CDX Section 5 Notices and Supports User Guide Primary Agent/Consultant


Section 5 Notices and Supports
User Guide - Primary
Agent/Consultant

Environmental Protection Agency

Office of Pollution Prevention and Toxics

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

Version 1.0
December 19, 2014

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Table of Contents

Table of Contents	i

List of Exhibits	v

1	Introduction	1

2	System Requirements	2

2.1	Supported Browsers	2

2.2	Screen Resolution	2

3	Primary Agent/Consultant Functions	3

3.1	Log into Section 5 Notices and Supports Application	4

3.2	Home Screen Navigation	5

3.3	Section 5 Notices and Supports Forms	7

3.4	Create Passphrase	12

3.5	Enter Passphrase	13

3.6	Navigation Tree	14

3.7	Action Bar	26

3.8	Attach Documents	28

3.9	Search Substance Registry Services (SRS)	33

3.10	Add Facility	37

4	Create Premanufacture Notice (PMN) Form	40

4.1 Create PMN Form	40

4.1.1	General Form Information	40

4.1.2	User Fees Certification	44

4.1.3	Agent Information	46

4.1.4	Technical Contact Information	51

4.1.5	Additional Submission Information	55

4.1.6	Chemical Identification	58

4.1.7	Class 1 or 2 Chemical Substances	60

4.1.8	Class 2 Substances	65

4.1.9	Additional Chemical Information	68

4.1.10	Polymer Identification Information	73

4.1.11	Monomers and Other Reactants	77

4.1.12	Production Volume and Hazard/Safety Information	82

4.1.13	Use Information	85

4.1.14	Physical and Chemical Properties Worksheet	90

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4.1.15	Physical and Chemical Properties Worksheet - Continued (Optional)	98

4.1.16	Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents	100

4.1.17	Site Information	103

4.1.18	Sites Controlled By Others	105

4.1.19	Submitter Operation Information	107

4.1.20	Occupational Exposures	112

4.1.21	Environmental Releases	116

4.1.22	Industrial Sites Controlled By Others	121

4.1.23	Exposures/Releases	125

4.1.24	Byproduct Information	130

4.1.25	Optional Pollution Prevention	132

4.1.26	Additional Attachments	134

4.1.27	Attachment Summary	136

4.1.28	Optional Cover Letter	137

4.1.29	Joint Submitter Information	139

4.1.30	Joint Submission Information	140

4.1.31	Notify Joint Submitter of Joint Submission Information	142

4.1.32	Letter of Support Submitter Information	145

4.1.33	Letter of Support Submission Information	147

4.1.34	Notify Secondary Submitter of Letter of Support Information	149

4.1.35	Upload XML	152

5	Create Biotechnology Form	155

5.1 Create Biotechnology Form	155

5.1.1	General Form Information	155

5.1.2	Joint Submitter Information	159

5.1.3	Joint Submission Information	160

5.1.4	Notify Secondary Submitter of Joint Submission Information	162

5.1.5	Letter of Support Submitter Information	164

5.1.6	Letter of Support Submission Information	166

5.1.7	Notify Secondary Submitter of Letter of Support Information	168

5.1.8	Technical Contact Information	170

5.1.9	Optional Cover Letter	174

6	Create Notice of Commencement (NOC) Form	176

6.1 Create NOC Form	176

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6.1.1	General Form Information	176

6.1.2	Technical Contact Information	177

6.1.3	Chemical Information	180

6.1.4	Site Information	184

6.1.5	CBI Substantiation Part 1	185

6.1.6	CBI Substantiation Part 2	188

6.1.7	CBI Substantiation Part 3	191

6.1.8	Optional Cover Letter	194

7	Create Support Form	196

7.1 Create Support Form	196

7.1.1	General Form Information	196

7.1.2	Original Submitter Information	199

8	Create Bona Fide Form	202

8.1 Create Bona Fide Form	202

8.1.1	General Document Information	202

8.1.2	Primary Contact Information	204

8.1.3	Technical Contact Information	207

8.1.4	Statement of Intent	210

8.1.5	Letter of Support Submitter Information	212

8.1.6	Letter of Support Submission Information	214

8.1.7	Notify Secondary Submitter of Letter of Support Information	216

8.1.8	Chemical Identification Information	218

8.1.9	Class 1 or 2/Biotechnology Chemical Substances	220

8.1.10	Class 2/Biotechnology Substances	224

8.1.11	Polymer Identification Information	227

8.1.12	Monomers and Other Reactants	230

8.1.13	Use Information	233

8.1.14	Submitter Site Identification	234

8.1.15	Document Management	236

8.1.16	Optional Cover Letter	238

9	Create Alternative Control Measures (ACM) Form	239

9.1 Create Alternative Control Measures Form	239

9.1.1	Contact Information	239

9.1.2	Attachments	242

10	Preview	245

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11	Validate	249

12	Submit to EPA via CDX	251

12.1	Submitting Official Information	251

12.2	Submitting On Behalf Of Company	253

12.3	LVE Certification	255

12.4	LOREX Certification	256

12.5	Submission Process: Validation	257

12.6	Cross-Media Electronic Reporting Regulation (CROMERR) Certification	259

12.7	Cross-Media Electronic Reporting Regulation (CROMERR) Login	260

12.8	Cross-Media Electronic Reporting Regulation (CROMERR) Security Question	260

12.9	Cross-Media Electronic Reporting Regulation (CROMERR) Submission	261

13	Download Copy of Record	263

14	Create an Amendment	265

15	Resources	267

Appendix A	270

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List of Exhibits

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

Exhibit 3-2: Chemical Information Submission System Screen	5

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

Exhibit 3-4: Section 5 Notices and Supports Forms Screen	11

Exhibit 3-5: Create Passphrase Screen	13

Exhibit 3-6: Enter Passphrase Screen	14

Exhibit 3-7: Navigation Prompt	15

Exhibit 3-8: Premanufacture Notice Navigation Tree (Scroll 1)	17

Exhibit 3-9: Premanufacture Notice Navigation Tree (Scroll 2)	18

Exhibit 3-10: Premanufacture Notice Navigation Tree (Scroll 3)	19

Exhibit 3-11: Premanufacture Notice Navigation Tree (Scroll 4)	20

Exhibit 3-12: Premanufacture Notice Navigation Tree (Scroll 5)	21

Exhibit 3-13: Biotechnology Navigation Tree	22

Exhibit 3-14: Notice of Commencement (NOC) Navigation Tree	23

Exhibit 3-15: Support Navigation Tree	23

Exhibit 3-16: Bona Fide Navigation Tree (Class 1 or 2 Chemical Substance)	24

Exhibit 3-17: Bona Fide Navigation Tree (Polymer)	25

Exhibit 3-18: Alternative Control Measures (ACM) Navigation Tree	26

Exhibit 3-19: Action Bar-Validate	26

Exhibit 3-20: Action Bar - Save	27

Exhibit 3-21: Action Bar - Preview	27

Exhibit 3-22: Action Bar - Submit	27

Exhibit 3-23: Action Bar - Links	28

Exhibit 3-24: Section 5 Document Types and Subtypes	29

Exhibit 3-25: Attach Documents Pop-Up Window	32

Exhibit 3-26: Search Substance Registry Services Pop-Up Window	34

Exhibit 3-27: Chemical Not Found In Substance Registry Services Pop-Up Window	36

Exhibit 3-28: Add Facility Message Pop-Up Window	38

Exhibit 3-29: Add Facility Pop-Up Window	39

Exhibit 4-1: General Form Information Screen (Scroll 1)	43

Exhibit 4-2: General Form Information Screen (Scroll 2)	44

Exhibit 4-3: User Fees Certification Screen	46

Exhibit 4-4: Agent Information Screen	48

Exhibit 4-5: Add Agent Pop-Up Window	51

Exhibit 4-6: Technical Contact Information Screen	53

Exhibit 4-7: Add Technical Contact Pop-Up Window	55

Exhibit 4-8: Additional Submission Information Screen	58

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Exhibit 4-9: Chemical Identification Screen	60

Exhibit 4-10: Class 1 or2 Chemical Substances Screen (Scroll 1)	64

Exhibit 4-11: Class 1 or 2 Chemical Substances Screen (Scroll 2)	65

Exhibit 4-12: Class 2 Substances Screen (Scroll 1)	67

Exhibit 4-13: Class 2 Substances Screen (Scroll 2)	68

Exhibit 4-14: Additional Chemical Information Screen (Scroll 1)	72

Exhibit 4-15: Additional Chemical Information Screen (Scroll 2)	73

Exhibit 4-16: Polymer Identification Information Screen (Scroll 1)	76

Exhibit 4-17: Polymer Identification Information Screen (Scroll 2)	77

Exhibit 4-18: Monomers and Other Reactants Screen (Scroll 1)	81

Exhibit 4-19: Monomers and Other Reactants Screen (Scroll 2)	82

Exhibit 4-20: Production Volume and Hazard/Safety Information Screen	85

Exhibit 4-21: Use Information Screen (Scroll 1)	89

Exhibit 4-22: Use Information Screen (Scroll 2)	90

Exhibit 4-23: Physical and Chemical Properties Worksheet Screen (Scroll 1)	97

Exhibit 4-24: Physical and Chemical Properties Worksheet Screen (Scroll 2)	98

Exhibit 4-25: Physical and Chemical Properties Worksheet - Continued (Optional) Screen.... 100

Exhibit 4-26: Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents Pop-Up Window (Scroll 1)	102

Exhibit 4-27: Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents Window (Scroll 2)	103

Exhibit 4-28: Site Information Screen	105

Exhibit 4-29: Sites Controlled By Others Screen	107

Exhibit 4-30: Submitter Operation Information Screen (Scroll 1)	111

Exhibit 4-31: Submitter Operation Information Screen (Scroll 2)	112

Exhibit 4-32: Occupational Exposures Screen (Scroll 1)	115

Exhibit 4-33: Occupational Exposures Screen (Scroll 2)	116

Exhibit 4-34: Environmental Releases Screen (Scroll 1)	120

Exhibit 4-35: Environmental Releases Screen (Scroll 2)	121

Exhibit 4-36: Industrial Sites Controlled By Others Screen (Scroll 1)	124

Exhibit 4-37: Industrial Sites Controlled By Others Screen (Scroll 2)	125

Exhibit 4-38: Exposures/Releases Screen (Scroll 1)	128

Exhibit 4-39: Exposures/Releases Screen (Scroll 2)	130

Exhibit 4-40: Byproduct Information Screen	131

Exhibit 4-41: Optional Pollution Prevention Screen	134

Exhibit 4-42: Additional Attachments Screen	136

Exhibit 4-43: Attachment Summary Screen	137

Exhibit 4-44: Optional Cover Letter Screen	138

Exhibit 4-45: Joint Submitter Information Screen	140

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Exhibit 4-46: Joint Submission Information Screen	142

Exhibit 4-47: Unique Identifier Notification Pop-Up Window (Scroll 1)	144

Exhibit 4-48: Joint Submission Unique Identifier Notification Pop-Up Window (Scroll 2)	145

Exhibit 4-49: Letter of Support Submitter Information Screen	147

Exhibit 4-50: Letter of Support Submission Information Screen	149

Exhibit 4-51: Unique Identifier Notification Pop-Up Window (Scroll 1)	151

Exhibit 4-52: Unique Identifier Notification Window (Scroll 2)	152

Exhibit 4-53: Upload XML Screen	154

Exhibit 5-1: General Form Information Screen (Biotechnology) (Scroll 1)	157

Exhibit 5-2: General Form Information Screen (Biotechnology) (Scroll 2)	158

Exhibit 5-3: Joint Submitter Information Screen (Biotechnology)	160

Exhibit 5-4: Joint Submission Information Screen (Biotechnology)	162

Exhibit 5-5: Unique Identifier Notification Pop-Up Window	164

Exhibit 5-6: Letter of Support Submitter Information Screen (Biotechnology)	166

Exhibit 5-7: Letter of Support Submission Information Screen	168

Exhibit 5-8: Unique Identifier Notification Pop-Up Window	170

Exhibit 5-9: Technical Contact Information Screen (Biotechnology)	172

Exhibit 5-10: Add Technical Contact Pop-Up Window	174

Exhibit 5-11: Optional Cover Letter Screen	175

Exhibit 6-1: General Form Information Screen (NOC)	177

Exhibit 6-2: Technical Contact Information Screen (NOC)	178

Exhibit 6-3: Add Technical Contact Pop-Up Window (NOC)	180

Exhibit 6-4: Chemical Information (Scroll 1)	183

Exhibit 6-5: Chemical Information Screen (Scroll 2)	184

Exhibit 6-6: Site Information Screen (NOC)	185

Exhibit 6-7: CBI Substantiation Part 1 Screen (Scroll 1)	187

Exhibit 6-8: CBI Substantiation Part 1 Screen (Scroll 2)	188

Exhibit 6-9: CBI Substantiation Part 2 Screen (Scroll 1)	190

Exhibit 6-10: CBI Substantiation Part 2 Screen (Scroll 2)	191

Exhibit 6-11: CBI Substantiation Part 3 Screen (Scroll 1)	193

Exhibit 6-12: CBI Substantiation Part 3 Screen (Scroll 2)	194

Exhibit 6-13: Optional Cover Letter Screen (NOC)	195

Exhibit 7-1: General Form Information Screen (Scroll 1) (Support)	198

Exhibit 7-2: General Form Information Screen (Scroll 2)	199

Exhibit 7-3: Original Submitter Information Screen	201

Exhibit 8-1: General Document Information Screen (Scroll 1)	203

Exhibit 8-2: General Document Information Screen (Scroll 2)	204

Exhibit 8-3: Primary Contact Information Screen (Scroll 1)	206

Exhibit 8-4: Primary Contact Information Screen (Scroll 2)	207

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Exhibit 8-5: Technical Contact Information Screen (Bona Fide) (Scroll 1)	209

Exhibit 8-6: Technical Contact Information Screen (Bona Fide) (Scroll 2)	210

Exhibit 8-7: Statement of Intent Screen	212

Exhibit 8-8: Letter of Support Submitter Information Screen	214

Exhibit 8-9: Letter of Support Submission Information Screen	216

Exhibit 8-10: Unique Identifier Notification Pop-Up Window	218

Exhibit 8-11: Chemical Identification Information Screen	220

Exhibit 8-12: Class 1 or 2/Biotechnology Chemical Substances Screen (Scroll 1)	223

Exhibit 8-13: Class 1 or 2/Biotechnology Chemical Substances Screen (Scroll 2)	224

Exhibit 8-14: Class 2/Biotechnology Substances Screen (Scroll 1)	226

Exhibit 8-15: Class 2/Biotechnology Substances Screen (Scroll 2)	227

Exhibit 8-16: Polymer Identification Information Screen	230

Exhibit 8-17: Monomers and Other Reactants Screen	233

Exhibit 8-18: Use Information Screen	234

Exhibit 8-19: Submitter Site Identification Screen	236

Exhibit 8-20: Document Management Screen	237

Exhibit 8-21: Optional Cover Letter Screen	238

Exhibit 9-1: Contact Information Screen	240

Exhibit 9-2: Add Contact Pop-Up Window	242

Exhibit 9-3: Attachments Screen	244

Exhibit 10-1: Preview Biotechnology Form Screen	245

Exhibit 10-2: Preview Biotechnology Form PDF	246

Exhibit 10-3: Preview NOC Form PDF	247

Exhibit 10-4: Preview Support Form PDF	248

Exhibit 11-1: Section 5 Notices and Supports Validation Pop-Up Window	250

Exhibit 12-1: Submitting Official Information Screen	253

Exhibit 12-2: Submitting On Behalf Of Company Screen	255

Exhibit 12-3: LVE Certification Screen	256

Exhibit 12-4: LOREX Certification Screen	257

Exhibit 12-5: Submission Process: Validation Screen	258

Exhibit 12-6: Submission Process: PDF Generation Screen	258

Exhibit 12-7: Cross-Media Electronic Reporting Regulation (CROMERR) Certification
Screen	259

Exhibit 12-8: Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen	260

Exhibit 12-9: Cross-Media Electronic Reporting Regulation (CROMERR) Security Question
Screen	261

Exhibit 12-10: Cross-Media Electronic Reporting Regulation (CROMERR) Submission
Screen	262

Exhibit 13-1: Download Copy of Record Screen	263

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Exhibit 13-2: Download Prompt Window	264

Exhibit 14-1: Section 5 Notices and Supports Form - Amendment	265

Exhibit 14-2: Unlock Prompt Message	266

Exhibit 15-1: Resources Screen (Scroll 1)	268

Exhibit 15-2: Resources Screen (Scroll 2)	269

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Revision Log

Date

Version
No.

Description

Author

Reviewer

Review
Date

09/20/13

0.01

Initial Draft of User Guide

C. Yeh
J. DeRosa

J. Ritchey

09/20/13

12/19/14

1.0

Updated Draft of Section 5 Notices
and Supports Primary
Agent/Consultant User Guide

C. Yeh

J. Bronick

12/19/14

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1 Introduction

This document presents the user guide for the Office of Pollution Prevention and Toxics (OPPT)
Section 5 Notices and Supports application submission process. This document is the user guide
for the Primary Agent/Consultant 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 Agent/Consultant, you can create or modify any Section 5 Notices and
Supports form. You can also delete Section 5 Notices and Supports forms, create revised notices,
and download the Copy of Record (CoR). You may not submit original main forms (including
Premanufacture Notice (PMN), Biotechnology, Bona Fide, or Notice of Commencement (NOC)
forms. You may submit Alternative Control Measures (ACM), Support forms, and amendments
to all forms.

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

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2 System Requirements

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

•	An e-mail account

•	JavaScript enabled web browser

•	Internet access

•	Adobe Acrobat Reader 5.0 or higher

•	CDX username and password

2.1	Supported Browsers

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

-	Go to the following link to download:
http://windows.microsoft.com/en-US/internet-explorer/downloads/ie

•	Mozilla Firefox 3.0 or above

-	Go to the following link to download:
http://www.mozilla.com/en-US/firefox/all-older.html

•	Safari 4 or above

-	Go to the following link to download:
http: // support. appl e. com/kb/dl 8 7 7

•	Google Chrome

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

•	Opera

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

2.2	Screen Resolution

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

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3 Primary Agent/Consultant Functions

This section describes how to:

• Access the application

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

• Start and complete the Section 5 Notices and Supports forms -PMN, Biotechnology, NOC,
Support, Bona Fide Notices, and/or ACM 721.30

• Submit Support and ACM forms

• Upload an Extensible Markup Language (XML) file

• Download a Copy of Record

• Create an amendment

The Primary Agent/Consultant is not responsible for the submission of original main forms,
including PMN, Biotechnology, NOC, or Bona Fide forms. The Primary Agent/Consultant is an
individual who serves as a consultant to a specific company. However, this individual is not
responsible for and does not have the authority to submit data since the agent/consultant does not
technically work for the submitting company.

As a Primary Agent/Consultant, you can create all form types within the Section 5 Notices and
Supports application. You are also responsible for submitting amendments, unlocking
submissions, and deleting forms. A Primary Agent/Consultant can submit a Support or ACM
form, but cannot submit any other form types, and may not assign Support users to a form.

You can save the form at any point during the data entry process. The save functionality will
allow 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

Leoend

X=Can Perform Function

A#

//
V

¦/

yd*

J

//
V

/

us

non-US

us

non-US

us

non-US

us

non-US

us

non-US

us

non-US

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



Create all oriainal main forms

X

X

X

X

















Submit oriainal main forms

X























Submit amendments (by editing the main
forms)

X

X

X

X

















Unlock all main forms

X

X

X

X

















Edit unlocked main forms

X

X

X

X

X

X













Delete forms

X

X

X

X

















Assign Supports

X

X





















Support and ACM forms



Create Support and ACM forms

X

X

X

X

















Submit oriainal ACM and SuDDort forms

X

X

X

X

















Submit amendment for older cases and
other support forms

X

X

X

X

















Unlock Support and ACM forms

X

X

X

X

















Edit unlocked Support and ACM forms

X

X

X

X

X

X













Delete forms

X

X

X

X

















Assign Supports

X

X





















LOS submissions



Create LOS for PMN, Biotechnology, or Bona
Fide













X

X

X

X





Submit original LOS for PMN. Biotechnology
or Bona Fide













X

X









Unlock LOS for PMN. Biotechnology or Bona
Fide













X

X

X

X





Edit unlocked LOS forms













X

X

X

X

X

X

Delete forms













X

X

X

X





Assign Supports













X

X









Joint submissions



Create Joint for PMN or Biotechnology













X

X

X

X





Submit original Joint for PMN or
Biotechnology













X











Submit amendments to Joint forms













X

X

X

X





Unlock Joint for PMN or Biotechnology













X

X

X

X





Edit Unlocked Joint forms













X

X

X

X

X

X

Delete forms













X

X

X

X





Assign Supports













X

X









3.1 Log into Section 5 Notices and Supports Application

After you create an account in CDX, click the 'Primary Agent/Consultant' 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

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

TSCA Section 5 Notices and Supports - ePMN

OK

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

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

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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' and 'Resources' screens. To navigate to any 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 or modify a Section 5 Notices and Supports form using the
'Section 5 Notices and Supports Forms' screen. For additional details about the 'Section 5
Notices and Supports Forms' screen, please refer to Section 3.3.

•	Resources: Click the 'Resources' link or tab to navigate to the 'Resources' screen. You can
find the Section 5 Notices and Supports user guide, as well as useful links for guidance
documents on the 'Resources' screen. For additional details about the 'Resources' screen,
please refer to Section 15.

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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 arid Supports Home Screen

Home | Forms | Resources

HOME

A Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

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) lor 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 Notice').

Resources

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

Agent/Consultant

An AgenfConsuitant has the ability to create, delete, amend, and/or unlock all Section 5 Notices and Supports
forms electronically to EPA. The Agent/Consultant has the ability to submit only certain forms to EPA.

Navigation: Click the 'Forms' link or tab to access the 'Section 5 Notices and Supports' screen
to create, unlock, edit, or delete forms.

3.3 Section 5 Notices and Supports Forms

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

Only one Section 5 Notices and Supports form is created per form alias. 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),'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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'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 3.4 for
further instructions on creating a new passphrase.

Edit an 'In Progress' form: To modify an existing Section 5 Notices and Supports form, click
the 'Alias' link for a form that has a status of 'In Progress.' You are required to enter the
passphrase associated with that particular form to access and continue editing 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 ( ¦ ) 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 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 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
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).

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- This column contains the following values for a Support form: 'Amendment,' 'Test Data,'
'Transfer Of Ownership,' 'Withdrawal Request,' 'Suspension Request,' or'Other
Correspondence.'

- NOC, 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 generates sequential case numbers for each
chemical identified within the form. A consolidated submission displays 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 suffixes: 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 suffixes: J-XX-XXXX for
MC AN, 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 suffix of BF-XX-XXXX.

- ACM forms will have a case number suffix 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 when you submit the form 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 to 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 by clicking the browser's refresh button for the 'Copy of
Record' icon ( ) to display.

• Action: Displays a 'Delete' icon ( <) 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
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 ( ' ) 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.

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•	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.

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



Home J Forms 7 Resources

SECTION 5 NOTICES AND SUPPORTS FORMS

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

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 ( B ) 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 ( rl ) 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.

6 items found.

Page 1 of 1

Items Per Page: 25 »

Alias C

Type

Subtype

Case Number

Status

Modify Date Submission Copy of Record

Action











Date :



ACM-20141208-
11:10:20 EST

ACM

In Progress

12/08/2014

X

Biotechnology-

20141208-
11:02:46 EST

Biotechnology

In Progress

12/08/2014

X

Bona Fide-
20141208-
11:03:12 EST

Bona Fide

In Progress

12/08/2014

X

NOC-20141208-
11:02:21 EST

NOC

In Progress

12/08/2014

X

Primary PMN-

20141208-
11:01:18 EST

Primary PMN

In Progress

12/08/2014

X

Support-
20141208-
11:01:43 EST

Support

In Progress

12/08/2014

X

Export options: 0 CSV | S Excel | "3 XML | "S PDF

Select the form type and then click Start New Form
Form Type: I Premanufacture Notice (PMN)

Start New Form

CDX Homepage | fvtyCDX 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.

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3.4 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 3-5 shows a screen capture of the 'Create Passphrase' screen for a Primary
Agent/C onsultant:

Exhibit 3-5: Create Passphrase Screen

mm

• l oyjed in as Jane Doe, Pnmary AgenUConsuflanl

Log Out

CREATEPASSPHRASE

Please create a passplwase (hat is at least B characters in lengln To better protect your form, your passphrase should contain a
combination ot letters and numbers. Your passphrase may Include spaces, but should not contain special characters (fof example, +, arid

*)¦

New Passphrase:

Confirm New Passphrase.

As an Authorized Official, you are responsible for remembenrig 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 A$ an Authorized Official, you are responsible for
remembering your passphrase anfl distnbuiing It to onty authorsed Supports

Note: It you lose or forget your passphrase, you will not be able to access your Section S Notices and Supports Form to
print, submit or make changes. You will need to complete a new Section 5 Notices and Supports Form arid create a new
passphrase tor 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.

Cwtcri

|ncx|J

COX Homepage | HyCDX Homepage I EPA Homepaoe I Terms and Conditions | PirvatyNoKe | CDx Helptestc (808)890-1995

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.

3.5 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.

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Exhibit 3-6 shows a screen capture of the 'Enter Passphrase' screen:

Exhibit 3-6: Enter Passphrase Screen

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

ENTERPASSPHRASE

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-

Cancel

|NexJ

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

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.

3.6 Navigation Tree

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

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

• Collapse and Expand folders: Each section of the form falls under a collapsible folder
within the navigation tree which allows you to save space or easily view items in the
navigation tree. When a folder is expanded, you can click the minus sign (-), the 'Folder'
icon (l ), 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.

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• 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 3-7 shows a screen capture of the 'Navigation Prompt' window:

Exhibit 3-7: Navigation Prompt

Windows Internet Explorer

Are you sure you want to leave the current page? Any unsaved changes will be lost

Cancel

• 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.

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

• Copy chemical folders: To copy a specific chemical folder, click the 'Copy' icon ( ) that
displays at the bottom of each chemical folder within the navigation tree of a PMN form.
When a chemical folder is copied, the chemical name, Chemical Abstracts Service Registry
Number (CASRN), and attached documents are removed from the copied chemical. This

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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copy functionality is not applicable to the Biotechnology, NOC, Support, Bona Fide, or ACM
forms, and is unavailable when amending a PMN form.

• Delete 'Submitter Controlled Operations' or 'Operations Controlled By Others'
folders: Click the 'Delete' icon ( *) that displays at the bottom of each 'Submitter
Controlled Operations' or 'Operations Controlled by Others' folder within the navigation tree
to delete a specific operations folder. When a 'Submitter Controlled Operations' or
'Operations Controlled by Others' folder is deleted, all information entered within the deleted
operation is lost and cannot be retrieved. 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 bar may freeze and prevent you from
using the navigation tree; 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 3-8 shows a screen capture of the 'PMN' navigation tree (Scroll 1):

Exhibit 3-8: Premanufacture Notice Navigation Tree (Scroll 1)

Premanufacture Notice ^

Primary Agent'Consultant



Primary PMN-20141208-







11:01:18 EST

l Ql General Form Information **¦

; Agent Information

IHSt

echnical Contact Information



Additional Submission
Information

i-L

Chemicals

^Class 1 or 2 Chemical





Substance





-c

Chemical







Identification







Class 1 or 2

Chemical

Substances







Class 2 Substances





Additional Chemical







Information





Production Volume







and HazardySafety







Information





_ Use Information



E

3|

^Physical &

Chemical
Properties

1^1 Physic al and
Chemical
Properties
Worksheet

= 1 Physical and

nheminal T

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Exhibit 3-9 shows a screen capture of the 'PMN' navigation tree (Scroll 2):

Exhibit 3-9: Premanufacture Notice Navigation Tree (Scroll 2)

Pre manufacture Notice

Primary Agent'Consuttant

Primary PMN-20141208-
11:01:18 EST

B .^Physical &
Chemical
Properties

Physic al and
Chemical
Properties
Worksheet

Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

' X Remove

® C opy

~ & Polymer Substance

?jChemical
Identification

mer
Identific ation
Information

"[] Monomers and
Other Reactants

J .Additional Chemical
Information

j Production Volume
and HazardVSafety
Information

[F|Use Inforrriation

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

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

Pre manufacture Notice 4

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

i S'ijjlf Physical 8.

Chemical
Properties

I ] mm* ¦sic al and
I | j | Chemical
Mji Properties
Mi! Worksheet

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

JC Remove

0 Copy

J^Add Consolidated
Chemical

_ Site Information

| {""IjjQsite Information

:""[5] Sites Controlled By
Others

Submitter Controlled
Operations

~ Ujoperation 1

!""~ Submitter Operation
Information

j | j'fSjoc c upational
I	Exposures

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Exhibit 3-11 shows a screen capture of the 'PMN' navigation tree (Scroll 4):

Exhibit 3-11: Premanufacture Notice Navigation Tree (Scroll 4)

Premanufacture Notice

Primary Agent'Consultant

Primary PMN-20141208-
11:01:18 EST

~ 	I Submitter Controlled

Operations

t' [Jjoperation 1

Submitter Operation
Information

"P^l Occupational
Exposures

Pi Environmental
Releases

"X Remove

Operation

Operations Controlled by
Others

U Ujoperation 1

Industrial Sites
Controlled By
Others

(j ;Exposures/Releases

f=lBv product
Information

'X Remove

,=jAdd Operation

Optional Pollution Prevention

2 .AdditionalAttachments

13 Attachment Summary

13 Optional Cover Letter

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Exhibit 3-12 shows a screen capture of the 'PMN' navigation tree (Scroll 5)

Exhibit 3-12: Premanufacture Notice Navigation Tree (Scroll 5)

Pre manufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

QBy product
Information

^Remove

B-

Operation
Optional Pollution Prevention
[S Additional Attachments
l^lAttac h ment Summary
Optional Cover Letter
Joint Submission

Ell

"[Joint Submission 1

Submitter
Information

[=| Joint Submission
Information

X Remove

"'%]Add Joint Submission

S 	iLetter of Support

Letter of Support 1

"]^~J Letter of Support
Submitter
Information

"|j Letter of Support
Submission
Information

" j€ Remove
""!¦%]Add Letter of Support

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 'Biotechnology' navigation tree:

Exhibit 3-13: Biotechnology Navigation Tree

Biotechnology ^

Primary Agent/Consultant

Biotech notogy-
20130808-15:00:20 EDT
General Form Information
Joint Submission
~ -jfjoint Submission t

| j—-[T^ 'joint Submitter
Information

| rj_2JJoint Submission
\ | Information

:"X Remove
: .Add Joint Submission
B-L Letter Of Support
f ijjtfLetter of Support 1

j""p|Letter of Support

! Submitter
j I | Information

j""E I Letter of Support
! i ! Submission
| i I Information

¦'X Remove
: _ Add Letter Of Support
Technical Contact Information
Optional Cover Letter

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Exhibit 3-14 shows a screen capture of the 'NOC' navigation tree:

Exhibit 3-14: Notice of Commencement (NOC) Navigation Tree

Notice of Commencement ^

Primary Agent'Consultant

NOC-20130808-16:04:26 EDT
General Form Information

i "[^jTechnical Contact Information

Chemical Information
!"¦•[] Submitter Site Information

CBI Substantiation
| j-[i|CBI Substantiation Part 1
; pg CBI Substantiation Part 2
! ;""[?jCBI Substantiation Part 3
:""|j Optional Cover Letter

Exhibit 3-15 shows a screen capture of the 'Support' navigation tree:

Exhibit 3-15: Support Navigation Tree

support	<

Primary Agent'Consultant
Su|)|)ort-20130619 10:07:32 EDT
General Form Information

Original Submitter Information

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Exhibit 3-16 shows a screen capture of the 'Bona Fide' navigation tree (Class 1 or 2 Chemical
Substance):

Exhibit 3-16: Bona Fide Navigation Tree (Class 1 or 2 Chemical Substance)

Bona Fide	^

Primary Agent'Corsultant

Bona Fide-20141208-11:03:12
EST

i""[5'General Document
Information

j""[5 Primary Contact Information

rfSjTechnical Contact Information

i""[l Statement of Intent

?"[_ Letter of Support

; ;-[i|Letter of Support

Submitter Information

""PMLetter of Support

Submission Information

S"i	iChemical

i i""p| Chemic al Identific ation
Information

j S <£> Chemical 7581

"[f | Class 1 or
! 2'Biotec hnology
¦ Chemic al
Substances

;—[¥ Class
j 2/Biotec hnology
; Substances

:""[^|Use Information
Site Information

J :""[f Submitter Site
Identification

Hi;|Document Management
"'"[^Optional Cover Letter

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Exhibit 3-17 shows a screen capture of the 'Bona Fide' navigation tree (Polymer):
Exhibit 3-17: Bona Fide Navigation Tree (Polymer)

Bona Fide	.

<

Primary Agent/Consultant

General Document
Information

l ""P Primary Contact Information

Technical Contact Information

Statement of Intent

-i"i	|Letter of Support

; i""2] Letter of Support

Submitter Information

'""[^letter of Support

Submission Information

S Chemical

j-'h Chemical Identification
Information

E-l ,4 Chemical 5ZOZ

H^lPolymer
! Identification
| | Information

j""[i?)Monomers and
I Other Reactants

U se In fo rmatio n

Site Information

*•"{=1 Submitter Site
identification

j--[== Document Management

Optional Cover Letter

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

Exhibit 3-18: Alternative Control Measures (ACM) Navigation Tree

ACM

Primary Agent/Consultant ^
ACM-20130520-16:42:43 EDT
HyCoiitact Information

""•[^lAttachmemts

3.7 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 3-19, Exhibit 3-20, Exhibit 3-21, and Exhibit 3-22 show screen
captures for the action bar:

Exhibit 3-19: 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
within the expandable/collapsible field set to save the information entered before being able
to click the ' Save' icon ( ) located within the action bar or use the 'Previous' and 'Next'
buttons to navigate to another page. Click the 'Previous' and 'Next' buttons on a form to save
the data entered within a form. Click the 'X' button in the upper right-hand corner of the
form in your browser to close the form without saving.

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Exhibit 3-20: Action Bar - Save

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 of the form if the form contains no CBI) or a
sanitized version of the PDF. Choosing either option will generate and display a watermarked
PDF version of the form in a separate tab in your internet browser. Please note that
attachment header sheets no longer generate within the PDF.

Exhibit 3-21: Action Bar - Preview

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 11 for more information on submitting a Section 5 Notices and Supports form.

Exhibit 3-22: Action Bar - Submit

Vatidate

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.

• Help Links: You can click any of 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.

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- 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 3-23 shows a screen capture of the action bar 'Help' links:

Exhibit 3-23: Action Bar - Links

3.8 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
change a CBI attachment to be non-CBI by un-checking the 'CBI' checkbox, a warning appears
to notify you that un-checking the 'CBI' checkbox will delete the sanitized file. If you neglect to
populate a required field and click the 'OK' button, an error message will display to indicate the
missing field and the application will delete the previously attached file.

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

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

• Type: Select the document type from the drop-down menu of the document that you upload.
This is a required field.

• Subtype: Select the document subtype from the drop-down menu of the document that you
upload. This is a required field.

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

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

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

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

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

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

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

Exhibit 3-24 displays a table of the document types and subtypes for each Section 5 Notices and
Supports form:

Exhibit 3-24: Section 5 Document Types and Subtypes

Form Type

Document Type

Document Subtypes

PMN &
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

GPC

• N/A

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Form Type

Document Type

Document Subtypes



Genetic Toxicity

•	Chromosomal Aberrations Assay

•	Genetic Mutation Assay

•	Unscheduled DNA (Deoxyribonucleic acid) Synthesis



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

Biotechnology

Published Literature

• N/A



Regs and Certifications

• N/A



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 3-25 shows a screen capture of the 'Attach Documents' pop-up window that displays
with the majority of forms:

Exhibit 3-25: Attach Documents Pop-Up Window

ATTACH DOCUMENTS

Type and Subtype TVPe:

Select the type and subtype Aquatic Ecotoxicity

of the attachment

Subtype:

Attachment

Select the file to attach

File:

Browse

Description

Provide a description of the
attachment

**Please do not include any
CBi infomation in the
description of the file
infomation.

Number of Pages

pages

CBI

Check to claim the attachment as CBI 0

Sanitized Attachment

Select the sanitized file to
attach

File:

Browse

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

| Cancel |

"ie

I

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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3.9 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 chemical has CASRNs, their chemical names will be compared.

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

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

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

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

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

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

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Exhibit 3-26 shows a screen capture of the 'Search Substance Registry Services' pop-up
window:

Exhibit 3-26: Search Substance Registry Services Pop-Up Window

cjlcspp

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^SRSj

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.

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

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

•	CASRN: Enter the 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.

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Exhibit 3-27 shows a screen capture of the 'Chemical Not Found In Substance Registry Services'
pop-up window:

Exhibit 3-27: Chemical Not Found In Substance Registry Services Pop-Up Window

Q

c^cspp

CHEMICAL NOT FOUND IN SUBSTANCE REGISTRY SERVICES -^

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

substance information has been fulfilled.

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

Chemical ID

Navigation: Click the 'OK' button to save the 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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3.10 Add Facility

The 'Add Facility' button displays on the 'Submitter Operation Information' screen and the
'Industrial Sites Controlled By Others' screen within a PMN form. This button also displays on
the 'Site Information' screen within aNOC form and the 'Submitter Site Identification' screen
within a Bona Fide form. The 'Add Facility' button is used to generate the 'Add Facility' pop-up
window and select the applicable sites for which you will be reporting. The 'Add Facility' drop-
down menu contains the sites that all AO users within the 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 site that you will be reporting on
from the drop-down menu.

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

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

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Exhibit 3-28 shows a screen capture of the 'Add Facility' pop-up window:
Exhibit 3-28: Add Facility Message Pop-Up Window

CSPP

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

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

Exhibit 3-29: Add Facility Pop-Up Window

CBS:

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

State:

Postal Code:

Add Facility

Cancel

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

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4 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. This PMN must be submitted at least 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 and click the
'Start New Form' button. Refer to Section 3.3 for additional details regarding the 'Section 5
Notices and Supports Forms' screen.

Refer to Section 3.4 for additional details regarding the 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 payment and connect related
submissions when additional communications (Letters of Support, Joint Submissions, and
corrections) are sent before a PMN/LVE case number has been assigned. The TS number can be
any six (6) character alphanumeric combination. The TS number should include two (2), three
(3), or four (4) letters. Company names, recognizable words, and 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
Marketing Exemption Application (TMEA),' 'Low Volume Exemption (LVE) @ 40 CFR

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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723.50 (c)(1),' 'Low Release/Low Exposure Exemption (LOREX) @ 40 CFR 723.50(c)(2),'
'LVE Modification,' 'LOREX Modification,' and 'Mock Submission.' Select 'PMN' if the
application is for a standard, fine-product new chemical substance for placement on the
TSCA inventory. Select 'Significant New Use Notice' for any notice that is marked in
accordance with a Significant New Use Rule (SNUR). Select 'TMEA' for any notice
submitted in accordance with the criteria listed in 40 CFR §720.38. A 'Mock Submission' is
an enforcement case where the chemical was manufactured/imported in the past and is not
currently being manufactured/imported by the company. This is a required field.

• TS Number: Enter the TS number related to the PMN form; this field accepts any six (6)
character alphanumeric combination. It is used by the financial institution that receives
payment for EPA when it notifies the Agency that the fee has been received. The TS number
should include two (2), three (3), or four (4) letters. Company names, recognizable words,
and 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
bottom of the screen within the action bar or by clicking the 'Next' button on the 'General
Form Information' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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• Check here if you have a Letter of Support pending: Check the 'Check here if you have a
Letter of Support pending' checkbox to indicate that the form is pending a Letter of Support.
A 'Letter of Support' folder displays within the navigation tree upon clicking the 'Save' icon
located at the bottom of the screen within the action bar or by clicking the 'Next' button on
the 'General Form Information' screen.

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

j""| Chemical
Identific ation

!""[ Class 1 or 2
Chemical
Substances

Class 2 Substances

nf'Additional Chemical
Information

reproduction Volume
and Hazard/Safety
Information

Use Information

Physical &

Chemical

Properties

""[jMPhysical and
Chemical
Properties
Worksheet

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

General Form Information

l™Quser Fees Certification

(=lAqent Information

'Technical Contact Information

i JIAdrfitional Submission
Information

@"i	iChemieals

! Class 1 or 2 Chemical
Substance

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST) > 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:
Type of Notice

Primary^^PMN^OI41208^1;Cn8 ES

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

IPremanufacture Notice (PMN)	| "

RMN 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:
Health effects data:

Risk assessments:
Structure/Activity





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| MyCDX Homepage

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CDX Helpdesk: (8*

38)890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 2014
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Exhibit 4-2 shows a screen capture of the 'General Form Information' screen (Scroll 2):
Exhibit 4-2: General Form Information Screen (Scroll 2)

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

General Form Information

--[=|User Fees Certification

"j nAgent Information

"12 Technical Contact Information

Additional Submission
Information

5 l	Chemicals

5"^CIass 1 or 2 Chemical
Substance

Q Chemical
Identification

Class 1 or 2
Chemical
Substances

Class 2 Substances

""^Additional Chemical
Information

'QProduction Volume
and Hazard/Safety
Information

QlJse Information

^Physical &

Chemical
Properties

Physical and
Chemical
Properties
Worksheet

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Home y Forms y Resources

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

iPremanufacture Notice (PMN)	| ¦»

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:

Health effects data:	~

Environmental effects data:

Physical/Chemical properties:

Test data not in the possession or control of the q

submitter:

Identify whether any of the below options apply.

Risk assessments:
Structure/Activity
relationships:
Other data:

~
U

~

Check here if you are filing a joint PMN:

Check here If you have a Letter of Support
pending:

fed
~

| Nexlj





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CDX Homepage |

| MyCDX Homepage

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: If you are filing a 'PMN' or 'SNUN' form, 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' form, 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' button 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.

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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

> (2fclMr

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

General Form Information

User Fees Certification

"| Agent Information

T ec hnic al Contac 11 nformation

=j Additional Submission
Information

Chemicals

i Class 1 or 2 Chemical
Substance

[""^Chemical
Identification

r"{j§)ciass 1 or 2
Chemical
Substanc es

[¦"HiClass 2 Substances

i""i ^Additional Chemical
Information

['"{^Production Volume
I and Hazard/Safety
Information

i""Quse Information

Physical &

Chemical
Properties

!"" "MPhysical and
Chemical
Properties
Worksheet

¦*> Logged in as Jarre Doe, Primary Agent/Consultant

Log Out

< Premanufacture Notice (Primary PMN-20141208-11:01:18 EST) > 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 S2500 specified in 40 CFR
700.45(b).

The Company named in Part I, Section A has remitted the fee of S1000 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 S100 In accordance with 40 CFR 700.45(b).

Previous



B

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Save

Preview

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

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

4.1.3 Agent Information

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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individual who is filling out the form, click the 'Copy CDX Registration' button to retrieve user
information entered during CDX registration. The system provides a checkbox for you to claim
entered contact information as confidential by checking the 'Check here to claim this
information as CBI' checkbox. Each agent will have an individual CBI claim. You will be able
to enter contact information for each agent, and click the 'OK' button, which will populate the
agent table located on the 'Agent Information' screen. Click the 'Delete' icon ( *) located under
the 'Actions' column to delete agents. To edit agent information, click the agent name link
within the 'Last Name' column, which will generate the 'Add Agent' pop-up window with the
previously entered agent information.

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

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

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

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

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

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

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

Exhibit 4-4: Agent Information Screen



T

T

¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

[^General Form Information

"byUser Fees Certification

Agent Information

T ec hnic al Contac 11 nformatbn

§ Additional Submission
Information

B"l	iChemicals

i $ & Class 1 or 2 Chemical
Substance

""[^1 Chemical
Identification

'"Qcfess 1 or 2
Chemical
Substances

'Class 2 Substances

iAdditional Chemical
Information

"'hjProduction Volume
and Hazard/Safety
Information

""Qllse Information

? "^Physical &

Chemical
Properties

""|^|Physical and
Chemical

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST} > Agent Information

AGENT INFORMATION

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

Last Name

First Name

Address

CBI

Actions

Previous

Next I





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Preview





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Privacy Notice |

CDX Helpdesk: (8f

J8) 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.

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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• Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim agent information as confidential. If the 'CBI'
checkbox is checked before clicking the 'Copy CDX Registration' button, the 'CBI'
checkbox will become unchecked upon navigating back to the pop-up window after copying
CDX registration information. Check the 'CBI' checkbox after importing CDX registration
information to claim agent information as confidential.

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

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

• Position: Enter the agent's job title.

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

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

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

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

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

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

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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• Country: Select the country of the agent's mailing address from the drop-down menu. Click
the 'Copy CDX Registration' button to populate the fields with CDX registration
information. This field is automatically set to 'United States' if a value is selected from the
'State' drop-down menu. This is a required field only if agent information will be added to
the form.

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:

Exhibit 4-5: Add Agent Pop-Up Window

CSPP

ADD AGENT

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

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

First Name:

Last Name:
Position:

Company Name:
Phone Number:

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.

ICancell

Navigation: Click the 'Cancel' button or the 'X' icon in the upper right-hand corner to stop the
process of adding 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 ( *) located under the 'Actions' column to
delete a technical contact. Click the technical contact name within the 'Last Name' column to
edit technical contact information.

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

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

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

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

General Form Information

•"FlUser Fees Certification

"1/'JAgent Information

|_ Technical Contact
Information

Additional Submission
Information

Ep Chemicals

jSjClass 1 or 2 Chemical
Substance

I = | Chemical
Identification

I " jClass 1 or 2
Chemical
Substances

Class 2 Substances

jAdditional Chemical
Information

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 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

Production Volume
and Hazard/Safety
Information

Use Information

5 tijlfPhysical &
Chemical
Properties

HjPny;

sic al arid





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CDX Homepage |

| MyCDX Homepage

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (86

i8> 890-1995

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
'Technical Contact Information' screen.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Country: Displays 'United States.'

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

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

&, CSPP

ADD TECHNICAL CONTACT

Please enter information for tne 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.)

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

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.

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.

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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.

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.

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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 (0) to save an individual
entry. Click the 'Form' icon (0) that displays after saving to edit an individual entry. Click
the 'Delete' icon ( *£) to delete individual entries. Click the 'Add' icon ( ) to generate blank
text fields to provide additional entries. This field is required if a form is a consolidated
submission, regardless of whether the 'None' checkbox is checked.

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

• Previously Submitted Notice Number - None: Check the 'None' checkbox for the
'Previously Submitted Notice Number' to indicate that there is no previously submitted
notice number. 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
(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, 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 (H) to save an individual entry.
Click the 'Form' icon (Hi) that displays after saving to edit an individual entry. Click the
'Delete' icon ( *) to delete individual entries. Click the 'Add' icon ( ) to generate blank
text fields to provide additional entries. This field is required, or the 'None' checkbox must
be checked.

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

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

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

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

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

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

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

General Form Information

"pjjUser Fees Certification

'"(?)Agent Information

'{ Technical Contact Information

Additional Submission
Information

B- Chemicals

j Class 1 or 2 Chemical
Substance

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Home y Forms " Resources
Premanufacture Notice (Primary PMN-20141208-11:01:18 EST) > Additional Submission Information

ADDITIONAL SUBMISSION INFORMATION

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

•&

3. Prenotice Communication Number:

None

Prenotice

Actions

~ CBI

Communication #

Chemical
Identification

Class 1 or 2

Chemical

Substances

Class 2 Substances

Additional Chemical
Information

I Production Volume
and Hazard/Safety
Information

"'i__ Use Information

Physical &
Chemical
j Properties

' ^'Physical and
Chemic al
Properties
Worksheet

4. Previously Submitted Notice Number:

None

Previously Submitted

Actions

CBI

Notice #

I I

5. Bona Fide Intent Notice Number:

None

Bona Fide Intent

Actions

CBI

Notice #

yx#

Manufacture or Import Options

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:

Q
~

Binding:
Binding:

-/ a

Validate Save

Preview

CDX Homepage

I MyCDX Homepage

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

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

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.

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The 'Chemical Identification' screen identifies the type of chemical the submitter will be
entering into the application. You will be able to file a 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

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

General Form Information

"'piUser Fees Certification

"bn Agent Information

"(3_lTechnical Contact Information

"[^ I Acklltlonal Submission
Information

@"l	Chemicals

<&Add Consolidated
Chemical

Ep"l_ Site Information

rhlSfte Information

"h Sites Controlled By
Others

B"L Submitter Controlled
Operations

^THoperation 1

Pi Submitter Operation
Information

^Occupational
Exposures

21 Environmental
Releases

X Remove

" Lr(=)Add Operation

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST} > Chemical Identification

CHEMICAL IDENTIFICATION

Chemical Type

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

Class 1 or 2 Chemical Substance q
Polymer

#

r

j

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.

|Next|



e

i	1

' =

Validate

Save

Preview

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

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

4.17 Class 1 or 2 Chemical Substances

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

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

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

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

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

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

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

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

For a class 2 substance chemical structure diagram:

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

2)	Describe the nature of the reaction or process.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Search SRS: Click the 'Search SRS' button to generate the 'Search Substance Registry
Services' pop-up window. Refer to Section 3.9 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.

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• 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.

• 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 3.8 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.

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•	Pages: Displays the number of pages a document contains

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

•	Actions: Click the 'Delete' icon 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 |E ) 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
3.7 for more information regarding the save functionality in an expandable/collapsible field
set.

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)



-S- Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

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< Premanufacture Notice (Primary PMN-20141208-11:01:18 EST) > Class 1 or 2 Chemical Substances

CLASS 1 OR 2 CHEMICAL SUBSTANCES



Expand All | Collapse All

Cancel

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

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

CASRN:

Chemical Name:

CBI:	«l

B.6. Generic Chemical Name:

B.1.C. ID Method

6 Method 1 (CAS Inventory Expert Service)
Include an attachment for the ID Method below.

B.1.d. Molecular Formula:

Method 2 (Other Method)

CBI:

B.1.e. Chemical Structure Diagram:

Include an attachment for the chemical structure diagram below.





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

Premartufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

General Form Information

r"|User Fees Certification

Agent Information

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~ Additional Submission
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B.1.C. ID Method

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

Method 2 (Other Method)

Include an attachment for the ID Method below.

B.1.d. Molecular Formula:

CBI: ~

B/I .e. Chemical Structure Diagram:

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

Attach Document

Section

File Name

Description Pages CBI Actions

Save

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.

Previous iNextl

—V

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Save

Preview

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Navigation: If you select the 'Class V 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.

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

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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 3.9 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 ( *£) to delete the entire chemical row permanently from the
system; a warning message displays to confirm the deletion of the chemical.

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

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

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

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

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

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window and initiate the document upload process. Refer to Section 3.8 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.'

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• Actions: Click the 'Delete' icon (3 ) to delete the entire document row permanently from the
system; a warning message displays to confirm the deletion.

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

7

¦*> Logged in as Jane Doe, Primary Agent/Consultant

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Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

!'"'[?jUser Fees Certification

Agent Information

!'"(^Technical Contact Information

rf 'Additional Submission
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4 Premanufacture Notice (Primary PMN-20141208-11:01:18 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: 1

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



Chemical Name

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

CASRN

Action

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





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Exhibit 4-13 shows a screen capture of the 'Class 2 Substances' screen (Scroll 2):
Exhibit 4-13: Class 2 Substances Screen (Scroll 2)

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

' j^jUser Fees Certification

i""MAgent Information

Technical Contact Information

r" Additional Submission
| Information

5"i_ Chemicals

5" & Class 1 or 2 Chemical
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B.1.e.2. Nature of Reaction CBI:

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

Attachments

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

Click here to attach a file Attach Document

Section	File Name Description

Previous

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Action

|^NextJ





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J8) 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 f
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

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captures other names for the chemical at hand in the 'Synonyms' and 'Trade Identification'
tables.

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

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

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

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

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

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

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

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• B.3. Impurities - Search SRS: Click the 'Search SRS' button to display the 'Search
Substance Registry Services' pop-up window. Refer to Section 3.9 for further details
regarding the search SRS functionality.

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

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

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

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

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

• B.7. Byproducts - Search SRS: Click the 'Search SRS' button to generate the 'Search
Substance Registry Services' pop-up window. Refer to Section 3.9 for further details
regarding the search SRS functionality.

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

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

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

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

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

• Synonym: Enter the synonym of the chemical; there is a maximum of five chemical
synonyms that can be added in the 'Synonyms' table. Additional synonyms can be provided
in an attachment. Synonyms include common chemical names used in scientific or technical
literature, and code numbers or code names referenced in the PMN and its attachments.
Indicate which synonyms may be proprietary and require CBI protection. Chemical name
synonyms must be consistent with the chemical structure and thus not misleading. If you add
a blank, editable line in this table and click the 'Next' button, no error will display indicating
that the blank line should be saved or deleted. If text is entered in a blank field and you click
the 'Next' button, the application will save the entered value. If you click the 'Form' icon

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(0), edit the entered values, and click the 'Next' button without saving the changed value, an
error will generate.

• Actions: Click the 'Add' icon ( ) to add a new text field to enter additional synonyms.

Click the 'Save' icon (H) to save a chemical synonym. Click the 'Form' icon (0) that
appears after saving to edit a chemical synonym. Click the 'Delete' icon ( *£) to delete a
previously added chemical synonym. To cancel changes to a field, simply clear the data
entered in the field.

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

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

• Actions: Click the 'Add' icon <+> to add a new text field to enter additional trade
identification names. Click the 'Save' icon (0) to save a trade identification name. Click the
'Form' icon (0) 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 3.8 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 ( <) 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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Exhibit 4-14 shows a screen capture of the 'Additional Chemical Information' screen (Scroll 1):
Exhibit 4-14: Additional Chemical Information Screen (Scroll 1)

(

^ Logged in as Jane Doe, Primary Agent/Consultant

Home y Forms y Resources

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST} > Additional Chemical Information y,
ADDITIONAL CHEMICAL INFORMATION

11:01:18 EST

General Form Information

B.3. Impurities

User Fees Certification

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

= |_ Agent Information

manufactured for commercial purpose. Provide the CAS Registry Number if available. If there are

Technical Contact Information

unidentified impurities, enter "unidentified."

^Additional Submission
Information

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

P" Chemicals

total weight %.

i 9 Jk Class 1 or 2 Chemical

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

Identification

; UCtess 1 or 2
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Impurity CASRN Maximum% CBl Action

Substances

j"" | Class 2 Substances

B.7. Byproducts

" Additional
Chemical
Information

Describe any byproducts resulting from the manufacture, processing, use, or disposal of the new

chemical substance. Provide the CAS Registry Number if available.

Production Volume

and Hazard/Safety

Information

Click the Search SRS button on the right to search SRS or to manually enter a byproduct. Search srs

I hi Use Information

Physical &

Byproduct Name CASRN CBl Action

Chemical

Properties

i i IPhysical and
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B.4. Synonyms CBI:D

Enter any chemical synonyms for the new chemical substance.

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

¦*> Logged in as: Jarre Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary AgentiConsultant

Primary PMN-20141208-
11:01:18 EST

T": General Form Information

f""I User Fees CertifKation

: ! Agent Information

Tec hnic al Contac 11 nformation

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Byproduct Name CASRN

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Enter any chemical synonyms for the new chemical substance.

Synonym

Actions

yx#

B.5. Trade identification CBI: -

List trade names tor the new chemical substance.

Trade Name

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

Click here to attach a file Attach Document

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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.

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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.

• 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.

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

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

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

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

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

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• 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 3.8 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.

• 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

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3.7 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)



<*> Logged in as Jarre Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

:—|j=J Physical ami
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4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST) > Polymer Identification Information
POLYMER IDENTIFICATION INFORMATION

0

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





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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
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December 19, 2014
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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)



Premanufacture Notice

Primary Agent'Consultant

Primary PMN-20141208-
11:01:18 EST

* Logged in as: Jane Doe, Primary Agent/Consultant

Log Out



il"fF [Physical and



Chemic al



Properties



Worksheet -



Continued



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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 Action

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

Use information

$ ^Physical &
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•Consolidated chemicals are entered by clicking the 'Add Consolidated Chemical' link within the navigation tree on the left.

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CDX Homepage

| 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 '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.

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.'

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

• (i) lowest number avg. molecular weight: Enter the lowest number average molecular
weight; the entered value must be a positive numerical value and can contain decimal values.
This is a required field if there is no pending Letter of Support or Joint Submission.

• (ii) max. weight % below 500 molecular weight: Enter the maximum weight percentage
below 500 molecular weight; the value entered must be a positive numerical value greater
than or equal to zero (0), but less than or equal to one hundred (100) and can contain decimal
values. This value must be less than or equal to the value specified in the '(iii) max. weight %
below 1000 molecular weight' field. This is a required field if there are no pending Joint
Submissions or Letters of Support.

• (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.

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

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

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

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

• Search SRS: Click the 'Search SRS' button to generate the 'Search Substance Registry
Services' pop-up window. Refer to Section 3.9 for additional details regarding the search
SRS functionality.

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

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

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

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

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

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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positive numerical value that is less than or equal to the typical composition value. This is a
required field.

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

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window. Refer to Section 3.8 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
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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)

A. Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Pre manufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

(Optional)

X Remove

0 Copy

Q' <2* Polymer Substance

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Identific ation

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Physical and
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Continued

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST)> Monomers and Cither 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: @ GPC • Other(Specify)

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.

:

n%

j%

(i)	lowest number avg. molecular weight:

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

(Hi) max. weight % below 1000 molecular weight: !	

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.

Expand All | Collapse All



D

~

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Validate

Save

Preview

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

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December 19, 2014
81

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CDX?

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)

Home J Forms J Resources

Pre manufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

(Optional)

X Remove

0 Copy

Q' ^Polymer Substance

j Chemical
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Expand All | Collapse All

-



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X

Click the button below to search ERA'S Substance Registry Services (SRS) for the desired



chemical







Search SRS







Monomer or other reactant:



CBI:Q



CAS Registry Number:







Chemical Name:







Typical Composition:

J%

CBI:0



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Composition Total:0%

Attachments

Attach Document

File Name

Description

Pages

CBI

Actions

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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'Maximum 12-month production.' The 'Maximum first 12-month production' value should be
less than or equal to the 'Maximum 12-month production' value. The maximum volume may not
exceed 100,000,000,000,000 kg/year for either field. The entered values will automatically
display decimal points upon navigating away from the page. Decimals are allowed up to the
milligram (.000001). Estimates should be on a 100% new chemical substance basis. Your
production volumes should be estimated as accurately as possible, but you are not bound to your
estimates unless you check the 'Binding' checkbox and are creating an LVE or LVE
modification submission. Include amounts you intend to produce for export. Provide an estimate
of the first 12 months of production and the maximum production volume for any consecutive
12-month period during the first three (3) years of commercial manufacture. You may upload an
attachment to enter additional production information.

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

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

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

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

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

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

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

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

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

• Maximum first 12-month production: Provide an estimate of the first 12 months of
production. The entered value must be a numerical value and must be greater than zero but
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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 3.8 for additional details regarding the attach document
functionality.

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

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

• Description: Displays the description associated with a document.

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

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

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

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 and Hazard/Safety Information Screen

A Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

; X Remove



^ Copy

Polymer Substance

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I'Ontinnall

Home y Forms * Resources
Premanufacture Notice (Primary PMN-20141208-11:01:18 EST) > Production Volume and Hazard/Safety Information
PRODUCTION VOLUME AND HAZARD/SAFETY INFORMATION

On a 100% new chemical substance basis, please provide the following production vblume 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: U Binding:

kg/yr
kg/yr

3. Hazard Information	Binding:

Include in the notice a copy or reasonable facsimile of any hazard warning statement, label, material
safety data sheet, or other information which will be provided to any person who is reasonably likely to be
exposed to this substance regarding protective equipment or practices for the safe handling, transport,
use. or disposal of the new substance.

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

Click here to attach a file Attach Document

Section	File Name Description	Pages

CBI

Actions





>/

a















Validate

Save

Preview



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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.

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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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When you click the 'Add Use' button, an expandable/collapsible field set opens and displays the
'Use Information' fields. Upon saving the entry, the expandable/collapsible field set collapses
and displays the 'Category of Use' and 'Production %' values.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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• 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 3.8 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.

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

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

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

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

i~ Chemicals

& & Class 1 or 2 Chemical
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""'^l Chemical
Identification

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< Premanufacture Notice (Primary PMN-20141208-11:01:18 EST) > Use Information

USE INFORMATION

9

Expand All | Collapse All
Cancel X

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

Category of Use:	CBI:® Binding:Q

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

C.2.b. Generic Use Description:

Total Production
for this Use:

i% CBI:Q
% CBI, J

In Formulation: |	

% of substance expected per use:

CBI:U Binding:Q





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~













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Preview



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 Agent/Consultant

December 19, 2014
89

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CDX-r

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 Agent/Consultant

Primary PMN-20141208-

11:01:18 EST
	Chemicals

^ & Class 1 or 2 Chemical
Substance

Chemical

i Identification

j-~p| Class 1 or 2
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Total Production | |% CBlO
for this Use:

j% cbiD

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% of substance expected per use:

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Consumer*:
Industrial:
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>
1%

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* If you have provided a "consumer" use, provide details: CBI:0

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File Name

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Preview



CDX Homepage

| MyCDX Homepage

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button to navigate to the '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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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button, you will navigate to the 'Physical and Chemical Properties Worksheet - Continued
(Optional)' screen. After clicking the 'Previous' button, the physical/chemical properties have
been removed from the 'Add Property' drop-down menu.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• 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

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

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

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

g/L.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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





Use Information

PHj|f Physical &
Chemical
Properties

{""I = [Physical and
Chemical
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| Worksheet

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Properties
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5 & Polymer Substance

Chemical
Identific ation

Polymer

Logged in as: Jane Doe, Primary Agent/Consultant

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Premanufacture Notice

Primary Agent'Consultant

Primary PMN-20141208-
11:01:18 EST

""f^l Class 1 or 2
Chemical
Substances

¦'"UlClass 2 Substances

[^Additional Chemical
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4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST) > Physical and Chemical Properties Worksheet

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET

&

To assist EPA's review of physical and chemical properties data, please complete the following worksheet for data
you provide and include it in the notice. Identify the property measured, the value of the property, the units in which
the property is measured (as necessary), and whether or not the property is claimed as confidential. The physical
state of the neat substance should be provided. These measured properties should be for the neat (100% pure)
chemical substance. Properties that are measured for mixtures or formulations should be so noted (% PMN
substance in). You should submit this worksheet as a supplement to your submission of test data. This worksheet is
not a substitute for submission of test data.

Expand All | Collapse All

~

Adsorption/ Coefficient

Edit

X

~

Boiling/sublimation temperature @ 12 torr pressure

Edit

X

~

Density/ relative density

Edit

X

~

Dissociation constant

Edit

X

~

Explodability

Edit

X

~

Flammability

Edit

X

~

Henry's Law constant

Edit

X

~

Melting Temperature

Edit

X

~

Octanol/ water partition coefficient

Edit

X

~

Particle size distribution

Edit

x

~

Physical state of neat substance

Edit

X

~

pH @ concentration 22

Edit

X

~

Solubility ©temperature 12°C solvent

Edit

X





-/ 8

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Validate Save

Preview





CDX Homepage

I MyCDX Homepage

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (81

38)890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
97

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CDX-r

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

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

Logged in as Jane Doe, Primary Agent/Consultant

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

j Class 1 or 2





Chemical





Substances



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(Optional)



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~"A Polymer Substance



"1!

-jChemic al





Identification



Polymer

Home T Forms Y Resources

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~ Density/ relative density

tdit X

^ ~ Dissociation constant

Edit X

~ Explodability

Edit X

~ Flammability

Edit X

~ Henry's Law constant

Edit X

~ Melting Temperature

Edit X

~ Octanol/ water partition coefficient

Edit X

~ Particle size distribution

Edit X

~ Physical state of neat substance

Edit X

~ pH @ concentration 22

Edit X

~ Solubility (Sftemperature 12°C solvent

Edit X

~ Solubility in Water @ temperature 12°C

Edit X

~ Spectra

Edit X

~ Vapor Pressure @ temperature 12°C

Edit X

~ Volatilization from water

Edit X

~ Volatilization from soil

Edit X

~ Other: Other

Edit X

j Add Property

| Next |





>/

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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'
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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 with which properties an attachment is associated. Check the properties that are
relevant to the document, and then select a type and subtype value for the document. You will be
able to attach a document, enter a description of the document, and list the number of pages.

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

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

• Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window. Refer to Section 3.8 for additional details regarding the attach document
functionality.

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

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

• Description: Displays the description associated with a document.

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

Class 1 or 2 Chemical
Substance

j-Rchemical
Identific ation

|""Qciass 1 or 2
Chemic al
Substances

r-0Class 2 Substances

I"" AckJitional Chemical
Information

j""FlProduction Volume
j and Hazard/Safety
Information

jpfSjUse Information

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Properties

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j j Chemical
Properties
Worksheet

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

!""X Remove

® Copy

¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 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 tile, and then upload
to attach a document to chemical properties.

Attach Document

File Name

Properties

Description

Pages

CBI

Actions

|NextJ





¦s ¦

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Preview



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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
refers to be selected. Select the type and subtype for the attachment and the properties relevant to
the document, attach the document, and enter the number of pages.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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The system allows the uploaded document to be claimed as CBI. If a document is claimed as
CBI, the system requires the sanitized version of the attached document to be uploaded. To
access or edit previously attached documents, click the appropriate file name of the document
within the 'File Name' column of the attachment table.

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

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

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

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

• Description: Enter the description associated with a document.

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 arid Chemical Properties Worksheet - Continued (Optional) Attach

Documents Pop-Up Window (Scroll 1)

o

& "

ATTACH DOCUMENTS

Type and Subtype

Selectthe type and subtype Physical Chemical Property »
of the attachment

Chemical Properties

Adsorption/ Coefficient

Boiling/ sublimation temperature @

Density/ relative density

Dissociation constant

Explodability

Flam (natality

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

Attachment	File;

Selectthe file to attach	Browse

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
102

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CDX-r

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 arid Chemical Properties Worksheet - Continued (Optional) Attach

Documents Window (Scroll 2)

Q

neruy a L
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CDXr

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
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CDX?

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

Exhibit 4-28: Site Information Screen

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

Comical
Properties
Worksheet

"'(3 i Physical and
Chemical
Properties
Worksheet -
Continued
(Optional)

"X Remove

B Copy

&Add Consolidated
Chemical

5"EjSite Information

i""[5JSite Information

I Sites Controlled By
Others

B"L Submitter Controlled
Operations

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{^ !Submitter Operation
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'(^Occupational
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'[§! Environmental

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST}> Site Information

SITE INFORMATION

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

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

#

jjJexJ



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¦0

¦

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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 '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
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

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

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 Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

Worksheet

:—QPhysical and
Chemical
Properties
Worksheet-
Continued
(Optional)

X Remove

"Si Copy

^Add ConsolkJated
Chemical

I Site Information

|W|S8te Information

RSites Controlled By
Others

® l_J Submitter Controlled
Operations

!r~ nrioperation 1

(j^Submitter Operation
Information

j ^Occupational
Exposures

H[Environmental
Releases

X Remove

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST}> Sites Controlled By Others

SITES CONTROLLED BY OTHERS

Do you have any sites controlled by others for which you have information to report?
® Yes O No

B.t.a. Operation description

Do you have site-specific Information?

«> Yes O No



The '# of Unknown Sites' field is required- Enter '0' if none.

I	I

# of unknown sites:

Previous

CBI: -
| Next |



IS



¦

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Save

Preview

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

Navigation: Click the 'Next' button to navigate to the 'Submitter 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
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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 2014
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designed to eliminate errors and ensure the completion of all relevant sections for a site. You will
be able to enter an operation alias to identify the operation. Importers are not required to
complete this section for operations outside the U.S.; however, any industrial processing or use
operation that takes place after import must be described. It should be noted that Toll
manufacturing sites are considered to be sites controlled by the submitter.

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

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

The system provides a text box for describing the process description. Additional process
information may also be included in an attachment. In the process description, include the
following information: (1) Diagram the major unit operation steps and chemical conversions.
Include interim storage and specify transport containers (e.g., 5-gallon pails, 55-gallon drum, rail
car, tank truck, etc.). (2) Provide the identity, approximate weight (by kilograms (kg) kg/day or
kg/batch on a new chemical substance basis), and entry point of all starting materials, feedstocks
(including reactants, solvents, catalysts, etc.), products, recycle streams, and wastes. Include
cleaning chemicals (note frequency if not used daily or per batch). (3) Identify by number the
points of release, including small or intermittent releases, to the environment of the new
chemical substance. If releasing to two media at the same step, assign a second release number
for the second medium.

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

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

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

•	Add Facility: Click the button to generate the 'Add Facility' pop-up window and select a site
from the drop-down menu to add to the 'Submitter Operation Information' screen. Refer to
Section 3.10 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

•	Process Description: Enter the process description. In the 'Process Description' text box, or
an attachment, address the following items: (1) Diagram the major unit operation steps and
chemical conversions. Include interim storage and transport containers (specify - e.g., 5-
gallon pails, 55-gallon drum, rail car, tank truck, etc.). (2) Provide the identity, the

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

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 3.8 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
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December 19, 2014
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Exhibit 4-30 shows a screen capture of the 'Submitter Operation Information' screen (Scroll 1):
Exhibit 4-30: Submitter Operation Information Screen (Scroll 1)

T

T

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

Eli "i Submitter Controlled
Operations

! $ [^Operation 1

jpfffl Submitter
Operation
| Information

Hfjfcc upational
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'""tglAdkJ Operation

' tilOperations Controlled by
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B Hfloperation 1

!""(Industrial Sites
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Information

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f"|3Optional Pollution Prevention

!""0 Additional Attac hments

! ""Q Attac hment Summary

" I ^(Optional Cover Letter

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST}> Submitter Operation Information
SUBMITTER OPERATION INFORMATION

Operation Alias:

The operation alias is a text 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 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 Postal Code CBI	Actions

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

J Class 1 or 2 Chemical Substance
~ Polymer Substance

A.1.b Operation Type CBI:Q

Please select the type of operations present at this site.

Manufacturing: §3

Processing: U

Use: ~

A.1.C. Operation Description

Amount and Duration (Complete 1 or 2 as appropriate):	CBI: ~

Is it batch or continuous?





a









mm.







Validate Save

Preview



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TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
111

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CDX?

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

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

Information

|""Nocc upational
Exposures

! rfWl Environmental
Releases

:""%Add Operation

?'i_ Operations Controlled by
Others

[^Operation 1

Q Industrial Sites
Controlled By
Others

-Rl Ex posures/Releas es

I ^[Byproduct
Information

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j : Add Operation

O ptional Pollution Prev ention

Additional Attac hments

j""| ^[Attachment Summary

Optional Cover Letter

P"i	Joint Submission

Bl^Joint Submission 1

'jjjjoint Submitter
Information

QJoint Submission

Home y Forms y Resources

Use: U

¦6- Logged in as Jane Doe, Primary Agent/Consultant

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A.1.C. Operation Description

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

• 1. Batch 02. Continuous
max kg/batch:

:

(100% new chemical substance)

hours/batch:
batches/year:

n

:

A.1.d Process Description

CBI: ~

Please describe the attached process/operation, (optional)

Attach Document

File Name

Description

Pages

CBI: ~

CBI

Actions





>/

S

¦













Validate

Save

Preview



CDX Homepage j

I MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888)890-1995

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

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

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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.

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

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

•	Worker Category (1): Select the category of work from the drop-down menu in which a
worker may be exposed to a chemical substance. This is a required field.

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

•	Worker Activity (1): Select the worker activity (e.g. bag dumping, tote filling, unloading
drums, sampling, cleaning, etc.) in which workers may be exposed to a chemical substance.
Please note that if you are populating this field via an XML file created from the ePMN thick
client, this drop-down menu will not populate. This is a required field.

•	User Defined Worker Activity: Enter the worker activity in which workers may be exposed
to a chemical substance. This field displays only for certain worker activity values.

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

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

•	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

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

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

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

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

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

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

•	Hours/Day (10): Enter the maximum duration occupational exposure occurs for the activity
for any worker in hours per day; this field allows decimal values. A value of zero (0) entered
in this field will display an error. This is a required field.

•	Days/Year (11): Enter the maximum duration occupational exposure occurs for the activity
for any worker in days per year; this field allows decimal values. A value of zero (0) entered
in this field will display an error. This is a required field.

•	CBI: Check the 'CBF checkbox to claim the maximum duration values as confidential.

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

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

A, Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST)> Occupational Exposures

OCCUPATIONAL EXPOSURES

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

0 Copy

J&Adtf Consolidated
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CDX Homepage

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[ EPA Homepage | Terms and Conditions |

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TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
115

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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 Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

111 Copy

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CDX Helpdesk: (8*

J8) 890-1995

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

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

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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.

•	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.

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

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

•	Release Number (1): Enter the number of each release point identified in the process
description on the 'Submitter Operation Information' screen. This is a required field.

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

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

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

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

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

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

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

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

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

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

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

•	Binding: Check the 'Binding' checkbox to claim the control technology description as
binding.

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

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

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

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Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

AOd consolidated
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4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST} > Environmental Releases

ENVIRONMENTAL RELEASES

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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 Agent/Consultant

December 19, 2014
120

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CDX?

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

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

consolidated
Chemical

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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 '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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
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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 3.10 for additional details regarding the add facility functionality.

•	Site Name: Displays the site name.

•	Address: Displays the site address.

•	City: Displays the site city.

•	State: Displays the site state.

•	Postal Code: Displays the site postal code.

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

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

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

•	Operation Description: Enter the operation process description. Cover the following items:

(1)	Diagram the major unit operation steps and chemical conversions, including interim
storage 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 2014
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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 3.8 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
Primary Agent/Consultant

December 19, 2014
123

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CDY-

Exhibit 4-36 shows a screen capture of the 'Industrial Sites Controlled By Others' screen (Scroll
1):

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

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-201412Q8-

11:01:18 EST
B HTloperation 1

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4 Premanufacture Notice (Primary PMN-20141208-11:01:18 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:

Add Facility

Site Name Address	City	State Postal Code

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

~	Class 1 or 2 Chemical Substance

~	Polymer Substance

Operation Description:

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

CBI: ~

CBI

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Preview



CDX Homepage |

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

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CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
124

-------
CDX-r

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

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



Premanufacture Notice

Primary Agent'ConsuRant

Primary PMN-20141208-

11:01:18 EST
^ Hfloperation 1

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Home y Forms * 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:

J Class 1 or 2 Chemical Substance
~ Polymer Substance

Operation Description:

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

CBI: ~

CBI

Actions

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File Name	Description	Pages

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CDX Homepage

| 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 '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

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Substance (6),' and '% in Formulation (7).' The screen displays fields in the environmental
release expandable/collapsible field set to enter information for 'Release Number (9),' the
amount of the new substance released directly 'to environment (10a),' the amount of new
substance released 'into control technology (10b),' 'Media of Release (12),' and 'Control
Technology (12).'

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

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

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

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

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

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

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

•	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

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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.

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

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

T

T

, Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

] i Information

j""[ ^|Occupational
| j Exposures

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< Premanufacture Notice (Primary PMN-20141208-11:01:18 EST}> Exposures/Releases

EXPOSURES/RELEASES

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

#

Letter of Activity (1):[

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

Days/Year (4b): |	

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Protective Equipment/ Engineering Controls (6):

Physical Form (6):
% New Substance (6): (
% in Formulation (7): |_

| Save |



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Preview

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

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

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

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

•	Amt New Substance Released Directly into Environment (10a): Enter an estimate of the
amount of the new substance released directly to the environment in Kg/day or Kg/batch.

•	Amt New Substance Released Directly into Environment Kg/Day: Select the 'Kg/Day'
radio button to indicate that the amount of substance released into environment measures in
kilograms per day.

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•	Amt New Substance Released Directly into Environment Kg/Batch: Select the
'Kg/Batch' radio button to indicate that the amount of substance released into environment
measures in kilograms per batch.

•	Amt New Substance Released Directly into Control Technology (10b): Estimate the
amount of the new substance released into control technology in Kg/Day or Kg/Batch.

•	Amt New Substance Released Directly into Control Technology Kg/Day: Select the
'Kg/Day' radio button to indicate that the amount of substance released into control
technology measures in kilograms per day.

•	Amt New Substance Released Directly into Control Technology Kg/Batch: Select the
'Kg/Batch' radio button to indicate that the amount of substance released into control
technology measures in kilograms per batch.

•	Media of Release (12): Select a value from the drop-down menu to capture the media of
release. The 'Media of Release' drop-down menu contains the following values: 'Fugitive
Air,' 'Off-Site Incineration,' 'On-site Incineration,' 'On-site WWT,' 'POTW,' 'Stack Air,'
'Surface Water,' and 'Other,' that will be used to limit the release of the new substance to the
environment. Please pay particular attention to the information within if this field is
populated via XML file. The information contained within the 'Media of Release & Control
Technology' field in the thick client separates into two (2) separate fields, the 'Media of
Release' drop-down menu and 'Control Technology' field when these fields are populated
via an XML file generated from the ePMN thick client.

•	If Other, Specify: Enter the other media of release.

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

•	Control Technology (12): Enter the control technology, if any, which will be used to limit
the release of the new substance to the environment. Please pay particular attention to the
information within if this field is populated via XML file. The information contained within
the 'Media of Release & Control Technology' field in the thick client separates into two (2)
separate fields, the 'Media of Release' drop-down menu and 'Control Technology' field
when these fields are populated via an XML file generated from the ePMN thick client.

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

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

Logged in as: Jane Doe. Primary Agent/Consultant

Log Out

Premanufacture Notice
Primary Agent/Consuttant

Physical and
Chemical
Properties
Worksheet

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Chemical
Properties
Worksheet -
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Release Number (9):

Amt New Substance Released Directly into Environment (10a):
] © Kg/Day © Kg/Batch

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© Kg/Day © Kg/Bateh

Media of Release (12):

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

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

•	Byproduct: Enter byproducts that may result from the operation.

•	Actions: Click the 'Save' icon (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 (
Hi) to edit a saved byproduct.

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

Exhibit 4-40: Byproduct Information Screen

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bms?

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

rPl Byproduct
information

:""1=]A Byproduct Information

BYPRODUCT INFORMATION

Identity1 byproducts that may result from the operation. Check the CBI checkbox it the information is
confidential.



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CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (868)890-1995

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

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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 attachment table.

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

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

Describe the expected net benefits, such as:

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

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

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

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

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

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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:

Clicking the link displays 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 3.8 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.

•	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.'

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• Actions: Click the 'Delete' icon (3 ) 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

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

" X Remove

i-r{=)AdkJ Operation

Optional Pollution Prevention

Additional Attac hments

Attac hmerrt Summary

Optional Cover Letter

@ ;	Joint Submission

$f|?Joint Submission 1

[^jjoint Submitter
Information

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Information

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Submission
Information

X Remove

¦[=]Add Letter of Support

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 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: U

•&

Attach Document
File Name

Description

Pages

CBI

Actions



>/

e

¦



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Preview

CDX Homepage | MyCDX Homepage | EPA Homepage I 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 yet been incorporated into the form. This screen is used as a carryover where
documents that did not have a suitable place in the application can be uploaded.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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 3.8 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.'

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

Exhibit 4-42: Additional Attachments Screen

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

:""JC Remove

Lr(=jAck3 Operation

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"[jy Letter of Support
Submitter
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Submission
Information

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i-HlAdd Letter of Support

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 EST} > Additional Attachments

ADDITIONAL ATTACHMENTS

Please use this page to attach documents that are riot 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



IS

¦0

¦

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Save

Preview

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

Navigation: Click the 'Next' button to navigate to the '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.

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

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

•	Pages: Displays the number of pages 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 Agent/Consuttant

Primary PMN-20141208-
11:01:18 EST

: X Remove

:"' tj=)Add Operation

j-'MOptional Pollution Prevention

!"Additional Attac hments

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j -jJiOptional Cover Letter

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: ^Add Letter of Support

¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

< Premanufacture Notice (Primary PMN-2014120B-11:01:18 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

Previous

Pages

Date

CBI

|NextJ





s/ B

Validate Save

Preview





CDX Homepage

| MyCDX Homepage |

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8i

38)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.

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.

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

Exhibit 4-44 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 4-44: Optional Cover Letter Screen

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consuttant

Primary PMN-20141208-
11:01:18 EST

:""X Remove

:""t[=|Add Operation

H_zJOptional Pollution Prevention

"[^Additional Attachments

""LjAttac hment Summary

!""l Optional Cover Letter

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! B'f^fjoint Submission 1

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p] Letter of Support
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Information

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Information

X Remove

%)Add Letter of Support

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 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 CBI: L

jj^extJ

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
3.7 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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December 19, 2014
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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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Exhibit 4-45 shows a screen capture of the 'Joint Submitter Information' screen:

Exhibit 4-45: Joint Submitter Information Screen

¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:10 EST

Ex pos u res /R eleas es

bj Byproduct
Information

X Remove

Lr|=jAdd Operation

""|_2 Optional Pollution Prevention

""{§i Additional Attac hments

""llAttac hment Summary

"[§ 'Optional Cover Letter

B	loint Submission

S^Joint Submission 1

Joint Submitter
information

I ! j""NJoint Submission
Information

: "L^Add Joint Submission

B "i_ Letter of Support

$ ^Letter of Support 1

Letter of Support
Submitter
| Information

rQ Letter of Support
I Submission
Information

"X Remove

'^Add Letter of Support

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 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:

m

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.

I	I

United States

|^NextJ





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CDXr

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 can
choose to send an email to the joint submitter identified on the 'Joint Submitter Information'
screen. The email will contain the unique identification number that will link the two forms.

When the joint submitter 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 have been 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 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
Primary Agent/Consultant

December 19, 2014
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Exhibit 4-46 shows a screen capture of the 'Joint Submission Information' screen:
Exhibit 4-46: Joint Submission Information Screen

Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

!® Exposures/Releases

""Hi By product
Information

""X Remove

: %)Add Operation

Optional Pollution Prevention

H_ AtkHtbnal Attac foments

"1 Attac hment Summary

'"QOptional Cover Letter

9l_]Joint Submission

S'flfjoint Submission 1

Joint Submitter
Information

Joint Submission
Information

f Joint Submission

Letter of Support

@ ^Letter of Support 1

i'"Q Letter of Support
j j Submitter
Information

! jj""QLetter of Support
Submission
Information

:""X Remove

' '%|Add Letter of Support

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

4 Premanufacture Notice (Primary PMN-20141208-11:01:18 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: abfade06-0699-454e-8b27-b2d92291 ff7c

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.



a

¦0

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Save

Preview

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

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.

4.1.31 Notify Joint Submitter of Joint Submission Information

You can access the 'LJnique 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 2014
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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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December 19, 2014
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Exhibit 4-47 shows a screen capture of the 'Unique Identifier Notification' pop-up window
(Scroll 1):

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



CSPP

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

Chemical 1
Chemical 2

¦&

From:
CC:

To:

Subject:
Message:

Jane.Doe@test.com

Jane.Doe@test.com





a

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 TEST GROUP. 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 abfade06-0699-454e-8b27-b2d92291ff7c

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 wAv.epa.aov/ODDt/newchems/. For additional
information or if you believe you have received this email in error, please
contact me.

Additional Comments:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
144

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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)

0

Chemical 2

From:

CC:

To:

2015 Primary PMN

As the Authorized Official of TEST GROUP, 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 abfade06-0699-454e-8b27-b2d92291ff7c

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 joint submitter and navigate back to
the 'Joint Submission Information' screen.

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.

Jane.Doe@test.com

Jane.Doe@test.com



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

/

Subject:
Message:

Additional Comments:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
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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.'

•	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
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December 19, 2014
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Exhibit 4-49 shows a screen capture of the 'Letter of Support Submitter Information' screen:
Exhibit 4-49: Letter of Support Submitter Information Screen



Premanufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

" Exposures/Releases

j-g) Byproduct
Information

""X Remove

4=) Add Operation

I _ Optional Pollution Prevention

!"" Additional Attac hments

Attachment Summary

|Optional Cover Letter

9"i	iJoint Submission

$ l^fjoint Submission 1

Joint Submitter
Information

lp (Joint Submission
Information

X Remove

L[=]Ac} Letter of Support Submitter Information
LETTER OF SUPPORT SUBMITTER INFORMATION

Please enter the contact information for the tetter 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.

Previous







V B

Validate Save

Preview



CDX Homepage |

| MyCDX Homepage

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button to navigate to the '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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 2014
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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
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December 19, 2014
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Exhibit 4-50 shows a screen capture of the 'Letter of Support Submission Information' screen:
Exhibit 4-50: Letter of Support Submission Information Screen

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Pre manufacture Notice

Primary Agent/Consultant

Primary PMN-20141208-
11:01:18 EST

Exposures/Releases

"Q By product
Information

X Remove

Operation

'[^Optional Pollution Prevention

' Additional Attac foments

; i Attachment Summary

"[ = (Optional Cover Letter

P":	Joint Submission

5'ljj|fjoint Submission 1

Joint Submitter
Information

Joint Submission
Information

X Remove

%Add Joint Submission

S I	jLetter of Support

5 {^Letter of Support 1

r"g] Letter of Support
Submitter
Information

I'"{5lLetter of Support
Submission
Information

%|Add Letter of Support

4 Premanufacture Notice (Primary PMN-2G141208-11:01:18 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: dcf07c77-9a2a-48ef-ac12-
55bc8a8a5010

This is the unique identification number for your Letter of Support 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 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.



s

¦

m

Validate

Save

Preview

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

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

Refer to Section 3.7 for the functionality available within the bottom action bar.

4.1.34 Notify Secondary Submitter of Letter of Support Information

You can access the 'LJnique Identifier Notification' window by clicking the 'Notify the
Secondary Submi tter of the letter of support submission' link from the 'Letter of Support
Submission Information' screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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The 'Unique Identifier Notification' window is used to notify the Letter of Support submitter of
the unique identification number. The 'Unique Identifier Notification' window displays a 'CC'
field for you to add other email addresses to the notification (including the original submitter), a
'To' field, and an 'Additional Comments' text box.

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

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

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

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

•	Subject: Displays ' YYYY Primary PMN.'

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 2014
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Exhibit 4-51 shows a screen capture of the 'Unique Identifier Notification' pop-up window
(Scroll 1):

Exhibit 4-51: Unique Identifier Notification Pop-Up Window (Scroll 1)

•3

$CSPP	u~*

Select the chemicals you want to notify the Secondary Submitter with

'J Chemical 1
~ Chemical 2

From:

CC:

To:

2015 Primary PMN

As the Authorized Official of TEST GROUP, I have identified you as a
Secondary Submitter of a letter of support 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 letter of support submission.

Unique Identifier dcf07c77-9a2a-48ef-ac12-55bc8a8a5010

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..gov/oppt/newchems/. For additional
information or if you believe you have received this email in error, please
contact me.

Jane.Doe@test.com

Jane.Doe@test.corn





/,

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

	A

Subject:
Message:

Additional Comments:

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

Primary Agent/Consultant	151

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CDX-r

Exhibit 4-52 shows a screen capture of the 'Unique Identifier Notification' window (Scroll 2):
Exhibit 4-52: Unique Identifier Notification Window (Scroll 2)

Chemical 2

From:

CC:

To:

Subject:
Message:

Jane.Doe@test.com

Additional Comments:

Jane.Doe@test.com





A

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 TEST GROUP. I have identified you as a
Secondary Submitter of a letter of support 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 letter of support submission.

Unique Identifier dcf07c77-9a2a-48ef-ac12-55bc8a8a5010

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.

Send

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.

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 ,pmn_tsca 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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If you upload an XML file into a pre-populated form, the XML file overwrites the contents of the
pre-populated form. In addition, uploading any file removes the attached documents within a
form, which must be re-attached. You must also add any sites identified within the form to your
CDX registration profile.

After uploading a file, click the 'Preview' icon ( ) located in the bottom action bar to view a
PDF preview of the form ensuring that all the data has populated correctly and any other
information is displayed accurately. In particular, ensure that the 'Letter of Activity (1),'
'Protective Equipment/Engineering Controls,' 'Physical Form,' 'Media of Release,' 'Control
Technology,' and '% New Substance' fields of entry have been populated correctly.

Please note that in IE 7, if an upload fails, the action bar at the bottom of the screen might be
misaligned when the 'Upload XML' screen reloads.

•	Upload archive file: Click the button to generate the 'File Upload' window to search for the
ZIP copy of record archive file populated with PMN information. The copy of record archive
file must contain the XML form in a file labeled 'formdata.xml.' The application processes
the ZIP copy of record archive file and displays any applicable error messages.

•	Export XML: Click the button to generate the XML file of the current PMN form that a user
can download.

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Exhibit 4-53 shows a screen capture of the 'Upload XML' screen:

Exhibit 4-53: Upload XML Screen

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Premanufacture Notice

Primary Agent/Consuftant

Primary PMN-201412G8-
11:01:18 EST

'Fj General Form Information

II,User Fees Certification

hj "lAgent Information

Technical Contac 11 nformation

Additional Submission
Information

Ep"i	Chemicals

i	Class 1 or 2 Chemical

Substance

| ~l Chemical
Identification

Pl Class 1 or 2
Chemical
Substances

Q Class 2 Substanc es

Additional C hemic al
Information

QProduction Volume
and Hazard/Safety
Information

H5]Use Information

? IjjlfPhysical &
I Chemical
I Properties

j""p] Physical and
Chemical

¦&

UPLOAD XML

Click the Upload XML File button below and select the ZIP archive tile you have populated with PMN [nformation.
I This archive must contain your form XML in a file labeled 'formdata.xml1.

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, all form contents will be
overwritten with the information stored within the imported XML file.

Ibxport XML



19

¦

¦

Validate

Save

Preview

CDX Homepage | MyCDX Homepage | EPA Homepage

Terms and Conditions

Privacy Notice | CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Validate' icon C ) located in the bottom action bar to validate the form.
Click the 'Save' icon (E ) located in the bottom action bar to perform a global save 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.

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5 Create Biotechnology Form

The Biotechnology form is used as a way 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 and click the 'Start
New Form' button. Refer to Section 3.3 for additional details regarding the 'Section 5 Notices
and Supports Forms' screen.

Refer to Section 3.4 for additional details regarding the 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.

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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 3.8.

•	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 even if
a Letter of Support or Joint Submission is claimed. Please refer to Section 3.8 for additional
details regarding the attach document process.

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

•	Description: Displays the description of a document.

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

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

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

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

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

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•	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 Agent/Consultant

Log Out

Biotechnology

Primary Agent/Consultant

Biotechnology-20141208-
11:02:46 EST

j~" General Form Information

S _ Joint Submission

S'ijjifjoint Submission 1

[=|joint Submitter
Information

! Joint Submission
Information

X Remove

%jAcW Joint Submission

g-r I Letter Of Support

5 {jjlfLetter of Support 1

"Q Letter of Support
Submitter
Information

'{^Letter of Support
Submission
Information

X Remove

i-jbjAdd Letter Of Support

^Technical Contact Information

Optional Cover Letter

4 Biotechnology (Biotechnology-20141208-11:02:46 EST) > General Form information

GENERAL FORM INFORMATION

Biotechnology-20141208-11:02:46 E

You may enter an alias for easier form identification or the system will provide a time stamp.
Form Alias:

III.	Type of Submission:

TS Number

IV.	Text/Comments CBI:

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 filing a consolidated	Number of Microorganisms: | (2-20)

Biotechnology form:

Check here if you are filing a joint	-1

Rintprhnnlnnv fnrrrr





>/

Validate

S

Save

n

Preview





CDX Homepage

| MyCDX Homepage |

EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8f

38)890-1995

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

Biotechnology-20141208-
11:02:46 EST

General Form Information

B i	iJoint Submission

Q'ijjlfJoint Submission 1

Joint Submitter
Information

[= [Joint Submission
f Information

" X Remov e

Joint Submission

l~l Letter Of Support

? i^Letter of Support 1

j J""l=l Letter of Support
Submitter
Information

E

Letter of Support

Submission

Information

" X Remove
! '"£jj=)Add Letter Of Support
"©Technical Contact Information
""©Optional Cover Letter

Home y Forms J Resources
III. Type of Submission:

TS Number:

<*¦ Logged in as Jane Doe, Primary Agent/Consultant

Log Out

IV. Text/Comments CBI:

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 filing a consolidated	u Number of Microorganisms: |
Biotechnology form:

Check here if you are filing a joint	—1
Biotechnology form:

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

J (2-20)







V s

Validate Save

Preview





CDX Homepage |

| MyCDX Homepage

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8f

38)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.

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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 ( *) 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
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Exhibit 5-3 shows a screen capture of the 'Joint Submitter Information' screen:

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

¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Biotechnology

Primary Agent/Consultant

Biotechnology-20141208-
11:02:46 EST

j""(3 General Form Information

P Joint Submission

5l||fjoint Submission 1

if'"'h Joint Submitter
Information

j"i ~| Joint Submission
| | Information

!""Lr[kjAdd Joint Submission

1'"" Letter Of Support

^ ljj|f Letter of Support 1

Letter of Support
Submitter
Information

" _ Letter of Support
Submission
| | Information

; X Remove

L[=jAdd Letter Of Support

(^Technical Contact Information

•g Optional Cover Letter

4 Biotechnology (Biotechnology-20141208-11:02:46 EST) > 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.

Check here to claim this information as CBI:
First Name:

~

Last Name:
Position:

Company Name:
Phone Number:

Phone Extension:
Email Address:
Mailing Address 1:

Mailing Address 2:

City:

State:

Postal Code:
Country:

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

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

Apartment, suite, etc.

United States
Previous







-------
CDXr

Joint Submission Process: A 'Special Information' field will be used to send information to the
joint submitter in an email sent by the primary submitter.

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

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

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

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

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

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

¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Biotechnology

Primary Agent/Consultant

Biotechnology-20141208-
11:02:46 EST

1 ~-:'l General Form Information

Joint Submission

i $'^Joint Submission 1

l""Qj°int Submitter
I Information

Joint Submission
Information

%)Add Joint Submission

B" Letter Of Support

^Letter of Support 1

I j—p j Letter of Support
Submitter
Information

j-| " | Letter of Support
I I Submission
I I Information

"""X Remove

:" %)Add Letter Of Support

"[^Technical Contact Information

Optional Cover Letter

4 Biotechnotogy (Biotechnology-20141208-11:02:46 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: 4cea7094-80f7-4c05-a054-
c9a220535646

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.

Previous	I Next







V s

Validate Save

Preview





CDX Homepage |

| MyCDX Homepage j

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (81

38)890-1995

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 'LJnique 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'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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
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Exhibit 5-5 shows a screen capture of the 'Unique Identifier Notification' pop-up window:
Exhibit 5-5: Unique Identifier Notification Pop-Up Window

©

CSPP	" rj

From:	Jane.Doe@testcom

Jane.Doe@test.com





/,

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

2015 Biotechnology

As the Authorized Official of TEST GROUP. 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 4cea7094-80f7-4c05-a054-c9a220535646

Information about the Section 5 programs, how to access the Section 5
Notices and Supports application, and instructions for reporting under the
Section 5 rule are available at www.eDa.gov/ODDt/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. 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'
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

Subject:
Message:

Additional Comments:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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filed. Click the 'Add Letter of Support' link within the navigation tree to add a Letter of Support.
The system will allow an unlimited number of Letters of Support to be filed. Remove a Letter of
Support by clicking the 'Remove' link ( ¦*) within the navigation tree.

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

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

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

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

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

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

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

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

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

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

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

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

•	State: 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
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Exhibit 5-6 shows a screen capture of the 'Letter of Support Submitter Information' screen:
Exhibit 5-6: Letter of Support Submitter Information Screen (Biotechnology)

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Biotechnology

Primary Agent/Consultant

Biotechnology-20141208-
11:02:46 EST

General Form Information

B"|	IJoint Submission

${0|fjoint Submission 1

QJoint Submitter
Information

Joint Submission
Information

Remove

: " ^Add Joint Submission

Ell Letter Of Support

Letter of Support 1

[^Letter of Support
Submitter
Information

^Letter of Support
Submission
Information

:""Lj=)Add Letter Of Support

Tec hnic al Contac 11 nformation

Optional Cover Letter

4 Biotechnology (Biotechnology-20141208-11:02:46 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 t:

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.

Previous

I Next I





B

Validate Save

Preview



CDX Homepage |

| MyCDX Homepage

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

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

5.1.6 Letter of Support Submission Information

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

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

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will also display on this screen. The unique identifier will auto-generate when a Letter of Support
submission is being established.

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

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

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

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

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

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Exhibit 5-7 shows a screen capture of the 'Letter of Support Submission Information' screen:
Exhibit 5-7: Letter of Support Submission Information Screen

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Biotechnology

Primary Agent/Consultant

Biotechnology-20141208-
11:02:46 EST

General Form Information

P"i	Joint Submission

S flfjoint Submission 1

"pjjoint Submitter
Information

HJoint Submission
Information

X Remove

%)Add Joint Submission

[Letter Of Support

S'MLetter of Support 1

Letter of Support
Submitter
Information

I-[Letter of Support
Submission
Information

: %)Add Letter Of Support

Tec hnic al Contac t Information

O ptiortal Cov er Letter

4 Biotechnology (Biotechnology-20141208-11:02:46 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: d9e50dad-4a58-4524-9772-
b030d68f245b

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.







*/

Validate

a

Save

Preview



CDX Homepage |

| MyCDX Homepage

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

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

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.

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•	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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Exhibit 5-8 shows a screen capture of the 'Unique Identifier Notification' window:
Exhibit 5-8: Unique Identifier Notification Pop-Up Window

Jane.Doe@testcom

Jane.Doe@test.com

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

2015 Biotechnology

As the Authorized Official of TEST GROUP, 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 d9e50dad-4a58-4524-9772-b030d68f245b

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. qq v/o ppt'newehems/. For additional
information or if you believe you have received this email in error, please
contact me.

Send

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' icon 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.

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

From:
CC:

To:

Subject:
Message:

Additional Comments:

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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 technical contact's last name .

•	First Name: Displays the technical contact's first name.

•	Address: Displays the technical contact's address.

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 5-9 shows a screen capture of the 'Technical Contact Information' screen:

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

Biotechnology

Primary Agent/Consultant

Biotechnology -20141208-
11:02:46 EST

i ll General Form Information

B'l Joint Submission

Ep ljjiJjomt Submission 1

""!=]Joint Submitter
Information

^jJoint Submission
Information

X Remove

!""%Add Joint Submission

— Letter Of Support

! Letter of Support 1

i""(f "J Letter of Support
Submitter
Information

i~| ~ I Letter of Support
Submission
Information

'"X Remove

L^Add Letter Of Support

Technical Contact
Information

A Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

4 Biotechnology (Biotechnology-20141208-11:02:46 EST) > Technical Contact Information

TECHNICAL CONTACT INFORMATION

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

&

Last Name

First Name

Previous

Address

CBI

Actions

| Next |

Optional Cover Letter





-¦

Validate Save

Preview



CDX Homepage |

I 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.

•	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.

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

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

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

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

•	Phone Number: Enter the technical contact's daytime U.S. phone number; this must be at
least 10 characters long and does not accept dashes. Click the 'Copy CDX Registration'
button to populate the fields with information entered during CDX registration. This is a
required field.

•	Phone Extension: Enter the technical contact's phone number extension if applicable.

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

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

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

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

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

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

•	Country: Displays 'United States.'

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Exhibit 5-10 shows a screen capture of the 'Add Technical Contact' pop-up window:
Exhibit 5-10: Add Technical Contact Pop-Up Window

c^cspp

ADD TECHNICAL CONTACT

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

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

First Name:

Last Name:
Position:

Company Name:
Phone Number:

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. boxr company name, etc.

Apartment, suite, etc.

nz

United States

Cancel

Navigation: Click the 'Cancel' button to stop populating technical contact information and
navigate back to the 'Technical Contact Information' screen. Click the 'OK' button to save and
populate the entered technical contact information and navigate back to the 'Technical Contact
Information' screen.

5.1.9 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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regarding the application; enter any necessary instructions into the blank text field. The cover
letter should be either fully CBI or non-CBI to eliminate user error to promote transparency
between the company and EPA.

•	Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim the cover letter information as confidential.

•	Optional Cover Letter: Enter the description and any additional special instructions
regarding the form.

Exhibit 5-11 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 5-11: Optional Cover Letter Screen



Biotechnology

Primary Agent/Consultant

Biotechnology-20141208-
11:02:46 EST

General Form Information

E3"l	iJoint Submission

$'ljjl?Joint Submission 1

J Joint Submitter
Information

[Sjjoint Submission
Information

X Remove

%jAdd Joint Submission

EH I Letter Of Support

Letter of Support 1

¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Q Letter of Support
Submitter
Information

'Q Letter of Support
Submission
Information

X Remove

Mi Add Letter Of Support

Technical Contact Information

Optional Cover Letter

4 Biotechnology (Biotechnology-20141208-11:02:46 EST) > 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: ~

#

Previous





>/

Validate

S

Save

Preview





CDX Homepage |

| MyCDX Homepage j

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8*

38)890-1995

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 ( ) located in the bottom action bar to view a PDF preview of the form.

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 3.3 for additional details regarding the 'Section 5
Notices and Supports Forms' screen.

Refer to Section 3.4 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.

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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 Agent/Consultant

NOC-20141208-11:02:21 EST
General Form Information

"^Technical Contact Information
"Qchemical Information

lSite Information
"| ^ Optional Cover Letter

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

4 Notice of Commencement (NOC-20141208-11:02:21 EST)> 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:	|NQC-2014120a-11-Q2:21 EST |

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

Case Number:

Please enter the case number in the following format: P-XX-XXXX, where 'XX' indicates the year in which the case number is
generated.

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

>/

B

¦

Validate

Save

Preview

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

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

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.

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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
di splays to confirm the deleti on of the techni cal contact.

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

Notice of Commencement

Primary A ge nf Consultant

NOC-20141208-11:02:21 EST

"'^General Form Information

[^[Technical Contact
j Information

{[Chemical Information

"i3jSite Information

: -1_2]Optional Cover Letter

•*> Logged in as Jane Doe, Primary Agent/Consultant

Log Out

4 Notice of Commencement (NOC-20141208-11:02:21 EST) > Technical Contact Information

TECHNICAL CONTACT INFORMATION

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

Last Name

First Name

Address

CBI

Actions





«/¦

Validate Save

Preview





CDX Homepage

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8£

S8) 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.

•	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.

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

•	Phone Extension: Enter the technical contact's phone number extension, if applicable.

•	Email Address: Enter the technical contact's email address. The email address must follow
the standard email address format: John.Doe@abc.com. If you have clicked the 'Copy CDX
Registration' button, the fields populate with information entered during CDX registration.

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

•	Mailing Address 2: Enter the second line of the technical contact's mailing address. If you
have clicked the 'Copy CDX Registration' button, the fields populate with information
entered during CDX registration.

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

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

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

•	Country: Displays 'United States.'

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

1

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:

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

Phone Extension:
Email Address:
Mailing Address 1:

Mailing Address 2:

City:

State:

Postal Code:
Country:

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

Apartment, suite, etc.

United States

| Cancel |



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

6.1.3

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.

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

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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 3.9 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 3.7
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.

•	Delete: Click the 'Delete' icon ( *) located in the upper right-hand corner of the
expandable/collapsible field set to delete the field set. A confirmation message displays to
confirm the deletion. The 'Delete' icon ( ¦*) displays when the user has clicked the 'Add New
Chemical' button.

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 2014
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Exhibit 6-4 shows a screen capture of the 'Chemical Information' screen (Scroll 1):

Exhibit 6-4: Chemical Information (Scroll 1)

T

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Notice of Commencement

Primary Agent/Consultant

NOC-20141208-11:02:21 EST

General Form Information
Technical Contact Information
\5 Chemical Information
"QlSite Information
1 Optional Cover Letter

^ Notice of Commencement (NOC-20141200-11:02:21 EST) > Chemical Information

CHEMICAL INFORMATION

Part V - Specific Chemical Identity

- CASRN:



Expand All | Collapse All
Cancel X

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

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





-------
CDX?

Exhibit 6-5 shows a screen capture of the 'Chemical Information' screen (Scroll 2):

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

Notice of Commencement

Primary Agent/Consultant

NOC-20141208-11:02:21 EST

General Form Information
HTechnical Contact Information
{^Chemical Information
Hi]Site Information
n§| Optional Cover Letter

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Home y Forms " Resoun
Search SRS

CASRN:

Chemical Name:

CBI:	8

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

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.

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

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

Previous

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CDX Homepage j

| MyCDX Homepage |

| EPA Homepage | Terms and Conditions |

Privacy Notice !

CDX Helpdesk: (81

38)890-1995

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.

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.

•	Add Site: Click the 'Add Site' button to generate the 'Add Site' pop-up window. Refer to
Section 3.10 for additional details regarding the add site functionality.

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

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

B-i

CBI Substantiation

pj = |CBI Substantiation Part 1
!""HCBI Substantiation Part 2
^ CBI Substantiation Part 3
""fljOptional Cover Letter

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Notice of Commencement

Primary Agent/Consultant

NOC-20141208-11:02:21 EST

i""2j General Form Information
i""l =ITechntcal Contact Information
; Chemtcal Information
|....g information

4 Notice of Commencement (NOC-20141208-11:02:21 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:|^dd_sitej

Registry ID

Site Name

Previous

Address

| Next |

CBI

Actions

>/

e

H

Validate

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

Navigation: If you claimed a chemical CBI, click the 'Next' button to navigate to the 'CBI
Substantiation Part I' 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'
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:

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

Primary Agent/Consultant	185

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CDXr

•	(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 Agent/Consultant

December 19, 2014
186

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Exhibit 6-7 shows a screen capture of the 'CBI Substantiation Part 1' screen (Scroll 1):
Exhibit 6-7: CBI Substantiation Part 1 Screen (Scroll 1)



Notice of Commencement

Primary Agent/Consultant

NOC-20141208-11:02:21 EST

"0 General Form Information

"'2iTechnical Contact Information

r"RiC hemic al Information

j""Hl Site Information

f$l CBI Substantiation

CBI Substantiation Part
1

""l^JCBI Substantiation Part 2
!"'QjB0l Substantiation Part 3
"(_=} Optional Cover Letter

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out

4 Notice of Commencement (NOC-20141208-11:02:21 EST) > CBI Substantiation Part 1	H

CBI SUBSTANTIATION PART 1

Substantiate confidentiality of claims if you mark the substance identity (Part V) as CBI by answering the
following questions. Please enter N/A if the question does not apply.

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

(B) 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	





v a

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Preview



CDX Homepage |

| MyCDX Homepage |

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Privacy Notice |

CDX Helpdesk: (888) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
187

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CDX?

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 Agent/Consultant

NOC-20141208-11:02:21 EST

!" "Q General Form Information
'I3Technical contact Information
(3Chemical Information
?H5)Site Information

@"l	CBI Substantiation

1""NCBI Substantiation Part

1

i""h|CBI Substantiation Part 2
"'"(JiCBI Substantiation Part 3
"2 Optional Cover Letter

Home y Forms J Resources

a specific event, or permanently? Why?

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

(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









*/

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a

Save

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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 '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 V 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

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

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
Primary Agent/Consultant

December 19, 2014
189

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CDY-

Exhibit 6-9 shows a screen capture of the 'CBI Substantiation Part 2' screen (Scroll 1):
Exhibit 6-9: CBI Substantiation Part 2 Screen (Scroll 1)

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Notice of Commencement

Primary Agent/Consultant

NOC-20141208-11:02:21 EST

!" "Q General Form Information

'I3Technical contact Information

(3Chemical Information

?H5)Site Information

@"i	iCBI Substantiation

i""j^|CBI Substantiation Part 1

!""fW|CBI Substantiation Part
2

"'"(JiCBI Substantiation Part 3
"2 Optional Cover Letter

4 Notice of Commencement (NOC-20141208-11:02:21 EST)> CBI Substantiation Part 2

CBI SUBSTANTIATION PART 2

Substantiate confidentiality of claims if you mark the substance identity (Part V) as CBI by answering the
following questions. Please enter N/A if the question does not apply.

(E) Is the fact that someone is manufacturing or importing this chemical substance for commercial
purposes available to the public, e.g. in technical journals or other publications; in libraries: or in State,
local, or Federal agency public files?

#

(F) What measures have you taken to prevent undesired disclosure of the fact that you are manufacturing
or importing this substance for a commercial purpose?

(G) To what extent has the fact that you are manufacturing or importing this chemical substance for a
commercial purpose been disclosed to others? What precautions have you taken in regard to these
disclosures? Has this information been disclosed to the public or to competitors?

v/ ¦ n

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
190

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CDX?

Exhibit 6-10 shows a screen capture of the 'CBI Substantiation Part 2' screen (Scroll 2):
Exhibit 6-10: CBI Substantiation Part 2 Screen (Scroll 2)

¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Notice of Commencement

Primary Agent/Consultant

NOC-20141208-11:02:21 EST

j PITS

General Form Information

Tec hnic al Contact Information

j""| Chemical Information

r-Qsite Information

	.CBI Substantiation

"QcBI Substantiation Part 1

CBI Substantiation Part
2

-0CBI Substantiation Part 3
Optional Cover Letter

(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?

| Next |







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9

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CDX Homepage

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8?

J8) 890-1995

Navigation: Click the 'Next' button to navigate to the 'CBI Substantiation Part 3' screen. You
can also access this screen by clicking the 'CBI Substantiation Part 3' link within the navigation
tree.

6.1.7 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:

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
191

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CDXr

•	(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 3.8 for additional details regarding the attach document functionality.

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

•	Description: Displays the description associated with a document.

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

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

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

•	(L) If the notice includes a health and safety study concerning the new chemical
substance, the submitter must also answer the question in 40 CFR 720.90(b)(2). Persons
must answer this question if a health and safety study was provided at any time in the
new chemical process.: Enter the answer to substantiation question L. This is a required
field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
192

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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)

A. Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

4 Notice of Commencement (NOC-20141208-11:02:21 EST)> CBI Substantiation Part 3

CBI SUBSTANTIATION PART 3

Substantiate confidentiality of claims if you mark the substance identity (Part V) as CBI by answering the
following questions. Please enter N/A if the question does not apply.

(I) If the chemical substance leaves the site of manufacture in a product that is available to either the
public or your competitors, can they identify the substance by analyzing the product?

Notice of Commencement

Primary Agent/Consultant

NOC-20141208-11:02:21 EST

r@ General Form Information

rf= Technical Contact Information

"[^Chemical Information

fll Site Information

" CBI Substantiation

!""[=! CBI Substantiation Part 1

rfpCSt Substantiation Part 2

""[2jCBI Substantiation Part
3

Optional Cover Letter

(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.

•y mn

Validate	Save	Preview

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 Agent/Consultant

December 19, 2014
193

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CDX?

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 Agent'Consuttant

NOC-20141208-11:02:21 EST

General Form Information

f'"[^ Technical Contact Information

|-f=lChemical Information

jHlsite Information

S I	CBI Substantiation

j-p|CBI Substantiation Part 1

r"KlCBI Substantiation Part 2

0CBI Substantiation Part
3

"f^l Optional Cover Letter

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

(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

^ex^







«/ ¦

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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 from the 'Site Information' screen if a chemical was not
claimed CBI, or the 'CBI Substantiation Part 3' screen to navigate to the 'Optional Cover Letter'
screen. You can also access this screen by clicking the 'Optional Cover Letter' link within the
navigation tree.

6.1.8 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 instmctions

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
194

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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)

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Notice of Commencement

Primary Agent'Consultant

NOC-20141208-11:02:21 EST

!™f=)General Form Information

i|Tec hn'rc al Contac 11 nformation
|al ~l C hemic al I nformation
f"l "jSrte Information
$1_JCBI Substantiation

'QCBI Substantiation Part 1
5)CBI Substantiation Part 2
ji]CBI Substantiation Part 3
"[^Optional Cover Letter

4 Notice of Commencement (NOC-20141208-11:02:21 EST) > 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: U

Previous





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CDX Homepage

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CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Validate' icon ( ) located in the bottom action bar to validate the form.
Click the 'Save' icon ( B) located in the bottom action bar to save the overall form. Click the
'Preview' icon ( ) to generate a PDF preview of the form.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 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,' '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 and click the 'Start New Form'
button. Refer to Section 3.3 for additional details regarding the 'Section 5 Notices and Supports
Forms' screen.

Refer to Section 3.4 for additional details regarding the 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. In addition, the calendar widget next
to the 'Original Submission Date' text field will be misaligned.

•	Form Alias: Enter the form alias. Upon navigating to the screen, the system auto-generates
an editable form alias comprised of .
This is a required field.

•	Case Number: Enter the case number that connects to the original submission in the system.
This is a type-ahead field that displays the forms that have been submitted under the same
organization. If the case number is in the application, the remaining fields on the 'General
Form Information' screen will populate. The 'Original Submitter Information' screen will
also populate for forms created within the thin client. In the case of legacy submissions, case
numbers must be manually entered. The case number must be in one of the following
formats: P-XX-XXXX for PMN, SN-XX-XXXX for SNUN, L-XX-XXXX for LVE, LM-
XX-XXXX for LVE Modifications, X-XX-XXXX for LOREX, XM-XX-XXXX for LOREX
Modifications, T-XX-XXXX for TMEA, I-XX-XXXX for Mock PMN, J-XX-XXXX for
MCAN, R-XX-XXXX for TERA, G-XX-XXXX for Tier-I, H-XX-XXXX for Tier-II, or BF-
XX-XXXX for Bona Fide. This field does not accept -0000 as a case number suffix. This is a
required field.

•	TS Number: Enter the TS number; this field accepts any six (6) character alphanumeric
combination. This value is determined by the company in order to identify the form for both
payments and connecting related submissions (Letters of Support, Joint Submissions and
corrections). 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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•	Type of Support: Select the type of support from the drop-down menu. This field contains
the following values: 'Amendment,' 'Suspension Request,' 'Test Data,' 'Transfer of
Ownership,' 'Withdrawal Request,' and 'Other Correspondence.' The 'Amendment' type is
unavailable when creating an amendment. This is a required field.

•	Check if requested by EPA/Contractor: Check the 'Check if requested by
EPA/Contractor' checkbox to display fields to enter information to identify the requestor that
asked you to submit support information.

•	Last Name: Enter the requestor's last name. This field displays if the 'Check if requested by
EPA/Contractor' checkbox is checked and is required if displayed.

•	First Name: Enter the requestor's first name. This field displays if the 'Check if requested
by EPA/Contractor' checkbox is checked and is required if displayed.

•	EPA/Contractor: Select a value from the drop-down menu to identify whether the requestor
is an EPA official, a contractor, or unknown. This drop-down menu contains the following
options: 'EPA,' 'Contractor,' and 'Unknown.'

•	Actions: Click the 'Save' icon (H) to save an individual EPA/contractor entry. Click the
'Form' icon (El) to edit an individual EPA/contractor entry. Click the 'Delete' icon (¦¦-*) to
delete an individual EPA/contractor entry. Click the 'Add' icon ( ) to add another entry to
enter EPA/contractor information.

•	CBI: Check the 'CBF checkbox to claim the support description or explanation of support as
confidential.

•	Description or Explanation of Support: Enter the support description or explanation of
support. Either the 'Description or Explanation of Support' field is required, or an attached
document is required.

•	Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window and attach documents describing the Support form. Attachments that are
uploaded include individual toxicity studies, GPC data, spectra, exposure monitoring
evaluations, physical and chemical properties data, SAR modeling, test samples
characterization data, explanatory comments, etc. Analytical tests should be provided with
their complete data set. For example, provide a GPC test report with time interval data and all
graphs. For ease of review, group attachments by type of data, e.g., physical/chemical
properties, fate information. Refer to Section 3.8 for additional details regarding the attach
document functionality.

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

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

•	Subtype: Displays the subtype of a document.

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 7-1 shows a screen capture of the 'General Form Information' screen (Scroll 1) for a
Support form:

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

A



* Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Support

Primary Agent'Consultant

Support-20141208-11:01:43 EST

General Form Information

Original Submitter Information

< Support (Support-20141208-11:01:43 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-20141208-11 :Q1:43 EST

I. Original Notice Submission Information

Case Number:

TS Number:

L

IV. Type of Support

i	nn

Check if requested by EPA/Contractor: ®
Last Name	First Name

EPA/Contractor

1 I

Actions

a,<4

V. Description or Explanation of Support

CBI:

V B = G

Validate	Save	Preview	Submit

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
198

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CDX-r

Exhibit 7-2 shows a screen capture of the 'General Form Information' screen (Scroll 2):
Exhibit 7-2: General Form Information Screen (Scroll 2)





Logged in as Jane Doe, Primary Agent/Consultant



J Forms T Resources

Log Out

Support

Primary Agent'Consurtant

Support-20141208-11:01:43 EST
|l l = iGeneral Form Information

•'""[§]Original Submitter Information

t-orm Alias:

I. Original Notice Submission Information

Case Number:

TS Number:

IV. Type of Support

1 -

Check if requested by EP/VContractor:
Last Name	First Name

EPA/Contractor

Actions

0X+

V. Description or Explanation of Support

CBI:

Attach Document



File Name Description

Subtype

Pages

CBI

Actions





jjlex^









Validate

e

Save

Preview

Submit



CDX Homepage

I MyCDX Homepage | EPA Homepage [ Terms and Conditions

I Privacy Notice

| CDX Helpdesk: (8*

38) 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 form for whom you are
filing the Support form.

• 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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•	Check here to claim this information as CBI: Check the 'Check here to claim this
information as CBI' checkbox to claim the 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
Primary Agent/Consultant

December 19, 2014
200

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CDY-

Exhibit 7-3 shows a screen capture of the 'Original Submitter Information' screen:
Exhibit 7-3: Original Submitter Information Screen

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Support

Primary Agent'Consultant

Support-20141208-11:01:43 EST

f"l£lGeneral Form Information

'"¦"5 Original Submitter
Information

4 Support (Support-20141208-11:01:43 EST)> 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

Check here to claim this information as CBI:



First Name:

Last Name:
Position:

Company Name:
Phone Number:

Phone Extension:
Email Address:
Mailing Address 1:

Mailing Address 2:

City:

State:

Postal Code:
Country:

:

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

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

Apartment, suite, etc.

United States





-/ B

Validate Save

Preview

Submit



CDX Homepage

| MyCDX Homepage

I EPA Homepage | Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (8f

38) 890-1995

Navigation: Click the 'Validate' icon ( ) 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 ( ) to generate a PDF preview of the form. Click the 'Submit' icon ( ) 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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December 19, 2014
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CDXr

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,
select 'Bona Fide' from the 'Form Type' drop-down menu and click the 'Start New Form'
button. Refer to Section 3.3 for additional details regarding the 'Section 5 Notices and Supports
Forms' screen.

Refer to Section 3.4 for additional details regarding the 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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December 19, 2014
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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)

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Bona Fide

Primary Agent/Consultant

Bona Ficle-20141208-11:03:12
EST

General Document
Information

Primary Contact Information

"{^Technical Contact Information

"!_ Statement of Intent

B' i Letter of Support

"(5] Letter of Support
Submitter Information

| "'"[^1 Letter of Support

Submission Information

V"I— Chemical

Chemical Identification
Information

& Chemical 7581

jj Class 1 or
2/Biotechnology
Chemical
Substances

[?JClass

2/Biotechnology
Substances

QlJse Information

B-|_ Site Information

Submitter Site
Identification

["[ilDocument Management

"[2 Optional Cover Letter

4 Bona Fide (Bona Fide-20141208-11:03:12 EST)> General Document information

GENERAL DOCUMENT INFORMATION

The form alias is a required field that allows the user to give the Bona Fide a name to be displayed in the
'Alias' field on the Section 5 Notices and Supports Forms screen. Its purpose is to make it easier for you
to distinguish between multiple forms. If an alias is not selected, the field will default to the date and time
the Bona Fide was created. The form alias may be changed at any time.



Form Alias:

Fide-20141208-11:03:12 EST

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: bfi

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
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





va

Validate Save

Preview





CDX Homepage

| MyCDX Homepage

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8t

38) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
203

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CDX?

Exhibit 8-2 shows a screen capture of the 'General Document Information' screen (Scroll 2):
Exhibit 8-2: General Document Information Screen (Scroll 2)

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

|f(i General Document
Information

1primary Contact Information

j"KTechnical Contact Information

r"h Statement of Intent

B 'l Letter of Support

"2) Letter of Support
Submitter Information

"[f; | Letter of Support
Submission Information

91_ Chemical

r"l2 Chemic al Identify ation
S j Information

i B ^Chemical 7581

j f"|2 (Class 1 or

2j'Biotec hnology
Chemical
i j Substances

2/Biotechnology
Substances

Information

5"[_Site Information

Submitter Site
l
-------
CDXr

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
Primary Agent/Consultant

December 19, 2014
205

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CDX?

Exhibit 8-3 shows a screen capture of the ' Primary Contact Information' screen (Scroll 1):
Exhibit 8-3: Primary Contact Information Screen (Scroll 1)

T

¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

r[§ General Document Information

j""|j Primary Contact Information

H '^Technical Contact Information

j""|j Statement of Intent

B |_ Letter of Support

j ~£: Letter of Support
Submitter Information

~ Letter of Support

Submission Information

m"[_. Chemical

j j--p j Chemic al Identific ation
Information

S & Chemical 7581

rj ^jCtass 1 or

2/Biotec hnology

Chemical

Substances

| 2/Biotec hnology
Substances

	l^'Use Information

l"R I Site Information

:—[f submitter Site
Identification

Doc ument Management

"¦^(Optional Cover Letter

< Bona Fide (Bona Fide-20141208-11:03:12 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:

[Miss

Jane

Doe

TEST GROUP

7032274019

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

Jane.Doe@test.com

12601 FAIR LAKES CIRCLE

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

Apartment, suite, etc.





Validate

9

Save

Preview





CDX Homepage

| MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (8?

J8) 890-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
206

-------
CDX?

Exhibit 8-4 shows a screen capture of the 'Primary Contact Information' screen (Scroll 2):
Exhibit 8-4: Primary Contact Information Screen (Scroll 2)

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

General Document Information

'[p] Primary Contact Information

j""pijTeci>nical Contact Information

Statement of Intent

El'1	I Letter of Support

Letter of Support
Submitter Information

pin [Letter of Support

Submission Information

lfl"i	Chemical

i""QChemical Identification
Information

j Chemical 7581

| ""[5 Class 1 or

2/Biotec hnobgy

Chemical

Substances

2/Biotec hnology
Substances

!""|W|Use Information

Ep"i_ Site Information

:""fS| Submitter Site
Identification

j""0Doc ument Management

I nr\

Optional Cover Letter

Home y Forms ~ Resources

¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

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:

Doe

TEST GROUP

17032274013	|

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

:

Jane.Doe@test.com
12601 FAIR LAKES CIRCLE

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

Apartment, suite, etc.

FAIRFAX

[Virginia

22033

United States



Previous







-------
CDXr

The technical contact is a subject matter expert (SME) who is capable of answering questions
related to the chemical submitted to EPA within the Bona Fide form. The technical contact does
not have to work at the port or site reported on the form but must possess sufficient knowledge to
answer EPA's questions pertaining to the chemical reported in the form.

The text fields on the 'Technical Contact Information' screen will be blank upon accessing the
screen. To add information, you will enter data into the blank text boxes for the listed text fields.
If you checked the 'I claim the entirety of the submission as CBI' checkbox on the 'General
Document Information' screen, all entered technical contact information will be flagged as CBI.

Please note that if you are using IE 7, there will be a spacing issue between the 'Suffix' drop-
down menu and the 'Title' text field.

•	Prefix: Select the technical contact's prefix from the drop-down menu.

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

•	Middle Initial: Enter the technical contact's middle initial.

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

•	Suffix: Select the technical contact's suffix from the drop-down menu.

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

•	Company Name: Enter the technical contact's company name.

•	Phone Number: Enter the technical contact's daytime U.S. phone number; dashes are
not allowed. This is a required field.

•	Phone Extension: Enter the technical contact's phone number extension.

•	Email Address: Enter the technical contact's email address. The email address must
follow the standard email address format: John.Doe@ABC.com. This is a required field.

•	Mailing Address 1: Enter the first line of the technical contact's mailing address.

•	Mailing Address 2: Enter the second line of the technical contact's mailing address.

•	City: Enter the city of the technical contact's mailing address.

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

•	Postal Code: Enter the postal code of the technical contact's mailing address.

•	Country: Displays 'United States.'

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
208

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CDX?

Exhibit 8-5 shows a screen capture of the 'Technical Contact Information' screen (Scroll 1):
Exhibit 8-5: Technical Contact Information Screen (Bona Fide) (Scroll 1)

A. Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

|tl General Document Information

r"(§ Primary Contact Information

r(5Technical Contact
Information

restatement of Intent

B"L Letter of Support

j -1 Letter of Support
Submitter Information

Letter of Support
Submission Information

5 	Chemical

!'*"[§ Chemical Identification
Information

| B & Chemical 7581

f|Class 1 or
2/Biotec hnology
Chemical
Substances

Class

2/Biotec hnology
Substances

J Use Information

0 Site Information

Submitter Site
l Technical Contact Information

TECHNICAL CONTACT INFORMATION

Please enter the information for the technical contact who wilt be responsible for providing additional
information if 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:



Do rvot enter any dashes (-) in Phone Number field above.)

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

Apartment, suite, etc.





^ B

Validate Save

Preview



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 Agent/Consultant

December 19, 2014
209

-------
CDX?

Exhibit 8-6 shows a screen capture of the 'Technical Contact Information' screen (Scroll 2):
Exhibit 8-6: Technical Contact Information Screen (Bona Fide) (Scroll 2)

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

General Document Information

j""[=) Primary Contact Information

j ^[Technical Contact
Information

Statement of Intent

^'!_lLetter of Support

"Q Letter of Support
Submitter Information

Letter of Support
Submission Information

0 Chemical

j""K|C hemic al loentific atbn
Information

B" A Chemical 7581

"Qciass 1 or
2/Biotec hnology
Chemical
Substances

=|ijcisss

2/Biotec hnology
Substances

Use Information

I	l Site Information

:'"l j; I Submitter Site
Identification

Document Management

'^Optional Cover Letter

Home J Forms
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:

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

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

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

Apartment, suite, etc.

n

United States

j^Jexlj





>/

Validate

a

Save

Preview



CDX Homepage |

| MyCDX Homepage

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button to navigate to the '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.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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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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December 19, 2014
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Exhibit 8-7 shows a screen capture of the ' Statement of Intent' screen:

Exhibit 8-7: Statement of Intent Screen



Logged in as Jane Doe, Primary Agent/Consultant

Bona Fide

Primary AgenttConsultant

< Bona Fide (Bona Fide-20141208-11:03:12 EST)> Statement of Intent ^

Bona Fide-20141208-11:03:12
EST

STATEMENT OF INTENT

j"|~!General Document Information

*



'p=] Primary Contact Information





["[^Technical Contact Information



Please setect whether you intend to manufacture and/or import the chemical.

H3 Statement of Intent







9 [__] Letter of Support





Manufacture:

i'"{Wl Letter of Support





Import: ~

Submitter Information



Date of expected Section 5 notification if the result is that the chemical is not on the inventory.

! ""0 Letter of Support





r i

Submission Information





EH [Chemical

i""Q C hemic al Icfentific ation



Previous j Next j

Information







| &&Chemical 7S81







Hip Class 1 or







2/Biotechnology







Chemical







Substances







H^HlScisss







2/Biotechnology







Substances







!-fp|Use Information







B"i	. Site Information







:"ff Submitter Site







Identification







f" Document Management

~





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CDXr

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
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December 19, 2014
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Exhibit 8-8 shows a screen capture of the 'Letter of Support Submitter Information' screen:
Exhibit 8-8: Letter of Support Submitter Information Screen

Logged in as. Jane Doe. Primary Agent/Consultant

Log Out

Bona Fide

Primary Agent/Consuttant

""[^General Document Information

HjM Primary Contact Information

^Technical Contact Information

" j^lStatement of Intent

?"L Letter of Support

Letter of Support
; Submitter Information!

[^ Letter of Support
Submission Information

1=1 Chemical

Chemical Identification
Information

$ & Chemical 11902

l-hPolymer
Identification
Information

j""|^ I Monomers and
] Other Reactants

:""QlJse Information

l5i_jSrte Information

I Submitter Site
Identification

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•¦¦¦ [% Optional Cover Letter

4 Bona Fide (Bona Fide-20130809-11:00:20 EDT) > 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.



Prefix:

First Name:

Middle Initial:

Last Name:

Suffix:

Title:

Company Name:
Phone Number:

Email Address:
Mailing Address 1:

Mailing Address 2:

City:

State:

Postal Code:
Country:

(Do not enter any dashes (-). To enter an extension, enter
the phone number and an X, followed by the extension.)

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

Apartment, suite, etc.

J

[United States^

j Next j





-------
CDXr

Submissions' box will also display on this screen. The unique identification number is generated
when you declare a Letter of Support submission is being established.

Letter of Support Submission Process: When you designate that a Letter of Support
submission is being filed, you will be asked to enter all the information within the 'Letter of
Support Submission' folder. The forms from the primary submitter will be linked, but not
combined by the system.

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

When the Letter of Support submitter accesses the 'Section 5 Notices and Supports Forms'
screen and creates a form to be filed, the user will be prompted to enter the unique identification
number on the 'Create Passphrase' screen. Once the unique identification number has been
entered, the system will link the primary and Letter of Support forms. You may add additional
Letters of Supports by clicking the 'Add Letter of Support' link within the navigation tree.

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

•	Letter of Support Submission Informational Text: Displays instructional text provided by
OPPT, the unique identifier number generated for the form, and allows you to email the
unique 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
submission.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 2014
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Exhibit 8-9 shows a screen capture of the 'Letter of Support Submission Information' screen:
Exhibit 8-9: Letter of Support Submission Information Screen

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

!""(¥'|General Document Information

]""[§ Primary Contact Information

HWfcechnical Contact Information

Statement of Intent

5"ClJLetter of Support

"{§ Letter of Support
Submitter Information

L Letter of Support

Submission Information

Chemical

'"[3!Chemical Identification
Information

B & Chemical 75B1

fU Class 1 or

2/Biotechnobgy
Chemical
Substances

h@ Class

2/Biotechnology
Substances

"i=lUse Information

B 'l	Site Information

I "'P Submitter Site
Identify ation

"[^'Document Management

:""F Optional Cover Letter

< Bona Fide (Bona Fide-20141208-11:03:12 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: 4856fb50-12b4-437d-98ba-
8ff7823b5ed9

This is the unique identification number for your joint submitter. Notify1 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.

>/

B

¦

Validate

Save

Preview

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

Navigation: Click the 'Notify the Secondary Submitter of the letter of support submission' link
to access the 'Unique Identifier Notification' pop-up window. Click the 'Next' button to navigate
to the 'Chemical Identification Information' screen. You can also access the 'Chemical
Identification' screen by clicking the 'Chemical Identification' link within the navigation tree.

8.1.7 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
SLibmission Information' screen.

The 'Unique Identifier Notification' window is used to notify the Secondary Submitter of the
'Unique Identifier Number.' The 'Unique Identifier Notification' screen displays a 'CC' field for
you to add other email addresses to the notification (including the original submitter), a 'To'
field, and an 'Additional Comments' text box.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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•	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
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December 19, 2014
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Exhibit 8-10 shows a screen capture of the 'Unique Identifier Notification' pop-up window:
Exhibit 8-10: Unique Identifier Notification Pop-Up Window



From:
CC:

To:

Subject:
Message:

Additional Comments:

Jane.Doe@test.com

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

/,

2015 Bona Fide

As the Authorized Official of TEST GROUP. I have identified you as a
Secondary Submitter of a letter of support submission for this 2015 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 4856fb50-12b4-437d-98ba-8ff7823boed9

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-aow'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. Click the 'X' icon in the
upper right-hand corner to cancel the unique identifier notification process.

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.

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

Exhibit 8-11 shows a screen capture of the 'Chemical Identification Information' screen:
Exhibit 8-11: Chemical Identification Information Screen

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Bona Fide

Primary AgenL'Consuttant

Bona Fide-20141208-11:03:12
EST

j""2'General Document Information

I" "[^ Primary Contact Information

f'pTechnical Contact Information

;—j=iStatement of Intent

0"[_ Letter of Support

H3„ Letter of Support
Submitter Information

Letter of Support
Submission Information

Chemical

'"[^IChemical Identification
Information

! B Chemical 7581

HI ^ | Class 1 or

2/Biotechnok>gy

Chemical

Substances

(I ipdjeSsw I

2/Biotec hftology
Substances

^K^JIUse Information

3 ;	Site Information

I	Submitter Site

Identify ation

"'5)Dociiment Management

< Bona Fide (Bona Fide-20141208-11:03:12 EST)> Chemical Identification Information

CHEMICAL IDENTIFICATION 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.

Previous

| Next |

>/

B

¦

Validate

Save

Preview

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

Navigation: If you selected the 'Class 1 or 2 Chemical Substance' radio button, click the 'Next'
button to navigate to the 'Class 1 or 2 Chemical Substances' screen. 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
numerous fields to identify the chemical in question. You will be able to enter multiple chemical

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 2014
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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 ( *) 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 ( *) 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
selected chemical by clicking the 'OK' button located at the bottom of the 'Add Chemical ID'
window.

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•	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 (¦ *) located under the 'Actions' column to delete unwanted documents. Click the
file name link under the 'File Name' column to access or edit previously attached documents.

•	Molecular Formula: Enter a molecular formula in a text field using a free text format. This
field is optional.

•	Chemical Structure Diagram: The system allows you to attach a chemical structure diagram.
This field is optional.

•	Attach Chemical Structure: Click the 'Attach Chemical Structure' button within the
'Chemical Identification Information' field set to access the 'Attach Chemical Structure' pop-
up window. You can attach the file(s) and enter a description of the document regarding the
chemical structure.

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

•	Description: Displays the description of the chemical structure.

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

•	Save: Click the button to save the information entered within the expandable/collapsible field
set. You must click this button instead of the 'Save' icon ( ) located within the bottom action
bar to successfully save the entered information within the field set before being able to
navigate away from the screen using the 'Previous' and 'Next' buttons. Refer to Section 3.7
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 Agent/Consultant

December 19, 2014
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CDX?

Exhibit 8-12 shows a screen capture of the 'Class 1 or 2/Biotechnology Chemical Substances'
screen (Scroll 1):

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

* Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

rwU General Document Information

H§ I Primary Contact Information

["{^Technical Contact Information

|H = 1 Statement of Intent

5"i_ Letter of Support

|""0 Letter of Support
i Submitter Information

: Letter of Support

Submission Information

S"L Chemical

"|_ Cbemic si Identific ation
Information

E ^Chemical 75&1

i" Class 1 or

2/Biotechnology
i Chemical
j Substances

pQcbaa

2/Biotec itnology
Substances

'"fiiUse Information

S |	Site Information

'"1 Submitter Site
Identific etion

'[^j Document Management

_ Optional Cover Letter

< Bona Fide (Bona Fide-20141208-11:03:12 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

0

Expand All [ Collapse All

Cancel

Class of Substance:

Class 1 O Class 2/Biotechnology

ClicR the button below to search EPA's Substance Registry Services (SRS) for the desired chemical.
Add Chemical ID

CASRN:

Chemical Name:

ID Method

G 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





>/

Validate

¦

Save

Preview



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 Agent/Consultant

December 19, 2014
223

-------
CDX?

Exhibit 8-13 shows a screen capture of the 'Class 1 or 2/Biotechnology Chemical Substances'
screen (Scroll 2):

Exhibit 8-13: Class 1 or 2/Biotechnology Chemical Substances Screen (Scroll 2)

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

""( General Document Information

p|Primary Contact Information

Q|Technical Contact Information

Statement of Intent

Ep Letter of Support

h"| ^ I Letter of Support
Submitter Information

"I JM Letter of Support

Submission Information

	Chemical

Chemical Identification
Information

Chemical 7581

1 or

2/Biotechnotogy
Chemical
I Substances

2/Biotechnology
Substances

"Quse Information

S"L Site Information

Submitter Site
Identification

Document Management

Optional Cover Letter

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

CASRN:

Chemical Name:

ID Method

G Method 1 (CAS Inventory Expert Service)
Attach IES Report

File Name

Method 2 (Other Method)

Description

Actions

Molecular Formula: (optional) [	I

Chemical Structure Diagram: (optional)

Include an attachment for the chemical structure diagram below.
Attach Chemical Structure

File Name

Description

Actions

Save

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

Add New Chemical

| Next |





>/

Validate

9

Save

Preview



CDX Homepage |

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Privacy Notice |

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.

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 (f )
within the action bar and clicking the 'Class 2/Biotechnology Substances' link within the
navigation tree.

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The 'Class 2/Biotechnology Substances' screen provides fields for you to enter 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 3.9 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 ( *) 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 3.8 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 ( *) 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 8-14 shows a screen capture of the 'Class 2/Biotechnology Substances' screen (Scroll 1):
Exhibit 8-14: Class 2/Biotechnology Substances Screen (Scroll 1)

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

I "piGeneral Document Information

p[§!Primary Contact Information

j—(^Technical Contact Information

Statement of Intent

B"l Letter of Support

Letter of Support
Submitter Information

""'M Letter of Support

Submission Information

S"L Chemical

j ""{jj Cftemic al Identify atbn
Information

I Q &Chemical 7581

rgjdass 1 or

2/Biotechnology

Chemical

Substances

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? Site Information

| !""p Submitter Site
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f"'@)Document Management

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¦ Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

4 Bona Fide (Bona Fide-20141208-11:03:12 EST) > Class 2/Biotechnology Substances

CLASS 2/BIOTECHNOLOGY SUBSTANCES

Class 2/Biotechnology Substance Details

Fill in below for a class 2/biotechnology 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 SR s Click the Search SRS button on the left to search or enter a precursor substance.

Chemical Name

Nature of Reaction

CASRN

Action

Range of Composition (Optional)

-------
CDY-

Exhibit 8-15 shows a screen capture of the 'Class 2/Biotechnology Substances' screen (Scroll 2):
Exhibit 8-15: Class 2/Biotechnology Substances Screen (Scroll 2)

Bona Fide

Primary Agent/Consultant

General Document Information
"[^ Primary Contact Information

Technical Contact Information
Misstatement of Intent
Letter of Support

r j^j Letter of Support
Submitter Information
j Letter of Support
Submission Information

B Chemical

r{§ I Chemical Identification
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i

"K Class 1 or 2
Chemical
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Logged in as Jane Doe. Primary Agent/Consultant

Log Out

Home J Forms T Resources
Fill in below for a class 2 substance. (1) List the immediate precursor substances with their respective CAS
Registry Numbers. (2) Describe the nature of the reaction or process. (3) Indicate the range of
composition and the typical composition (where appropriate).

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)

Optional Attachments

Attach Document

File Name

Description

Actions

Previous







•/ a

Validate Save

Preview



CDX Homepage |

| MyCDX Homepage |

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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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Click the 'Add New Chemical' button to create a chemical substance. Upon clicking the 'Add
New Chemical' button, an expandable/collapsible field set generates that contains numerous
fields that pertain to the particular polymer. The system provides numerous fields for you to
enter multiple chemical substances, each with unique information, by clicking the 'Add New
Chemical' button for each chemical you wish to identify.

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

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

•	Add New Chemical: Click the button to generate the 'Polymer Identification Information'
field set.

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

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

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

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

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

•	Add Chemical ID: Click the 'Add Chemical ID' button within the 'Polymer Identification
Information' field set to generate the 'Add Chemical ID' pop-up window. You can search for
the reported chemical(s) either by the 'CASRN' or 'CA Index Name or Other Synonym.' If
you retrieve zero results, the system provides fields for you to enter the chemical information
by filling in the 'Chemical Name' and the 'Chemical Abstract Services Registry Number'
(CASRN) under the manual entry field set. The system provides functionality for you to enter
the selected chemical by clicking the 'OK' button located at the bottom of the 'Add Chemical
ID' window.

•	Chemical Name: The system provides fields for you to identify the 'Chemical Name' and
the CASRN (if available). The system provides functionality for you to search for the

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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chemical substance using the 'Add Chemical ID' search or manually enter the chemical
information in the 'Add Chemical ID' pop-up.

•	ID Method: The system shall require that you identify which ID method was used to
determine the chemical identity. When you select 'Method 1 (CAS Inventory Expert
Service),' the system generates an 'Attach IES Report' button for you to attach an IES report.
If you select 'Method 1,' you are required to attach an IES report. You can also select
'Method 2 (Other Method).'

•	Attach IES Report: 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 ( ¦*) 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 ( *) 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
3.7 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 ( *) 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 Agent/Consultant

December 19, 2014
229

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Exhibit 8-16 shows a screen capture of the 'Polymer Identification Information' screen:
Exhibit 8-16: Polymer Identification Information Screen



Logged In as: Jane Doe, Primary Agent/Consultant

Log Out

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

General Document Information
pg Primary Contact information

!""0Tecttnical Contact Information

^ r=\

Statement of Intent
S"[	Letter of Support

'"[^Letter of Support

Submitter Infonmation
" "[^'Letter of Support

Submission Information

[3' Chemical

Chemical Identification
Information
:" ! ^Letter of Support

Submission Information

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Chemical Identification
Information

H Chemical 9015

j""| IPoiymer

Identification
Information

Monomers and
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"I Use Information

Site Information

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Identification

'[^Document Management
Optional Cover Letter

4 Bona Fide (Bona Fide-20141208-11:03:12 EST) > Polymer Identification Information

POLYMER IDENTIFICATION INFORMATION

Expand All | Collapse All

Cancel

Click the button below to add a substance to this document.
Add Chemical ID

CASRN:
Chemical Name:

ID Method

<§> Method 1 (CAS Inventory Expert Service)
Attach IES Report

File Name

O Method 2 (Other Method)

Description

Actions

Chemical Structure Diagram (optional):

Include an attachment for the chemical structure diagram below.

Attach Chemical Structure
File Name

Description

Actions

| Save |

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

Previous







s/ 9

Validate Save

Preview



CDX Homepage

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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 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.

The 'Monomers and Other Reactants' screen is used to identify the chemical measurements and
monomers that make up a polymer. The 'Monomers and Other Reactants' screen has an 'Add

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
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CDXr

Monomer' button that allows you to identify the monomer(s) that make up the polymer
composition.

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

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

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

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

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

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

•	Search SRS: Click the 'Search SRS' button to generate the 'Search Substance Registry
Services' pop-up window. Refer to Section 3.9 for additional details regarding the search
SRS functionality.

•	CAS Registry Number: Displays the CASRN for the specified monomer; this field
populates based on information entered on the 'Search Substance Registry Services' pop-up
window. This is a required field.

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

•	Include in Identity: Check the 'Include in Identity' checkbox to claim the value for
'Monomer or Other Reactant' as part of the monomer identification.

•	Typical Composition: Enter the 'Typical Composition' value that a monomer contributes to
a polymer; the value entered must be a positive numerical value greater than zero (0) and less
than or equal to 100 with up to three decimal points. If the value entered is less than or equal
to '2' a warning will be displayed in the global 'Validate' function or during the submission
process indicating that the 'Typical Composition' is a value that is less than or equal to 2%
and asking the user whether it should be included in the 'Chemical Identity.' This is a
required field.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
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3.7 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 3.8 for additional details regarding the attach document
functionality.

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

•	Description: Displays the description associated with a document.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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December 19, 2014
232

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CD*r

Exhibit 8-17 shows a screen capture of the 'Monomers and Other Reactants' screen:
Exhibit 8-17: Monomers and Other Reactants Screen

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out



Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

'[^General Document Information

"[^ Primary Contact Information

[^Technical Contact Information

"'(] Statement of Intent

Letter of Support

"(f= I Letter of Support
Submitter Information

Letter of Support
Submission Information

I"Lj Chemical

i~ Chemic al Identific ation
Information

B & Chemical 9015

Polymer

Identification

Information

!""[ Monomers and
Other Reactants

j:""F"lUse Information

Site Information

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Identification

Doc ument Management

HP [Optional Cover Letter

4 Bona Fide (Bona Fide-20141208-11:03:12 EST) > Monomers and Other Reactants

MONOMERS AND OTHER REACTANTS

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

Expand All | Collapse All

#

Cancel

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

Search SRS

CAS Registry Number:

Monomer or other reactant:

Include in Identity:

Typical Composition:	%

Save

Click to add a monomer Add Monomer

Composition Total:0%

Optional Attachments

Attach Document

File Name

Description
Previous

Actions

>/

Validate

Save

Preview

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

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

8.1.13 Use Information

You can navigate to the 'Use Information' screen by clicking the 'Next' button from the 'Class 1
or 2/Biotechnology 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	December 19, 2014

Primary Agent/Consultant	233

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CDY-

How will the substance be used?: Enter the data regarding how the chemical substance
is intended to he used. This is a required field.

Exhibit 8-18 shows a screen capture of the 'Use Information' screen:

Exhibit 8-18: Use Information Screen

T

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

Bona Fide

Primary Agent/Consultant

j'""QjGeneral Document Information

r{§] Primary Contact Information

!" ©Technical Contact Information

Statement of Intent

B Letter of Support

-j= Letter of Support
Submitter Information

•j JJ Letter of Support
Submission Information

B L Chemical

!Chemical Identification
Information

C he m ica 146&08

|""[J Polymer
Identification
Information

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' ©IUse Information

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submitter Site
Identification

J Document Management
H^IOptional Cover Letter

4 Bona Fide (Bona Fide-20130809-11:00:20 EDT) > Use Information

USE INFORMATION

How will the substance be used?







v m

Validate Save

Preview





CDX Homepage |

I MyCDX Homepage |

I EPA Homepage | Terms and Conditions |

Privacy Notice |

CDXHelpdesk: (8*

*8)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. A screen captures specific data for the site of
manufacture and/or port of entry by allowing you to identify sites based on sites with which you
are registered. The system requires you to select from the 'Site of Manufacture or Import' drop-

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

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 3.10 for additional details regarding the add site functionality.

•	EPA Registry ID: Displays the EPA Registry ID of the site and/or port.

•	Site of Manufacture or Port of Entry: Displays the site of manufacture or port of entry
depending on the checkbox (es) the user checks on the 'Statement of Intent' screen. This is a
required field if the checkboxes were checked.

•	Site Name: Displays the site name of the site or port. This is a required field.

•	Address: Displays the address of the site or port. This is a required field.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
Primary Agent/Consultant

December 19, 2014
235

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CDY-

Exhibit 8-19 shows a screen capture of the 'Submitter Site Identification' screen:
Exhibit 8-19: Submitter Site Identification Screen

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

j General Document Information

- jPrimary Contact Information

""^Technical Contact Information

"[^'Statement of Intent

H i iLetter of Support

^Letter of Support
Submitter Information

Letter of Support
Submission Information

@"l	i Chemical

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Chemical 9019

[5] Class 1 or
2/Biotechnology
Chemical
Substances

1^1 Use Information

=l"l_JSite Information

| !~p|Submitter Site
Identification

hh I Document Management

¦"2 Optional Cover Letter

4 Bona Fide (Bona Fide-20141208-11:03:12 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











V 9

Validate Save

Preview



CDX Homepage

MyCDX Homepage

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Next' button to navigate to the '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 19, 2014
236

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CDX-r

•	Attach Document: Click the 'Attach Document' button to generate the 'Attach Documents'
pop-up window to upload documents. Refer to Section 3.8 for additional details regarding
the attach document functionality.

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

•	Document Type: Displays the document type associated with the uploaded document.

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

Exhibit 8-20 shows a screen capture of the 'Document Management' screen:

Exhibit 8-20: Document Management Screen



T

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

Bona Fide

Primary Agent/Consultant

Bona Fide-20141208-11:03:12
EST

[""[^jGeneral Document Information
["'{^Primary Contact Information
f-gTechnical Contact Information
i""F Statement of Intent

?"L Letter of Support

|j pry

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Hp)Letter of Support

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9 "l_ Chemical

j Q|,ernjc a| icfentjfic ation
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Identification

"j_2 Document Management

O ptional C over Letter

4 Bona Fide (Bona Fide-20141208-11:03:12 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

Action

| Next |



B

¦

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Save

Preview

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

Navigation: Click the 'Next' button to navigate to the '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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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.

Exhibit 8-21 shows a screen capture of the 'Optional Cover Letter' screen:

Exhibit 8-21: Optional Cover Letter Screen

El-

Chemical

Chemical Identification
Information

E3 Chemical 9019

i""! jClass 1 or

2/Biotechnology
Chemical
Substances

:"'Quse Information

y "LjSite Information

| :"j = Submitter Site
Identification

j-WDocument Management

"' "Q Optional Cover Letter

Logged in as: Jane Doe, Primary Agent/Consuttant

Log Out

Bona Fide

Primary Agent/Consuttant

Bona Fide-20141208-11:03:12
EST

1General Document Information

UlPrimary Contact Information

'2 Tec hnic al Contact Information

¦Q Statement of Intent

Ep"i_ Letter of Support

' l=l Letter of Support
Submitter Information

"[j | Letter of Support
Submission Information

4 Bona Fide (Bona Fide-20141208-11:03:12 EST) > Optional Cover Letter

OPTIONAL COVER LETTER

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





>/

Validate

B

Save

Preview



CDX Homepage |

| MyCDX Homepage

| EPA Homepage | Terms and Conditions |

Privacy Notice |

CDX Helpdesk: (888) 890-1995

Navigation: Click the 'Validate' icon < > located in the bottom action bar to validate the form.
Click the 'Save' icon (E ) located in the bottom action bar to save the overall form. Click the
'Preview' icon (IP) to generate a PDF preview of the form.

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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 3.3 for additional details regarding the 'Section 5 Notices and Supports Forms' screen.

Refer to Section 3.4 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 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 ( *) to delete a contact from the table. A warning message
displays to confirm deletion of the contact.

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Exhibit 9-1 shows a screen capture of the 'Contact Information' screen:

Exhibit 9-1: Contact Information Screen



ACM

Primary Agent/Consultant
ACM-20141208-11:10:20 EST

i""gjContact |nforma(jon

""[^Attachments

Home y Forms J Resources
« ACM (ACM-20141208-11:10:20 EST) > Contact Information

A Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

CONTACT INFORMATION

You may enter an alias for easier form identification or the system will provide a time stamp.
Form Alias:	1ACM-20141208-11:10:20 EST |



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

Last Name	First Name	Address	CBI	Actions





>/ B

Validate Save

Preview

m

Submit



CDX Homepage |

| MyCDX Homepage |

| EPA Homepage | Terms and Conditions

| Privacy Notice

| CDX Helpdesk: (8J

38)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

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

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Exhibit 9-2 shows a screen capture of the 'Add Contact' pop-up window:

Exhibit 9-2: Add Contact Pop-Up Window

o

£ 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:

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.

i	i =

i i

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.

The 'Attachments' screen provides an 'Attach Document' button for you to upload
documentation that fulfills the specified requirements, and a text field to provide the 40 CFR 721
citation to which the documentation refers.

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•	Attach Document: Click the 'Attach Document' button to attach documents that fulfill the
outlined requirements in the instructional text. At least one document is required. Refer to
Section 3.8 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) numerical characters; letters or other
characters are not allowed. This is a required field.

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

Exhibit 9-3: Attachments Screen

ACM

Primary AgenfConsultant
ACM-20141208-11:10:20 EST

'"[^Contact Information
j Attachments

Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

< ACM(ACM-20U1208-11:10:20 EST) > 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 CFR 721: |	|

Previous



B



m

Validate

Save

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Submit

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

Navigation: Click the 'Validate' icon (* ) 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 initiate the submission process.

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10 Preview

The system provides the option to preview a form at any point during the submission process.
Click the 'Preview' icon ( ), located within the bottom action bar, to see a PDF version of the
form. A screen will display for you to view either the 'Full' or the 'Sanitized' version of the PDF
differentiated by buttons. After you choose either the 'Full' or 'Sanitized' PDF, the application
generates a draft, watermarked PDF version of the form.

Please note in IE 7, the 'Preview EPMN FORM' screen text might be misaligned.

The watermark reads 'Not for Submission' and displays across each page in the background. The
form preview displays the entire form in a printable format. The preview functionality provides
the flexibility to track the status of the form and see the entire form in a single viewpoint.

Exhibit 10-1 shows a screen capture for the 'Preview' of the Biotechnology form:
Exhibit 10-1: Preview Biotechnology Form Screen

Biotechnology

Primary Agent/Consultant

Biotech nology-
20130808-15:00:20 EDT

"'[^General Form Information

B-,	Joint Submission

| S i|f Joint Submission 1

•"2)Joint Submitter
Information

•Qjoint Submission
Information

X Remove

^Add Joint Submission

Letter Of Support

S'ljjULetter of Support 1

""PiLetter of Support
Submitter
Information

'"[=1 Letter of Support
Submission
Information

XRemove

%|Add Letter Of Support
| ^Technical Contact Information
Optional Cover Letter

y Forms y Resources

* Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

PREVIEW EPMN FORM

Please choose a Regular or Sanitized PDF.



>/

H

m

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Save

Preview

CDXHomepage | MyCDXHomepage | EPAHomepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (383) 390-1995

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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Exhibit 10-2 shows a screen capture for the 'Preview' of the Biotechnology form:

Exhibit 10-2: Preview Biotechnology Form PDF

CBI SUBMISSION

BO2014P1

Form Approved. O.M.B. Nos. 2070-0012 and 207(MJ03S

EPA Biotecli Form

Biotech Form Report Number

Mark (X) if anything is CBI [

I. SUBMITTER IDENTIFICATION INFORMATION

CBI ~

Fust Name

Last Name

Position

Company

Mailing Address
(Number & Street)

City

State

Postal Code

M

e-mail

Telephone
(include area code)

La. JOINT SUBMITTER — If you are submitting this notice as part of a joint submission, mark (X) _

CBI ~

First Name

Last Name

—

=

Position

Company

Co

Mailing Address
(Number & Street)

City

State

Postal C ode

e-mail

Tel

lone

¦ area code)

II. TECHNICAL CONTACT IDENTIFICATION INFORMATION

3

CBI ~

First Name

Position

Mailing Address
(Number & Street)

City

e-mail

ZZ

Last Name

.ompany

tate

Postal Code

Telephone
(include area code)

III. TYPE OF SUBMISSION (Check One)

MCAN (Microbial Commercial Activity Notice)
TERA (TSCA Experimental Release Application)
Tier I Exemption
I I Tier II Exemption
] Biotech TME (Test Market Exemption)

IV. TEXT / COMMENTS

CBI ~

EPA Form Number 6300-17 (6-09)

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Exhibit 10-3 shows a screen capture for the 'Preview' of the NOC form:

Exhibit 10-3: Preview NOC Form PDF









MOC2014P1

Form Approved. O.M.B. No. 2070-0012

CBI SUBMISSION

{(S)

U.S. Environmental Protection Agency
CD A NOTICE OF COMMENCEMENT OF
trA MANUFACTURE OR IMPORT i«craSm

Report Number



Part I - SUBMITTER IDENTIFICATION D^ntc™,™*



Manu-
facturer/
Importer

(in U.S.)

Name of Authorized Official

Mailing Address (number and street)

CBI*

(first) (last)



Company Name

City

State

Zip











Technical
Contact

(in U.S.)

Name

Telephone Number



(first) (last)

A

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:

to

"Date of commencement Is the dace cf completion of non-eotempS manufacture of She first amount (bath, tfrum, etc.)
'"For Importees, the date of commencement is the dale thai the new chemical sufcs*.ance clears U.S. customs.

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





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

identity of each chemical substance.)

/YV



Part VI - Generic Chemical Name (if rftwrtai c entity is ciaimec car):



Part VII - Substance Identity Confidentiality Status:



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



1 previously claimed the substance identity as confidential and hereby relinqtish that claim.



1 did not clavn the substance identity as confidential in my original PMN submission.

The public reporting and recordkeeping burden for this collection of inhumation is estimated fa 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 Dhnsionr U.S. Environments Protection
Agency (2S22T)r 1200 Pennsylvania Ave., NW. Washington, D.C. 2046Q. Include the OMB control number in any ccrresponcence. Do not send the
completed EPA Form 7710-56 to ihis address.

You must submit your completed notice no later than 3D calendar days after the first date of commercial manufacture/importation to the address
shown below:	U.S. Environmental Protection Agency

OPPT Document Control Office (7407M)

1200 Pennsylvania Ave.. NW
Washington, D.C. 20400
ATTN: Notice of Commencement

Signature of authorized official



Date



Nate: CBI" - icten to 1?ie term 'Canflcwdnl Business InTannnUar'. Ma* (X) h ITe to* irthe Hormsdon ti to M t»dd CanflcerOnl

EPA Form 7710-56 (6-09)

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Exhibit 10-4 shows a screen capture for the 'Preview' of the Support form:

Exhibit 10-4: Preview Support Form PDF













SUP2014P1

NON-CBI SUBMISSION

Form Approved. O.M.B. 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

II. ORIGINAL NOTICE SUBMITTER IDENTIFICATION

CBI ~

Authorized Official
Name

Position

Mailing Address
(Number & Street)

(first)

(last)

Company Nam<

Co

5=

City

State

istal

Code

e-mail

elude area code)

m. CURRENT SUPPORT DOCUMENT IDENTIFICATION INFORMATION

CBI

~

Name

(first)



v

(last)

Position

Company Name

Mailing Address
(Number & Street)

City



State

Postal Code

Province

Country

e-mail

_

Telephone
(include area code)

IV TYPE OF SUPPORT (Check One)

Transfer of Ownership

~

~

Suspension Request

Withdrawal Request

~

Other Correspondence

~

TEST DATA (Health/Eco/Fate)

~

Amendment (Changes made to PMN pages 1-13, MSDS or Physical-Chemical

Check if requested by EPA'' contractor

~

EPA person/contractor

Submitter Signature

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11 Validate

You can click the 'Validate' icon (*) at any stage of completing a Section 5 Notices and
Supports form. The 'Section 5 Notices and Supports Validation' pop-up window displays when
you click the 'Validate' icon ( ). 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 ( U) and can be fixed by clicking the
error link. The links will display the Screen Title Name (e.g., Chemical Identification) and the
associated error. After you click a link, the main application screen will display the section
where the error occurred so you can easily fix the error. Once you have fixed the error(s), click
the 'Validate' icon ( ) again to refresh the 'Section 5 Notices and Supports Validation' pop-up
window. If the information you fixed passes validation, the error will be removed from the
'Section 5 Notices and Supports Validation' pop-up window. 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
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Exhibit 11-1 shows a screen capture for the 'Section 5 Notices and Supports Validation' pop-up
window:

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

s^CSPP

SECTION 5 NOTICES AND SUPPORTS VALIDATION
Errors:

•	Technical Contact Information

4S 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 Operation Controlled bv Others has been added.

•	Submitter Controlled Operations
° Operation 1

¦	Submitter Operation Information

® Operation Alias is reduired.

•	Operations Controlled by Others
° Operation 1

¦	Industrial Sites Controlled By Others

@ Alias is required.

Warnings:

•	Joint Submission 1

° 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.

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12 Submit to EPA via CDX

As a Primary Agent/Consultant, you have the ability to sign and submit an original Support or
ACM form to EPA via CDX. You also have the ability to submit amendments to all form types.
You can save your form at any point during the data entry process and 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 Primary Authorized Officials or Agents/Consultants 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 Authorized Officials and Agents/Consultants 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.

A 'Submitting On Behalf Of checkbox will also be displayed on the screen. After you check the
checkbox, click the 'Next' button to navigate to the 'Submitting On Behalf Of screen. The
'Submitting On Behalf Of checkbox is only displayed for amendments/revisions/updates/etc. to
the original submission.

•	Submitting On Behalf Of: This checkbox displays for original Support forms and
amendments/revisions/updates to an original submission.

•	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: Displays 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.

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•	Phone Number: Displays the phone number of the submitting official, which has been pre-
populated from CDX registration information.

•	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.

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Exhibit 12-1 shows a screen capture of the 'Submitting Official Information' screen:
Exhibit 12-1: Submitting Official Information Screen



A Logged in as: Jane Doe, Primary Agent/Consultant

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.

~

Submitting on Behalf Of:

CBI:

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
Doe

Not Applicable
TEST GROUP
7032274019
Jane.Doe@test.com
12601 FAIR LAKES CIRCLE

FAIRFAX

VA

22033
US

Cancel

^extj

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
'SubmissionProcess: Validation' screen.

12.2 Submitting On Behalf Of Company

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 for Support forms and amendments/revisions/updates/etc. to an original submission.

After checking the 'Submitting On Behalf Of checkbox on the 'Submitting Official
Information' screen, you will be taken to the 'Submitting On Behalf Of Company' screen to
enter in the company information that you are submitting the form on behalf of. Click the
'Cancel' button to navigate to the form that you are submitting.

• CBI: Check the 'CBI' checkbox to claim the 'Submitting On Behalf Of information as
confidential.

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•	Prefix: Select the prefix of the 'Submitting On Behalf Of individual on whose behalf you
are submitting this form.

•	First Name: Enter the first name of the 'Submitting On Behalf Of individual on whose
behalf you are submitting this form. This is a required field.

•	Middle Initial: Enter the middle initial of the 'Submitting On Behalf Of individual on
whose behalf you are submitting this form.

•	Last Name: Enter the last name of the 'Submitting On Behalf Of individual on whose
behalf you are submitting this form. This is a required field.

•	Suffix: Select the suffix of the 'Submitting On Behalf Of individual on who behalf you are
submitting this form.

•	Job Title: Enter the job title of the 'Submitting On Behalf Of individual on whose behalf
you are submitting this form.

•	Company Name: Enter the company name of the 'Submitting On Behalf Of individual on
whose behalf you are submitting this form. This is a required field.

•	Phone Number: Enter the phone number of the 'Submitting On Behalf Of individual on
whose behalf you are submitting this form. This is a required field.

•	Phone Extension: Enter the phone number extension of the 'Submitting On Behalf Of
individual on whose behalf you are submitting this form.

•	Email Address: Enter the email address of the 'Submitting On Behalf Of individual on
whose behalf you are submitting this form. 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 'Submitting On Behalf
Of individual on whose behalf you are submitting this form. This is a required field.

•	Mailing Address 2: Enter the second line of the mailing address of the 'Submitting On
Behalf Of individual on whose behalf you are submitting this form.

•	City: Enter the city of the mailing address of the 'Submitting On Behalf Of individual on
whose behalf you are submitting you are submitting this form. This is a required field.

•	State: Select the state from the drop-down menu of the mailing address of the ' Submitting
On Behalf Of individual on whose behalf you are submitting this form. This is a required
field if the 'Country' field is set to 'United States.'

•	Postal Code: Enter the postal code of the 'Submitting On Behalf Of individual on whose
behalf you are submitting this form. This is a required field.

•	Country: Enter the country of the ' Submitting On Behalf Of individual on whose behalf
you are submitting this form.

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Exhibit 12-2 shows a screen capture of the 'Submitting On Behalf Of Company' screen:
Exhibit 12-2: Submitting On Behalf Of Company Screen





A Logged in as: Jane Doe, Primary Agent/Consultant

Log Out





SUBMITTING ON BEHALF OF COMPANY Q



CBI:

~



Prefix:

I -



First Name:

I I



Middle Initial:

I I



Last Name:

I I



Suffix:

I I - I



Job Title:

I I



Company Name:

I I



Phone Number:

I I



Phone Extension:

I I



Email Address:

I I



Mailing Address 1:

I I



Mailing Address 2:

I I



City:

I I



State:

I I - I



Postal Code:

I I



Country:

United States ~





Cancel Next



CDX Homepage

I 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 proceed to the
'Submission Process: Validation' screen. Click the 'Cancel' button to navigate back to the form
from which you initiated the submission process.

12.3 LVE Certification

Click the 'Next' button from the 'Submitting on Behalf Of 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.

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Exhibit 12-3 shows a screen capture of the 'LVE Certification' screen:

Exhibit 12-3: LVE Certification Screen

LVE CERTIFICATION

I certify, under penalty of law, ttiat the following is true

The manufacturer submitting this notice intends to manufacture or Import the new chemical substance fof commercial purposes, oth« than In

small quantities solely 'or research and development, under tne terms of 40 CFR 723 50

The manufacturer is familiar wflfi the terras of tfiis section and will comply witn those terms

The rww cnertutal suCstartce for wnich the notice Is submitted meets all applicable exemption conditions

In accordance witn A D CFFf 723 50(c)(1), Die manufacturer intends to commence manufacture of the exempted substance for commefciaa
purposes within i year or the date of the expiration of trie 3D day rewe* penod

CfflKet

h: may

CD* Kom*pi(te I ktrCDX Homepage r £P* Homepage i Terms ano Condition! i	Mobto I COX Hewdesk 1808} 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.

12.4 LOREX Certification

Click the 'Next' button on the 'Submitting on Behalf Of 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.

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Exhibit 12-4 shows a screen capture of the 'LOREX Certification' screen:

Exhibit 12-4: LOREX Certification Screen

Jane Doe. Primary AjfenljConsuJlanL
Log Out

LOREX CERTIFICATION

1 certify, under pens*/ a: Hnlpat it (48S:> 69 [1193-5

Navigation: Click the 'I Certify' button to continue with submitting the form and proceed to the
'SubmissionProcess: Validation' screen.

12.5 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.

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Exhibit 12-5 shows a screen capture of the 'Submission Process: Validation' screen:
Exhibit 12-5: Submission Process: Validation Screen

CSB PJ

A Logged in as Jane Doe. Primary Agent/Consultant

Log Out

SUBMISSION PROCESS: VALIDATION

~ _

Validation

ira

QJ

PGfOiflenlioo

CROMEftfi

Subfnn

Running validation on your tfatfa
Processing Please watt

(Please arable arry pop-up blockers within your internet browser settings to aeew for me varidabon pop-up to be displayed if validation

errors a*e present.)

CD>: Hea ififiJ-js I HtfCDX HomMaOf I EPAHOniepjiJ-o I Ttms itld CMIOOOftS l Privacy none 0 I CO:-: HclpdiSV iSBSt SSD1 '3'J5

Exhibit 12-6 shows a screen capture of the 'Submission Process: PDF Generation' screen:
Exhibit 12-6: Submission Process: PDF Generation Screen

Jane Doe. Primary AgenVConwSanl
Log Out

SUBMISSION PROCESS: PDF GENERATION
Your PDF preview transaction was successful'

View POF Continue

CDxMtnieijjfr | MyCOX Womipaijfl : EPAHome0»ge I Teims andCwWwts I Piryaev Nolit a i COX He-!(idu sk r-BSB.i £30-' 994

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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.

12.6 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. A screenshot of the compliancy agreement is shown below in Exhibit
12-7. 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 12-7 shows a screen capture for the 'Cross-Media Electronic Reporting Regulation
(CROMERR) Certification' screen:

Exhibit 12-7: Cross-Media Electronic Reporting Regulation (CROMERR) Certification

Screen

* L oqtjed .n :i.;- Jane Doe. Primary AgenUConsullanl

Log Out

&SRRJ

CROSS-MEDIA ELECTRONIC REPORTING REGULATION (CROMERR} CERTIFICATION

~ -

Validation

PDF (kneraclon

CROMERR

Submit

1 certify, under penalty of law, that this document and all attachments were prepared under irry direction Of SL-pervlston *1 accordance wsil
a system designed to assure that qualified personnel property gamer and evaSuate the information submitted Based on my inquiry of the
person or persons wtio manage the system, or those persons directly response Kx garnering the Infoiwa&on, the information submitted
is, to the best of my Knowledge arid belief, true, accurate, ano complete i am aware that there are significant penalties ror stitarnittmg fstse
information. Including the possibility of fines 3nd imprisonment for knowing violation;

Cancel

I Certify

COK Hameeipt I htyCDX Homepage 1 EPAHwnaeage | Terms and Commons | PiNatyHsIHe 1 CDX Heipdeik (888) MO-1 MS

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Navigation: Click the 'I Certify' button to continue with submitting the form and proceed to the
'CROMERR Login' screen.

12.7 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 12-8 shows a screen capture of the 'Cross-Media Electronic Reporting Regulation
(CROMERR) Login' screen.

Exhibit 12-8: Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen

E

rJ



• Logged in as: Jane Doe, Primary Agent/Consultant

Log Out

CROSS-MEDIA ELECTRONIC REPORTING REGULATION (CROMERR) LOGIN

r

&

^ — 12 — (3 — 5]

v_

Validation

PDF Generation

CROMERR

Submit

Please login with your CDX password:

Cancel

Next

CDX Homepage | MyCDX Homepage | ERA 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.

12.8 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.

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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 12-9 shows a screen capture of the 'Cross-Media Electronic Reporting Regulation
(CROMERR) Security Question' screen:

Exhibit 12-9: Cross-Media Electronic Reporting Regulation (CROMERR) Security

Question Screen

Jane Doe. Pnmar> A/jentConsoiLam
Log Out

CROSSMEOIA ELECTRONIC REPORTING REGULATION (CROMERR) SECURITY QUESTION

V _

Vthdjlton	JW&HWfitkwi	CPOMfftfl	Stibm*

*	V	W	«

Vvn* 15 your Taworte CKX*^

Cancol	Hoxl

Ci-y. MtfT-epjflB 1 MtCCiX MOflWfUje I EP* l+jfrtdpij* | Ttrfnt ind C«H3H>«n I PflrtcyN.-illct I COX Hr^c-fui. (£;SSl SS3i

Navigation: Answer the security question and click the 'Next' button to navigate to the
'CROMERR Submission' screen.

12.9 Cross-Media Electronic Reporting Regulation (CROMERR) Submission

You can access the 'Cross-Media Electronic Reporting Regulation (CROMERR) Submission'
screen by entering the answer to the security question and by clicking the 'Next' button on the
'CROMERR Security Question' 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.

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

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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



Jane Doe. Primary AgenUCon&i>tarrt
Log Out

CROSS-MEDIA ELECTRONIC REPORTING REGULATION (CROMERR) SUBMISSION

~ -

VjilieUrtQn

PC# OnprAlton

CROMERR

frubmn

4*

y

Tne lutwmswn wat mm do tre EPA Tne Copy of Pec ora link » snow for downloM erf tne Copy of Record ane stgfiawe tor trus
vutxikjixxi win appear othe form* list when tne Epa rece^Ti ana processes your su&mtsvson

Fmi*h

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 ( ¦ ) under
the 'Action' column and will display a status of 'Submitted.'

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13 Download Copy of Record

To download a Copy of Record, navigate to the 'Section 5 Notices and Supports Forms' screen
and locate an 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.
You will be taken 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 be taken to 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.

Exhibit 13-1 shows a screen capture of the 'Download Copy of Record' screen:

Exhibit 13-1: Download Copy of Record Screen



DOWNLOAD COPY OF RECORD"

you can rum opwfiroad me copy of Retwctef tne ppmm vx>mi»wn

"1

Oowntwd Copy C Rwora
Filt Him*	Action

copy or Ret two	*

Hmd*

*• l otfjc<3 n a ¦ jane Doe, Pinrray AgcnlConsu^anl

LOfl Out

CDX Horn*©I *»CCJX HMMplft I EPA Mom*pi| Tumi *ia Cooaaofn | Pnvicy M0(M | CDXH»lpo»4l »l«i

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

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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 be taken to 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 be taken to the 'Download Copy of Record' screen.

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 NOC-20121127_COR_20121127 zip

You have chosen to open:

NOC-20121127_COR_20121i27.zip

which is a: WinZip File

from: https://devngn.epacdxnode.net

What should Firefox do with this file?

® Open with WinZip (default)

O Save File

H 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

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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.

Exhibit 14-1 shows a screen capture of the 'Section 5 Notices and Supports Forms' screen:
Exhibit 14-1: Section 5 Notices and Supports Form - Amendment

ESRE

Forms T Resources

SECTION S NOTICES AND SUPPORTS FORMS

m as Jane Doe, Primary Agertl/ConSuHarrt
Log Out

*	If submitting a form for the First time in Ifie Section S Notices and Supports application, select tne torn type from tne drop-down menu and
Click Start New Form

*	To edit an In Progress form, click Ifie form alias link in the Alias column in the ta We Delow

•	To access and edit a form previous^ submitted ttiroi/gn CDX. unlock ffie nofrn Oy clicking trie lock ( <3) Icon and enter tne passphrase
*itien prompted All additional changes made to tne form win ce stitsmitted as an amendment

•	T« dwmtoad a copy of recoup for a submitted fo/m, click tfte green airrttw (¦*-) icon and enter the passphrase when prompted

•	You may delete any form ttiat nas ncK yet been submitted tjy clicking the delete (X) icon

*	aji columns may1 be sorteo by clicking tne column header

8 items found

Page i of 1

items Per Page

25 »

AH.**



Siiiryjw

C«#

Stnfiif

Modify

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Copy of Ad Kin







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Drift

[tola

Record

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EOT

emu IMe- Z0130502-13:16143 cur	Bona FUe

MC-J0130MM31J19EDT	NOC

Piimaiy PMN- 20130502-13:10 31	Piimwy PMH
EDT

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Submitted

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Select the furm type and lTL-n dick Start Mew Form

m Progress	0W0I3013

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&	05MSf20!3 BSTOSfflm
SubmlllKl

In Progress	05(t
-------
CDXr

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.

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 3.5 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 the following sections for additional instructions:

•	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.

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Exhibit 15-1 shows a screen capture of the 'Resources' screen (Scroll 1):

Exhibit 15-1: Resources Screen (Scroll 1)

T

A Logged in as Jane Doe, Primary Agent/Consultant

Log Out

RESOURCES

Section 5 Notices and Supports User Guide
This guide describes each screen of the Section 5 Notices and Supports software and provides information on how to use the system to complete a
Section 5 Notices and Supports form. The guide also contains instructions for registering with CDX, submitting the Section 5 Notices and Supports
form, and amending a previous submission. You can download and print the guide for quick reference.

User Guide

Helpful Web Links

Click the link provided below to access additional information related to the Regulatory Impact Analysis for the Regulation of Microbial Products of

Biotechnology: Government Costs.

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 Inventory

Click the link provided below to access additional information related to Substance Registry Services.

Substance Registry Services fSRS)

Click the link provided below to access additional information related to the Facility Registry System.

Facility Registry System fFRSl

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.
National Pollutant Discharge Elimination System fNPDES)

Click the link provided below to access additional information related to the New Chemicals Program.
New Chemicals Program Homepage

CDX Homepage | MyCDX Homepage | EPA Homepage | Terms and Conditions | Privacy Notice | CDX Helpdesk: (383} 890-1995

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Exhibit 15-2 shows a screen capture of the 'Resources' screen (Scroll 2):

Exhibit 15-2: Resources Screen (Scroll 2)

T

T

Logged in as Jane Doe, Primary Agent/Consultant

Log Out

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 i'G2 FR 17910)

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 fSRS)

Click the link provided below to access additional information related to the Facility Registry System.

Facility Registry System fFRSl

Click the link provided below to access additional information related to Inventory Expert Services.
CAS Inventory Expert Sen/ices

Click the link provided below to access additional information related to the National Pollutant Discharge Elimination System.
National Pollutant Discharge Elimination System fNPDESl

Click the link provided below to access additional information related to the New Chemicals Program.
New Chemicals Prooram 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 f II 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-epa.aov.

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

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Appendix A

The following table displays all the definitions, acronyms, and abbreviations used in this
document and their full name.

Definitions, Acronyms, and Abbreviations

Acronym

Full Name

ACM

Alternative Control Measures

AO

Authorized Official

BCF/BAF

Bioconcentration Factors/Bioaccumulation Factors

CBI

Confidential Business Information

CA

Chemical Abstracts

CAS

Chemical Abstracts Service

CASRN

Chemical Abstracts Service Registry Number

CDX

Central Data Exchange

CFR

Code of Federal Regulations

CoR

Copy of Record

CROMERR

Cross-Media Electronic Reporting Regulation

CSPP

Chemical Safety and Pesticide Programs

CSV

Comma-Separated Values

DNA

Deoxyribonucleic Acid

EPA

Environmental Protection Agency

EST

Eastern Standard Time

ETI

Environmental Technology Initiative

FR

Federal Regulation

FRS

Facility Registry System

GPC

Gel-permeation Chromatography

ID

Identification

IE

Internet Explorer

IES

Inventory Expert Service

IH

Industrial Hygienist

IR

Infrared

KG

Kilogram

LOREX

Low Release/Low Exposure Exemption

LOS

Letter of Support

LVE

Low Volume Exemption

MCAN

Microbial Commercial Activity Notice

MS

Mass Spectrometry

MSDS

Material Safety Data Sheet

NIOSH

National Institute for Occupational Safety and Health

NMR

Nuclear Magnetic Resonance

NOC

Notice of Commencement

NPDES

National Pollutant Discharge Elimination System

OPPT

Office of Pollution Prevention and Toxics

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Acronym

Full Name

PDF

Portable Document Format

PMN

Premanufacture Notice

POTW

Publicly Owned Treatment Works

PPE

Personal Protective Equipment

PPM

Parts Per Million

RCRA

Resource Conservation and Recovery Act

SAR

Structure-Activity Relationship

SDS

Safety Data Sheet

SME

Subject Matter Expert

SNUN

Significant New Use Notice

SNUR

Significant New Use Rule

SRS

Substance Registry Services

STN

Scientific and Technical Information Network

TERA

TSCA Experimental Release Application

TME

Test Market Exemption

TMEA

Test Marketing Exemption Application

TS

Toxic Substances

TSCA

Toxic Substances Control Act

UV

Ultraviolet

XML

Extensible Markup Language

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