form Alias: Enter the form alias. Upon navigating to the screen, the application displays an
auto-generated editable form alias in the following format: . 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

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Marketing Exemption Application (TMEA),' 'Low Volume Exemption (LVE) @ 40 CFR
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 numerical 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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bottom of the screen within the action bar or by clicking the 'Next' button on the 'General
Form Information' screen.

• 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)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

j""[f General Form Information

i""[3jUser Fees Certification

f"[5jAgent information

i"'f| Technical Contact Information

}""|3 Additional Submission
Information

?"[_ Chemicals

! Class 2 Chemical

Substance

H3 Chemical
Identification

""(f Class 1 or 2
Chemical
Substances

jAdditional Chemical
Information

j?iProduction Volume
and Hazard/Safety
Information

!""[§jUse information

^'flfPhysical &

Chemical
Properties

Physical and
Chemical
[ j Properties
; ! Worksheet

I "-|i Physical and

Logged in as: Jane Doe, Primary Authorized Official

Log Out

irne y Forms T User Management ™ Resources
4 Premanufacture Notice (Primary PMN-20140527-12:59:24 EDT) > General Form Information

GENERAL FORM INFORMATION

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

The form alias is a required 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 any time.

Form Alias Primary PMN-20140527-12:59:24 EC

Type of Notice

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

PMN Identification

Please enter the 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:

Risk assessments:

•J

Validate Save

Preview

Submit

CDX Homepage

| MyCDX Homepage ]

I EPA Homepage | Terms and Conditions

| Privacy Notice

| CDXHelpdesk: (8£

38) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
47

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CD)Sr

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 Authorized Official

Primary PMN-20140527-12:59:24
EDT

General Form Information

HWjUser Fees Certification

j-"FlAgent Information

'[^Technical Contact Information

H Additional Submission
Information

B'i_ Chemicals

j Class 2 Chemical
{ Substance

Hi Chemical
Identification

l^jClass 1 or 2
Chemical
Substances

*"[§ Additional Chemical
Information

"'[^Production Volume
and Hazard/Safety
Information

f ifyUse Information

5'l^Physical &

Chemical
Properties

"[^'|Physical and
Chemical
Properties
Worksheet

"g:Physical and

* Logged in as: Jane Doe, Primary Authorized Official

Log Out

Home T Forms T User Management T Resources

ocicLt uit lype ui iui uit lyptr ui iuiiii yuu wibn tu niS"

PMN Identification

Please enter the TS Number and/or Payment ID (it 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 g

submitter:

Identify whether any of the below options apply.

Risk assessments
Structure/Activity
relationships'
Other data:

O
Q

Check here if you are filing a Joint PMN:

Check here if you have a Letter of Support
pending:

B
0

¦/ B

•

Validate Save

Preview

Submit

CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (8J

38)890-1995

Navigation: If you are filing a 'PMN ' or 'SNUN,' click the 'Next' button to navigate to the
'User Fees Certification' screen. You can also access this screen by clicking the 'User Fees
Certification' link within the navigation tree for an in progress form. If you are not filing a
'PMN' or 'SNUN,' click the 'Next' button to navigate to the 'Agent Information' screen. You
can also access this screen by clicking the 'Agent Information' link within the navigation tree for
an in progress form. The 'Save' icon in the action bar or the 'Next' button must be clicked before
the links within the navigation tree generate and are available to a user.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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4.1.2 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 for an in progress
form.

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 Authorized Official

Primary PMN-20140527-12:59:24
EDT

General Form Information
BSu ser Fees Certification

Agent Information

I ^Technical Contact Information

Additional Submission
Information

Chemicals

$' jJjClass 2 Chemical
Substance

Chemical
Identification

"[?) Class 1 or 2
Chemical
Substances

j =|Class 2 Substances

'[^Additional Chemical
Information

"1^1 Production Volume
and Hazard/Safety
Information

i" "Quse Information
B {^Physical &

Chemical
Properties

hQ Physical and
Chemical

Logged in as: Jane Doe, Primary Authorized Official

Log Out

me y Forms T User FJlanagement T Resources
< Premanufacture Notice (Primary Pr.riJ 20140527-12:59:24 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 11000 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).

-------
CDX.

'PMN' or 'SNUN.' You can also navigate to this screen by clicking the 'Agent Information' link
within the navigation tree.

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

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

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

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

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

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

• Actions: Click the 'Delete' icon (J€) 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

y User Management J

Logged in as Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

H3General Form Information

'r'{2_ Agent Information

!""Q:Tecfinical Contact Information

Additional Submission
Information

5H_ Chemicals

<&Add Consolidated
Chemical

B"l_ Site Information

!j'~[^lSite Information

Sites Controlled By
Others

S"L Submitter Controlled
Operations

"%|Add Operation

5"( Operations Controlled by

Others

'"%|Add Operation
Optional Pollution Prevention
^Additional Attac hments
f"h Attachment Summary
^ Optional Cover Letter

4 Premanufacture Notice (Primary PMN-20141201-11:36:29 EST) > Agent Information

AGENT INFORMATION

To add a new Agent click the Add Agent button [AddAgenJ
Last Name First Name Address

CBI

Actions

Validate

Save

Preview

Submit

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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4.1.3.1 Add Agent

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

The identification of an agent is optional.

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

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

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

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

• Position: Enter the agent's job title.

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

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

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

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

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

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

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

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 4-5 shows a screen capture of the 'Add Agent' pop-up window:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CD)Sr

Exhibit 4-5: Add Agent Pop-Up Window

•ffl

CSPP

ADD AGENT

Please enter the information for the agents who will be responsible for supporting the information on the
form. Check to claim information as CBI or click the 'Copy CDX Registration1 button to populate from CDX
(if applicable)

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

First Name:

Last Name:
Position:
Company Name
Phone Number:

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.

Cancel

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.

4.1.4

Technical Contact Information

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

The technical contact should be able to answer, or obtain answers to, questions related to the
chemical submitted to EPA within the PMN form. The technical contact does not have to

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physically work at the site reported on the form, but must be readily available by phone or email.
It is required to identify at least one technical contact.

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

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

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

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

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

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

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

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

Exhibit 4-6: Technical Contact Information Screen

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

H General Form Information

;""j=|Agent Informatton

iplTechnical Contact
Information

i"'I ^Additional Submission
I reformation

— Chemicals

J^Add Consolidated
C hemic al

^'Q Site Information

'"Msite Information

"QSites Controlled By
Others

9"i i Submitter Controlled

Operations

:""^Add Operation

Operations Controlled by

Others

""L^jAdd Operation

[^Optional Pollution Prevention

Additional Attac hments

"hiAttachment Summary

Optional Cover Letter

y User Management j

Logged in as Jane Doe, Primary Authorized Official

Log Out

< Premanufacture Notice (Primary PMN-20141201-11:36:29 EST) > Technical Contact Information

TECHNICAL CONTACT INFORMATION

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

Last Name

First Name

Address

CBI

Actions

|^NexJ

—— V

Validate

Save

Preview

Submit

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

4.1.4.1 Add Technical Contact

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

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

• 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. Check the 'CBI' checkbox after importing CDX
registration information to claim a technical contact as confidential.

• 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

£ CSPP

¦o

ADD TECHNICAL CONTACT

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

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

First Name:

Last Name:
Position:

Company Name:
Phone Number:

Phone Extension:
Email Address:
Mailing Address 1:

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

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

Mailing Address 2:

City:

State:

Postal Code:
Country:

Apartment, suite, etc.

United States

Cancel

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

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4.1.5 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.

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 entered identification number(s) 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 entered identification number(s) 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 entered identification number(s) 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
upon clicking the 'Save' button located in the bottom action bar.

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.

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Please note that in IE 7, leaving an identification number field blank and clicking the 'Save' icon
located within the 'Actions' column header 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.

• Prenotice Communication Number - None: Check the 'None' checkbox for the 'Prenotice
Communication Number' to indicate that there is no prenotice communication number.

Check the 'None' checkbox to remove the 'Prenotice Communication #' 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 (H) 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. Check the 'None' checkbox to remove 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 (a
PMN, SNUN, LVE, LVE Modification, LoREX, LoREX Modification, or TMEA case
number format); this value accepts alphanumeric characters and dashes. 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, 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. Check the
'None' checkbox to remove 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 (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

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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.

• 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

Logged in as Jane Doe, Primary Authorized Official

Log Out

Home y Forms y User Management J Resources
4 Premanufacture Notice (Primary PMN-20141201-11:36:29 EST) > Additional Submission Information

ADDITIONAL SUBMISSION INFORMATION

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

3. Prenotice Communication Number

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-11:36:29
EST

j"" General Form Information

j Agent Information
I ^Technical Contact Information
Additional Submission
Information
t? Chemicals
| $ ^Chemical 5863

! j j"'j Chemical

identification

Class 1 or 2
Chemical
Substances

j - j^Ctess 1 or 2
Chemical
Substances

j""|_jClass 2 Substances

Additional Chemical
information

Production Volume
and Hazard/Safety
information

=""| - jUse Information
(5'ljj|fPhysical &

Chemical
Properties

Physical and
Chemical
Properties
Worksheet

""|jf|Ptiysicai and ,

Chemical

4. Previously Submitted Notice Number:

5. Bona Fide Intent Notice Number

Manufacture or Import Options

~ None

Prenotice

Actions

~ CBl

Communication #

I I

yx#

~ None

Previously Submitted

Actions

~ CBl

Notice #

II II

yx#

~ None

Bona Fide Intent

Actions

~ CBl

Notice #

yx#

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

Manufacture:
Import:

~
~

Binding:
Binding:

~
~

Validate

Save

Preview

Submit

Navigation: Click the 'Next' button to navigate to the 'Chemical Identification' screen. You
may also access this screen by clicking the 'Add Consolidated Chemical' link within the
navigation tree.

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4.1.6 Chemical Identification

You can access the 'Chemical Identification' screen by clicking the 'Next' button from the
'Additional Submission Information' screen. You may also click the 'Add Consolidated
Chemical' link within the navigation tree access the 'Chemical Identification' screen.

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 4-9 shows a screen capture of the 'Chemical Identification' screen:

Exhibit 4-9: Chemical Identification Screen

Y User Management j

Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice 4
Primary Authorized Official

Primary PMN-20140313-10:33:26
EDT

Additional Submission
Information

B'i_ Joint Submission

5 fij|f Joint Submission 1

f"hjJoint Submitter
Information

Joint Submission
I ! Information

!""X Remove

. =jAdd Joint Submission

Letter of Support

5"||fl_etter of Support 1

i I J^ILetter of Support
I ! Submitter
Information

i " "I ^Letter of Support
; Submission
j ! Information

""X Remove

] "Lrg]Add Letter of Support

Chemicals

^Add Consolidated
Chemical

_ Site Information

j""lj Submitter Controlled Site

Premanufacture Notice (Primary PMN-20140313-10:33:26 EDT) > Chemical kleirtification

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 below.

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,

Validate

Save

Preview

Submit

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.

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

4.1.7 Class 1 or 2 Chemical Substances

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

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.

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).

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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.

• 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 (X) 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.

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

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

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

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• 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 3.10 for additional details regarding the search
SRS functionality.

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

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

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

• 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 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 (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 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
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 if there is no pending Letter of Support or Joint Submission for
the form.

• IES Order #: Enter the IES order number of the report. This field only displays when the
'Method 1 (CAS Inventory Expert Service)' radio button is selected. This is a required field
if the 'Method 1 (CAS Inventory Expert Service)' radio button is selected and if there is no
pending Letter of Support or Joint Submission for the form.

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

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

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• 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 3.6 for further details regarding the attach document
functionality.

• Section: Displays the section associated with a document.

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

• Description: Displays the description associated with a document.

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

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 4-10 shows a screen capture of the 'Class 1 or 2 Chemical Substances' screen (Scroll 1):
Exhibit 4-10: Class 1 or 2 Chemical Substances Screen (Scroll 1)

A Logged in as: Jane Doe, Primary Authorized Official

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Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

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4 Premanufacture Notice (Primary PMN-20141201 -11:36:29 EST) > Class 1 or 2 Chemical Substances

CLASS 1 OR 2 CHEMICAL SUBSTANCES

Expand All | Collapse All
Cancel X

B. 1 a. Class of Substance:

Class 1 O Class 2 CBI: U

Click the button below to search EPA's Substance Registry Services (SRS) for the desired chemical-
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CASRN:

Chemical Name:

CBI: 8

B.6. Generic Chemical Name:

B.t.c. ID Method

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

Include an attachment for the ID Method below.

Method 2 (Other Method)

B.1.d. Molecular Formula:

CBI:

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V s

Validate Save

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Submit

CDX Homepage

| MyCDX Homepage

| EPA Homepage | Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
71

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CD)Sr

Exhibit 4-11 shows a screen capture of the 'Classl or 2 Chemical Substances' screen (Scroll 2):
Exhibit 4-11: Class 1 or 2 Chemical Substances Screen (Scroll 2)

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Logged in as: Jane Doe, Primary Authorized Official
Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

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B.1.d. Molecular Formula:

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CBI:

B.1.e_ Chemical Structure Diagram:

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

Attach Document

Section

File Name

Description

Pages CBI Actions

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|^NextJ

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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 CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
72

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CDX.

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

4.1.8 Class 2 Substances

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

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 boxes 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 3.10 for additional 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 (X) 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.

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• 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 3.6 for further
details regarding the attach document functionality.

• Section: Displays the section associated with a document.

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

• Description: Displays the description associated with a document.

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

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

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

Exhibit 4-12 shows a screen capture of the 'Class 2 Substances' screen (Scroll 1):

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
74

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CD)Sr

Exhibit 4-12: Class 2 Substances Screen (Scroll 1)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

General Form Information

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4 Premanufacture Notice (Primary PMN-20141201-11:36:29 EST) > 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.1.e.1. Precursor Substances CBI:

Search srs Click the 'Search SRS' button to search ERA'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.I.e.2. Nature of Reaction CBI: 1

CASRN

Action

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

—-I—
-------
CD)Sr

Exhibit 4-13: Class 2 Substances Screen (Scroll 2)

Pre manufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

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Preview

Submit

CDX Homepage

I MyCDX Homepage

I EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (888) 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.

4.1.9 Additional Chemical Information

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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An 'Impurities' table displays information regarding the impurities that may be reasonably
anticipated to be in the respective chemical or polymer as manufactured for commercial purpose.
Click the 'Search SRS' button to access the 'Search SRS' pop-up window and populate the
'Impurities' table. You will also be able to enter a chemical using the 'Chemical Name' and
'CASRN' field (if applicable) on the 'Chemical Not Found In Substance Registry Services' pop-
up window. If there are unidentified impurities, enter "unidentified." You also have the option of
claiming the chemical as confidential by checking the 'CBI' checkbox. A 'Maximum %' field is
also displayed which captures the maximum percentage for the impurity. Documents may be
attached for the 'Impurities' section if necessary.

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

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

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

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

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

The attachments table displays the section of the page the document is associated with, the file
name and file extension of the document, the document description, the number of pages in the
document, and if the document was claimed CBI. Click the 'Delete" icon (X) 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 3.10 for further details
regarding the search SRS functionality.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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• Impurity: Displays the name of the impurity. An impurity is a chemical substance that you
did not intend to be present with your PMN substance. List all known impurities that are
present, regardless of their weight percent. List the expected maximum percentage of each
impurity and indicate its confidentiality status. An impurity may be suggestive of chemical
precursors or chemical processes. Click the 'Impurity' link to navigate to the 'Search
Substance Registry Services' pop-up window to edit chemical information for an impurity.

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

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

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

• Action: Click the 'Delete" icon (X) 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 3.10 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 (X) to delete the entire byproduct entry permanently from
the system; a warning message displays to confirm the deletion.

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

• Synonym: Enter the synonym of the chemical; there is a maximum of five chemical
synonyms that can be added in the 'Synonyms' table. Additional synonyms can be provided
in an attachment. Synonyms include common chemical names used in scientific or technical
literature, and code numbers or code names referenced in the PMN and its attachments.
Indicate which synonyms may be proprietary and require CBI protection. Chemical name
synonyms must be consistent with the chemical structure and thus not misleading. If you add
a blank, editable line in this table and click the 'Next' button, no error will display indicating
that the blank line should be saved or deleted. If text is entered in a blank field and you click
the 'Next' button, the application will save the entered value. If you click the 'Form' icon
(II), edit the entered values and click the 'Next' button without saving the changed value, an
error will generate.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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• Actions: Click the 'Add' icon ( ) to add a new text field to enter additional synonyms.

Click the 'Save' icon () to save a chemical synonym. Click the 'Form' icon (13) that
appears after saving to edit a chemical synonym. Click the 'Delete' icon (X) to delete a
previously added chemical synonym. To cancel changes to a field, simply clear the data
entered in the field.

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

• Trade Name: Enter the trade identification name. List any trade name that is used, or will be
used, for the neat chemical substance, whether or not they are registered brands/trademarks.
There is no limit to the number of trade names that can be added. Check the 'CBI' checkbox
to indicate the CBI status of trade names. If you add a blank, editable line in this table and
click the 'Next' button, no error will display indicating that the blank line should be saved or
deleted. If text is entered in a blank field and you click the 'Next' button, the application will
save the entered value. If you click the 'Form' icon (13), 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 (_) to save a trade identification name. Click the
'Form' icon (ll) to edit a trade identification name. Click the 'Delete' icon (^) to delete a
previously added trade identification name.

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

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window. Refer to Section 3.6 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.'

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

Exhibit 4-14 shows a screen capture of the 'Additional Chemical Information' screen (Scroll 1):

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
79

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CD)Sr

Exhibit 4-14: Additional Chemical Information Screen (Scroll 1)

Home y Forms ~ User Management ~ Resources

Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

Agent Information

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Additional Submission
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Chemical 5863

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4 Premanufacture Notice (Primary PMN-20141201 -11:36:29 EST) > 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 Maximum% CBI Action

B.7. Byproducts

Describe any byproducts resulting from the manufacture, processing, use, or disposal of the new
chemical substance. Provide the CAS Registry Number if available.

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

B.4. Synonyms CBI: U

Enter any chemical synonyms for the new chemical substance.

-------
CD)Sr

Exhibit 4-15 shows a screen capture of the 'Additional Chemical Information' screen (Scroll 2):
Exhibit 4-15: Additional Chemical Information Screen (Scroll 2)

Pre manufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

j'"{S]Agent Information

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Byproduct Name CASRN CBI

Action

B.4. Synonyms CBI: B

Enter any chemical synonyms for the new chemical substance.

Synonym

Actions

IX#

B.5. Trade Identification CBI:

List trade names for the new chemical substance-

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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.

4.1.10 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.

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

• Delete: Click the 'Delete" icon (X) 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 button to generate the 'Search SRS' pop-up window. Refer to Section
3.10 for additional details regarding the search SRS functionality.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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• CASRN: Displays the CASRN of the chemical identified on the 'Search SRS' pop-up
window, if applicable.

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

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

• 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 the 'Method 1 (CAS
Inventory Expert Service)' radio button is selected.

• 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 3.6 for additional details regarding the attach document functionality.

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

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

• Description: Displays the description of a document.

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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• 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 (I ) 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
3.9 for more information regarding the save functionality in an expandable/collapsible field
set.

Exhibit 4-16 shows a screen capture of the 'Polymer Identification Information' screen (Scroll

1):

Exhibit 4-16: Polymer Identification Information Screen (Scroll 1)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

Properties *

Worksheet

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< Premanufacture Notice (Primary PMN-20140527-12:59:24 EDT) > Polymer Identification Information

POLYMER IDENTIFICATION INFORMATION

Chemical

Expand All | Collapse All

Cancel

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

CASRN:

Chemical Name'

CBI: 0

Generic chemical name:

ID Method

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

Method 2 (Other Method)

Include an attachment for the ID Method below.

Chemical Structure Diagram:

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

Attach Document

>/ ¦

Validate Save

Preview

Submit

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Exhibit 4-17 shows a screen capture of the 'Polymer Identification Information' screen (Scroll
2):

Exhibit 4-17: Polymer Identification Information Screen (Scroll 2)

y Forms y User Management J Resources

A Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

Properties
Worksheet

"Fl Physical and
Chemical
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[ Properties

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ID Method

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Method 2 (Other Method)

Include an attachment for the ID Method below.

Chemical Structure Diagram:

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

Attach Document

Section

File Name

Description

Pages CBI Actions

Save

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

Add New Chemical

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

| Next |

•/ B

Validate Save

Preview

Submit

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*8)890-1995

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

4.1.11 Monomers arid 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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The 'Monomers and Other Reactants' screen is used to identify the chemical measurements and
monomers that make up a polymer. The screen is divided into two sections to identify different
elements describing a polymer: 'Polymer Weight Information' and 'Monomers and Other
Reactants.'

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

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

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

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

• Method of Measurement: Only a single response option can be selected for 'Method of
Measurement;' valid values include 'GPC' and 'Other (Specify).' Gel-permeation
chromatography (GPC) is a well-established method for establishing the number average
molecular weight (Mn) and weight fractions below 500 and 1,000 Daltons. It may not be
useful for all polymer evaluations; however, solubility problems and misleading calibration
standards can lead to questionable GPC data. Correction estimates can be documented and
presented in cases where only a soluble fraction of the polymer can be analyzed. This is a
required field if there is no pending Letter of Support or Joint Submission for the form.

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

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

• (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.

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

• 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 3.10 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).

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

• Maximum Residual: Enter the maximum residual value. Indicate the maximum weight
percent of each monomer or other reactant that may be present as a residual in the polymer as
manufactured for commercial purposes. Enter a percent value less than or equal to the
maximum weight; do not use ppm units (1 ppm = 0.0001 wt%). The value entered must be a
positive numerical value that is less than or equal to the typical composition value. This is a
required field.

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

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window. Refer to Section 3.6 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 CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

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Exhibit 4-18 shows a screen capture of the 'Monomers and Other Reactants' screen (Scroll 1):
Exhibit 4-18: Monomers and Other Reactants Screen (Scroll 1)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-

11:36:29 EST

I ; i jprtysicai ana
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Properties
Worksheet -
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>me ™ Forms T User Management Y Resources
« Premanufacture Notice (Primary PMN-20141201 -11:36:29 EST) > Monomers and Other Reactants

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(Specily)

Specify other method of measurement:

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: L

B.2.b. Monomers and Other Reactants

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

wt%).

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

•

Validate

Save

Preview

Submit

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CD)Sr

Exhibit 4-19 shows a screen capture of the 'Monomers and Other Reactants' screen (Scroll 2):
Exhibit 4-19: Monomers and Other Reactants Screen (Scroll 2)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-

11:36:29 EST

(jHKnysicai ano
Chemical
Properties
Worksheet -
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(Optional)

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J^Chemical
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i T Forms T User Management T Resources

i ii iC nuu iviui iui 11 v_-1 uuitun iu uuu niunOun-i j mat m icmc-

Expand A!! | 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:
CAS Registry Number:
Chemical Name:

CBlO

Typical Composition: | |%

CBI:0

Maximum Residual: I |%

CBI:0

Save

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

Composition Total:0%

Attachments

Attach Document

File Name

Description

Pages

CBI

Actions

>/ ¦

Validate Save

Preview

Submit

CDX Homepage

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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4.1.12 Production Volume and Hazard/Safety Information

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

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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• CBI: Check the 'CBI' checkbox to claim the production volume information as confidential.

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

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

• 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 3.6 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 (X) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 4-20 shows a screen capture of the 'Production Volume and Hazard/Safety Information'
screen:

Exhibit 4-20: Production Volume arid Hazard/Safety Information Screen

Y User Management j

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Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

i Class 2 Chemical
Substance

[^|Chemical
Identification

Q Class 1 or 2
Chemical
Substances

:Additional Chemical
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i""QPhysical and
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4 Premanufacture Notice (Primary PMN-20140527-12:59:24 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

C.1. Production Volume

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

CBI: L) Binding:

kg/yr
kg/yr

3. Hazard Information Binding: I

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

Validate

Save

Preview

Submit

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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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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4.1.13 Use Information

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

The 'Use Information' screen captures data about how the new chemical substance is intended to
be used by function and application. Function refers to the chemical purpose for which the
substance is designed and is often based on the physical and chemical properties of the
substance. Application refers to how the substance is used in particular processes or products. An
example of a function and application would be as a dispersive dye for finishing polyester fibers.
When you navigate to the screen, the screen contains instructional text and an 'Add Use' button.
When you click the 'Add Use' button, an expandable/collapsible field set opens and displays the
'Use Information' fields. Upon saving the entry, the expandable/collapsible field set collapses
and displays the 'Category of Use' and 'Production %' values.

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

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

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

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

• 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'

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link displays when the expandable/collapsible field set has been saved and the data is not
currently editable.

• 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.

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

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

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

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

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

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

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

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

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

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

• Site Limited %: Enter the site limited percentage of substance expected per use for the
submitted substance. Blank fields are recognized as zeroes. This field allows for decimal
values. Break down the use(s) by percentage for the indicated end user categories. For

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example, site-limited means the substance will only be used on the adjacent property unit
where manufactured and will not intentionally be removed from the site except for waste
disposal.

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

• Industrial %: Enter the industrial percentage of substance expected per use for the
submitted substance. Blank fields are recognized as zeroes. This field allows for decimal
values. Break 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 3.6 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.

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3.9 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.

Exhibit 4-21 shows a screen capture of the 'Use Information' screen (Scroll 1):

Exhibit 4-21: Use Information Screen (Scroll 1)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

General Form Information

User Fees Certification

"0Agent Information

"\2 'Technical Contact Information

"[£ Additional Submission
Information

Chemicals

y User Management J

Logged in as Jane Doe, Primary Authorized Official

Log Out

4 Premanufacture Notice (Primary PMN-20140527-12:59:24 EDT) > Use Information

USE INFORMATION

3 2 Chemical

Substance

I Chemical
Identification

•"FI Class 1 or 2
Chemical
Substances

j; Additional Chemical
Information

( Production Volume
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Information

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5 Physical &
Chemical
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Physical and
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Properties
Worksheet

Physical and

Expand All | Collapse All

Cancel

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

Category of Use: CBI:® Binding:D

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

C.2.b. Generic Use Description:

Total Production
for this Use:

In Formulation

]% CBI:U
% CBI:Q

% of substance expected per use:

CBI: BindingO

-/ g

•

Validate Save

Preview

Submit

CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (8£

38)890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 4-22 shows a screen capture of the 'Use Information' screen (Scroll 2):

Exhibit 4-22: Use Information Screen (Scroll 2)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

f"l " General Form Information

"PlUser Fees Certification

Agent Information

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Information

@"i Chemicals

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Home y Forms y User Management J Resources

% of substance expected per use: CBI: J Binding! J

-8- Logged in as: Jane Doe, Primary Authorized Official

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Site Limited:
Consumer":
Industrial:
Commercial.

Total: 0 %

* IT you have provided a "consumer" use. provide details: CBI: I

Attach Document

File Name

Description

Save

Pages CBI Actions

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Production Total:0%

Mk.

Validate

Save

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CDX Homepage |

I MyCDX Homepage

I EPA Homepage |

Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (888) 890-1995

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

4.1.14 Physical and Chemical Properties Worksheet

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

The 'Physical and Chemical Properties Worksheet' screen is used to capture optional
information about a chemical's properties. EPA uses the chemical properties to determine
additional safety data about a chemical; the properties are used to determine potential risks and
exposures of the chemicals.

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

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

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

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

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

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

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

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

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

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

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

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

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

Please note that in IE 7, all physical/chemical properties you wish to add must be identified
before navigating away from this page; otherwise, the properties are removed from the 'Add
Property' drop-down menu. In addition, you will be able to add the 'Henry's Law constant'
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 (X) located in the upper right-hand corner of an
expandable/collapsible field set to delete the field set. A confirmation message displays to
confirm the deletion.

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

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

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

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

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

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

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

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

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

• 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.

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

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

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

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

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

• 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.

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

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

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

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

• 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

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from the drop-down menu. This is a required field if the 'Solubility in Water @ temperature'
property is selected.

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

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

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

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

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

• 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.

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• 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.

Exhibit 4-23 shows a screen capture of the 'Physical and Chemical Properties Worksheet' screen
(Scroll 1):

Exhibit 4-23: Physical and Chemical Properties Worksheet Screen (Scroll 1)

Y User Management y

* Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice
Primary Authorized Official

Primary PMN-20140313-10:33:26
EDT

Chemical
Identification

^[Polymer
Identification
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| l" j - [Monomers and
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!"" [Additional Chemical
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4 Premanufacture Notice (Primary PMN-20140313-10:33:26 EDT) > Pliysical and Chemical Properties Worksheet

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET

T o 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. Identify1 the property measured, the value of the property, the units in which the
property is measured (as necessary), and whether or not the property Is claimed as confidential. The physical state of
the neat substance should be provided. These measured properties should be for the neat (100% pure) chemical
substance. Properties that are measured for mixtures or formulations should be so noted (% PMN substance in). You
should submit this worksheet as a supplement to your submission of test data. This worksheet is not a substitute for
submission of test data.

Expand All | Collapse All

Adsorption/ Coefficient

Edit

Boiling/sublimation temperature @ 1 torr pressure

Edit

Density/ relative density

Edit

Dissociation constant

Edit

Explodability

Edit

Flammability

Edit

Henry's Law constant

Edit

Melting Temperature

Edit

Octanol/ water partition coefficient

Edit

Particle size distribution

Edit

Physical state of neat substance

Edit

pH @ concentration 10

Edit

Solubility ^temperature 15°C solvent

Edit

Solubility in Water @ temperature 15°C

Edit

Spectra

Edit

Vapor Pressure @ temperature 15°C

Edit

Volatilization from water

Edit

•y¦

•

Validate Save

Preview

Submit

CDX Homepage

| MyCDX Homepage

I EPA Homepage | Terms and Conditions

I Privacy Notice

I CDX Helpdesk: (8f

38) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
105

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CD)Sr

Exhibit 4-24 shows a screen capture of the 'Physical and Chemical Properties Worksheet' screen
(Scroll 2):

Exhibit 4-24: Physical and Chemical Properties Worksheet Screen (Scroll 2)

¦ Logged in as: Jane Doe, Primary1 Authorized Official

Log Out

&SB0

Home T Forms T User Management ~ Resources

substance. Properties that are measured for mixtures or formulations should be so noted (% PMN substance in). You
Premanufacture Notice «3|10U|Ci submit this worksheet as a supplement to your submission of test data. This worksheet is not a substitute for
ubmission of test data.

Expand All | Collapse All

Primary Authorized Official
Primary PMN-20140313-10:33:26

EDT

i /jChemical
j Identification

j _iPolymer
Identification
Information

fj^ [Monomers and
Other Reactants

j""l^[Additional Chemical
Information

f"! [Production Volume
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j-j=jUse Information

$ ^Physical &
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IjjPhysical and
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Continued
(Optional)

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9 Polymer Substance

f"i" [Chemical
Identification

!_ [Polymer
Identification
Information

j^[Monomers and
Other Reactants

Adsorption/ Coefficient

Edit

Boiling/sublimation temperature @ 1 torr pressure

Edit

Density relative density

Edit

Dissociation constant

Edit

Explodability

Edit

Flammability

Edit

Henry's Law constant

Edit

Melting Temperature

Edit

Octanol/ water partition coefficient

Edit

Particle size distribution

Edit

Physical state of neat substance

Edit

pH @ concentration 10

Edit

Solubility (^temperature 15°C solvent

Edit

Solubility in Water @ temperature 15°C

Edit

Spectra

Edit

Vapor Pressure @ temperature 15°C

Edit

Volatilization from water

Edit

Volatilization from soil

Edit

~ Add Property

| Next |

j"" iAdditional Chemical

Validate

Save

Preview

Submit

CDX Homepage |

[ MyCDX Homepage [

I EPA Homepage |

Terms and Conditions

I Privacy Notice

| CDX Helpdesk: (888) 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
'Physical and Chemical Properties Worksheet - Continued (Optional)' link within the navigation
tree.

4.1.15 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'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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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 displays.

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 which properties an attachment is associated with. 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 (X) 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 3.6 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 a document by displaying either a ' Y' or an 'N.'

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CDXr

Exhibit 4-25 shows a screen capture of the 'Physical and Chemical Properties Worksheet -
Continued (Optional)' screen:

Exhibit 4-25: Physical and Chemical Properties Worksheet - Continued (Optional) Screen

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

Information

'[?]Use Information

5 ljj|fPhysical &

Chemical
Properties

| Physical and
Chemical
Properties
Worksheet

Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

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I ® Copy

" & Chemical 6487

I l""F I Chemical

Identification

"[5! Polymer
Identification
Information

"I ^ j Monomers and
Other Reactants

j Additional Chemic al
Information

-'51Production Volume
and Hazard/Safety

Logged in as: Jane Doe, Primary Authorized Official

Log Out

Home J Forms y User Management y Resources

< Premanufacture Notice (Primary PMN-20141201-11:36:29 EST)> Physical and Chemical Properties Worksheet - Continued
(Optional)

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET - CONTINUED (OPTIONAL)

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

Attach Document

File Name

Properties

Description

Pages

CBI

Actions

|^NextJ

Validate

Save

Preview

Submit

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

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

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

When attaching a document, the properties selected on the 'Physical and Chemical Properties
Worksheet' screen will display with checkboxes to allow the properties to which the attachment

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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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
'Physical and Chemical Properties Worksheet' screen that can be potentially associated with
a document. Check the appropriate chemical properties that are associated with a document
that is being attached. These checkboxes are enabled only if 'Physical Chemical Property' is
selected from the 'Type' drop-down menu.

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

• Description: Enter the description associated with a document.

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
109

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CD)Sr

Exhibit 4-26 shows a screen capture of the 'Attach Documents' pop-up window (Scroll 1) from
the 'Physical and Chemical Properties Worksheet - Continued (Optional)' screen:

Exhibit 4-26: 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 Physical Chemical Property

of the attachment

Chemical Properties

Adsorption/ Coefficient

Boiling/ sublimation temperature @

Density/ relative density

Dissociation constant

Explodability

Flammability

Henry's Law constant

Melting Temperature

Octanol/water partition coefficient

Particle size distribution

Physical state of neat substance

pH @ concentration [concentration]

Solubility ©temperature solvent

Solubility in Water ©temperature

Spectra

Vapor Pressure ©temperature
Volatilization from water
Volatilization from soil
Other Property

Attachment File:

Selectthe file to attach Browse

Description

Provide a description of the
attachment

**P!ease do not include any
CBf infomt ation in trie
description of trie file
infomation.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 15, 2014

Primary Authorized Official 110

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CD)Sr

Exhibit 4-27 shows a screen capture of the 'Attach Documents' pop-up window (Scroll 2) on the
'Physical and Chemical Properties Worksheet - Continued (Optional)' screen:

Exhibit 4-27: Physical and Chemical Properties Worksheet - Continued (Optional) Attach

Documents Pop-Up Window (Scroll 2)

Boiling/ sublimation temperature @

Density/ relative density

Dissociation constant

Expiodabiiity

Flammability

Henry's Law constant

Melting Temperature

Octanol/ water partition coefficient

Particle size distribution

Physical state of neat substance

pH @ concentration [concentration]

Solubility ©temperature solvent

Solubility in Water ©temperature

Spectra

Vapor Pressure ©temperature
Volatilization from water
Volatilization from soil
Other Property

Attachment

Select the file to attach

File:

Browse

Description

Provide a description of the
attachment

**Piease ofo not include any
CBf infomation in the
description of the ftie
infomation.

Number of Pages pages

CBI Check to claim the attachment as CBI W

Sanitized Attachment F'10

Select the sanitized file to Browse

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

not containing any CBI data.

Cancel

Navigation: Click the 'Cancel' button or 'X' icon 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 CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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information and navigate back to the 'Physical and Chemical Properties Worksheet - Continued
(Optional)' screen.

4.1.17 Site Information

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

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

• Do you have sites controlled by the submitter?: Select the 'Yes' radio button to indicate
that you have submitter controlled sites to identify; this response automatically generates the
screens within the 'Submitter Controlled Operations' folder in the 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 CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
112

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CD)Sr

Exhibit 4-28 shows a screen capture of the 'Site Information' screen:

Exhibit 4-28: Site Information Screen

Y User Management J

Logged in as Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

reproduction Volume
and Hazard/Safety
Information

i""|j Use Information

$'l^Physical &

Chemical
Properties

i""N Physical and
Chemical
Properties
Worksheet

•"[l I Physical and
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Continued
(Optional)

X Remove

IE) Copy

^Add Consolidated
Chemical

4 Premanufacture Notice (Primary PF.1N-20140527-12:59:24 EDT) > Site Information

SITE INFORMATION

1. Do you have sites controlled by the submitter?
Yes No

2. Do you have sites controlled by others?
Yes No

Site Information

= fZN

Site Information

Sites Controlled By Others

S Submitter Controlled
Operations

•y¦

Validate Save

Preview

Submit

CDX Homepage

I MyCDX Homepage |

I EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (8J

58)890-1995

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

4.1.18 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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operations outside the U.S.; however, you must report any processing or use activities after
import. Complete a separate 'Operations Controlled By Others' section for each type of
processing, or use operation involving the new chemical substance. If the same operation is
performed at more than one site, describe the typical operation common to these sites. The
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 CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

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CD)Sr

Exhibit 4-29 shows a screen capture of the 'Sites Controlled By Others' screen:

Exhibit 4-29: Sites Controlled By Others Screen

*• Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140408-11:18:01
EDT

V i j-aue miuniiauuM

Sites Controlled By
Others

@ I Submitter Controlled

Operations

i Ep niloperation 1

Submitter Operation
Information

[j Occupational
Exposures

^Environmental
Releases

"X Remove

^Add Operation

Operations Controlled by
Others

i S {^Operation 1

\w_ Industrial Sites
Controlled By
Others

0 Exposures/Releases

i""^ Byproduct
j Information

:""X Remove

"%)Add Operation

Home y Forms y User Management * Resources
4 Premanufacture Notice (Primary PMN-20140408-11:18:01 EDT) > Sites Controlled By Others

SITES CONTROLLED BY OTHERS

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

Yes No
B.1.a. Operation description

Do you have site-specific information?

Yes O No

The '# of Unknown Sites' field is required. Enter '0' if none
# of unknown sites:

CBI:P
I Next I

s/ a

Validate Save

Preview

Submit

CDX Homepage

| MyCDX Homepage |

| EPA Homepage | Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (8f

38) 890-1995

Navigation: Click the 'Next' button to navigate to the 'Submitter Operation Information' screen.
You can also click the 'Add Operation' link under the 'Submitter Controlled Operations' folder
within the navigation tree to generate the submitter controlled operation screens or click the
'Submitter Operation Information' link under the 'Submitter Controlled Operations' folder
within the navigation tree.

4.1.19 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CDX.

within the navigation tree. You can add additional sites by clicking the 'Add Operation' link
within the navigation tree under the 'Submitter Controlled Operations' folder.

The 'Submitter Operation Information' screen captures information about an operation that
occurs at a particular site or group of sites. You are asked a series of questions, and based on the
responses, a series of fields displays regarding a specific operation. The guided approach is
designed to eliminate errors and ensure the completion of all relevant sections for a site. You will
be able to enter an operation alias to identify the operation. Importers are not required to
complete this section for operations outside the U.S.; however, any industrial processing or use
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 (X) 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 3.11 for additional details regarding the add facility functionality.

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• Site Name: Displays the site name.

• Address: Displays the site address.

• City: Displays the site city.

• State: Displays the site state.

• Postal Code: Displays the site postal code.

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

• Actions: Click the 'Delete' icon (X) 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 with associated checkbox(es).

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

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

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

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

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

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

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

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

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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• Days/year: Enter the number of days per year that the chemical is processed or
manufactured; this value cannot exceed 365. This field only displays when you select the
'Continuous' radio button, and is a required field. This field accepts decimal values.

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

• Process Description: Enter the process description. In the 'Process Description' text box, or
an attachment, address the following items: (1) Diagram the major unit operation steps and
chemical conversions. Include interim storage and transport containers (specify - e.g., 5-
gallon pails, 55-gallon drum, rail car, tank truck, etc.). (2) Provide the identity, the
approximate weight (by kg/day or kg/batch on a 100% new chemical substance basis), and
entry point of all starting materials and feedstocks (including reactants, solvents, catalysts,
etc.), and of all products, recycle streams, and wastes. Include cleaning chemicals (note
frequency if not used daily or per batch). (3) Identify by number the points of release,
including small or intermittent 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 3.6 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CD)Sr

Exhibit 4-30 shows a screen capture of the 'Submitter Operation Information' screen (Scroll 1):
Exhibit 4-30: Submitter Operation Information Screen (Scroll 1)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

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4 Premanufacture Notice (Primary PMN-20141201-11:36:29 EST) > Submitter Operation Information

SUBMITTER OPERATION INFORMATION

Postal Code

CBI

Actions

Operation Alias:

The operation alias is a text tield 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 only required if a letter of support and/or Joint submission Is pending: otherwise, this field
is optional.

Please select the site to report operations on:
Add Facility

Site Name Address City State

Select the chemical(s) that this submission pertains to:

~ Chemical 1

~ Chemical 2

A.1.b Operation Type CBI:

Please select the type of operations present at this site.

Manufacturing:

Processing:

Use:1

A.1.C. Operation Description

Amount and Duration (Complete 1 or 2 as appropriate):
Is it batch or continuous?

CBI: ~

i ]

Validate

Save

Preview

Submit

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

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119

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CD)Sr

Exhibit 4-31 shows a screen capture of the 'Submitter Operation Information' screen (Scroll 2):
Exhibit 4-31: Submitter Operation Information Screen (Scroll 2)

Pre manufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

j jX Remove
B Copy

Consolidated
Chemical

Site Information

r'iJjSite Information

.Sites Controlled By
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Use: U

A.1.c. Operation Description

Amount and Duration (Complete 1 or 2 as appropriate):
Is it batch or continuous?

A Logged in as: Jane Doe, Primary Authorized Official

Log Out

' 1. Batch 2. Continuous
max kg/batch:

(100% new chemical substance)

hours/batch:
batches/year:

A.1.d Process Description

CBI: ~

Please describe the attached process/operation, (optional)

Attach Document

File Name

Description

Pages

CBI: U

CBI

Actions

-------
CDX.

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

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

• 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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• User Defined Worker Activity: Enter the worker activity in which workers may be exposed
to a chemical substance. This field displays only for certain worker activity values.

• Protective Equipment/Engineering Controls (3): Enter the protective
equipment/engineering controls used to protect workers. This is a required field.

• CBI: Check the 'CBI' checkbox to claim the protective equipment/engineering controls
information as confidential.

• Binding: Check the 'Binding' checkbox to claim the protective equipment/engineering
controls information as binding.

• Physical Form(s) (5): Enter the physical forms(s) of the new chemical substance (e.g., solid,
crystal, granule, powder, or dust) at the time of exposure. Be as specific as possible on the
physical form (e.g., is the PMN substance isolated as a crystalline or amorphous powder, wet
cake, flake solid, granular solid, or a fused solid?). If data on particle size of solids are
available, it should be included as an attachment. For wet cakes, a percent moisture estimate
may prevent EPA from making an estimate that is too conservative. Please pay particular
attention to the information within if this field is populated via XML file. The information
contained within the 'Physical Forms and % New Substance' field in the thick client
separates into two (2) separate fields, the 'Physical Form(s)' field and '% New Substance'
field when these fields are populated via an XML file generated from the ePMN thick client.
This is a required field.

• Binding: Check the 'Binding' checkbox to claim the physical form(s) information as
binding.

• % New Substance (5): Enter the percentage of new chemical substance (if part of a mixture)
at the time of exposure. A value of zero (0) entered in this field will display an error. Please
pay particular attention to the information if this field is populated via XML file. The
information contained within the 'Physical Forms and % New Substance' field in the thick
client separates into two (2) separate fields, the 'Physical Form(s)' field and '% New
Substance' field when these fields are populated via an XML file generated from the ePMN
thick client. This is a required field that accepts decimal values.

• Binding: Check the 'Binding' checkbox to claim the percentage new substance information
as binding.

• # Workers Exposed (8): Enter the number of workers exposed. Estimate the maximum
number of all workers involved in each activity for all sites combined. This is a required
field.

• CBI: Check the '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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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• 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 (f ) 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
3.9 for more information regarding the save functionality in an expandable/collapsible field
set.

Exhibit 4-32 shows a screen capture of the 'Occupational Exposures' screen (Scroll 1):
Exhibit 4-32: Occupational Exposures Screen (Scroll 1)

Home y Forms * User Management y Resources
4 Premanufacture Notice (Primary PMN-20141201-11:36:29 EST} > Occupational Exposures

OCCUPATIONAL EXPOSURES

¦S. Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

0 Copy

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Chemical

S I Site Information

"!_f_ Site Information

Sites Controlled! By
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Worker Category (1):

Loading into Transport Containers/Vessels

Worker Activity (1):

Protective Equipment' Engineering Controls (3):

Physical Form(s) (5):

% New Substance (5):

# Workers Exposed (8):
Maximum Duration
Hours/Day (10):

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Submit

CDX Homepage

I MyCDX Homepage

I EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (8t

IQ) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
123

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CD)Sr

Exhibit 4-33 shows a screen capture of the 'Occupational Exposures' screen (Scroll 2):
Exhibit 4-33: Occupational Exposures Screen (Scroll 2)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

-a

Copy

: J^Add Consolidated
Chemical

M" Site Information

" Site Information

.Sites Controlled By
Others

EfH' I Submitter Controlled
Operations

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Loading into Transport Containers/Vessels

Worker Activity (1):

Protective Equipment' Engineering Controls (3):

Logged in as Jane Doe, Primary Authorized Official
Log Out

Physical Form(s) (5):
% New Substance (5):

# Workers Exposed (8):
Maximum Duration
Hours/Day (10):
Days/Year (11): |

Save

Click the Add button to add an occupational exposure. Add

Q Q

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Submit

CDX Homepage |

I MyCDX Homepage |

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December 15, 2014
124

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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.

4.1.21 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 'Environmental Release and Disposal -
Submitter Controlled Sites' expandable/collapsible field set.

• 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.

• 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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CDX.

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

• Amount of new substance released to Environment (2a): Select the applicable radio
button and enter the amount of new substance released to environment. Release estimates
should be consistent with the release levels shown on the preceding flow diagram on the
'Submitter Operation Information' screen. Include intermittent release estimates from
cleaning of equipment and transportation containers, even if cleaned off-site. Either the
'Amount of new substance released to Environment' or the 'Amount of new substance
released to Control Technology' field should be populated.

• Amount of new substance released to Environment kg/day: Select the radio button to
claim that the amount of new substance released to the environment is measured in kilograms
per day.

• Amount of new substance released to Environment kg/batch: Select the radio button to
claim that the amount of new substance released to the environment is measured in kilograms
per batch.

• Amount of new substance released to Control Technology (2b): Enter the amount of new
substance released to control technology. Release estimates should be consistent with the
release levels shown on the proceeding flow diagram on the 'Submitter Operation
Information' screen. Include intermittent release estimates from cleaning of equipment and
transportation containers, even if cleaned off-site. Either the 'Amount of new substance
released to environment' or the 'Amount of new substance released to Control Technology'
field should be populated.

• Amount of new substance released to Control Technology kg/day: Select the radio button
to claim that the amount of new substance released to control technology is measured in
kilograms per day.

• Amount of new substance released to Control Technology kg/batch: Select the radio
button to claim that the amount of new substance released to control technology is measured
in kilograms per batch.

• Media of Release (4): Identify the media of release (i.e., stack air, fugitive air, surface water,
on-site or off-site land or incineration, POTW, or other (please specify)) to which the new
substance will be released from that release point from the drop-down menu. This is a
required field.

• CBI: Check the 'CBI' checkbox to claim the media of release as confidential.

• If Other, specify: Enter the other media of release when you select 'Other' from the 'Media
of Release' drop-down menu.

• Control Technology Description (5a): Enter the control technology description. Describe
control technology, if any, and control efficiency used to limit the release of the new
substance to the environment. For releases disposed of on land, characterize the disposal
method and state whether it is approved for disposal of Resource Conservation and Recovery
Act (RCRA) hazardous waste. For each site, describe any additional disposal methods that
will be used and whether the waste is subject to secondary or tertiary on-site treatment.
Indicate if you want this information to bind. Check the 'CBI' checkbox if the information is
confidential. This is a required field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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• Binding: Check the 'Binding' checkbox to claim the control technology description as
binding.

• Release after Control Technology (5b): Enter the release after control technology. Estimate
the amount released to the environment after control technology (in kilograms per day). This
is a required field.

• 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 CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 4-34 shows a screen capture of the 'Environmental Releases' screen (Scroll 1):
Exhibit 4-34: Environmental Releases Screen (Scroll 1)

Home y Forms J User Management J Resources
-< Premanufacture Notice (Primary PMN-20140527-12:59:24 EDT) > Environmental Releases

ENVIRONMENTAL RELEASES

•#> Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140527-12:59:24
EDT

<&Add Consolidated
Chemical

~ Site Information

"I2_ Site Information

"h Sites Controlled By Others

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Release Number (1): [

Amount of new substance released
to Environment (2a)

Cancel

CBI Binding

O to Control Technology (2b):

Media of Release (4):

Control Technology Description (5a):

Kg/Day Kg/Batch

Release after Control Technology (5b):

Save

Validate

Save

Preview

Submit

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CD)Sr

Exhibit 4-35 shows a screen capture of the 'Environmental Releases' screen (Scroll 2):
Exhibit 4-35: Environmental Releases Screen (Scroll 2)

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Logged in as: Jane Doe, Primary Authorized Official

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Primary Authorized Official

Primary PMN-20140527-12:59:24
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Chemical

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Click the Add button to add an environmental release and disposal J Add

A.S.7. Mark the destinations of release to water

I POTW: Name'

Navigable Waterway: Name
Other (Specify):

NPDES#
NPDES #.

Name

CBI
CBI: ~
CBI: B

Validate

Save

Preview

Submit

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
129

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CDX.

Navigation: Click the 'Next' button to navigate to the 'Industrial Sites Controlled By Others'
screen. You can also access this screen by clicking the 'Industrial Sites Controlled By Others'
link within the navigation tree. Click the 'Add Operation' link under the 'Operations Controlled
By Others' folder within the navigation tree to generate the screens for an operation controlled
by others.

4.1.22 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 'Industrial Sites Controlled By
Others' screen also displays a field to add an operation process description. In the operation
description, include the following information: (1) Diagram the major unit operation steps and
chemical conversions, including interim storage and specify transport containers (e.g., 5-gallon
pails, 55-gallon drums, rail cars, tank trucks, etc.). On the diagram, identify by letter and briefly
describe each worker activity. (2) Either in the diagram or in the text field, provide the identity,
the approximate weight (by kg/day or kg/batch, on a 100% new chemical substance basis), and
entry point of all feedstocks (including reactants, solvents and catalysts, etc.), products, recycle
streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch).
(3) Either in the diagram or in the text field, identify by number the points of release, including
small or intermittent releases, to the environment of the new chemical substance.

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

• Add Facility: Click the button to generate the 'Add Facility' pop-up window and select a site
from the drop-down menu to add to the 'Industrial Sites Controlled By Others' screen. Refer
to Section 3.11 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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CDX.

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

• Actions: Click the 'Delete' icon (X) 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 3.6 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
131

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CD)^

Exhibit 4-36 shows a screen capture of the 'Industrial Sites Controlled By Others' screen (Scroll

1):

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
132

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CD)Sr

Exhibit 4-36: Industrial Sites Controlled By Others Screen (Scroll 1)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

'Sites Controlled By
Others

j"I_ Submitter Controlled
Operations

$ [^Operation 1

j" I Submitter Operation
Information

"1 ^Occupational
Exposures

Y User Management J

A Logged in as Jane Doe, Primary Authorized Official

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4 Premanufacture Notice (Primary PMN-20141201-11:36:29 EST}> Industrial Sites Controlled By Others

INDUSTRIAL SITES CONTROLLED BY OTHERS

Operation Alias:

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:

rH Environmental
Releases

" X Remove

" ^=] Add Operation

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Site Name Address City State Postal Code

Select the chemical(s) that this submission pertains to:

~ Chemical 1

~ Chemical 2

Operation Description:

B.1b. Please describe the attached process/operation (optional)

CBI: ~

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uresVReleases

j""hj By product
Information

:""Lr[=jAdd Operation
i ""j^jOptional Pollution Prevention
pp ;Additional Attachments
[""U Attac hment Summary

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•

Submit

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CDX Homepage |

[ MyCDX Homepage

I EPA Homepage |

Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (888) 890-1995

Exhibit 4-37 shows a screen capture of the 'Industrial Sites Controlled By Others' screen (Scroll
2):

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
133

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CD)Sr

Exhibit 4-37: Industrial Sites Controlled By Others Screen (Scroll 2)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

jJ Sites Controlled By
Others

B"F- Submitter Controlled
Operations

! Sfjfloperation 1

[SubmitterOperation
Information

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Exposures

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Log Out

Home y Forms Y User Management Y Resources
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

Select the chemical(s) that this submission pertains to:

CBI

Actions

O Chemical 1
~ Chemical 2

Operation Description:

B.1.b. Please describe the attached process/operation (optional)
CBI: ~

Attach Document
File Name

Description

Pages

CBI

Actions

^Nextj

¦0

Validate

Save

Preview

Submit

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

4.1.23 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 'Letter of Activity (1),' '#
Workers Exposed (2),' 'Duration of Exposure Hours/Day (4a),' 'Duration of Exposure
Days/Year (4b),' 'Protective Equipment/Engineering Controls (6),' 'Physical Form (6),' '% New
Substance (6),' and '% in Formulation (7).' The screen displays fields in the environmental

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
134

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CDX.

release expandable/collapsible field set to enter information for 'Release Number (9),' the
amount of the new substance released directly 'to environment (10a),' the amount of new
substance released 'into control technology (10b),' 'Media of Release (12),' and 'Control
Technology (12).'

Information entered into the 'Duration of Exposure Hours/Day (4a)' and 'Duration of Exposure
Days/Year (4b)' fields must be a positive whole number or decimal. The system does not allow
special characters to be saved in these fields. If further explanation is required regarding duration
of exposure, please provide this in an attachment.

• Add: Click the 'Add' button to generate the 'Worker Exposure' expandable/collapsible field
set.

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

• Letter of Activity (1): Indicate the activities in which workers may be exposed to the
specified substance.

• CBI: Check the 'CBI' checkbox to claim the letter of activity as confidential.

• # Workers Exposed (2): Enter an estimate of the number of workers exposed for all sites
combined.

• CBI: Check the 'CBI' checkbox to claim the number of workers exposed as confidential.

• Duration of Exposure Hours/Day (4a): Enter an estimate of the typical duration of
exposure per worker in hours/day. This field allows decimal values.

• Duration of Exposure Days/Year (4b): Enter an estimate of the typical duration of
exposure per worker in days/year. This field allows decimal values.

• 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
135

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CDX.

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 'CBF checkbox to claim the protective equipment/engineering controls
information as confidential.

• Physical Form (6): Enter a description of physical forms of exposure. Please pay particular
attention to the information populated in this field if this field is populated via XML file. The
information contained within the 'Protective Equipment/Engineering Controls/Physical
forms' field in the thick client separates into two (2) separate fields, the 'Protective
Equipment/Engineering Controls' and 'Physical Forms' field when these fields are populated
via an XML file generated from the ePMN thick client.

• % New Substance (6): Describe percentage of new chemical substance (if in mixture).

• % in Formulation (7): Estimate the percent of the new substance as formulated when
packaged or used as a final product.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
136

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CD)Sr

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

Exhibit 4-38: Exposures/Releases Screen (Scroll 1)

J®. /aravtTi

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

I Sites Controlled By
Others

B"l_i Submitter Controlled
Operations

Urioperation 1

j""hiSubmitter Operation.
Information

!""[§] Occupational
Exposures

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"(jJ Byproduct
Information

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l""I Optional Pollution Prevention

!""[ !Additional Attachments

Attachment Summary

Optional Cover Letter

y User Management y

Logged in as Jane Doe, Primary Authorized Official

Log Out

4 Premanufacture Notice (Primary PMN-20141201-11:36:29 EST}> Exposures/Releases

EXPOSURES/RELEASES

B.2. Worker Exposure/Environmental Release - Sites Controlled by Others

Expand All | Collapse All

Letter of Activity (1): |

# Workers Exposed (2):
Duration of Exposure
Hours/Day (4a): Q

Days/Year (4b):

Protective Equipment/ Engineering Controls (6):

Cancel

CBI

Q
O

Physical Form (6):

% New Substance (6):
% in Formulation (7): I

—— >/

Validate

Save

Preview

Submit

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

• Release Number (9): Enter the number of each release point from the process diagram
previously entered.

• CBI: Check the 'CBF checkbox to claim the release number information as confidential.

• A nit 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
137

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CDX.

• 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)
distinct 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
138

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CD)Sr

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

Exhibit 4-39: Exposures/Releases Screen (Scroll 2)

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140408-11:18:01
EDT

Home J Forms y User Management | Resources

% in Formulation (7): [_ j%

Save

A. Logged in as: Jane Doe, Primary Authorized Official

Log Out

* Click Add to add a worker exposure | Add

Consolidated
Chemical

Site Information

" h Submitter Controlled Site
Information

rR|Sites Controlled By Others

@Submitter Controlled
Operations

! $ OTloperation 1

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j_^ Optional Pollution Prevention

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Release Number (9): I

Amt New Substance Released Directly into Environment (10a):
O Kg/DayKg/Batch

Amt New Substance Released Directly into Control Technology (10b):
Kg/Day O Kg/Batch

Media of Release (12):

Control Technology (12):

Expand All | Collapse All
Cancel X

CBI

Save

Click Add to add an environmental disposal | Add

^ ¦

Validate Save

Preview

Submit

CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (8£

38) 890-1995

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

4.1.24 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
139

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CD)Sr

Note that in IE 7, the right side of the 'Byproduct' text box may be cut off.

• CBI: Check the TBI" 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

(i ) to edit a saved byproduct.

Exhibit 4-40 shows a screen capture of the 'Byproduct Information' screen:

Exhibit 4-40: Byproduct Information Screen

Submitter Operation
Information

IJQcc upational
Exposures

i Environmental
} \ Releases

'X Remove

' "i%Add Operation

"III Operations Controlled by
Others

^ HTIoperation 1

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Others

; pj[5 I Ex pos ures/Releases

[Byproduct
Information

"%Add Operation

"[^'Optional Pollution Prevention

.Additional Attac hments

Attac hment Summary

Optional Cover Letter

•6. Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

Sites Controlled By
Others

$"(_J Submitter Controlled
Operations

l=i ffloperation 1

Home y Forms J User Management y Resources
4 Premanufacture Notice (Primary PMN-20141201 -11:36:29 EST)> Byproduct Information

BYPRODUCT INFORMATION

Identify byproducts that may result from the operation. Check the CBI checkbox if the information is
confidential.

B.2.14. Byproducts CBI:

Byproduct

Actions

y ,

— y/

Validate

Save

Preview

Submit

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
140

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CDX.

4.1.25 Optional Pollution Prevention

You can navigate to the 'Optional Pollution Prevention' screen by clicking the 'Next' button
from the 'Byproduct Information' screen. You can also access this screen by clicking the
'Optional Pollution Prevention' link within the navigation tree.

The 'Optional Pollution Prevention' screen provides fields for companies to enter data about
their pollution prevention efforts. The company has the option of entering information as a free
text field or as an attachment. The company can claim the information as confidential by
checking the 'CBI' checkbox.

The system allows an uploaded document to be claimed as CBI. If a document is claimed as
CBI, the system requires the sanitized version of the attached document to be uploaded. To
access or edit previously attached documents, click the appropriate file name of the document
within the 'File Name' column of the document table.

The attachment table displays the file name and file extension of the document, the document
description, the number of pages the document contains, and the CBI status of the document.
Click the 'Delete" icon (X) located within the 'Actions" column to delete unwanted documents.

You may provide information not reported elsewhere in this form regarding your efforts to
reduce or minimize potential risks associated with activities surrounding manufacturing,
processing, use, and disposal of the PMN substance on the 'Optional Pollution Prevention'
screen. Include new information pertinent to pollution prevention, including source reduction,
recycling activities and safer processes or products available due to the new chemical substance.
Source reduction includes the reduction in the amount or toxicity of chemical wastes by
technological modification, process and procedure modification, product reformulation, and/or
raw materials substitution. Recycling refers to the reclamation of useful chemical components
from wastes that would otherwise be treated or released as air emissions or water discharges, or
land disposal. Quantitative or qualitative descriptions of pollution prevention, source reduction
and recycling should emphasize potential risk reduction in addition to compliance with existing
regulatory requirements. EPA is interested in the information to assess overall net reductions in
toxicity or environmental releases and exposures, not the shifting of risks to other media (e.g., air
to water) or non-environmental areas (e.g., occupational or consumer exposure). To the extent
known, information about the technology being replaced will assist EPA in its relative risk
determination. In addition, information on the relative cost or performance characteristics of the
PMN substance to potential alternatives may be provided.

Describe the expected net benefits, such as:

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

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

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

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

(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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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EPA strongly encourages submitters to provide pollution prevention data in their notices, as this
information assists the Agency in balancing the benefits of a PMN substance against its unique
risks.

While Agency staffers frequently receive information on the benefits of the PMN substance with
respect to its use(s), data on pollution prevention effects are rarely included. This section should
be utilized to indicate to EPA benefits in terms of the raw materials incorporated, the
manufacturing process, emission reductions, less toxic waste byproducts, or lower risks upon end
use and disposal. You should consider the entire life cycle of the PMN substance in your
evaluation.

Also consider opportunities for product stewardship or other risk management controls that could
significantly reduce risk characteristics of the new substance (e.g., disposal techniques that can
be easily implemented and substantially reduce waste toxicity).

Initiatives in the New Chemicals Program such as Environmental Technology Initiative (ETI) for
Chemicals, and the Pollution Prevention Recognition Project, are geared towards incorporating
this type of information into the Agency's risk management decision making and recognizing
innovative chemical design or technological innovation that shows potential for environmental
and human health benefits.

Describe any pollution prevention benefits here, and indicate if this information is confidential
business information. Attempt to quantify the expected benefits to the extent possible and avoid
exaggeration and highly speculative statements. The following questions can be used to assess
pollution prevention benefits:

(1) Are there pollution prevention benefits associated with the new PMN chemical?

(2) Does it allow reduction of elimination of (more) toxic solvents?

(3) Does it reduce disposal to land, or in safer forms, compared to the chemistry it replaces?

(4) Can it be recycled more easily than existing materials?

(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.

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window. Refer to Section 3.6 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.'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CD)Sr

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 4-41 shows a screen capture of the 'Optional Pollution Prevention' screen:

Exhibit 4-41: Optional Pollution Prevention Screen

Premanufaeture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

l"F. Submitter Controlled
Operations

? HTIoperation 1

J Submitter Operation

Occ upational
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Eriv ironmental
Releases

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J Additional Attachments
Attac hment Summary
""[^Optional Cover Letter

y User Management y

Logged in as Jane Doe, Primary Authorized Official

Log Out

4 Premanufaeture Notice (Primary PMN-20141201-11:36:29 EST) > Optional Pollution Prevention
OPTIONAL POLLUTION PREVENTION

In this section you may provide information not reported elsewhere in this form regarding your efforts to
reduce or minimize potential risk associated with activities surrounding manufacturing, processing, use.
and disposal of the chemical substance.

Please click here to review additional information that should be included on this page.

Check here to claim this information as CBI: i

Attach Document
File Name

Description

Pages

CBI

Actions

Validate

Save

Preview

Submit

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 'Additional Attachments' screen. You can
also access this screen by clicking the 'Additional Attachments' link within the navigation tree.

4.1.26

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
143

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• 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 generate the 'Attach Documents'
pop-up window. Refer to Section 3.6 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.

• 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 (X) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
144

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CDXr

Exhibit 4-42 shows a screen capture of the 'Additional Attachments' screen:

Exhibit 4-42: Additional Attachments Screen

y User Management j

A Logged in as Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

El 'l Submitter Controlled

Operations

B {^Operation 1

ph i Submitter Operation
Information

"j J Occupational
Exposures

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Releases

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{ ; Others

Exposures/Releases

Byproduct
Information

X Remove

:~H=)A Additional Attachments

ADDITIONAL ATTACHMENTS

Please use this page to attach documents that are not listed on other parts of the form (test data. EPA
correspondence, etc). Please click here to view a list of commonly attached documents and where they
should be attached.

Attach Document

File Name Description

Pages

Date

CBI

Action

Validate

Save

Preview

Submit

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

4.1.27 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 that the attached document is associated.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
145

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CD)Sr

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

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

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

• Date: Displays the upload date of a document that was uploaded on the 'Attach Documents'
pop-up window.

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

Exhibit 4-43 shows a screen capture of the 'Attachment Summary' screen:

Exhibit 4-43: Attachment Summary Screen

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

Submitter Controlled
Operations

? nioperation 1

bj Submitter Operation
Information

[^Occupational
Exposures

|_fj Environmental
Releases

X Remove

:""^Add Operation

Operations Controlled by
Others

0 {^Operation 1

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Controlled By
Others

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^Byproduct
Information

:" "X Remove
%Add Operation
Optional Pollution Prevention
'5 Additional Attachments
H Attachment Summary
"h Optional Cover Letter

y User Management y

A Logged in as Jane Doe, Primary Authorized Official

Log Out

4 Premanufacture Notice (Primary PMN-20141201-11:36:29 EST} > Attachment Summary

ATTACHMENT SUMMARY

The documents included In the form are listed below. The attachments displayed are for viewing
purposes only: edits can be made by navigating back to the original page where they were uploaded.

Section

File Name

Description

Pages

Date

CBI

v ¦

Validate Save

Preview

Submit

CDX Homepage

I MyCDX Homepage

| EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (8t

J8) 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 CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
146

-------
CDX.

4.1.28 Optional Cover Letter

You can navigate to the 'Optional Cover Letter' screen by clicking the 'Next' button from the
'Attachment Summary' screen. You can also access this screen by clicking the 'Optional Cover
Letter' link within the navigation tree.

The 'Optional Cover Letter' screen is used to communicate information with EPA that is not
collected elsewhere in the form. The cover letter is used to give OPPT resources and special
instructions regarding the application.

• Check 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
147

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CD)Sr

Exhibit 4-44 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 4-44: Optional Cover Letter Screen

Y User Management J

A Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141128-
11:49:15 EST

[ I oypiuuuui

Information

X Remove

'[=lAdd Operation

'{^Optional Pollution Prevention

Additional Attac hments

_ Attac foment Summary

Optional Cover Letter

El Joint Submission

attest

r p Joint Submitter
Information

l""Q]Joint Submission
Information

X Remove

:(=|Add Joint Submission

Q" Letter of Support

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[^[Letter of Support
Submitter
Information

"0 Letter of Support
Submission
Information

X Remove

$'^Letter of Support 2

0 Letter of Support
Submitter
Information

Q Letter of Support
Submission
Information

X Remove

:ill Add Letter of Support

4 Premanufacture Notice (Primary PMN-20141128-11:49:15 EST) > Optional Cover Letter

OPTIONAL COVER LETTER

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

Check here to claim this information as CBl:

Validate

Save

Preview

Submit

CDX Homepage

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

Navigation: If you are not filing a Joint or Letter of Support submission, please refer to Section
3.9 for the functionality available within the bottom action bar. If you are submitting a Joint
Submission, 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 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'

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

4.1.29 Joint Submitter Information

You can access the 'Joint Submitter Information' screen by clicking the 'Next' button from the
'Optional Cover Letter' 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 captures 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 submitter.

• 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.'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

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

Exhibit 4-45: Joint Submitter Information Screen

•A Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141128-
11:49:15 EST

"''L:[=|Add Operation

B Operations Controlled by
Others

? [^Operation 1

I industrial Sites
Controlled By
Others

j" Q Ex pos ures/Releas es

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Letter of Support

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Information

X Remove

•l=}Add Letter of Support

Home y Forms j User Management y Resources

4 Premanufacture Notice (Primary PMN-20141128-11:49:15 EST) > Joint Submitter Information

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 main submitter. Check to claim information as CBI.

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.)

I I

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

Apartment, suite, etc.

United States

Validate

Save

Preview

Submit

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
150

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CDX.

4.1.30 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 captures information to send 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.

Joint Submission Process: When you designate that a Joint Submission is being filed, you will
be asked to enter all the information within the 'Joint Submission' folder. When the primary
submitter navigates to the 'Joint Submission Information' screen, the primary submitter must
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 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 4-46 shows a screen capture of the 'Joint Submission Information' screen:

Exhibit 4-46: Joint Submission information Screen

y User Management y

A Logged in as Jarie Doe, Primary Authorized Official

Log Out

Pre manufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

j""Q Ex pos ures/Releas es

j""hj By product
Information

X Remove

:""Lj^Add Operation

"i Optional Pollution Prevention

H " Additional Attac foments

PplAttac foment Summary

QOptional Cover Letter

B"I_JJoint Submission

$^Joint Submission 1

i""(=|Joint Submitter
Information

Joint Submission
Information

^Add Joint Submission

S | iLetter of Support

Letter of Support 1

'[^Letter of Support
Submitter
Information

Letter of Support
Submission
Information

X Remove

%]Add Letter of Support

4 Premanufacture Notice (Primary PMN-20141201-11:36:29 EST) > 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: d8d5c29c-5297-4a60-ba29-
ad65a59a6a98

This is the unique identification number for your joint submitter. Notify the
Secondary 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 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.

Validate

Save

Preview

Submit

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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152

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CDX.

4.1.31 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 4-47 shows a screen capture of the Joint Submission unique identifier notification pop-up
window (Scroll 1):

Exhibit 4-47: Joint Submission Unique Identifier Notification Pop-Up Window (Scroll 1)

$CSPP

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

0 Chemical t
~ Chemical 2

From:
CC:

To:

Subject:
Message:

Jane.Doe@test.com

Jane.Ooe@jtest.corn

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

2015 Primary PMN

As the Authorized Official of CGI TEST
COMPANY, I have identified you as a
Secondary Submitter of a joint submission
for this 2015 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 d8d5c29c-5297-4a60-
ba29-ad65a59a6a98

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
154

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CD)Sr

Exhibit 4-48 shows a screen capture of the Joint Submission unique identifier notification pop-up
window (Scroll 2):

Exhibit 4-48: Joint Submission Unique identifier Notification Pop-Up Window (Scroll 2)

box to start entering email addresses.

Subject:
Message:

2015 Primary PMN

As the Authorized Official of CGI TEST
COMPANY, I have identified you as a
Secondary Submitter of a joint submission
for this 2015 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 beiow 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 d8d5c29c-5297-4a60-
ba29-ad65a59a6a98

Additional Comments:

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 wvw.eoa.aov/ODOt/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 joint submitter and navigate back to
the 'Joint Submission Information' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CDX.

4.1.32 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 'Optional Cover
Letter' 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 captures 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.

• 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.'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

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

Exhibit 4-49 shows a screen capture of the 'Letter of Support Submitter Information' screen:
Exhibit 4-49: Letter of Support Submitter Information Screen

* Logged in as Jane Doe. Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141128-
11:49:15 EST

[=jAdd Operation

? i_ Operations Controlled by
Others

y [^Operation 1

"2} Industrial Sites
Controlled By
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"(5 Exposures/Releases

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Information

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jifi Optional Cover Letter

P"Q|Joint Submission

;Joint Submitter
Information

"MJoint Submission
I Information

'X Remove

''""Ly|Add Joint Submission

B"L Letter of Support

B-I^test

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Submitter
Information

j""|_ Letter of Support
Submission
Information

- iiAdd Letter of Support

Home y Forms J User Management y Resources
4 Premanufacture Notice (Primary PMN-20141128-11:49:15 EST} > Letter of Support Submitter Information

LETTER OF SUPPORT SUBMITTER INFORMATION

Please enter the contact information for the letter of support submitter who will be responsible for
providing supporting information to the main PMN submission. Check to claim information as CBI.

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.

¦s S

Validate Save

Preview

Submit

CDX Homepage |

I MyCDX Homepage |

I EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
157

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CDX.

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.

4.1.33 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 displays fields
that capture information to pass onto the Letter of Support submitter. A text box captures
information to send to the Letter of Support submitter in an email sent by the primary submitter.
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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
158

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CD)Sr

Exhibit 4-50 shows a screen capture of the 'Letter of Support Submission Information' screen:
Exhibit 4-50: Letter of Support Submission Information Screen

Premanufacture Notice

Primary Authorized Official

Primary PMN-20141201-
11:36:29 EST

j {""(jMExposures/Releases

!"{§! By product
Information

:X Remove

""•I^jAcfd Operation

|' "(3 Optional Pollution Prevention

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Tp I Attac foment Summary

i Optional Cover Letter

P"l_ Joint Submission

j 9 i^Joint Submission 1

HH)Joint Submitter
Information

rljjJoint Submission
i information

X Remove

"%lAdd Joint Submission

S"L_ Letter of Support

Letter of Support 1

_)Letter of Support
Submitter
Information

I! Letter of Support
Submission
Information

""%jAdd Letter of Support

y User Management j

¦*> Logged in as: Jane Doe, Primary Authorized Official

Log Out

4 Premanufacture Notice (Primary PMN-20141201-11:36:29 EST)> 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

Unique Identifier for Letter of Support Submission: 0fe6d0cc-4e69-422b-b223-
93a4154ae467

This is the unique identification number for your Letter of Support submitter.
Notitv 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 send the information to EPA The information collected in
the primary and secondary forms(s) will be linked by the unique identifier. The
original notice will not undergo a review process until all forms have been
received.

|^PrevioysJ

Validate

Save

Preview

Submit

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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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.

Refer to Section 3.9 for the functionality available within the bottom action bar.
4.1.34 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.

• 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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CDX.

Exhibit 4-51 shows a screen capture of the Letter of Support unique identifier notification pop-up
window:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
161

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CD)Sr

Exhibit 4-51: Letter of Support Unique Identifier Notification Pop-Up Window

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

£ Chemical 1

From:
CC:

To:

Subject:
Message:

Jane.Doe(@test.com

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 f6630013-d64c-4c17-90f7-
8000e4af3899

Additional Comments:

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.

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CDX.

4.1.35 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, review the 'Letter of Activity (1),' 'Protective
Equipment/Engineering Controls,' 'Physical Form,' 'Media of Release,' 'Control Technology,'
and '% New Substance' fields of entry to confirm that they 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 CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 4-52 shows a screen capture of the 'Upload XML' screen:

Exhibit 4-52: Upload XML Screen

Logged in as: Jane Doe, Primary Authorized Official

Log Out

Premanufacture Notice

Primary Authorized Official

Primary PMN-20140408-11:18:01
EDT

? nf"lope ration 1

Submitter Operation
Information

—f^j Occupation a I
Exposures

""ijj Environmental
Releases

X Remove

'""4=1 Add Operation

m"L Operations Controlled by
Others

! $ Hflope ration 1

f j I Industrial Sites
Controlled By
Others

|""[§ Exposures/Releases

If j^| Byproduct
Information

:""X Remove

Add Operation

r'^Optional Pollution Prevention

I""|_2 Additional Attachments

Attachment Summary

""5jOptional Cover Letter

J Forms J User Management y Resources

UPLOAD XML

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

Please refer to the help text for guidance regarding multicomponent consolidated submissions.

Upload archive file

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

Export Xml

Validate

Save

Preview

Submit

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. Click the 'Submit' icon ( ) located in the bottom action bar to begin the submission
process.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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5 Create 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 Create Biotechnology Form

To create a new Biotechnology form, navigate to the 'Section 5 Notices and Supports Forms'
screen and select 'Biotechnology' from the 'Form Type' drop-down menu. Refer to Section 3.4
for additional details regarding the 'Section 5 Notices and Supports Forms' screen.

Refer to Section 3.5 for additional details regarding the create passphrase process.

5.1.1 General Form Information

You can access the 'General Form Information' screen by creating a passphrase on the 'Create
Passphrase' screen or by entering the 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 auto-generates 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 and should include two (2), three (3), or four (4) letters.
Company names, recognizable words, and numerical series are not recommended.

The 'Text/Comments' text box captures information regarding the submission/attachment. A
'CBI' checkbox displays above the 'Text/Comments' text box to claim the information as
confidential.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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The 'General Form Information' screen displays the option to attach a document by clicking the
'Attach Document' button. For more information regarding the attach document functionality,
please refer to Section 3.6.

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

• Type of Submission: Select the submission type from the drop-down menu. This drop-down
menu contains the following values: 'MCAN (Microbial Commercial Activity Notice),'
'TERA (TSCA Experimental Release Application),' 'Tier I Exemption,' 'Tier II Exemption,'
and 'Biotechnology TME (Test Market Exemption).'

• 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 numerical series are not recommended. This field is required
if 'MCAN' is selected from the 'Type of Submission' drop-down menu, but is also required
regardless of the submission type if a Letter of Support is pending, and/or if a joint
Biotechnology form is being filed.

• Text/Comments: Enter a description of the form and/or attachment.

• CBI: Check the 'CBI' checkbox to claim the 'Text/Comments' information as confidential.

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window. Upload attachments including published literature, regulations and
certifications, ID data, construct data, effects data, MSDS, manufacturing details, use details,
inactivation data, and/or other types of documents. At least one document is required to be
uploaded even if a Letter of Support or Joint Submission is claimed. Please refer to Section
3.6 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 (X) 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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CD)Sr

• 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.

Exhibit 5-1 shows a screen capture of the 'General Form Information' screen (Scroll 1) in a
Biotechnology form:

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

Logged in as: Jane Doe, Primary Authorized Official

Log Out

Biotechnology

Primary Authorized Official

Biotechnology-20141202-
08:53:54 EST
|""[§ General Form Information
P"[_jJoint Submission
5'ljjifjoint Submission 1

Joint Submitter
Information

Joint Submission
Information

X Remove

%|Add Joint Submission

EfH Letter Of Support

$ {^Letter of Support 1

2 l Letter of Support
Submitter
Information

U | Letter of Support
Submission
Information

X Remove

%lAeki Letter Of Support

""j jTechnical Contact Information

Optional Cover Letter

Home y Forms y User Management * Resources
-4 Biotechnology (Biotechnology-20141202-08:53:54 EST) > General Form Information

GENERAL FORM INFORMATION

You may enter an alias for easier form identification or tne system will provide a time stamp.

Form Alias:

III. Type of Submission:

TS Number:

Biotechnology-20141202-08:53:54 E

HI E

IV. Text/Comments CBI:U

Please describe the submission and/or attachment

Please provide your Biotech submission information in one or more attachments.

Attach Document

File Name

Description

Pages

CBI

Actions

Check here if you are tiling a consolidated Number of Microorganisms: 1(2-20)

Biotechnology form:

Check here if you are filing a joint ®

Rintprhnnlnnv form-

•s¦

Validate Save

Preview

Submit

CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions

I Privacy Notice

| CDX Helpdesk: (86

18) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
167

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CD)Sr

Exhibit 5-2 shows a screen capture of the 'General Form Information' screen (Scroll 2) in a
Biotechnology form:

Exhibit 5-2: General Form information Screen (Biotechnology) (Scroll 2)

Biotechnology

Primary Authorized Official

Biotechnology-20141202-
08:53:54 EST
General Form Information

Q'l Joint Submission

? ^Joint Submission 1

i"j ~'jJoint Submitter
Information

j""'QjJoint Submission
Information

:™X Remove

:""Lrll|Add Joint Submission

$'[_) Letter Of Support

| ^Letter of Support 1

j""| 'Letter of Support
| Submitter

Information

| |""m Letter of Support

Submission
! Information

X Remove

| Letter Of Support

-["^Technical Contact Information

'-|3jOptional Cover Letter

Home j Forms * User Management J Resources

Form Alias" lBiotechnology-20141202-08:53:54 ^

Logged in as Jane Doe, Primary Authorized Official

Log Out

. Type of Submission:

TS Number:

IV. Text/Comments CBl:

Please describe the submission and/or attachment.

Please provide your Biotech submission information in one or more attachments.
Attach Document

File Name Description Pages CBl

Check here if you are filing a consolidated U dumber of Microorganisms: ~
Biotechnology form:

Check here if you are filing a joint ®

Biotechnology form:

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

Actions

(2-20)

Validate Save

Preview

Submit

CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions

i Privacy Notice

| CDX Helpdesk: (8!

B8) 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 after clicking the 'Save' icon within the
bottom action bar. 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 after clicking the 'Save' icon within the bottom action bar. Click the 'Next'
button to navigate to the 'Technical Contact Information' screen if you are not filing either a
Letter of Support or a Joint Biotechnology form. You can also navigate to this screen by clicking
the 'Technical Contact Information' link within the navigation tree.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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5.1.2 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 after clicking the 'Save' icon within the bottom action bar. 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 (X) 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 of the 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: Select the state of the mailing address of the joint submitter from the drop-down
menu. 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 CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
169

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CDXr

Exhibit 5-3 shows a screen capture of the 'Joint Submitter Information' screen:
Exhibit 5-3: Joint Submitter Information Screen (Biotechnology)

Biotechnology

Primary Authorized Official

Biotechnology-20140408-
11:20:52 EDT

i""[^;General Form Information

EH_ Joint Submission

| $'!jj|fjoint Submission 1

Joint Submitter
Information

Joint Submission
Information

^Add Joint Submission

B' i Letter Of Support

^ ^Letter of Support 1

rrs

Letter of Support
Submitter
Information

j""i Letter of Support
Submission
Information

: "X Remove

"%jAcM Letter Of Support

Technical Contact Information

"Fj Option a I Cover Letter

Home y Forms y User Management * Resources
4 Biotechnology (Biotechnology-20140408-11:20:52 EDT) > Joint Submitter Information

JOINT SUBMITTER INFORMATION

Please enter the information for the joint submitter who will be responsible for
supporting the information on the form. Check to claim information as CBI

>*• Logged in as: Jane Doe, Primary Authorized Official

Log Out

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
Previous

Validate

Save

Preview

Submit

5.1.3 Joint Submission Information

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 captures information to send 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 CIS 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.

• 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 5-4 shows a screen capture of the 'Joint Submission Information' screen:

Exhibit 5-4: Joint Submission Information Screen (Biotechnology)

y User Management y

Logged iin as Jane Doe, Primary Authorized Official

Log Out

Biotechnology

Primary Authorized Official

Biotechnology-20140408-
11:20:52 EDT

j""[^General Form Information

E3" . Joint Submission

EHjjlfjoint Submission 1

j""l =l|Joint Submitter
Information

I"" I = [Joint Submission
Information

%jA

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: 0550c93b-bcbb-49bb-9833-bef8f1cd83f3 This is the unique identification number for your joint submitter. Notify the Secondary 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 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. s/ Validate Save Preview m Submit CDX Homepage I MyCDX Homepage ! | EPA Homepage | Terms and Conditions | Privacy Notice I CDX Helpdesk: (888) 890-1995 TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 171

-------
CDX.

Navigation: 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 navigate to this screen by clicking the 'Technical Contact Information' link
within the navigation tree.

5.1.4 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 original submitter.

• CC: Contains the email address from CDX registration information, and the editable email
address of the technical contact.

• 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 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
172

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CD)Sr

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

0

C^CSPP

Subject:	2015 Biotechnology

Message:	As the Authorized Official of CGI TEST COMPANY. I have identified you as a

Secondary Submitter of a joint submission for this 2015 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 d2b7815d-71 d8-4a8e-a406-1 ab118df2b4b

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, ep a. a o v/o p Dt1 n ewe hem s/. 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' 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.

5.1.5 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'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide	December 15, 2014

Primary Authorized Official	173

-------
CDX.

screen. 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 (X) 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: Select the state of the mailing address of the Letter of Support submitter from the
drop-down menu. 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.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
174

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CD)Sr

Exhibit 5-6 shows a
Exhibit 5-





screen capture of the 'Letter of Support Submitter Information' screen:
6: Letter of Support Submitter Information Screen (Biotechnology)

Logged in as: Jane Doe, Primary Authorized Official

Log Out

Biotechnology

Primary Authorized Official

Biotechnology-20141202-
08:53:54 EST

r"(f General Form Information

"I_ Joint Submission

S'l^fjoint Submission 1

'Qjoint Submitter
Information

i Joint Submission
Information

X Remove

:'"'L^|Add Joint Submission

?"l_ Letter Of Support

El'Letter of Support 1

if'U)Letter of Support

Submitter
! Information

: |""j = | Letter of Support
Submission
Information

"%|Add Letter Of Support

!'"{§ Tec hnical Contact Information

jjQptional Cover Letter

Home y Forms y User Management y Resources

4 Biotechnology (Biotechnology-20141202-08:53:54 EST} > Letter of Support Submitter information
LETTER OF SUPPORT SUBMITTER INFORMATION

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

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 rvot enter any dashes (-) in Phone Number field above.)

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

Apartment, suite, etc.

: -

| Next |



-------
CDX.

to enter information to pass to the secondary submitter. A text box is used to send information in
an email to the secondary submitter. A 'Unique Identifier for Letter of Support Submissions' box
will also display on this screen. The unique identifier auto-generates 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
176

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CD)Sr

Exhibit 5-7 shows a screen capture of the 'Letter of Support Submission Information' screen:
Exhibit 5-7: Letter of Support Submission Information Screen (Biotechnology)

Biotechnology

Primary Authorized Official

Biotech nology-20140408-
11:20:52 EDT

ii~"| — iGeneral Form Information

EH - Joint Submission

I 5 fi?Jcint Submission 1

Qjoint Submitter
Information

(5)Joint Submission
Information

X Remove

Joint Submission

5 I	Letter Of Support

fS'ijjlf Letter of Support 1

['"£§ Letter of Support
Submitter
Information

!""lj Letter of Support
Submission
i I Information

!""%lA 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



Unique Identifier for Letter of Support Submission: f8172400-d8c1-4143-a700-
e1edbe811e17

This is the unique identification number for your Letter of Support submitter The
Secondary Submitter will need this identification number to complete the form.
Notify the Secondary Submitter of the Letter of Support submission

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 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

Previous





>/

Validate

a

Save

Preview

e

Submit



CDX Homepage

| MyCDX Homepage |

| EPA Homepage |

Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (81

38)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.

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5.1.7 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
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 original submitter.

•	CC: This editable text field automatically populates with the email address from CDX
registration information, and the email address of the technical contact.

•	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 automatically populates 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 5-8 shows a screen capture of the unique identifier notification pop-up window:
Exhibit 5-8: Unique Identifier Notification Pop-Up Window

C^CSPP

From:

CC:

To:

Subject:
Message:

Jane_Doe@test.com



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

2015 Biotechnology

As the Authorized Official of CGI TEST COMPANY. I have identified you as a
Secondary Submitter of a letter of support submission for this 2015
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 58220b1e-4c6f-4cad-99f4-464d2da527c8

Additional Comments:

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/odpt/'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 secondary submitter and navigate
back to the 'Letter of Support Submission Information' screen. Click the 'X' in the upper right-
hand corner to cancel the unique identification number notification process and navigate back to
the 'Letter of Support Submission Information' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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5.1.8 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 also navigate
to the 'Technical Contact Information' screen by clicking the 'Technical Contact Information'
link within the navigation tree.

The 'Technical Contact Information' screen displays an 'Add Technical Contact' button. Click
the 'Add Technical Contact' button to generate an 'Add Technical Contact' pop-up window to
enter information into the text fields. Click the 'Copy CDX Registration' button to populate the
text fields using your CDX registration information. Check the 'Check here to claim this
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 (X) to delete the technical contact information from the
table. A warning message displays to confirm the deletion.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 5-9 shows a screen capture of the 'Technical Contact Information' screen:
Exhibit 5-9: Technical Contact information Screen (Biotechnology)

Biotechnology

Primary Authorized Official

Biotechnology-20141202-
08:53:54 EST

General Form Information

@;f" lJoint Submission

@'fijlfjoint Submission 1

"Qjoint Submitter
Information

"MJoint Submission
Information

X Remove

l^dlAdd Joint Submission

Letter Of Support

$ ^Letter of Support 1

Q Letter of Support
Submitter
Information

I=| Letter of Support
Submission
Information

JC Remove

%)Add Letter Of Support

Technical Contact
Information

"2]Optional Cover Letter

y User Management y

Logged in as Jane Doe, Primary Authorized Official

Log Out

Biotechnology (Biotechnology-20141202-08:53:54 EST) > Technical Contact Information
TECHNICAL CONTACT INFORMATION

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

&

Last Name

First Name

Address

CBI

Actions



>/ ¦ n e

Validate	Save	Preview	Submit

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (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.

5.1.8.1 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide	December 15, 2014

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CDX.

•	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. Click the 'Copy CDX Registration'
button to populate the fields with information entered during CDX registration. This is a
required field.

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

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

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

•	Phone Number: Enter the daytime U.S. phone number of the technical contact; this must be
at least 10 characters long and does not accept dashes. Click the 'Copy CDX Registration'
button to populate the fields with information entered during CDX registration. This is a
required field.

•	Phone Extension: Enter the technical contact's phone number extension if applicable.

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

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

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

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

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

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

•	Country: Displays 'United States.'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 5-10 shows a screen capture of the 'Add Technical Contact' pop-up window:

Exhibit 5-10: Add Technical Contact Pop-Up Window

CSPP

ADD TECHNICAL CONTACT

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

	1

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

Apartment, suite, etc.

United States

Cancel

R

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

5.1.9 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
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 5-11 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 5-11: Optional Cover Letter Screen

Biotechnology

Primary Authorized Official

Biotechnology-20140408-
11:20:52 EDT

General Form Information

?"l	Joint Submission

Sljj^fjoint Submission 1

™Qjoint Submitter
Information

"'{=)Joint Submission
Information

:""X Remove

| :," Lrg)Add Joint Submission

Letter Of Support

S'ljjlf Letter of Support 1

j"j l Letter of Support
Submitter
Information

[^Letter of Support
Submission
Information

X Remove

| {

:""L"[=lAdd Letter Of Support
"ITechnical Contact Information
"(Optional Cover Letter

y User Management y

• Logged in as: Jane Doe, Primary Authorized Official

Log Out

< Biotechnology (Biotechnoiogy-20140408-11:20:52 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: ~

&





>/

Validate

a

Save

Preview

m

Submit

CDX Homepage |

I MyCDX Homepage |

I EPA Homepage |

Terms and Conditions

I Privacy Notice

I CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CDX.

Navigation: Click the 'Validate' icon ( ) 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. Click the 'Submit' icon ( ) located in the bottom action bar to begin the submission
process.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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6 Create 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 Create NOC Form

To create a new NOC form, navigate to the 'Section 5 Notices and Supports Forms' screen and
select 'Notice of Commencement (NOC)' from the 'Form Type' drop-down menu and click the
'Start New Form' button. Refer to Section 3.4 for additional details regarding the 'Section 5
Notices and Supports Forms' screen.

Refer to Section 3.5 for additional details regarding the create passphrase process.
6.1.1 General Form Information

You can access the 'General Form Information' screen by creating a passphrase on the 'Create
Passphrase' screen or entering the passphrase on the 'Enter Passphrase' screen. The 'General
Form Information' 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
capture 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. Select
the 'First Commercial Manufacture' radio button to generate a date field and calendar widget
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. Select
the 'First Commercial Importation' radio button to generate a date field and calendar widget
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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
186

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CDXr

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

Exhibit 6-1: General Form Information Screen (NOC)

Notice of Commencement

Primary Authorized Official

NOC-20140408-11:19:27 EDT
rg General Form Information

"QiTechnical Contact Information
"j -1Chemical Information
Submitter Site Information

? I	CBI Substantiation

i" j^jCBI Substantiation Part 1
rglCBI Substantiation Part 2
:""I5]CBI Substantiation Part 3
"[? Optional Cover Letter

Logged in as Jane Doe, Primary Authorized Official

Log Out

ime y Forms T User Management * Resources
4 Notice of Commencement (NOC-2G140408-11:19:27 EDT) > General Form Information

GENERAL FORM INFORMATION

You may enter an alias for easier form identification or the system will provide a time stamp.
Form Alias"

NOC-20140408-11:19:27 EDT

Part II - Premanufacture Notice (PMM) 'P' or Microbial Commercial Activity Notice (MCAN) 'J' Case
Number

Case Number:

Please enter the case number in the following format: P-XX-0999, where 'XX' indicates the year in which the case
number is generated, and the leading 0'- is required.

Manufacture/Import Information

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

First Commercial Manufacture
First Commercial Importation

>/

e

¦

¦

Validate

Save

Preview

Submit

CDXHomepage I MyCDXHomepage I EPAHomepage I Terms and Conditions | Privacy Notice I CDXHelpdesk: (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.

6.1.2 Technical Contact Information

You can access the 'Technical Contact Information' screen by clicking the 'Next' button from
the 'General Form Information' screen. You can also 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 (NOC)

Home y Forms y User Management y Resources

Notice of Commencement ^ Notice of Commencement (NOC-20141202-08:50:01 EST) > Technical Contact Information
Primary Authorized Official	TECHNICAL CONTACT INFORMATION

NOC-20141202-08:50:01 EST

j""2)General Form Information

r [_ITechmcal Contact
Information

Chemical Information

:H ^jSite Information

H3Optional Cover Letter

Logged in as: Jane Doe, Primary Authorized Official

Log Out

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

Last Name

First Name

Address

CBI

Actions

|^Ne«J





>/ g

Validate Save

Preview

e

Submit

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 'Chemical Information' screen. You can
also access this screen by clicking the 'Chemical Information' link within the navigation tree.

6.1.2.1 Add Technical Contact

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CDX.

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

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

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

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

•	Phone Number: Enter the technical contact's daytime U.S. phone number; this must be at
least 10 characters long and does not accept dashes. Click the 'Copy CDX Registration'
button to populate the fields with information entered during CDX registration. This is a
required field.

•	Phone Extension: Enter the technical contact's phone number extension, if applicable.

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

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

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

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

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

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

•	Country: Displays 'United States.'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

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CD)Sr

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





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
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.

1-

United States
Cancel

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

6.1.3 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.

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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
chemicals submitted under a NOC 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 3.10 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. This is a required field if
there is no pending Letter of Support or Joint Submission for the form.

•	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 3.9
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 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 (X) 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 (X) displays when the user has clicked the 'Add New
Chemical' button.

•	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.

•	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 enables the first radio button
and disables 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 disables the first radio button and enables 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.

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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) (ISIOC)



y User Management y

* Logged in as Jane Doe, Primary Authorized Official

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Notice of Commencement

Primary Authorized Official

NOC-20141202-08:50:01 EST

hj ? General Form Information
j—^Tecfinical Contact Information
r"F Chemical Information

Site Information
UQoptional Cover Letter

4 Notice of Commencement (NOC-20141202-08:50:01 EST) > Chemical Information

CHEMICAL INFORMATION

Part V ¦ Specific Chemical Identity

Expand All | Collapse All

CASRN:

Cancel

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

CASRN:

Chemical Name:

CBI:	W

Generic Chemical Name

PLEASE NOTE: 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 ID.

Save

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





Validate

a

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December 15, 2014
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CD)Sr

Exhibit 6-5 shows a screen capture of the 'Chemical Information' screen (Scroll 2):
Exhibit 6-5: Chemical Information Screen (Scroll 2) (NOC)

Notice of Commencement

Primary Authorized Official

NOC-20141202-08:50:01 EST

^General Form Information
rPTechnical Contact Information
j — Chemical Information
"[^j Site Information
•fS] Optional Cover Letter

Home y Forms
Search SRS

CASRN:

Chemical Name:
CBI:

Generic Chemical Name

y User Management y

Logged in as Jane Doe, Primary Authorized Official

Log Out

PLEASE NOTE: 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 ID-

Save

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

component. Add New Chemical

Part VII ¦ Substance Identity Confidentiality Status

- 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.

-11 previously claimed the substance identity as confidential and hereby relinquish that claim.

.11 did not claim the substance identity as confidential in my ortainalPMN submission.

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

6.1.4

Site Information

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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The 'Site Information' screen identifies the site at which the manufacture or import of the
chemical occurs. You are able to identify sites via the 'Add Site' pop-up window. To do so, click
the 'Add Site' button. You must select a site before moving on to the 'CBI Substantiation Part V
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 3.11 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 (NOC)



Notice of Commencement

Primary Authorized Official

NOC-2Q141202-08:50:01 EST

hp]General Form Information
r"[%echrtical Contact Information
rg)Chemical Information
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¦< Notice of Commencement (NOC-20141202-08:50:01 EST)> Site information

SITE INFORMATION

Part IV - Manufacturing Plant Site(s) or Importing Site(s)

Importers, provide street address of destination.

Click to add a new site: Add Site

Logged in as: Jane Doe, Primary Authorized Official

Log Out

Registry ID

Site Name

Previous

Address

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•&

CBI

Actions





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•

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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button to navigate to the 'Optional Cover Letter' screen. You can also access this screen by
clicking the 'Optional Cover Letter' link within the navigation tree.

6.1.5 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.
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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
196

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CD)Sr

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)



Y User Management J

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Notice of Commencement

Primary Authorized Official

NOC-20140408-11:19:27 EDT

i""p General Form information
r"|j^Technica Contact Information
pfijChemicai Information
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4 Notice of Commencement (NOC-20140408-11:19:27 EDT) > CBI Substantiation Part 1

CBI SUBSTANTIATION PART 1

Substantiate confidentiality of claims if you mark the substance identity (PartV) 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) 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?

>/

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•

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Submit

CDXHomepage | MyCDXHomepage | EPAHomepage | Terms and Conditions | Privacy Notice | CDXHelpdesk: (888) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
197

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CD)Sr

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 Authorized Official

NOC-20140408-11:19:27 EDT

General Form Information
i""[^Technical Contact Information

	" Chemical Information

rQ Submitter Site Information
S"i	CBI Substantiation

i""jjMCBI Substantiation Part
1

j""f^]CBI Substantiation Part 2

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Optional Cover Letter

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(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?

Previous

|^NextJ





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CDX.

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.

6.1.6 CBI Substantiation Part 2

You can access the 'CBI Substantiation Part 2' screen by clicking the 'Next' button from the
'CBI Substantiation Part 1' screen. You can also access this screen by clicking the 'CBI
Substantiation Part 2' link within the navigation tree.

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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Exhibit 6-9 shows a screen capture of the 'CBI Substantiation Part 2' screen (Scroll 1):
Exhibit 8-9: CBI Substantiation Part 2 Screen (Scroll 1)



J User Management J

*• Logged in as Jane Doe, Primary Authorized Official

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Notice of Commencement

Primary Authorized Official

NOC-20140408-11:19:27 EDT

hp General Form Information

Technical Contact Information

i""|_ Chemica Information

;""[j Submitter Site Information

S CBI Substantiation

Kjf CBI Substantiation Part 1

n? CBI Substantiation Part
2

CBI Substantiation Part 3
'2 Optional Cover Letter

^ Notice of Commencement (NOC-20140408-11:19:27 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 tiles?

(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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CD)Sr

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)

*• Logged in as: Jane Doe, Primary Authorized Official

Log Out

Notice of Commencement

Primary Authorized Official

NOC-20140408-11:19:27 EDT

I'"5 General Form Information

	Technical Contact Information

r'EiChemical Information

j-'i "[Submitter Site Information

&"i_ CBI Substantiation

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"^glCBI Substantiation Part
2

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Optional Cover Letter

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(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?

j^JextJ





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n

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CDX Homepage |

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TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
201

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CDX.

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.

6.1.7 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.

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 3.6 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 (J€) 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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)



y User Management y

Logged in as: Jane Doe, Primary Authorized Official

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Notice of Commencement

Primary Authorized Official

NOC-20141202-08:50:01 EST

f-p General Form Information

Tec hn ic al C ontac 11 nformation

"'{^J Chemical Information

1 = Site Information

01	iCBI Substantiation

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3

"'"[^Optional Cover Letter

4 Notice of Commencement (NOC-20141202-08:50:01 EST) > CBI Substantiation Part 3

CBI SUBSTANTIATION PART 3

Substantiate confidentiality of claims if you mark the substance identity (PartV) 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.

>/ b n m

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
203

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CD)Sr

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 Authorized Official

NOC-20141202-08:50:01 EST

!""[= General Form Information
;""f=jjTechnic al Contact Information
ri^jCbemkal Information
i""Qs#e Information
B _ CBI Substantiation

CBI Substantiation Part 1
-dGBl Substantiation Part 2
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Optional Cover Letter

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(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 any time in the new chemical process.)

Previous

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CDX Homepage

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| CDX Helpdesk: (SI

38)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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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6.1.8 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
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 (NOC)



Notice of Commencement

Primary Authorized Official

NOC-20141202-08:50:01 EST

General Form Information
Technical Contact Information
Chemical Information
|""[Hsite Information
0" CBI Substantiation

-@CBI Substantiation Part 1
CBI Substantiation Part 2
|p|CBI Substantiation Part 3
Optional Cover Letter

J User Management y

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4 Notice of Commencement (NOC-20141202-08:50:01 EST)> Optional Cover Letter

OPTIONAL COVER LETTER

IT you would like to Include a cover letter, write it here.

Check here to claim this information as CBi: -|

Previous





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TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
205

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CDX.

Navigation: Click the 'Validate' icon ( ) located 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 ( ) to generate a PDF preview of the form. Click the 'Submit' icon ( ) located
in the bottom action bar to begin the submission process.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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7 Create 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 Create Support Form

To create a new Support form, navigate to the 'Section 5 Notices and Supports Forms' screen
and select 'Support' from the 'Form Type' drop-down menu. Refer to Section 3.4 for additional
details regarding the 'Section 5 Notices and Supports Forms' screen.

Refer to Section 3.5 for additional details regarding the create passphrase process.

7.1.1	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.

•	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. 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 MC AN, 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). This field will auto-populate if the 'Case Number' field is linked to a form that
is recognized by the application. The TS number should include two (2), three (3), or four (4)
letters. Company names, recognizable words and numerical series are not recommended.

•	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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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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 (B) to edit an individual EPA/contractor entry. Click the 'Delete" icon (X) 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 3.6 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 (X) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 7-1 shows a screen capture of the 'General Form Information' screen (Scroll 1) for a
Support form:

Exhibit 7-1: General Form information Screen (Scroll 1) (Support)

Logged In as: Jane Doe, Primary Authorized Official

Log Out

Support

Primary Authorized Official

Support-20141202-08:48:56 EST
General Form Information

[Original Submitter Information

Home y Forms ™ User Management " Resources
< Support (Support-20141202-08:48:56 EST} > General Form Information

GENERAL FORM INFORMATION

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 any time.

Form Alias	Support-20141202-08:48:56 EST

I. Original Notice Submission Information

Case Number:
TS Number:

J

IV. Type of Support

L

Check if requested by EPAContractor: '*<
Last Name	First Name

EPAVContractor

J c

1 -

Actions

V. Description or Explanation of Support CBI:1

y/ B ~

Validate	Save	Preview	Submit

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
209

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CD)Sr

Exhibit 7-2 shows a screen capture of the 'General Form Information' screen (Scroll 2) for a
Support form:

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

Support

Primary Authorized Official

Support-20141202-08:48:56 EST
General Form Information

Original Submitter Information

Home T Forms y User Management T Resources

i-orm Alias:	^

I. Original Notice Submission Information

¦*> Logged in as: Jane Doe. Primary Authorized Official

Log Out

Case Number:
TS Number:

IV. Type of Support

:

Check if requested by EPAContractor: '•*
Last Name	First Name

: c

EPA/Contractor

: -

Actions

ax#

V. Description or Explanation of Support

CBI: U

Attach Document



File Name Description

Subtype

Pages

CBI Actions





|*Next |







>/

Validate

5

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Submit

CDX Homepage

I MyCDX Homepage | EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (888) 890-1995

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

7.1.2 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 forai for whom you are
filing the Support form.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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CDX.

•	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 original submitter's first name. Click the 'Copy CDX Registration'
button to populate the fields with information entered during CDX registration. This is a
required field.

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

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

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

•	Phone Number: Enter the original submitter's daytime phone number; U.S. or international.
Click the 'Copy CDX Registration' button to populate the fields with information entered
during CDX registration. This is a required field.

•	Phone Extension: Enter the original submitter's phone number extension, if applicable.

•	Email Address: Enter the original submitter'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 information entered during CDX registration.

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

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

•	City: Enter the city of the original submitter's mailing address. Click the 'Copy CDX
Registration' button to populate the fields with information entered during CDX registration.
This is a required field.

•	State: Select the original submitter's state from the drop-down menu. Click the 'Copy CDX
Registration' button to populate the fields with information entered during CDX registration.
This is a required field.

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

•	Country: Displays 'United States.'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 7-3 shows a screen capture of the 'Original Submitter Information" screen:
Exhibit 7-3: Original Submitter information Screen (Support)



Support

Primary Authorized Official

Support-20140408-11:18:40 EDT

General Form Information

" | jOnginal Submitter
Information

•S- Logged in as: Jane Doe, Primary Authorized Official

Log Out

>me J Forms T User Management Y Resources
4 Support(Support-20140408-11:18:40 EDT)> Original Submitter Information

ORIGINAL SUBMITTER INFORMATION

Please enter the information of the Authorized Official who submitted the original PMN/Biotech/Bona Fide
form for which you are filing a Support document.

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.)

r

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

Apartment, suite, etc.

United States





Validate

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Preview

m

Submit

CDX Homepage |

I MyCDX Homepage |

I EPA Homepage |

Terms arid Conditions

I Privacy Notice

I CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Validate' icon C ) located in the bottom action bar to validate the form.
Click the 'Save' icon (E ) located in the bottom action bar to save the overall form. Click the
'Preview' icon (^) located in the bottom action bar to generate a PDF preview of the form.
Click the 'Submit' icon ( ) located in the bottom action bar to initiate the submission process.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CDX.

8 Create 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 Create Bona Fide Form

To create a new Bona Fide form, navigate to the 'Section 5 Notices and Supports Forms' screen
and select 'Bona Fide' from the 'Form Type' drop-down menu. Refer to Section 3.4 for
additional details regarding the 'Section 5 Notices and Supports Forms' screen.

Refer to Section 3.5 for additional details regarding the create passphrase process.

8.1.1 General Document Information

You can access the 'General Document Information' screen by clicking the 'Start New Form'
button and creating a new passphrase, or 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 a user must differentiate between forms to the help desk. If a form
alias is not entered, the system will provide a default alias comprised of a form type and date and
time stamp in the following format: .

You can claim the entirety of the form as CBI. The entire form will be claimed as CBI if you
check the 'I claim the entirety of the submission as CBI' checkbox. The entire form will be
considered non-CBI if you leave the 'I claim the entirety of the submission as CBI' checkbox
unchecked.

You can indicate that a technical contact will be identified by checking the 'Technical Contact'
checkbox. The technical contact must possess sufficient knowledge to answer any questions EPA
may have about the chemical reported in the form. The application generates 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 Secondary Authorized Official will have a
unique identification number that will link the forms. The unique identification number will be
sent to the Letter of Support submitter, via email. At submission of the primary Bona Fide form,
the unique identification number will link the two forms together. The information submitted in
both forms will be kept separate, but linked, by the system. The Primary and Secondary AO will
only be able to view information submitted by their own company.

•	Form Alias: Enter the form alias. Upon navigating to the screen, the screen auto-generates
an editable form alias comprised of .
This is a required field.

•	I claim the entirety of this submission as CBI: Check the 'I claim the entirety of this
submission as CBI' checkbox to flag all data contained within the form as confidential.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

•	Technical Contact: Check the 'Technical Contact' checkbox to generate 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 generate 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.'

Exhibit 8-1 shows a screen capture of the 'General Document Information' screen (Scroll 1):
Exhibit 8-1: General Document information Screen (Scroll 1)

y User Management y

•*> Logged in as Jane Doe, Primary Authorized Official

Log Out

Bona Fide

Primary Authorized Official

Bona Fide-20140408-11:25:34
EDT

'[j General Document
Information

¦'"(DPrimary Contact Information

j-f^iStatement of Intent

B"l . Chemical

Chemical Identification
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B JkClass 1 Chemical
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I [Class 1 or
I 2/Biotechnology
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2/Biotechnology
Substances

"~f^'|Use Information

5"l_lSite Information

(Submitter Site
Identification

Hi" (Document Management

Optional Cover Letter

4 Bona Fide (Bona Fide-20140408-11:25:34 EDT) > General Document Information	^

GENERAL DOCUMENT INFORMATION

The form alias is a required field thai 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 any time

Bona Fide-20140408-11:25:34 EDT

Form Alias:

Please check all applicable checkboxes below

This Bona Fide Notice can be claimed entirely as Confidential Business Information (CBI). Please check
the 'I claim the entirety of the submission as CBI' checkbox to claim your entire submission as CBI

I claim the entirety of the submission as CBI:

The technical contact is a subject matter expert (SME) who is capable of answering questions related to
the chemical within the Bona Fide. The technical contact does not have to 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 check the Technical Contact' checkbox below to identify a
technical contact for your submission.

Technical Contact:

The 'Letter of Support' screen is used to enter contact information regarding the Letter of Support

>/

B

B

e

Validate

Save

Preview

Submit

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
214

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CD)Sr

Exhibit 8-2 shows a screen capture of the 'General Document Information' screen (Scroll 2):
Exhibit 8-2: General Document information Screen (Scroll 2)

Bona Fide

Primary Authorized Official

Bona Fide-20140408-11:25:34
EDT

General Document
Information

Primary Contact Information

—fi;[Technical Contact Information

""i^J Statement of Intent

@"l	iLetter of Support

"l 'MLetter of Support
Submitter Information

Letter of Support
Submission Information

P L Chemical

"[^JChemical Identification
Information

El-

lass 1 Chemical
Substance

j" "P^ Class 1 or
j 2/Biotechnology
Chemical
Substances

rmciass

2/Biotechnology
Substances

:""[^iUse Information
Site Information

"N=,Submitter Site

Logged in as Jane Doe, Primary Authorized Official

Log Out

¦me y Forms Y User Management Y Resources

This Bona Fide Notice can be claimed entirely as Confidential Business Information (CBI). Please check
the 'I claim the entirety of the submission as CBI' checkbox to claim your entire submission as CBI.

I claim the entirety of the submission as CBI: ~

The technical contact is a subject matter expert (SME) who is capable of answering questions related to
the chemical within the Bona Fide. The technical contact does not have to 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 check the Technical Contact' checkbox below to identify a
technical contact for your submission.

Technical Contact: J

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: '<

>/

B

¦

•

Validate

Save

Preview

Submit

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,

8.1.2 Primary Contact Information

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

The data fields on the 'Primary Contact Information' screen are pre-populated based on
information entered during CDX registration. All fields are editable allowing for necessary
updates. The 'Job Title' field on this screen is not pre-populated from CDX registration and is a
required field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide	December 15, 2014

Primary Authorized Official	215

-------
	

If you checked the 'I claim the entirety of the submission as CBI' checkbox on the 'General
Document Information' screen, all entered primary contact information is flagged as CBI.

The following fields are captured and displayed from the logged in user'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 phone number; dashes are not
allowed. This is a required field.

•	Phone Extension: Enter the extension to the primary contact's daytime phone number.

•	Email Address: Enter the primary contact's email address. The email address must
follow the standard email address format: John.Doe@ABC.com. This is a required field.

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

•	Mailing Address 2: Enter the second line of the primary contact's mailing address.

•	City: Enter the city of the primary contact's mailing address.

•	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 CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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CD)Sr

Exhibit 8-3 shows a screen capture of the 'Primary Contact Information' screen:

Exhibit 8-3: Primary Contact Information Screen

Logged in as Jane Doe, Primary Authorized Official

Log Out

Bona Fide

Primary Authorized Official

Bona Fide-20141205-13:19:43
EST

HP General Document Information

|""QPrimary Contact Information

Tec hnic al Contac 11 nformation

Pi SJ Statement of Intent

Letter of Support

""NI Letter of Support
Submitter Information

i2) Letter of Support

Submission Information

_|Chemical

Chemic al Identify ation
Information

Site Information

"j^i Submitter Site
Identification

Doc umertt Management

Optional Cover Letter

Home y Forms y User Management J Resources
Bona Fide (Bona Fide-20141205-13:19:43 EST}> 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

TE

[Test

Test Company

1234567890

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

jane.doe@test.com

123 Main Street

Street address,. P.O. box, company r

Apartment, suite, etc.

[Main

Alabama

12345

United States



Previous



| Next |



1

n

m

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Preview

Submit

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (388)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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
217

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You can also access this screen by clicking the 'Statement of Intent' link within the navigation
tree.

8.1.3 Technical Contact Information

If you indicated on the 'General Document Information' screen that technical contact
information would be provided, click the 'Next' button from the 'Primary Contact Information'
screen 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.

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 j ob 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 CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
218

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CD)Sr

Exhibit 8-4 shows a screen capture of the 'Technical Contact Information' screen (Scroll 1):
Exhibit 8-4: Technical Contact Information Screen (Scroll 1)

me y Forms J User Management j Resources
4 Bona Fide (Bona Fide-20140515-10:10:10 EDT) > Technical Contact Information

TECHNICAL CONTACT INFORMATION

•*> Logged in as: Jane Doe, Primary Authorized Official

Log Out

Please enter the information for the technical contact who will be responsible for providing additional
information if required.

Bona Fide

Primary Authorized Official

Bona Fide-20140515-10:10:10
EDT

General Document Information

Primary Contact Information

!""[§ Technical Contact
Information

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? Letter of Support

Letter of Support
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B Chemical

'"0Chemical Identification
Information

B Chemical 18328

^Polymer
Identification
Information

Monomers and
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_jUse Information

?"|	iSite Information

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l^lDocument Management

OOptional Cover Letter

Prefix:

First Name:

Middle Initial:

Last Name:

Suffix:

Title.

Company Name
Phone Number:

Phone Extension:
Email Address:
Mailing Address 1:

Mailing Address 2

City:

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

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

Apartment, suite, etc.





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CDX Homepage |

| MyCDX Homepage I

I EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (8?

58)890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CD)Sr

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

Primary Authorized Official

Bona Fide-20140515-10:10:10
EDT

General Document Information

Primary Contact Information

Technical Contact
Information

r-fi]Statement of Intent

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Middle Initial.

Last Name:

Suffix:

Title

Company Name:
Phone Number:

Phone Extension
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Mailing Address 1:

Mailing Address 2

City:

State:

Postal Code:
Country:

Y User Management J Resources

]

A Logged in as: Jane Doe, Primary Authorized Official

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

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

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CDX Homepage |

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I EPA Homepage | Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (8f

58)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.

8.1.4 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. You can also navigate to this screen 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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CDX.

The 'Statement of Intent' screen requires you to indicate whether your intent is to manufacture
and/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 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 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 CIS 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

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Bona Fide

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4 Bona Fide (Bona Fide-20140408-11:25:34 EDT) > Statement of Intent

Bona Fide-20140408-11:25:34
EDT

STATEMENT OF INTENT

General Document Information





!""h Primary Contact Information





I (Technical Contact Information
!""[§ Statement of Intent



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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 captures 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 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 CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
223

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CD)Sr

Exhibit 8-7 shows a screen capture of the 'Letter of Support Submitter Information' screen:
Exhibit 8-7: Letter of Support Submitter Information Screen

* Logged in as: Jane Doe, Primary Authorized Official

Log Out

Home J Forms y User Management J Resources
r Bona Fide (Bona Fide-20141202-08:57:56 EST)> Letter of Support Submitter Information

LETTER OF SUPPORT SUBMITTER INFORMATION

Please enter the contact information for the Letter of Support submitter who will be completing the Letter
of Support.

Bona Fide

Primary Authorized Official

Bona Fide-20141202-08:57:56
EST

General Doc ument I nformation

Primary Contac 11 nformation

& Technical Contact Information

"BStatement of Intent

0 I	Letter of Support

"|j§ Letter of Support
Submitter Information

"¦[5 Letter of Support

Submission Information

E! Chemical

Chemical Identification
Information

EH iSite Information

""fi Submitter Site
Identific ation

r"2)Document Management

~"(f Optional Cover Letter

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:

XE

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

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

Apartment, suite, etc.

Previous

| Next |





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Submit



CDX Homepage |

I MyCDX Homepage |

I EPA Homepage |

Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (81

38)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.

8.1.6 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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CDX.

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
submitter. A text field captures information to send 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 generates
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 CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
225

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CD)Sr

Exhibit 8-8 shows a screen capture of the 'Letter of Support Submission Information' screen:
Exhibit 8-8: Letter of Support Submission Information Screen

y User Management y

A Logged in as: Jane Doe, Primary Authorized Official

Log Out

Bona Fide

Primary Authorized Official

Bona Fide-20141128-14:19:27
EST

""If |General Document Information

Primary Contact Informatbn

"ijTechnic al Contact Information

"h Statement of Intent

3 i_ Letter of Support

H3Letter of Support

Submitter Information

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Submission Information

f "l_ Chemical

i :""2 ] C hemic al Identific ation
Information

Site Information

4 Bona Fide (Bona Fide-20141128-14:19:27 EST) > 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

""1 = [Submitter Site
Icfentific ation

""(3)Document Management

'"[fliOptional Cover Letter

Unique Identifier for Letter of Support Submission: a89f9a97-f706-4aa1-a3bc-
69ad4967786d

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.

| Next |





-------
	

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 Information' screen by clicking the 'Chemical Identification Information' link
within the navigation tree.

8.1.7 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 Identifier Number.' The 'Unique Identifier Notification' pop-up 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.

•	From: Displays the email address of the logged in user 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 logged in user, 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 CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CDX.

Exhibit 8-9 shows a screen capture of the 'Notify Letter of Support Submitter' pop-up window:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
228

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CD)Sr

Exhibit 8-9: Notify Letter of Support Submitter Pop-Up Window

C^CSPP

From:

CC:

To:

Jane.Doe@test.com

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

Subject:	2015 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 a89f9a974706-4aa1-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/op pt'ne wchems/. 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 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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8.1.8 Chemical Identification Information

You can navigate to 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.

•	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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
230

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CDXr

Exhibit 8-10 shows a screen capture of the 'Chemical Identification Information' screen:
Exhibit 8-10: Chemical Identification information Screen

Logged in as: Jane Doe, Primary Authorized Official

Log Out

4 Bona Fide (Bona Fide-20140408-11:25:34 EDT) > Chemical Identification Information

CHEMICAL IDENTIFICATION INFORMATION

Bona Fide

Primary Authorized Official

Bona Fide-20140408-11:25:34
EDT

"2; Gen era I Document Information

j"'2 Primary Contact Information

"| ~'Technical Contact Information

"j 2": Statement of Intent

? Letter of Support

| {""*[= Letter of Support
| Submitter Information

Letter of Support
Submission Information

B"L Chemical

I r® Chemical Identification
Information

! class 1 Chemical
Substance

l""pl Class 1 or
j 2/Biotechnology
Chemical
Substances

2/Biotechnology
Substances

I :"~jj|jUse Information
B'L Site Information

Chemical Type

Complete either item 1 (Class 1 or 2/Biotechnology Chemical Substance) or 2 (Polymer) as appropriate
Indicate which selection you intend to complete below.

Class 1 or 2/Biotechnology Chemical Substance

Polymer

Chemical Alias:

The chemical alias is an optional field that changes the folder name in the navigation tree on the left-hand
side of the screen.

j^NextJ

Submitter Site

>/

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¦

*

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Submit

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions

Privacy Notice | CDX Helpdesk: (888)890-1995

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.

8.1.9 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.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014

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CDX.

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.
Click the 'Delete" icon (X) located under the 'Actions" column to delete unwanted documents.
Click the appropriate file name of the document within the 'File Name' column of the
attachment table to access or edit previously attached documents.

Please note that if you are using IE 7, part of the content on this screen displays behind the Bona
Fide navigation tree and certain fields on this screen may display twice.

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

•	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 (X) 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.

•	Class of Substance: In the section, 'Class of Substance,' you identify whether a 'Class 1' or
'Class 2/Biotechnology' chemical substance is being reported. When you select the 'Class
2/Biotechnology' chemical substance radio button, you are indicating that some portions of the
structure may not be known and an additional screen will appear within the navigation tree that
provides fields for you to enter information concerning how the chemical was created. If
multiple class 2 chemical substances are added, one 'Class 2/Biotechnology Substances' screen
will apply to all chemical substances.

•	Add Chemical ID: You can access the 'Add Chemical ID' pop-up window by clicking the
'Add Chemical ID' button within the 'Chemical Identification Information' field set. You can
search for the reported chemical(s) either by the 'CASRN' or 'CA Index Name or Other
Synonym.' If you retrieve zero results, the system provides fields for you to enter the chemical
information by filling in the 'Chemical Name' and the 'Chemical Abstract Services Registry
Number' under the manual entry field set. The system provides functionality to enter the

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CDX.

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
closes and the document information displays in a table format on the 'Class 1 or
2/Biotechnology Chemical Substances' screen. The document attachment table displays the file
name of the document(s) and the user-provided description of the document(s). Click the
'Delete" icon (X) 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 (X) 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 3.9
for more information regarding the save functionality in an expandable/collapsible field set.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
233

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CD)Sr

Exhibit 8-11 shows a screen capture of the 'Class 1 or 2/Biotechnology Chemical Substances'
screen (Scroll 1):

Exhibit 8-11: Class 1 or 2/Biotechnology Chemical Substances Screen (Scroll 1)

Logged in as: Jane Doe, Primary Authorized Official

Log Out

Bona Fide

Primary Authorized Official

Bona Fide-20141128-14:19:27
EST

j-"[ = I General Document Information

l Primary Contact Information

H^Technical Contact Information

fj-j Statement of Intent

5 i_iLetter of Support

rEiLetter of Support
Submitter Information

"'1^! Letter of Support

Submission Information

$'"l	.Chemical

Chemical Identification
Information

El & Chemical 4865

Class 1 or
2/Biotechnology
Chemical
Substances

;'"|_jjllse Information

?"i	iSite Information

: |JJ Submitter Site
Identification

Document Management

JOptional Cover Letter

>me y Forms y User Management | Resources
4 Bona Fide (Bona Fide-20141128-14:19:27 EST) > Class 1 or 2/Biotechnology Chemical Substances

CLASS 1 OR 2/BIOTECHNOLOGY CHEMICAL SUBSTANCES

Class 1 or 2/Biotechnology Chemical Substances
Chemical Identification Information

Expand All | Collapse All

Cancel

Class of Substance:

' Class 1 O Class 2/Biotechnology

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

CASRN:

Chemical Name:

ID Method

O Method 1 (CAS Inventory Expert Service)
Attach IES Report

File Name

. Method 2 (Other Method)

Description

Actions

Molecular Formula: (optional)

Chemical Structure Diagram: (optional)

Include an attachment for the chemical structure diagram below.
Attach Chemical Structure

File Name

Description

Actions

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



Previous



| Next |



e

H

¦

Validate

Save

Preview

Submit

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

Navigation: If you selected the 'Class 1' radio button, click the 'Save' button within the
expandable/collapsible field, then click the 'Next' button to navigate to the 'Use Information'
screen. If you selected the 'Class 2/Biotechnology' radio button, click the 'Save' button within
the expandable/collapsible field set, then click the 'Next' button to navigate to the 'Class
2/Biotechnology Substances' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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8.1.10 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.

•	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 3.10 for additional 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 (X) 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.

•	Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window and upload a document. Refer to Section 3.6 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.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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)



Bona Fide

Primary Authorized Official

Bona Fide-20140408-11:25:34
EDT

j""[ General Document Information
I Primary Contact Information
'[^Technical Contact Information
g1Statement of Intent
Letter of Support

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Submitter Information

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j N Chemical Identification
Information

^Chemical 17S63

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2/Biotechnology
Chemical
;j Substances

Class

2/Biotechnology
Substances

	IjjUse Information

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y User Management J

Logged in as Jane Doe, Primary Authorized Official

Log Out

4 Bona Fide (Bona Fide-20140408-11:25:34 EDT) > Class 2/Biotechnology Substances

CLASS 2/BIOTECHNOLOGY SUBSTANCES

Class 2/Biotechnology Substance Details

Fill in below for a class 2/biotechnoiogy substance. (1) List the immediate precursor substances with their
respective CAS Registry Numbers. (2) Describe the nature of the reaction or process. (3) Indicate the
range of composition (where appropriate).

Precursor Substances

Search srs 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)





Validate Save

Preview

m

Submit



CDX Homepage

| MyCDX Homepage |

| EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (8£

J8) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CD)Sr

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 Authorized Official

Bona Fide-20140408-11:25:34
EDT

i""[IjGeneral Document Information

rf^ I Primary Contact Information

|-[3 Technical Contact Information

l" "j^ Statement of Intent

9"|_ Letter of Support

j'"b Letter of Support
| Submitter Information

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Chemical Name

Nature of Reaction

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CASRN

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|^NextJ





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H

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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.

8.1.11 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 after clicking the 'Save' icon within the bottom
action bar.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 (X) 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
chemical substance using the 'Add Chemical ID' search or manually enter the chemical
information in the 'Add Chemical ID' pop up.

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•	ID Method: The system shall require that you identify which ID method was used to
determine the chemical identity. When you select 'Method 1 (CAS Inventory Expert
Service),' the system generates an 'Attach IES Report' button for you to attach an IES report.
If you select 'Method 1,' you are required to attach an IES report. You can also select
'Method 2 (Other Method).'

•	Attach IES Report: Click the 'Attach IES Report' button within the 'Polymer Identification
Information' field set after selecting the 'Method 1 (CAS Inventory Expert Service)' radio
button to access the 'Attach IES Report' pop-up window. After you attach the document(s),
and click the 'OK' button, the 'Attach IES Report' pop-up window closes and the document
information displays in a table format on the '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 (X) 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.

•	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 (X) 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
3.9 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 displays 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. Click the 'Delete" icon (X) located under the
'Actions' column to delete unwanted documents. Click the appropriate file name of the
document within the 'File Name' column of the attachment table to access or edit previously
attached documents.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

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CD)Sr

Exhibit 8-14 shows a screen capture of the 'Polymer Identification Information' screen:
Exhibit 8-14: Polymer Identification Information Screen

rjgsfis

Logged in as: Jane Doe, Primary Authorized Official

Bona Fide ^ Bona Fide (Bona Fide-20141202-Q8:57:56 EST) > Polymer Identification Information ^
Primary Authorized Official POLYMER IDENTIFICATION INFORMATION
Bona Fide-20141202-08:57:56

EST

j" {^General Document Information
I j;(Primary Contact Information

Expand Al! | Collapse All

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File Name Description Actions



Information

; l^! Monomers and
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? 1_ Site Information







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

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

8.1.12 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 (X) 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 3.10 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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CDX.

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
3.9 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 3.6 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 (X) to delete the entire attached document row permanently
from the system. A warning message displays to confirm the deletion of the document.

Exhibit 8-15 shows a screen capture of the 'Monomers and Other Reactants' screen:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
242

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CDXr

Exhibit 8-15: Monomers and Other Reactants Screen



p Polymer

Identification
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QlJse Information

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Bona Fide

Primary Authorized Official

Bona Fide-20140515-10:10:10
EDT

' "l2:]General Document Information

"PiPrimary Contact Information

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j""P]Statement of Intent

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me y Forms y User Management J Resources
4 Bona Fide (Bona Fide-20140515-10:10:10 EDT) > 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 X

Click the button below to search ERA'S Substance Registry Services (SRS) for the desired
chemical.

Search SRS

CAS Registry Number:

Monomer or other reactant:

Include in Identity:	~

Typical Composition:	I	|%

Save

Click to add a monomer Add Monomer

Composition Total:0%

Optional Attachments

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Description
Previous	| Next |

Actions

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Validate	Save	Preview	Submit

CDXHomepage | MyCDXHomepage | EPAHomepage | Terms and Conditions | Privacy Notice | CDXHelpdesk: (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.

8.1.13 Use Information

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

The 'Use Information' screen captures data about the chemical substance's intended use. When
you navigate to the screen, the screen contains a text box with instructional text that reads, 'How
will the substance be used?' Enter the specific data for the chemical substance and then advance
to the next screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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• 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:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
244

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CD)Sr

Exhibit 8-16: Use Information Screen



Y User Management J

¦ft. Logged in as Jane Doe, Primary Authorized Official

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Bona Fide

Primary Authorized Official

Bona Fide-20140408-11:25:34
EDT

""|^)Gerieral Document Information
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5":_ Lette r of Su pport

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4 Bona Fide (Bona Fide-20140408-11:25:34 EDT) > Use Information

USE INFORMATION

How will the substance be used?

| Next |







•v¦

Validate Save

H

Preview

¦

Submit

COX Homepage |

[ MyCDX Homepage |

| EPA Homepage | Terms and Conditions

| Privacy Notice

I CDX Helpdesk: (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.

8.1.14 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.

The 'Submitter Site Identification' screen captures information about the identification of the
sites of manufacture and/or the port of entry. 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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•	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 (X) to delete the entire site row permanently from the
system. A warning message displays to confirm the deletion of the site.

Exhibit 8-17 shows a screen capture of the 'Submitter Site Identification' screen:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
246

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CDXr

Exhibit 8-17: Submitter Site Identification Screen



Bona Fide

Primary Authorized Official

Bona Fide-20141202-08:57:56
EST

I General Document Information

Primary Contact Information

|""Rtechnical Contact Information

Statement of Intent

IpiliLetter of Support

r"|5JLetter of Support
Submitter Information

Letter of Support
Submission Information

P" Chemical

Chemical Identification
Information

Chemical 7036

Polymer
Identification
Information

"g] Monomers and
Other Reactants

"(5)Use Information

P'LjSite Information

Submitter Site
Identification

Document Management

Optional Cover Letter

y User Management y

Logged in as Jane Doe, Primary Authorized Official

Log Out

4 Bona Fide (Bona Fide-20141202-08:57:56 EST) > Submitter Site Identification

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 ID Site of

Site Name

Address

Actions

Manufacture







or Port of Entry







Previous

| Next |

>/

B

~

«

Validate

Save

Preview

Submit

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 'Document Management' screen. You can
also access this screen by clicking the 'Document Management' link within the navigation tree.

8.1.15 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 check that the correct documents have been attached.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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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 3.6 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 (X) to delete the entire document row permanently from the
system. A warning message displays to confirm the deletion of the document.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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CDXr

Exhibit 8-18 shows a screen capture of the 'Document Management' screen:

Exhibit 8-18: Document Management Screen



y User Management j

Logged in as Jane Doe, Primary Authorized Official

Log Out

Bona Fide

Primary Authorized Official

Bona Fide-20141202-08:57:56
EST

General Document Information

j""Q Primary Contact Information

"^Technical Contact Information

'[ Statement of Intent

Letter of Support

j™[ Letter of Support

Submitter Information

' j_ Letter of Support

Submission Information

Chemical

"[ Chemical Identification
Information

& Chemical 7036

"bj|] Polymer
Identification
Information

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IRflSubmitter Site
Identification

j""FlDocument Management

Optional Cover Letter

< Bona Fide (Bona F»de-20141202-08:57:56 EST) > Document Management	^

DOCUMENT MANAGEMENT

Please attach at least one of each of the following documents:

•	Spectrum of Substance: Infrared spectrum or alternative spectra or other data which identify the
substance.

•	Statement of Commercialization: 1) A brief statement 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.

Document Name

Attach Document

Document Type

Previous

Action

| Next |



B

¦



Validate

Save

Preview

Submit

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.

8.1.16 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
249

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CD)Sr

Exhibit 8-19 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 8-19: Optional Cover Letter Screen

y User Management y

Logged in as Jane Doe, Primary Authorized Official

Log Out

Bona Fide

Primary Authorized Official

Bona Fide-20140515-10:10:10
EDT

General Document Information

rQPrimary Contact Information

j—Qrechnical Contact Information

Statement of Intent

5 I	ILetter of Support

|—[jgLetter of Support
Submitter Information

Letter of Support
Submission Information

P"i_ Chemical

-RChemical Identification
! Information

&& Chemical 18328

=] Polymer
Identification
Information

Monomers and
Other Reactants

j^]Use Information

=H Site Information

! '"1^1 Submitter Site
Identification

(""[^Document Management

Optional Cover Letter

¦< Bona Fide (Bona Fide-20140515-10:10:10 EDT) > Optional Cover Letter

OPTIONAL COVER LETTER

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





>/ B

Validate Save

Preview

•

Submit



CDX Homepage |

| MyCDX Homepage |

I 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 (E ) located in the bottom action bar to save the overall form. Click the
'Preview' icon ( ) located in the bottom action bar to generate a PDF preview of the form
Click the 'Submit' icon ( ) located in the bottom action bar to initiate the submission process.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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250

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9 Create Alternative Control Measures (ACM) Form

The Section 5 Notices and Supports application allows 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 Create Alternative Control Measures Form

To create a new ACM form, navigate to the 'Section 5 Notices and Supports Forms' screen and
select 'Alternative Control Measures (ACM)' from the 'Form Type' drop-down menu. Refer to
Section 3.4 for additional details regarding the 'Section 5 Notices and Supports Forms' screen.

Refer to Section 3.5 for additional details regarding the create passphrase process.

9.1.1 Contact Information

You can access the 'Contact Information' screen by entering the passphrase on the 'Enter
Passphrase' screen or creating a passphrase on the 'Create 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 displays
under the form alias header 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 generate the 'Add Contact' window, which allows a user
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 (X) to delete a contact from the table. A warning message
displays to confirm deletion of the contact.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
251

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CDXr

Exhibit 9-1 shows a screen capture of the 'Contact Information' screen:

Exhibit 9-1: Contact Information Screen (ACM)

Logged in as Jane Doe, Primary Authorized Official

Log Out

ACM

Primary Authorized Official
ACM-20141202-08:58:13 EST

r"F' Contact Information

"[^'Attac foments

Home J Forms Y User Management y Resources
< ACM {ACM-20141202-08:58:13 EST) > Contact Information

CONTACT INFORMATION

You may enter an alias for easier form identification or the system will provide a time stamp.

Form Alias:

ACM-20141202-08:58:13 EST

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

Last Name	First Name	Address	CBI

|^NextJ

Actions





V ¦

Validate Save

Preview

¦

Submit

CDX Homepage |

| MyCDX Homepage |

EPA Homepage | Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (888) 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.

9.1.1.1 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 'Check here to claim this
information as CBI' checkbox to claim the contact information as confidential. If the 'CBI'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide	December 15, 2014

Primary Authorized Official	252

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CDX.

checkbox is checked before clicking the 'Copy CDX Registration' button, the 'CBI'
checkbox becomes unchecked upon navigating back to the screen after copying CDX
registration information. Check the 'CBI' checkbox after importing CDX registration
information to claim a contact as confidential.

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

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

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

•	Phone Number: Enter the contact's daytime phone number; dashes are not allowed. Click
the 'Copy CDX Registration' button to populate the fields with information entered during
CDX registration. This is a required field.

•	Phone Extension: Enter the 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. Click the 'Copy CDX Registration'
button to populate the fields with information entered during CDX registration. This is a
required field.

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

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

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

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

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

•	Country: Displays 'United States.'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
253

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CDXr	

Exhibit 9-2 shows a screen capture of the 'Add Contact' pop-up window:

Exhibit 9-2: Add Contact Pop-Up Window (ACM)

©

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 cdx Registration
Check here to claim this information as CBI:

First Name:

Last Name
Company Name:

Phone Number

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

Phone Extension
Email Address
Mailing Address 1:

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

Mailing Address 2

City
State:

Postal Code
Country

Cancel	| OK |

Apartment, suite, etc.

United States

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.

9.1.2 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
254

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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.

•	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 3.6 for additional information regarding the attach document functionality.

•	File Name: Displays the file name and file extension of a document.

•	Description: Displays the description of a document.

•	Pages: Displays the number of pages a document 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 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
255

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CD)Sr

Exhibit 9-3 shows a screen capture of the 'Attachments' screen:

Exhibit 9-3: Attachments Screen (ACM)

ACM

Primary Authorized Official
ACM-20140408-11:26:12 EDT

I Contact Information
Attachments

A Logged in as: Jane Doe, Primary Authorized Official

Log Out

Home y Forms y User Management * Resources
^ ACM (ACM-20140408-11:26:12 EDT} > Attachments

ATTACHMENTS

Please remember to upload documentation that fulfills the following requirements under 721.33:
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 CFR721:

-------
CD)Sr

10 Preview

The system provides the option to preview a form at any point during the submission process.
Click the 'Preview' icon ( P). located within the bottom action bar, to see a PDF version of the
form. A screen will display for you to view either the 'Full' or the 'Sanitized' version of the PDF
differentiated by buttons. After you choose either the 'Full' or 'Sanitized' PDF, the application
generates a draft, watermarked PDF version of the form.

Please note in IE 7, the 'Preview EPMN FORM' screen text might be misaligned.

The watermark reads 'Not for Submission' and displays across each page in the background. The
form preview displays the entire form in a printable format. The preview functionality provides
the flexibility to track the status of the form and see the entire form in a single viewpoint.

Exhibit 10-1 shows a screen capture of the 'Preview EPMN Form' screen:

Exhibit 10-1: Preview EPMN Form Screen

ACM	<

Primary Authorized Official

ACM-20140408-11:26:12 EDT

"{^[Contact Information
:|_ Attachments

Home J Forms J User Management y Resources

PREVIEW EPMN FORM

Please choose a Regular or Sanitized PDF.

Logged in as: Jane Doe, Primary Authorized Official

Log Out



Full Version Sanitized Version

Note: If you mate no CBI claims, the two versions will be the same.





•y¦

Validate Save

Preview

•

Submit

CDX Homepage |

I MyCDX Homepage |

| EPA Homepage | Terms and Conditions

I Privacy Notice

I CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
257

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CD)Sr

Exhibit 10-2 shows a screen capture for the 'Preview' of the Biotechnology form:

Exhibit 10-2: Preview Biotechnology Form PDF

CBI SUBMISSION

B?02£114P1

Form Approved. O.M.B. Mos. 2D70-C012 and 2D70-0D38

EPA Biotech Form

Biotech Form Report Number

Mark (X) if anything is CBI [

I. 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 - If you are submitting this notice as parr of a joint submission.

3®

CBI ~

First Name

Last Name

Position

Company

Mailing Address
(Number & Street)

City

State



e-mail

Teli

II. TECHNICAL CONTACT IDENTIFICATION INFORMATION

3

CBI ~

First Name

Last Name

Position

	

-ompany

Mailing Address
(Number & Street)

City

e-mail

tate

Postal Code

Telephone
(include area code)

III. TYPE OF SUBMISSION (Check One)

MCAN (Microbial Commercial Activity Notice)
TERA. (TSCA Experimental Release Application)
I I Tier I Exemption
I I Tier II Exemption
Q Biotech TME (Test Market Exemption)

IV. TEXT 1 COMMENTS

CBI ~

EPA Form Number 5300-17 (6-09)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
258

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CD)Sr

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.B. No. 2O70-OD12

CBI SUBMISSION

U.S. Environmental Protection Agency
pp. A NOTICE OF COMMENCEMENT OF
IZ KM MANUFACTURE OR IMPORT |40CFRij720.102)

Report Number

Part I - SUBMITTER IDENTIFICATION

~oonefit Centra :

Manu-
facturer/
Importer

(in U.S.)

Name of Authorized Official

Mailing Address (number and street)

CBI*

1
I



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 or commencement is the date of corrpletten of ncn-exempc manufacture of trie first amount {Cattv drum, etc.)
"Tor Importees. tne oate of commencement is 1f>e date that the new chemical sue stance clears U.S. customs

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

Part V - Specific Chemical Identity: {For Consolidated! submissions, each substance must have a separate NOC form with the specific

identity of eacfr drtemtcal suostance.)

^r\





Part VI - Generic Chemical Name (if chennai identity is claimed cbi1):

	

Part VII - Substance Identity Confidentiality Status:

I wish to continue to claim the substance identity confidential and the substantiation to support thits claim is attached. Failure to submit
the requirec substantiation in accordance with 40 CFR 720.35(b) will result an a waiver of your claim.

sly claimed the substance identity as confidential and hereby relinquish that ciaim.

1 did not clain the substance identity as confidential in my original PMN submission.

The public reporting and recordkeeping burden for this collection of information 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 estanates. aind any suggested methods for minimizing respondent
burden, intruding through the use of automated collection techniques to the Director, Collection Strategies Division. U.S. Environmental Protection
Agency (2S22T), 1200 Pennsylvania Ave., NW. Washington, D.C. 20400. Include the OMB control number in any conespondence. Do not send the
completed EPA Form 7710-56 to this address.

You must submit your completed notice no later than 3D calendar days after the first date of commercial manufacturefrmportation to the address
shown below:	U.S. Environmental Protection Agency

OPPT Document Control Office (7407M)

1200 Pennsylvan a Ave., NW
Washington, D.C. 20400
ATTN : Notce of Commencement

Signature of authorized official



Date



Nate: CBI" - fctera to Ifte term "ConfUen*al Business Mbfnuttnr. Marie 00 lr 8-e box If the F-ormaSon ta In &e hdd CanTVrweal

EPA Form 7710-56 (6-09)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
259

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CDX.

Exhibit 10-4 shows a screen capture for the 'Preview' of the Support form:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
260

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CD)Sr

Exhibit 10-4: Preview Support Form PDF

MON-C8I SUBMISSION

Farm Approved.	No. 2070-0173.

EPA Support Form

Support Form Report Number

Mark (X) if anything is CBI

~

I. ORIGINAL NOTICE SUBMISSION IDENTIFICATION

Report Number

TS

Number

Case
Number

Original Submission Date

Original Submission Media Type

H. ORIGINAL NOTICE SUBMITTER IDENTIFICATION

I CBI| ~

Authorized Official
Name

Position

Mailing Address
(Number & Street)

(first)

(last)

Company N;

ame

_



City

e-mail

State



1 Code

le area code)

IB. CURRENT SUPPORT DOCUMENT IDENTIFICATION INFORMATION

CBI

~

Name

(first)

	

(last)

Position

—

Company Name

Mailing Address
(Number & Street)

£

City

SO

State

Postal Code

Province

Country

e-mail

Telephone
£ndud^re^ode^

IV. TYPE OF SUPPORT (Check One)

Transfer of Ownership

S
~

Suspension Request

Withdrawal Request

~

Other Correspondence

~

TEST DATA (Health/Eco/Fate)

~

Amendment (Changes made to PMN pages 1-13, MSDS or Physical/Chemical
properties)

Check if requested by EPA1' contractor

~

EPA person,' contractor

Submitter Signature

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
261

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CDX.

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 ( ). Disable the pop-up blocker within your internet browser so
that the 'Section 5 Notices and Supports Validation' pop-up 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 aligns to the right side of the 'Section 5 Notices and
Supports Validation' pop-up window.

Validation Errors: Errors are denoted by an 'Error' icon (©) 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. You must fix all validation errors
to submit the form to CDX successfully.

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 pass validation and
continue to submit a form to CDX with active warning messages.

You can close the 'Section 5 Notices and Supports Validation' pop-up window by clicking the
'X' button located at the upper right-hand corner of the window.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
262

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CD)Sr

Exhibit 11-1 shows a screen capture for the 'Section 5 Notices and Supports Validation' pop-up
window:

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

cspp

SECTION 5 NOTICES AND SUPPORTS VALIDATION
Errors:

•	Technical Contact Information

& Contact is required.

•	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 Oberation Controlled bv Others has been added.

•	Submitter Controlled Operations
o Operation 1

¦ Submitter Operation Information
# Operation Alias is required.

•	Operations Controlled by Others
o Operation 1

• Industrial Sites Controlled By Others
4# Alias is required.

Warnings:

•	Joint Submission 1

o Joint Submission Information

: You did not notify the Secondary Submitter of the joint submission.

•	LOS Submission 1

° Letter of Support Submission Information

: You did not notify the Secondary Submitter of the letter of support submission.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
263

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CDX.

12 Submit to EPA via CDX

As a Primary AO, you have the ability to sign and submit a Section 5 Notices and Supports form
to EPA via CDX. You can save your form at any point during the data entry process. Any
assigned Supports for your form cannot submit the Section 5 Notices and Supports form. The
save functionality will allow you to return to that same form at any point in the future.

Once you complete all required information and correct all items failing validation, the system
will allow the Section 5 Notices and Supports form to be successfully submitted.

12.1 Submitting Official Information

Click the 'Submit' icon ( ) that is located in the bottom action bar of the Section 5 Notices and
Supports application to access the 'Submitting Official Information' screen. This screen only
displays to a Primary AO upon submission.

After clicking the 'Submit' icon ( ), the system requires you to review your contact
information provided during CDX registration. The system also requires you to identify your job
title. Click the 'Home' button to navigate to the Section 5 Notices and Supports 'Home' screen.

The following statement which displays to the Primary AO and Secondary AO must be
confirmed before the system will allow you to move forward: "Please confirm that you are the
legally responsible party from the submitting company." If you check this checkbox associated
with the statement, the application navigates to either the appropriate certification screen or the
'Cross-Media Electronic Reporting Regulation (CROMERR)' screen. If you do not check the
checkbox associated with this statement, the application takes you back to the 'Section 5 Notices
and Supports Forms' screen.

Please note in IE 7, the 'Cancel' and 'Next' buttons will be misaligned in the center of the
'Submitting Official Information' screen.

•	CBI: Check the 'CBI' checkbox to claim the submitting official's information as
confidential.

•	Please confirm that you are the legally responsible party from the submitting company:

Check the checkbox to confirm that the individual submitting the form has permission to do
so.

•	First Name: Displays the first name of the submitting official, which has been pre-populated
from CDX registration information.

•	Middle Initial: Displays the middle initial of the submitting official, which has been pre-
populated from CDX registration information.

•	Last Name: Displays the last name of the submitting official, which has been pre-populated
from CDX registration information.

•	Job Title: Enter the job title of the submitting official. This is a required field.

•	Company Name: Displays the company name of the submitting official, which has been
pre-populated from CDX registration information.

•	Phone Number: Displays the phone number of the submitting official, which has been pre-
populated from CDX registration information.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
264

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CDX.

•	Email Address: Displays the email address of the submitting official, which has been pre-
populated from CDX registration information.

•	Mailing Address 1: Displays the first line of the mailing address from CDX registration
information.

•	Mailing Address 2: Displays the second line of the submitting official's mailing address,
which has been pre-populated from CDX registration information.

•	City: Displays the city of the submitting official's mailing address, which has been pre-
populated from CDX registration information.

•	State: Displays the state of the submitting official's mailing address, which has been pre-
populated from CDX registration information.

•	Postal Code: Displays the postal code of the submitting official's mailing address, which has
been pre-populated from CDX registration information.

•	Country: Displays the country of the submitting official's mailing address, which has been
pre-populated from CDX registration information.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
265

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CD)Sr

Exhibit 12-1 shows a screen capture of the 'Submitting Official Information' screen:

Exhibit 12-1: Submitting Official Information Screen

Logged in as: Jane Doe, Primary" Authorized Official

Log Out

SUBMITTING OFFICIAL INFORMATION	®

The information below has been pre-populated from CDX registration. If the information listed is
incorrect please make the appropriate edits to your user information in CDX registration.

CBI:	~

This confirmation is required to proceed with the submission process

Please confirm that you are the legally responsible party from the submitting company ~

First Name:

Middle Initial:

Last Name:
Job Title:

Company Name:
Phone Number:
Email Address:
Mailing Address 1:
Mailing Address 2:
City:

State:

Postal Code:
Country:

Jane
E

Doe

TEST COMPANY
7034349615
Jane.Doe@test.com
12601 FAIR LAKES CIRCLE

FAIRFAX
VA

22033
US

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

Navigation: Click the 'Next' button to continue with submitting the form and navigating to the
'Submission Process: Validation' screen or a certification screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

12.2 LVE Certification

Click the 'Next' button from the 'Submitting Official Information' screen to access the 'LVE
Certification' screen. This screen displays when 'LVE' or 'LVE Modification' is selected from
the 'Type of Notice' drop-down menu on the 'General Form Information' screen for a PMN
form. If the notice type is not 'LVE' or 'LVE Modification,' click the 'Next' button to navigate
to the 'Submission Process: Validation' screen or a different certification screen.

Exhibit 12-2 shows a screen capture of the 'LVE Certification' screen:

Exhibit 12-2: LVE Certification Screen



y User Management J

Logged in as: Jane Doe, Primary Authorized Official

Log Out

LVE CERTIFICATION

I certify, under penalty of law, that the following is true:

The manufacturer submitting this notice Intends to manufacture or import the new chemical substance for commercial purposes, other than In

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

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

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

In accordance with 40 CFR 723.50(c)(1), the manufacturer intends to commence manufacture of the exempted substance for commercial
purposes within 1 year of the date of the expiration of the 30 day review period.

Cancel	|l Certify!

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

Navigation: Click the 'I Certify' button to continue with submitting the form and navigate to the
'Submission Process: Validation' screen. Click the 'Cancel' button to stop the submission
process.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide	December 15, 2014

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CD)Sr

12.3 LOREX Certification

Click the 'Next' button on the 'Submitting Official Information' screen to access the 'LOREX
Certification' screen. This screen displays when 'LOREX' or 'LOREX Modification' is selected
from the 'Type of Notice' drop-down menu on the 'General Form Information' screen for a
PMN form.

Exhibit 12-3 shows a screen capture of the 'LOREX Certification' screen:

Exhibit 12-3: LOREX Certification Screen

Home y Forms y User Management J Resources

* Logged in as: Jane Doe, Primary Authorized Official

Log Out



LOREX CERTIFICATION

I certify, under penalty of law, that the following is true:

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

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

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

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

Cancel

I Certify]

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

Navigation: Click the 'I Certify' button to continue with submitting the form and proceed to the
'SubmissionProcess: Validation' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide	December 15, 2014

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CD)Sr

12.4 Submission Process: Validation

Click the 'Submit' icon ( ) that is located in the bottom action bar of the Section 5 Notices and
Supports form to begin the submission process and access the 'Submission Process: Validation'
screen.

The first step in the submission process will validate the information entered within the Section 5
Notices and Supports form. After a form is validated, the system will generate a PDF.

Exhibit 12-4 shows a screen capture of the 'Submission Process: Validation' screen:

Exhibit 12-4: Submission Process: Validation Screen

mm

A Logged in as: Jane Doe, Primary Authorized Official

Log Out







SUBMISSION PROCESS: VALIDATION









r

Validation

PDF Generation CROMERR

-

ua

Submit







V



















Running validation on your data















Processing. Please wait...









(Please disable any pop-up Plockers within your internet browser settings to allow for the validation pop-up to be displayed if validation









errors are present.)











CDX Homepage

MyCDX Homepage

| EPA Homepage | Terms and Conditions |

Privacy Notice | CDX Helpdesk: (888) 890-1995



TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 12-5 shows a screen capture of the 'Submission Process: PDF Generation' screen:
Exhibit 12-5: Submission Process: PDF Generation Screen





Logged in as: .Jane Doe, Primary Authorized Official

Log Out

SUBMISSION PROCESS: PDF GENERATION

Your PDF preview transaction was successful!



View PDF Continue

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms ant) Conditions | Privacy Notice | CDX Helpdesk: (888) 890-1S95

Navigation: Click the 'View PDF' button to generate and view a PDF of the form. Click the
'Continue' button to continue with submitting the form and proceed to the 'Cross-Media
Electronic Reporting Regulation (CROMERR) Certification' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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12.5 Cross-Media Electronic Reporting Regulation (CROMERR) Certification

Click the 'Continue' button on the 'Submission Process: PDF Generation' screen to access the
'Cross-Media Electronic Reporting Regulation (CROMERR) Certification' screen.

CROMERR provides the legal framework for electronic reporting under all of EPA's
environmental regulations.

After clicking the 'Continue' button, the system requires you to certify that the form is
CROMERR compliant. By clicking the 'I Certify' button on the 'Cross-Media Electronic
Reporting Regulation (CROMERR) Certification' screen, you authenticate all of the information
entered in the form. Click the 'Cancel' button to navigate back to the Section 5 Notices and
Supports application.

Exhibit 12-6 shows a screen capture for the 'Cross-Media Electronic Reporting Regulation
(CROMERR) Certification' screen:

Exhibit 12-6: Cross-Media Electronic Reporting Regulation (CROMERR) Certification Screen

m

*• Logged in as: Jane Doe. Primary Authorized Official

Log Out

CROSS-MEDIA ELECTRONIC REPORTING REGULATION (CROMERR) CERTIFICATION

/ _

Validation

PDF Generation



CROMERR

Hi

Submit

9

I certify, under penalty of law, that this document and all attachments were prepared under my direction of supervision in accordance with
a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the
person or persons who manage the system, or those persons directly responsible for gathering the information, the information submitted
is, to the best of my knowledge and belief, true, accurate, and complete. I am aware that there are significant penalties for submitting false
information, including the possibility of fines and imprisonment for knowing violations.

Cancel

I Certify

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

Navigation: Click the 'I Certify' button to continue with submitting the form and proceed to the
'CROMERR Login' screen.

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CD)Sr

12.6 Cross-Media Electronic Reporting Regulation (CROMERR) Login

You can access the 'Cross-Media Electronic Reporting Regulation (CROMERR) Login' screen
by clicking the 'I Certify' button on the 'Cross-Media Electronic Reporting Regulation
(CROMERR) Certification' screen.

To proceed with the submission, log into CDX using the credentials you provided during CDX
registration:

• Please login with your CDX password: Enter your CDX registration password.

Exhibit 12-7 shows a screen capture of the 'Cross-Media Electronic Reporting Regulation
(CROMERR) Login' screen:

Exhibit 12-7: Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen

• Logged In as: Jane Doe, Primary1 Authorized Official

Log Out

CROSS-MEDIA ELECTRONIC REPORTING REGULATION (CROMERR) LOGIN

r

%

/ -

Validation

PDF Generation

a _» LB

CROMERR
%

Submit

Please login with your password:

Cancel

Next

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

Navigation: Enter your CDX registration password and click the 'Next' button to navigate to the
'CROMERR Security Question' screen.

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12.7 Cross-Media Electronic Reporting Regulation (CROMERR) Security Question

You can access the 'Cross-Media Electronic Reporting Regulation (CROMERR) Security
Question' screen by entering your CDX registration password on the 'Cross-Media Electronic
Reporting Regulation (CROMERR) Login' screen and clicking the 'Next' button.

The 'Cross-Media Electronic Reporting Regulation (CROMERR) Security Question' screen
randomly selects and displays one of the five CROMERR eSIG-PIN questions you answered on
the '20-5-1 Question' screen during the initial login to CDX.

eSIG-PIN Authorization Code: Provide one of the five secret answers to the questions that
were pulled from the list of 20 CDX security questions.

Exhibit 12-8 shows a screen capture of the 'Cross-Media Electronic Reporting Regulation
(CROMERR) Security Question' screen:

Exhibit 12-8: Cross-Media Electronic Reporting Regulation (CROMERR) Security Question Screen

0

Logged in as: Jane Doe, Primary Authorized Official

Log Out

CROSS-MEDIA ELECTRONIC REPORTING REGULATION (CROMERR) SECURITY QUESTION

&

^	- Si

Validation

\t

PDF Generation

CROMERR

Submit

What is your favorite book?

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

Navigation: Answer the security question and click the 'Next' button to navigate to the 'Submit
to CDX' screen.

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CD)Sr

12.8 Submit to CDX

You can access the 'Submit to CDX' screen after answering the 20-5-1 security question on the
'Cross-Media Electronic Reporting Regulation (CROMERR) Security Question' screen and
clicking the 'Next' button.

On the 'Submit to CDX' screen, you will see a certification message. Read the message and
acknowledge by clicking the 'Confirm' button. Once you have clicked the 'Confirm' button,
your form will be submitted to CDX.

This screen is only applicable to the original forms (PMN, NOC, Biotechnology, Bona Fide, and
ACM). This screen will display during the submission process for joint submissions and Letters
of Support. This screen is not applicable to Support forms and amendments to original
submissions.

Exhibit 12-9 shows a screen capture of the 'Submit To CDX' screen:

Exhibit 12-9: Submit To CDX Screen

[3

A Logged in as: Jane Doe, Primary'Authorized Official

Log Out

SUBMIT TO CDX

/ - is - & - Si

Validation

PDF Generation

CROMERR

Submit

I hereby certify to the best of my knowledge and belief that (1) all information entered on this form is complete and accurate; and (2) any
confidentiality claims are true and correct as to that information for which they have been asserted. Any knowing and willful
misinterpretation is subject to criminal penalty pursuant to 18 use 1001

Cancel

Confirm!

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

Navigation: Click the 'Confirm' button to navigate to the 'Cross-Media Electronic Reporting
Regulation (CROMERR) Submission' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 15, 2014
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CD)Sr

12.9 Cross-Media Electronic Reporting Regulation (CROMERR) Submission

You can access the 'Cross-Media Electronic Reporting Regulation (CROMERR) Submission'
screen by acknowledging the certification to submit to CDX by clicking the 'Confirm' button on
the 'Submit to CDX' screen.

On the 'Cross-Media Electronic Reporting Regulation (CROMERR) Submission' screen, you
will see a message indicating the form has been successfully submitted to CDX.

Exhibit 12-10 shows a screen capture of the 'Cross-Media Electronic Reporting Regulation
(CROMERR) Submission' screen:

Exhibit 12-10: Cross-Media Electronic Reporting Regulation (CROMERR) Submission Screen

Logged in as: Jane Doe, Primary Authorized Official

Log Out

CROSS-MEDIA ELECTRONIC REPORTING REGULATION (CROMERR) SUBMISSION

&



Validation

PDF Generation

a

CROMERR

v_

Si

Submit

The submission was sent to the EPA. The Copy of Record link to allow for download of the Copy of Record and signature for this
submission will appear in the Forms list when the EPA receives and processes your submission.

] Finish

CDX Homepage

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

Navigation: Click the 'Finish' button to navigate back to the Section 5 Notices and Supports
'Home' screen. Click the 'Forms' link or tab to find your locked submission. The 'Section 5
Notices and Supports Forms' screen will display the submission with a 'Lock' icon (0 ) under
the 'Action' column and will display a status of'Submitted.'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CDX.

13 Download Copy of Record

To download a Copy of Record, navigate to the 'Section 5 Notices and Supports Forms' screen
and locate a form alias for which you have successfully completed a submission and which has a
status of' Submitted.'

Click the 'Copy of Record' icon ( ) from the 'Section 5 Notices and Supports Forms' screen to
navigate to the 'Enter Passphrase' screen to login into CDX. The 'Enter Passphrase' screen
requires you to enter the passphrase originally associated with the form. If your passphrase is
entered correctly, you will access the 'Cross-Media Electronic Reporting Regulation
(CROMERR) Login' screen where you are required to enter your credentials you provided
during CDX registration. Once you have provided the correct CDX password, click the 'Next'
button to navigate to the 'Cross-Media Electronic Reporting Regulation (CROMERR) Security
Question' screen. The 'Cross-Media Electronic Reporting Regulation (CROMERR) Security
Question' screen randomly selects and displays one of the five CROMERR eSIG-PIN questions
that you answered on the 20-5-1 Question screen during CDX registration. Answer the
CROMERR security question and click the 'OK' button. If your answer was successful, you will
be taken to the 'Download Copy of Record' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CDY?

Exhibit 13-1 shows a screen capture of the 'Download Copy of Record' screen:

Exhibit 13-1: Download Copy of Record Screen

EJ



¦ Logged in as: Jane Doe, Primary Authorized Official

Log Out

DOWNLOAD COPY OF RECORD®

You can now download the Copy of Record for the ePMN submission















Download Copy of Record:







File Name







Action



Copy of Record

Home





*



CDX Homepage |

| MyCDX Homepage | EPA Homepage

| Terms and Conditions |

| Privacy Notice

I CDX Heipdesk: (888) 890-1995

The 'Download Copy of Record' screen displays the 'File Name' and 'Action' columns in a
table format. Click the 'Copy of Record' icon ( ) to download the individual files uploaded
during the submission process, PDF version of the submission or the XML version of the Section
5 Notices and Supports form. When you click the 'Copy of Record' icon ( ), the system will
allow you to view or download the individual files that were uploaded during the submission
process.

After you click the 'Copy of Record' icon ( ), enter the passphrase associated with the case
number, and click the 'Next' button. If the passphrase was correctly entered, the application will
take you to the 'CROMERR Login' screen to enter the CDX password. If your login was
successful, you will access the 'CROMERR Security Question' screen. The 'CROMERR
Security Question' screen randomly selects and displays one of the five CROMERR eSIG-PIN
questions that you answered on the 20-5-1 Question screen during the initial login to CDX.
Answer the CROMERR security question and click the 'OK' button. If your answer was
successful, you will navigate to the 'Download Copy of Record' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CDY?

Exhibit 13-2 shows a screen capture of the 'Download Prompt' window (this may be different
depending on the browser used):

Exhibit 13-2: Download Prompt Window

Opening Support_B-00-0001_Support-20140402-17_40_03_EDT_20140402.... I £3
You have chosen to open:

... rt_B - 00- 0001_Su pport- 2 0140402 -1 7_40_03_EDT_2 0140402 .zip

which is: WinZip File

from: https://devngn.epacdxnode.net

What should Firefox do with this file?

o Open with WinZip (default]

¦ | Save File

O Do this automatically for files like this from now on.

OK

Cancel

If you click the 'Copy of Record' icon ( ) you will download:

•	A PDF version of the Section 5 Notices and Supports form

•	An XML version of the Section 5 Notices and Supports form

•	The documents attached to a Section 5 Notices and Supports form

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CDX.

14 Create An Amendment

To amend a submitted Section 5 Notices and Supports form, navigate to the 'Section 5 Notices
and Supports Forms' screen and locate a submission that you previously submitted with a status
of 'Submitted.' In addition to displaying a status of'Submitted' under the 'Status' column, the
'Lock' icon ( ¦ ) will be displayed under the 'Action' column. Click the 'Lock' icon ( ¦ ) under
the 'Action' column to start an amendment.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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CD)Sr

Exhibit 14-1 shows a screen capture of the 'Section 5 Notices and Supports Forms' screen:
Exhibit 14-1: Section 5 Notices and Supports Forms Screen - Amendment



b <§§(?(?

A Logged in as: Jane Doe, Primary Authorized Official

Log Out

Home y Forms y User Management * Resources

SECTION 5 NOTICES AND SUPPORTS FORMS

If submitting a form for the first time in the Section 5 Notices and Supports application, select the form type from the drop-down menu and
click Start New Form

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

To access and edit a form previously submitted through CDX. unlock the form by clicking the lock (|2]) icon and enter the passphrase
when prompted. All additional changes made to the form will be submitted as an amendment.

To download a copy of record for a submitted form, click the green arrow (^) icon and enter the passphrase when prompted.

You may delete any form that has not yet been submitted by clicking the delete (X) icon.

All columns may be sorted by clicking the column header.

7 items found.

Page 1 of 1

Items Per Page: 25 ~

Alias £

Type -i

Subtype

Case Number $

Status

Modify

Submission

Copy of Action











Date

Date t

Record

ACM-20141128-11:30:18 EST

In 11/28/2014
Progress

Biotechnology-20141128-11:36:12 Biotechnology
EST

TIER1



In

Progress

11/28/2014





X

Biotechnology-20141128-11:37:23 Biotechnology
EST

TERA

R-15-0001, R-15-0002, R-15-
0003

In

Progress

11/28/2014

11/28/2014

4

IB

Bona Fide-20141128-11:31:55 EST Bona Fide



BF-15-0015

In

Progress

11/28/2014

11/28/2014



B

NOC-20141128-11:45:27 EST

Primary PMN-20141128-11:49:15 Primary PMN PMN
EST

Support-20141128-11:46:06 EST Support Amendment

In 11/28/2014
Progress

In 11/28/2014
Progress

In 11/28/2014 11/28/2014
Progress

x
x

a

Export options: 0 CSV | 8 Excel | ^3 XML | "3 PDF

Select the form type and then click Start New Form
Form Type: Premanufacture Notice (PMN)

Start New Form

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

Navigation: After clicking the 'Lock' icon ( ¦ ), a prompt will display to confirm the
amendment process. If you do not want to continue with the amendment, click the 'Cancel'
button to cancel the amendment process and return to the 'Section 5 Notices and Supports
Forms' screen. Click the 'OK' button to close the prompt and continue with the amendment.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 14-2 shows a screen capture of the 'Unlock Prompt' message:

Exhibit 14-2: Unlock Prompt Message

This will begin the amendment process. Once this form is unlocked, the only way to lock it again is to resubmit to the EPA. Do you wish to proceed?







OK





Cancel





After you click the 'OK' button, you will be taken to the 'Enter Passphrase' screen. You must
enter the passphrase originally associated with the submission to start the amendment process.
After you enter the passphrase and click the 'Next' button, you will be taken to the first screen in
the specific Section 5 Notices and Supports form. Refer to Section 3.7 for further instructions on
the 'Enter Passphrase' screen.

After a submission has been unlocked, the 'Section 5 Notices and Supports Forms' screen will

display a status of 'In Progress' under the 'Status' column, and the 'Unlocked' icon ( ¦ ) will
display under the 'Action' column; however, you will not see these changes until you navigate
back to the 'Section 5 Notices and Supports Forms' screen.

•	Refer to Section 1 through Section 4.1.35 for instructions on editing a revised PMN form.

•	Refer to Section 1 through Section 5.1.9 for instructions on editing a revised Biotechnology
form.

•	Refer to Section 1 through Section 6.1.8 for instructions on editing a revised NOC form.

•	Refer to Section 1 through Section 7.1.2 for instructions on editing a revised Support form.

•	Refer to Section 1 through Section 8.1.16 for instructions on editing a revised Bona Fide
form.

•	Refer to Section 1 through Section 9.1.2 for instructions on editing a revised ACM form.

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15 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: Click this link to generate the 'Regulatory Impact Analysis for the
Regulation of Microbial Products of Biotechnology: Government Costs' screen in a new
browser window.

•	Microbial Products of Biotechnology: Final Rule (62 FR 17910): Click this link to
generate the 'Microbial Products of Biotechnology: Final Rule (62 FR 17910)' screen in a
new browser window.

•	Points to Consider in the Preparation of TSCA Biotechnology Submissions for
Microorganisms: Click this link to generate the 'Points to Consider in the Preparation of
TSCA Biotechnology Submissions for Microorganisms' PDF in a new browser window.

•	CDX Homepage: Click this link to generate the CDX Homepage in a new browser window.

•	TSCA Chemical Substances Inventory: Click this link to generate the 'TSCA Chemical
Substances Inventory' screen in a new browser window.

•	Substance Registry Services (SRS): Click this link to generate the 'Substance Registry
Services (SRS)' screen in a new browser window.

•	Facility Registry System (FRS): Click this link to generate the 'Facility Registry System
(FRS)' screen in a new browser window.

•	CAS Inventory Expert Services: Click this link to generate the 'CAS Inventory Expert
Services (IES)' screen in a new browser window.

•	National Pollutant Discharge Elimination System (NPDES): Click this link to generate
the 'National Pollutant Discharge Elimination System (NPDES)' screen in a new browser
window.

•	New Chemicals Program Homepage: Click this link to generate the 'New Chemicals
Program' screen in a new browser window.

•	Status of Section 5 Notices: Click this link to generate the 'Status of Section 5 Notices'
screen in a new browser window.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 15-1 shows a screen capture of the 'Resources' screen (Scroll 1):

Exhibit 15-1: Resources Screen (Scroll 1)



A Logged in as: Jane Doe, Primary Authorized Official





Home T Foi ins T User Management y Resources

&

RESOURCES

Section 5 Notices and Supports User Guide
This guide describes each screen of the Section 5 Notices and Supports software and provides information on how to use the system to complete a
Section 5 Notices and Supports form. The guide also contains instructions for registering with CDX, submitting the Section 5 Notices and Supports
form, and amending a previous submission. You can download and print the guide for quick reference.

User Guide

Helpful Web Links

Click the link provided below to access additional information related to the Regulatory Impact Analysis for the Regulation of Microbial Products of

Biotechnology: Government Costs.

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 <62 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 Homepage

Click the link provided below to access additional information related to the Toxic Substances Control Act (TSCA) Chemical Substances Inventory.

TSCA Chemical Substances Inventor/

Click the link provided below to access additional information related to Substance Registry Services.

Substance Registry Services CSRSI

Click the link provided below to access additional information related to the Facility Registry System.

Facility Registry System fFRSI

Click the link provided below to access additional information related to Inventory Expert Services.
CAS Inventory Expert Services

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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283

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CD)Sr

Exhibit 15-2 shows a screen capture of the 'Resources' screen (Scroll 2):

Exhibit 15-2: Resources Screen (Scroll 2)



Logged in as: Jane Doe, Primary Authorized Official

Log Out

Home J Forms f User Management y Resources

Click the link provided below to access additional information related to T3CA Biotechnology Regulations
Microbial Products of Biotechnology: Final Rule f62 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 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

Click the link provided below to access additional information related to Substance Registry Services.

Substance Registry Services fSRSI

Click the link provided below to access additional information related to the Facility Registry System.

Facility Registry System fFRSI

Click the link provided below to access additional information related to Inventory Expert Services.

CAS Inventory Expert Services

Click the link provided below to access additional information related to the National Pollutant Discharge Elimination System.

Mational Pollutant Discharge Elimination System fNPDES'i

Click the link provided below to access additional information related to the New Chemicals Program.

New Chemicals Program Homepage

Click the link provided below to access information related to the status of Section 5 Notices.

Status of Section 5 Notices

For technical 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.

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: i

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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

I ACM

I Alternative Control Measures

I AO

I Authorized Official

I BCF/BAF

f

| Bioconcentration Factors/Bioaccumulation Factors

CBI

I Confidential Business Information

CA

[ Chemical Abstracts

CAS

[ Chemical Abstracts Service

CASRN

| Chemical Abstracts Service Registry Number

: cdx

| Central Data Exchange

I CFR

[ Code of Federal Regulations

I CoR

| Copy of Record

I CROMERR

[ Cross-Media Electronic Reporting Regulation

CSPP

| Chemical Safety and Pesticide Programs

CSV

[ Comma-Separated Values

I DNA

[ Deoxyribonucleic Acid

EPA

[ Environmental Protection Agency

I EST

[ Eastern Standard Time

| ETI

I Environmental Technology Initiative

I FR

[ Federal Regulation

FRS

| Facility Registry System

I GPC

[ Gel-permeation Chromatography

I ID

I Identification

IE

[ Internet Explorer

i IES

[ Inventory Expert Service

IH

I Industrial Hygienist

IR

[ Infrared

KG

[ Kilogram

LOREX

[ Low Release/Low Exposure Exemption

I LOS

I Letter of Support

I LVE

[ Low Volume Exemption

: MCAN

[ Microbial Commercial Activity Notice

MS

[ Mass Spectrometry

MSDS

I Material Safety Data Sheet

NIOSH

[ National Institute for Occupational Safety and Health

NMR

[ Nuclear Magnetic Resonance

I NOC

[ Notice of Commencement

NPDES

I National Pollutant Discharge Elimination System

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
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Acronym

Full Name

OPPT

I Office of Pollution Prevention and Toxics

PDF

I Portable Document Format

I PMN

[ Premanufacture Notice

POTW

| Publicly Owned Treatment Works

PPE

[ Personal Protective Equipment

PPM

I Parts Per Million

i RCRA

[ Resource Conservation and Recovery Act

SAR

[ Structure-Activity Relationship

I SDS

! Safety Data Sheet

I SME

f

| Subject Matter Expert

I 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

I TME

[ Test Market Exemption

TMEA

[ Test Marketing Exemption Application

I TS

| Toxic Substances

TSCA

[ Toxic Substances Control Act

I uv

i Ultraviolet

I XML

i Extensible Markup Language

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Authorized Official

December 15, 2014
286

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