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TDD 9.21 OPPT CIS Section 5 Notices and Supports Primary Authorized Official User Guide v1_12152014

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Section 5 Notices and Supports User
Guide – Primary Authorized Official
Environmental Protection Agency
Office of Pollution Prevention and Toxics

Delivery Order # GS00Q09BGD0022
Task Order # EP-G11H-00154
Project # TDD 9.21
Version 1.0
December 15, 2014

Table of Contents
Table of Contents......................................................................................................................... i
List of Exhibits ............................................................................................................................. v
1

Introduction ........................................................................................................................1

2

System Requirements ........................................................................................................2
2.1

Supported Browsers .....................................................................................................2

2.2

Screen Resolution ........................................................................................................2

3

Primary Authorized Official (AO) Functions ........................................................................3
3.1

Log into Section 5 Notices and Supports Application ....................................................4

3.2

Home Screen Navigation ..............................................................................................5

3.3

User Management ........................................................................................................7

3.4

Section 5 Notices and Supports Forms .........................................................................9

3.5

Create Passphrase .....................................................................................................14

3.6

Attach Documents ......................................................................................................15

3.7

Enter Passphrase .......................................................................................................21

3.8

Navigation Tree ..........................................................................................................21

3.9

Action Bar ...................................................................................................................33

3.10

Search Substance Registry Services (SRS) ...............................................................35

3.11

Add Facility .................................................................................................................40

4

Create Premanufacture Notice (PMN) Form .....................................................................44
4.1

Create PMN Form ......................................................................................................44

4.1.1

General Form Information .....................................................................................44

4.1.2

User Fees Certification .........................................................................................49

4.1.3

Agent Information .................................................................................................50

4.1.3.1
4.1.4
4.1.4.1

Add Agent ....................................................................................................53
Technical Contact Information ..............................................................................56
Add Technical Contact .................................................................................58

4.1.5

Additional Submission Information ........................................................................61

4.1.6

Chemical Identification ..........................................................................................65

4.1.7

Class 1 or 2 Chemical Substances .......................................................................67

4.1.8

Class 2 Substances ..............................................................................................73

4.1.9

Additional Chemical Information ...........................................................................76

4.1.10

Polymer Identification Information .........................................................................81

4.1.11

Monomers and Other Reactants ...........................................................................85

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4.1.12

Production Volume and Hazard/Safety Information ...............................................91

4.1.13

Use Information ....................................................................................................94

4.1.14

Physical and Chemical Properties Worksheet .......................................................99

4.1.15

Physical and Chemical Properties Worksheet – Continued (Optional) ................ 106

4.1.16

Physical and Chemical Properties Worksheet – Continued (Optional) Attach
Documents .........................................................................................................108

4.1.17

Site Information...................................................................................................112

4.1.18

Sites Controlled By Others ..................................................................................113

4.1.19

Submitter Operation Information ......................................................................... 115

4.1.20

Occupational Exposures .....................................................................................121

4.1.21

Environmental Releases .....................................................................................125

4.1.22

Industrial Sites Controlled By Others .................................................................. 130

4.1.23

Exposures/Releases ...........................................................................................134

4.1.24

Byproduct Information .........................................................................................139

4.1.25

Optional Pollution Prevention .............................................................................. 141

4.1.26

Additional Attachments .......................................................................................143

4.1.27

Attachment Summary .........................................................................................145

4.1.28

Optional Cover Letter ..........................................................................................147

4.1.29

Joint Submitter Information .................................................................................149

4.1.30

Joint Submission Information ..............................................................................151

4.1.31

Notify Joint Submitter of Joint Submission Information........................................ 153

4.1.32

Letter of Support Submitter Information .............................................................. 156

4.1.33

Letter of Support Submission Information ........................................................... 158

4.1.34

Notify Secondary Submitter of Letter of Support Information............................... 160

4.1.35

Upload XML ........................................................................................................163

5

Create Biotechnology Form ............................................................................................165
5.1

Create Biotechnology Form ......................................................................................165

5.1.1

General Form Information ...................................................................................165

5.1.2

Joint Submitter Information .................................................................................169

5.1.3

Joint Submission Information ..............................................................................170

5.1.4

Notify Secondary Submitter of Joint Submission Information .............................. 172

5.1.5

Letter of Support Submitter Information .............................................................. 173

5.1.6

Letter of Support Submission Information ........................................................... 175

5.1.7

Notify Secondary Submitter of Letter of Support Information............................... 178

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5.1.8

Technical Contact Information ............................................................................ 180

5.1.8.1
5.1.9
6

Add Technical Contact ...............................................................................181
Optional Cover Letter ..........................................................................................184

Create Notice of Commencement (NOC) Form .............................................................. 186
6.1

Create NOC Form ....................................................................................................186

6.1.1

General Form Information ...................................................................................186

6.1.2

Technical Contact Information ............................................................................ 187

6.1.2.1

Add Technical Contact ...............................................................................188

6.1.3

Chemical Information ..........................................................................................190

6.1.4

Site Information...................................................................................................194

6.1.5

CBI Substantiation Part 1 ....................................................................................196

6.1.6

CBI Substantiation Part 2 ....................................................................................199

6.1.7

CBI Substantiation Part 3 ....................................................................................202

6.1.8

Optional Cover Letter ..........................................................................................205

7

Create Support Form ......................................................................................................207
7.1

Create Support Form ................................................................................................207

7.1.1

General Form Information ...................................................................................207

7.1.2

Original Submitter Information ............................................................................ 210

8

Create Bona Fide Form ..................................................................................................213
8.1

Create Bona Fide Form ............................................................................................213

8.1.1

General Document Information ........................................................................... 213

8.1.2

Primary Contact Information ...............................................................................215

8.1.3

Technical Contact Information ............................................................................ 218

8.1.4

Statement of Intent .............................................................................................220

8.1.5

Letter of Support Submitter Information .............................................................. 222

8.1.6

Letter of Support Submission Information ........................................................... 224

8.1.7

Notify Secondary Submitter of Letter of Support Information............................... 227

8.1.8

Chemical Identification Information ..................................................................... 230

8.1.9

Class 1 or 2/Biotechnology Chemical Substances .............................................. 231

8.1.10

Class 2/Biotechnology Substances ..................................................................... 235

8.1.11

Polymer Identification Information ....................................................................... 237

8.1.12

Monomers and Other Reactants ......................................................................... 240

8.1.13

Use Information ..................................................................................................243

8.1.14

Submitter Site Identification ................................................................................245

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8.1.15

Document Management......................................................................................247

8.1.16

Optional Cover Letter ..........................................................................................249

9

Create Alternative Control Measures (ACM) Form ......................................................... 251
9.1

Create Alternative Control Measures Form ............................................................... 251

9.1.1

Contact Information ............................................................................................251

9.1.1.1
9.1.2

Add Contact ...............................................................................................252
Attachments........................................................................................................254

10

Preview ..........................................................................................................................257

11

Validate ..........................................................................................................................262

12

Submit to EPA via CDX ..................................................................................................264

12.1

Submitting Official Information ..................................................................................264

12.2

LVE Certification .......................................................................................................267

12.3

LOREX Certification .................................................................................................268

12.4

Submission Process: Validation ................................................................................269

12.5

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

12.6

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

12.7

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

12.8

Submit to CDX ..........................................................................................................274

12.9

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

13

Download Copy of Record ..............................................................................................276

14

Create An Amendment ...................................................................................................279

15

Resources ......................................................................................................................282

Appendix A .............................................................................................................................285

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List of Exhibits
Exhibit 3-1: Section 5 Notices and Supports User Roles Matrix ..................................................4
Exhibit 3-2: Chemical Information Submission System Screen ...................................................5
Exhibit 3-3: Section 5 Notices and Supports Home Screen .........................................................7
Exhibit 3-4: User Management Screen ........................................................................................9
Exhibit 3-5: Section 5 Notices and Supports Forms Screen ......................................................13
Exhibit 3-6: Create Passphrase Screen.....................................................................................15
Exhibit 3-7: Section 5 Document Types and Subtypes ..............................................................17
Exhibit 3-8: Attach Documents Pop-Up Window........................................................................20
Exhibit 3-9: Enter Passphrase Screen .......................................................................................21
Exhibit 3-10: Navigation Prompt Pop-Up Window .....................................................................22
Exhibit 3-11: Premanufacture Notice Navigation Tree (Scroll 1) ................................................24
Exhibit 3-12: Premanufacture Notice Navigation Tree (Scroll 2) ................................................25
Exhibit 3-13: Premanufacture Notice Navigation Tree (Scroll 3) ................................................26
Exhibit 3-14: Premanufacture Notice Navigation Tree (Scroll 4) ................................................27
Exhibit 3-15: Premanufacture Notice Navigation Tree (Scroll 5): ...............................................28
Exhibit 3-16: Biotechnology Navigation Tree .............................................................................29
Exhibit 3-17: Notice of Commencement (NOC) Navigation Tree ...............................................30
Exhibit 3-18: Support Navigation Tree.......................................................................................30
Exhibit 3-19: Bona Fide Navigation Tree (Class 2 Substance) ..................................................31
Exhibit 3-20: Bona Fide Navigation Tree (Polymer) ...................................................................32
Exhibit 3-21: Alternative Control Measures (ACM) Navigation Tree .......................................... 33
Exhibit 3-22: Action Bar - Validate .............................................................................................33
Exhibit 3-23: Action Bar - Save .................................................................................................34
Exhibit 3-24: Action Bar - Preview .............................................................................................34
Exhibit 3-25: Action Bar - Submit ..............................................................................................34
Exhibit 3-26: Action Bar - Help Links .........................................................................................35
Exhibit 3-27: Search Substance Registry Services Pop-Up Window ......................................... 37
Exhibit 3-28: Chemical Not Found In Substance Registry Services Pop-Up Window ................ 39
Exhibit 3-29: Add Facility Message Pop-Up Window .................................................................41
Exhibit 3-30: Add Facility Pop-Up Window ................................................................................42
Exhibit 4-1: General Form Information Screen (Scroll 1) ...........................................................47
Exhibit 4-2: General Form Information Screen (Scroll 2) ...........................................................48
Exhibit 4-3: User Fees Certification Screen ...............................................................................50

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Exhibit 4-4: Agent Information Screen .......................................................................................52
Exhibit 4-5: Add Agent Pop-Up Window ....................................................................................56
Exhibit 4-6: Technical Contact Information Screen ....................................................................58
Exhibit 4-7: Add Technical Contact Pop-Up Window .................................................................60
Exhibit 4-8: Additional Submission Information Screen .............................................................64
Exhibit 4-9: Chemical Identification Screen ...............................................................................66
Exhibit 4-10: Class 1 or 2 Chemical Substances Screen (Scroll 1) ............................................ 71
Exhibit 4-11: Class 1 or 2 Chemical Substances Screen (Scroll 2) ............................................ 72
Exhibit 4-12: Class 2 Substances Screen (Scroll 1) ..................................................................75
Exhibit 4-13: Class 2 Substances Screen (Scroll 2) ..................................................................76
Exhibit 4-14: Additional Chemical Information Screen (Scroll 1) ................................................80
Exhibit 4-15: Additional Chemical Information Screen (Scroll 2) ................................................81
Exhibit 4-16: Polymer Identification Information Screen (Scroll 1) ............................................. 84
Exhibit 4-17: Polymer Identification Information Screen (Scroll 2) ............................................. 85
Exhibit 4-18: Monomers and Other Reactants Screen (Scroll 1) ...............................................89
Exhibit 4-19: Monomers and Other Reactants Screen (Scroll 2) ...............................................90
Exhibit 4-20: Production Volume and Hazard/Safety Information Screen .................................. 93
Exhibit 4-21: Use Information Screen (Scroll 1) .........................................................................97
Exhibit 4-22: Use Information Screen (Scroll 2) .........................................................................98
Exhibit 4-23: Physical and Chemical Properties Worksheet Screen (Scroll 1) ......................... 105
Exhibit 4-24: Physical and Chemical Properties Worksheet Screen (Scroll 2) ......................... 106
Exhibit 4-25: Physical and Chemical Properties Worksheet - Continued (Optional) Screen .... 108
Exhibit 4-26: Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents Pop-Up Window (Scroll 1) ........................................................................... 110
Exhibit 4-27: Physical and Chemical Properties Worksheet - Continued (Optional) Attach
Documents Pop-Up Window (Scroll 2) ........................................................................... 111
Exhibit 4-28: Site Information Screen ......................................................................................113
Exhibit 4-29: Sites Controlled By Others Screen ..................................................................... 115
Exhibit 4-30: Submitter Operation Information Screen (Scroll 1) ............................................. 119
Exhibit 4-31: Submitter Operation Information Screen (Scroll 2) ............................................. 120
Exhibit 4-32: Occupational Exposures Screen (Scroll 1) ......................................................... 123
Exhibit 4-33: Occupational Exposures Screen (Scroll 2) ......................................................... 124
Exhibit 4-34: Environmental Releases Screen (Scroll 1) ......................................................... 128
Exhibit 4-35: Environmental Releases Screen (Scroll 2) ......................................................... 129
Exhibit 4-36: Industrial Sites Controlled By Others Screen (Scroll 1) ....................................... 133
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Exhibit 4-37: Industrial Sites Controlled By Others Screen (Scroll 2) ....................................... 134
Exhibit 4-38: Exposures/Releases Screen (Scroll 1) ............................................................... 137
Exhibit 4-39: Exposures/Releases Screen (Scroll 2) ............................................................... 139
Exhibit 4-40: Byproduct Information Screen ............................................................................ 140
Exhibit 4-41: Optional Pollution Prevention Screen ................................................................. 143
Exhibit 4-42: Additional Attachments Screen ........................................................................... 145
Exhibit 4-43: Attachment Summary Screen .............................................................................146
Exhibit 4-44: Optional Cover Letter Screen .............................................................................148
Exhibit 4-45: Joint Submitter Information Screen..................................................................... 150
Exhibit 4-46: Joint Submission Information Screen ................................................................. 152
Exhibit 4-47: Joint Submission Unique Identifier Notification Pop-Up Window (Scroll 1).......... 154
Exhibit 4-48: Joint Submission Unique Identifier Notification Pop-Up Window (Scroll 2).......... 155
Exhibit 4-49: Letter of Support Submitter Information Screen .................................................. 157
Exhibit 4-50: Letter of Support Submission Information Screen............................................... 159
Exhibit 4-51: Letter of Support Unique Identifier Notification Pop-Up Window ......................... 162
Exhibit 4-52: Upload XML Screen ...........................................................................................164
Exhibit 5-1: General Form Information Screen (Biotechnology) (Scroll 1) ................................ 167
Exhibit 5-2: General Form Information Screen (Biotechnology) (Scroll 2) ................................ 168
Exhibit 5-3: Joint Submitter Information Screen (Biotechnology) ............................................. 170
Exhibit 5-4: Joint Submission Information Screen (Biotechnology) .......................................... 171
Exhibit 5-5: Unique Identifier Notification Pop-Up Window ...................................................... 173
Exhibit 5-6: Letter of Support Submitter Information Screen (Biotechnology) .......................... 175
Exhibit 5-7: Letter of Support Submission Information Screen (Biotechnology) ....................... 177
Exhibit 5-8: Unique Identifier Notification Pop-Up Window ...................................................... 179
Exhibit 5-9: Technical Contact Information Screen (Biotechnology) ........................................ 181
Exhibit 5-10: Add Technical Contact Pop-Up Window ............................................................. 183
Exhibit 5-11: Optional Cover Letter Screen .............................................................................184
Exhibit 6-1: General Form Information Screen (NOC) ............................................................. 187
Exhibit 6-2: Technical Contact Information Screen (NOC) ....................................................... 188
Exhibit 6-3: Add Technical Contact Pop-Up Window (NOC) .................................................... 190
Exhibit 6-4: Chemical Information Screen (Scroll 1) (NOC) ..................................................... 193
Exhibit 6-5: Chemical Information Screen (Scroll 2) (NOC) ..................................................... 194
Exhibit 6-6: Site Information Screen (NOC) ............................................................................. 195
Exhibit 6-7: CBI Substantiation Part 1 Screen (Scroll 1) .......................................................... 197

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Exhibit 6-8: CBI Substantiation Part 1 Screen (Scroll 2) .......................................................... 198
Exhibit 6-9: CBI Substantiation Part 2 Screen (Scroll 1) .......................................................... 200
Exhibit 6-10: CBI Substantiation Part 2 Screen (Scroll 2) ........................................................ 201
Exhibit 6-11: CBI Substantiation Part 3 Screen (Scroll 1) ........................................................ 203
Exhibit 6-12: CBI Substantiation Part 3 Screen (Scroll 2) ........................................................ 204
Exhibit 6-13: Optional Cover Letter Screen (NOC) .................................................................. 205
Exhibit 7-1: General Form Information Screen (Scroll 1) (Support).......................................... 209
Exhibit 7-2: General Form Information Screen (Scroll 2) (Support).......................................... 210
Exhibit 7-3: Original Submitter Information Screen (Support) .................................................. 212
Exhibit 8-1: General Document Information Screen (Scroll 1) ................................................. 214
Exhibit 8-2: General Document Information Screen (Scroll 2) ................................................. 215
Exhibit 8-3: Primary Contact Information Screen ..................................................................... 217
Exhibit 8-4: Technical Contact Information Screen (Scroll 1) ................................................... 219
Exhibit 8-5: Technical Contact Information Screen (Scroll 2) ................................................... 220
Exhibit 8-6: Statement of Intent Screen ...................................................................................222
Exhibit 8-7: Letter of Support Submitter Information Screen .................................................... 224
Exhibit 8-8: Letter of Support Submission Information Screen................................................. 226
Exhibit 8-9: Notify Letter of Support Submitter Pop-Up Window .............................................. 229
Exhibit 8-10: Chemical Identification Information Screen......................................................... 231
Exhibit 8-11: Class 1 or 2/Biotechnology Chemical Substances Screen (Scroll 1)................... 234
Exhibit 8-12: Class 2/Biotechnology Substances Screen (Scroll 1) ......................................... 236
Exhibit 8-13: Class 2/Biotechnology Substances Screen (Scroll 2) ......................................... 237
Exhibit 8-14: Polymer Identification Information Screen .......................................................... 240
Exhibit 8-15: Monomers and Other Reactants Screen............................................................. 243
Exhibit 8-16: Use Information Screen ......................................................................................245
Exhibit 8-17: Submitter Site Identification Screen .................................................................... 247
Exhibit 8-18: Document Management Screen ......................................................................... 249
Exhibit 8-19: Optional Cover Letter Screen .............................................................................250
Exhibit 9-1: Contact Information Screen (ACM) ....................................................................... 252
Exhibit 9-2: Add Contact Pop-Up Window (ACM) .................................................................... 254
Exhibit 9-3: Attachments Screen (ACM) ..................................................................................256
Exhibit 10-1: Preview EPMN Form Screen ..............................................................................257
Exhibit 10-2: Preview Biotechnology Form PDF ...................................................................... 258
Exhibit 10-3: Preview NOC Form PDF ....................................................................................259

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Exhibit 10-4: Preview Support Form PDF ................................................................................261
Exhibit 11-1: Section 5 Notices and Supports Validation Pop-Up Window............................... 263
Exhibit 12-1: Submitting Official Information Screen ................................................................ 266
Exhibit 12-2: LVE Certification Screen ....................................................................................267
Exhibit 12-3: LOREX Certification Screen ...............................................................................268
Exhibit 12-4: Submission Process: Validation Screen ............................................................. 269
Exhibit 12-5: Submission Process: PDF Generation Screen ................................................... 270
Exhibit 12-6: Cross-Media Electronic Reporting Regulation (CROMERR) Certification Screen271
Exhibit 12-7: Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen ......... 272
Exhibit 12-8: Cross-Media Electronic Reporting Regulation (CROMERR) Security Question
Screen............................................................................................................................273
Exhibit 12-9: Submit To CDX Screen ......................................................................................274
Exhibit 12-10: Cross-Media Electronic Reporting Regulation (CROMERR) Submission Screen275
Exhibit 13-1: Download Copy of Record Screen...................................................................... 277
Exhibit 13-2: Download Prompt Window .................................................................................278
Exhibit 14-1: Section 5 Notices and Supports Forms Screen - Amendment ............................ 280
Exhibit 14-2: Unlock Prompt Message ....................................................................................281
Exhibit 15-1: Resources Screen (Scroll 1) ...............................................................................283
Exhibit 15-2: Resources Screen (Scroll 2) ...............................................................................284

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Revision Log
Date
09/20/13

12/15/14

Version
No.
0.01

1.0

Description

Author

Reviewer

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

C. Yeh

S. Mulvey

J. DeRosa

J. Ritchey

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

C. Yeh

J. Bronick

Review
Date
09/20/13

12/15/14

Incorporated OPPT comments given on
11/07/2013
Incorporated Release 1.00
enhancements, other OPPT comments

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide
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1

Introduction

This document presents the user guide for the Office of Pollution Prevention and Toxics (OPPT)
Section 5 Notices and Supports application submission process. This document is the user guide
for the Primary Authorized Official (AO) user of the Section 5 Notices and Supports application.
The Section 5 Notices and Supports application is the electronic, web-based tool provided by
Environmental Protection Agency (EPA) for the submission of Section 5 Notices and Supports
data. As a Primary AO, you can create, modify, and/or submit a Section 5 Notices and Supports
form. You can also delete Section 5 Notices and Supports forms, create amendments, and
download the Copy of Record (CoR).
For questions concerning the Toxic Substances Control Act (TSCA) Section 5 Notices and
Supports software requirements, please contact the Central Data Exchange (CDX) Help Desk at
helpdesk@epacdx.net or call 1-888-890-1995 between the hours of 8 am – 6 pm Eastern
Standard Time (EST). For questions concerning the TSCA Section 5 Notices and Supports
reporting requirements, please contact the TSCA Hotline at TSCA-Hotline@epamail.epa.gov or
call 202-554-1404 between the hours of 8:30 am – 5:00 pm EST.

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2

System Requirements

To use the Section 5 Notices and Supports application to submit a Section 5 Notices and
Supports form, the following are required:
• An e-mail account
• JavaScript enabled web browser
• Internet access
• Adobe Acrobat Reader 5.0 or higher
• CDX username and password
2.1
Supported Browsers
• Internet Explorer (IE) 7 or above (Internet Explorer 8 or higher is recommended; issues
found using IE 7 will be resolved on a case-by-case basis during post-production and known
issues within IE 7 are identified within the appropriate sections of this guide)
−

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

• Mozilla Firefox 3.0 or above
−

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

• Safari 4 or above
−

Go to the following link to download:
http://support.apple.com/kb/dl877

• Google Chrome
−

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

• Opera
−

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

2.2

Screen Resolution

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

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3

Primary Authorized Official (AO) Functions

This section describes how to:
• Access the application
• Navigate the Section 5 Notices and Supports ‘Home’ screen
• Assign Supports to complete a form
• Start and complete the Section 5 Notices and Supports forms – Premanufacture Notice
(PMN), Biotechnology, Notice of Commencement (NOC), Support, Bona Fide Notices, and
Alternative Control Measures (ACM) 721.30
• Upload an extensible markup language (XML) file
• Download a Copy of Record
• Create an amendment
The Primary AO is responsible for the submission of original main forms, including PMN,
Biotechnology, NOC, Support, Bona Fide, or ACM forms. As a Primary AO, you can create a
new form. You are also responsible for submitting amendments, unlocking submissions, and
deleting forms. You can assign Supports (or other authorized individuals) to edit and complete a
form on your behalf. The Primary AO can be thought of as a primary company authorized
official, specifically in regards to any sponsored individuals.
You can save the form at any point during the data entry process. The save functionality allows
you to return to that same form at any point in the future. You can print the form at any point;
however, the ‘Not for Submission’ watermark will be placed on the form anytime the form is
printed prior to actual submission.

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

3.1

Log into Section 5 Notices and Supports Application

After you create an account in CDX, click the ‘Primary Authorized Official’ link for the
Chemical Safety and Pesticide Programs (CSPP) data flow to navigate to the ‘Chemical
Information Submission System’ screen.

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

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.
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The Section 5 Notices and Supports ‘Home’ screen is the first screen within the Section 5
Notices and Supports application. It provides you with links and tabs to access the ‘Section 5
Notices and Supports Forms,’ ‘User Management,’ and ‘Resources’ screens. To navigate to
either of these screens, click the corresponding screen link (highlighted in blue text), or click the
screen tab (located within the application header). The links and tabs provide the same
functionality.
There is a ten (10) minute logout timer for this application; the application will automatically log
you out after ten minutes of inactivity and navigate you back to the CDX login screen.
• Forms: Click the ‘Forms’ tab or link to navigate to the ‘Section 5 Notices and Supports
Forms’ screen. You can create, modify, or delete a Section 5 Notices and Supports form
using the ‘Section 5 Notices and Supports Forms’ screen. For additional details about the
‘Section 5 Notices and Supports Forms’ screen, please refer to Section 3.4.
• User Management: Click the ‘User Management’ link or tab to navigate to the ‘User
Management’ screen. You can manage the access rights of Supports per form alias using the
‘User Management’ screen. For additional details about the ‘User Management’ screen,
please refer to Section 3.3.
• Resources: Click the ‘Resources’ link or tab to navigate to the ‘Resources’ screen. You can
find the Section 5 Notices and Supports user guide, as well as useful links for guidance
documents on the ‘Resources’ screen. For additional details about the ‘Resources’ screen,
please refer to Section 15.

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Exhibit 3-3 shows a screen capture of the Section 5 Notices and Supports ‘Home’ screen:
Exhibit 3-3: Section 5 Notices and Supports Home Screen

Navigation: Click the ‘User Management’ link or tab to access the ‘User Management’ screen to
assign Supports or Primary Agents/Consultants (if applicable).
3.3

User Management

You can access the ‘User Management’ screen by clicking the ‘User Management’ link on the
Section 5 Notices and Supports ‘Home’ screen or by clicking the ‘User Management’ tab from
the application header.
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On the ‘User Management’ screen, you have the ability to assign one or more Supports or
Primary Agents/Consultants to have access to modify any of the Section 5 Notices and Support
forms you have created.
Form Alias: A form alias will not be available in this drop-down menu until one has been
created. Select a form alias from the drop-down menu to begin assigning Supports or Primary
Agents/Consultants. Once a form alias has been selected, the ‘Assign Users’ group box will
update to display only the Supports or Primary Agents/Consultants who have identified you as
their AO during CDX registration, or a user you have specified that is able to submit on your
behalf.
Form Information: This field set displays information pertaining to the form you selected from
the ‘Form Alias’ drop-down menu.
• Form Alias: Displays the form alias that a form is given.
• TS Number: Displays the toxic substances (TS) number that is entered for that specific form
(if applicable).
• Form Type/SubType: Displays the type of form, which may include ‘Primary PMN,’
‘Biotechnology,’ ‘NOC,’ ‘Support,’ ‘ Bona Fide,’ ‘or ‘ACM.’ This field also displays the
subtype of the form, if applicable. NOC, Bona Fide, and ACM forms do not have subtype
values.
• Last Modified: Displays the date and time the form was last modified.
Assign Users: This box shows all the Supports or Primary Agents/Consultants you can assign to
complete a Section 5 Notices and Supports form for the form alias selected. To move support
persons from the ‘Unassigned’ group box to the ‘Assigned’ group box, highlight an individual or
multiple Support(s) or Primary Agent(s)/Consultant(s) and click the ‘add >>’ button.
• Unassigned: This box/field contains the registered Support(s) and/or Primary
Agent(s)/Consultant(s) associated with the AO who can potentially be assigned to access and
edit the selected form. To move support persons from the ‘Unassigned’ group box to the
‘Assigned’ group box, highlight an individual or multiple support persons and click the ‘add
>>’ button. To highlight multiple support persons hold down the  key on your
keyboard while clicking each Support and/or Primary Agent/Consultant. To highlight
multiple consecutive support persons, hold down the  key on your keyboard while
clicking the first and last Support and/or Primary Agent/Consultant in the list.
• Assigned: This box/field contains the registered Support(s) and/or Primary
Agent(s)/Consultant(s) given permission, by the AO, to access and edit the selected form.
This group box shows all support persons assigned to complete the Section 5 Notices and
Supports form for a single form alias. To move Supports and/or Primary Agents/Consultants
from the ‘Assigned’ group box to the ‘Unassigned’ group box highlight individual or
multiple support persons and click the ‘<< remove’ button. To highlight multiple support
persons hold down the  key on your keyboard while clicking each Support and/or
Primary Agent/Consultant. To highlight multiple consecutive support persons, hold down the
 key on your keyboard while clicking the first and last Support and/or Primary
Agent/Consultant in the list.

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• Add >>: Click the button to move Supports and/or Primary Agents/Consultants from the
‘Unassigned’ box to the ‘Assigned’ box.
• << Remove: Click the button to move Supports and/or Primary Agents/Consultants from the
‘Assigned’ box to the ‘Unassigned’ box.
When you have finished assigning the Supports and/or Primary Agents/Consultants, click the
‘Save’ button that displays after selecting a form to save the selection.
Exhibit 3-4 shows a screen capture of the ‘User Management’ screen:
Exhibit 3-4: User Management Screen

Navigation: Click the ‘Forms’ tab located within the application header to navigate to the
‘Section 5 Notices and Supports Forms’ screen.
3.4

Section 5 Notices and Supports Forms

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

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Only one Section 5 Notices and Supports form is created per form alias, which helps differentiate
between forms. Each column within the table of the ‘Section 5 Notices and Supports Forms’
screen can be sorted by clicking the individual column headers.
Start New Form: To create a new Section 5 Notices and Supports form, select one of the
following options from the ‘Form Type’ drop-down menu and click the ‘Start New Form’
button: ‘Premanufacture Notice (PMN),’ ‘Support,’ ‘Notice of Commencement (NOC),’
‘Biotechnology,’ ‘Bona Fide,’ or ‘Alternative Control Measures (ACM).’ You are required to
create a passphrase that will be associated with that particular form. Make sure to create a
passphrase that you will remember, as it cannot be retrieved or reset. Refer to Section 3.5 for
further instructions on creating a passphrase.
Edit an ‘In Progress’ Form: To modify an existing Section 5 Notices and Supports form, click
the ‘Alias’ link for a form with a status of ‘In Progress.’ You are required to enter the passphrase
associated with that particular form to access and edit the form. It is possible for more than one
user to modify a form simultaneously; the user that clicks the ‘Save’ button first will have his/her
changes saved. Refer to Section 14 for further instructions on viewing and modifying a form that
is ‘In Progress.’
Amend a submitted form: To edit an already submitted Section 5 Notices and Supports form
(i.e., to create an amendment), you must first unlock the particular submission by clicking the
‘Lock’ icon ( ) under the ‘Action’ column. You will be required to enter the passphrase
associated with that particular submission to gain access and continue amending the submission.
All further changes that are made will be submitted as an amendment. Refer to Section 14 for
further instructions on creating an amendment.
The ‘Section 5 Notices and Supports Forms’ screen displays the following columns of
information:
• Alias: Displays the form alias you provided on the ‘General Form Information’ screen within
a PMN, Biotechnology, NOC, or Support form; the ‘General Document Information’ screen
within a Bona Fide Notice; or the ‘Contact Information’ screen within an ACM form. The
‘Alias’ column will display a default alias comprised of a form type, date stamp, and time
stamp in the following format: 
if you accept the system-generated ‘Form Alias’ on the first screen in a Section 5 Notices and Supports form. A form alias is helpful when a user or company has multiple forms and/or when you must differentiate between forms. Click the form alias link to navigate to the ‘Enter Passphrase’ screen to access a form. • Type: Displays the form type pertaining to the reported chemical substance or mixture. This column can contain the following values: ‘Primary PMN,’ ‘Biotechnology,’ ‘Support,’ ‘NOC,’ ‘Bona Fide,’ or ‘ACM.’ • Subtype: Displays the form subtype pertaining to the form type for the reported chemical substance or mixture. − This column contains one of the following values for a PMN form: ‘MOCK_SUBMISSION,’ ‘LOREX_MODIFICATION,’ (Low Release/Low Exposure Exemption Modification) ‘LVE_MODIFICATION,’ (Low Volume Exemption TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 10 Modification) ‘LOREX,’ ‘LVE,’ ‘TMEA,’ (Test Marketing Exemption Application) ‘SNUN,’ (Significant New Use Notice) or ‘PMN.’ − This column contains the following values for a Biotechnology form: ‘MCAN,’ (Microbial Commercial Activity Notice) ‘TERA,’ (TSCA Experimental Release Application) ‘TIER1,’ ‘TIER2,’ or ‘Biotechnology_TME’ (Biotechnology Test Market Exemption). − This column contains the following values for a Support form: ‘Amendment,’ ‘Test Data,’ ‘Transfer Of Ownership,’ ‘Withdrawal Request,’ ‘Suspension Request,’ or ‘Other Correspondence.’ − NOC forms, ACM forms, and Bona Fide Notices do not have subtypes. • Case Number: Displays the form case number pertaining to the reported chemical substance or mixture after EPA receives the submission. In all cases, the ‘XX’ represents the fiscal year in which the form was submitted, and the ‘XXXX’ represents the order in which the form was received. A consolidated submission will generate sequential case numbers for each chemical identified within the form and will display all case numbers associated with that specific form. If the form has not been submitted and received, the ‘Case Number’ field remains blank. − A PMN submission can have the following case number formats: P-XX-XXXX for PMN, SN-XX-XXXX for SNUN, L-XX-XXXX for LVE, LM-XX-XXXX for LVE Modifications, X-XX-XXXX for LOREX, XM-XX-XXXX for LOREX Modifications, TXX-XXXX for TMEA, and I-XX-XXXX for Mock PMN notice types. − A Biotechnology form can have the following case number formats: J-XX-XXXX for MCAN, R-XX-XXXX for TERA, G-XX-XXXX for Tier I Exemption, H-XX-XXXX for Tier II. − Bona Fide forms will have a case number format of BF-XX-XXXX. − ACM forms will have a case number format of ACM-XX-XXXX. − NOC and Support forms will display user-specified case numbers. • Status: Displays the status of the Section 5 Notices and Supports form. The values will display as either ‘In Progress’ or ‘Submitted.’ • Modify Date: Displays the date the form was last modified. • Submission Date: Displays the date the form was submitted to EPA via CDX. This date populates only after the form has been submitted. • Copy of Record: Click the ‘Copy of Record’ icon ( ) to navigate to the ‘Enter Passphrase’ screen, then the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Login’ screen to continue to the ‘Copy of Record’ screen. The ‘Copy of Record’ icon ( ) displays only after the form has been completed. Refer to Section 13 for further instructions on downloading the copy of record. If you have just submitted via CDX, the ‘Copy of Record’ icon ( ) may take 15-20 minutes to display. In addition, you must refresh the ‘Section 5 Notices and Supports Forms’ screen for the ‘Copy of Record’ icon ( ) to display. • Action: Displays a ‘Delete’ icon ( ) for all forms with a status of ‘In Progress.’ Click the ‘Delete’ icon to delete a form. This column displays a ‘Lock’ icon ( ) for all forms that TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 11 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. • Export Options: Displays ‘CSV,’ ‘Excel,’ ‘XML,’ and ‘PDF’ links for you to export the ‘Section 5 Notices and Supports Forms’ screen in one of the specified formats as an Excel spreadsheet, Comma-Separated Values (CSV) file, XML file, or portable document format (PDF). The export options section will not display until a form is created. • Form Type: Select the form type that you would like to create from the drop-down menu. This drop-down menu contains the following values: ‘Premanufacture Notice (PMN),’ ‘Support,’ ‘Notice of Commencement (NOC),’ ‘Biotechnology,’ ‘Bona Fide,’ and ‘Alternative Control Measures (ACM).’ This drop-down menu is only available to Primary Authorized Officials and Primary Agents/Consultants. • Start New Form: Click this button to start a new form after selecting a form type and navigate to the ‘Create Passphrase’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 12 Exhibit 3-5 shows a screen capture of the ‘Section 5 Notices and Supports Forms’ screen: Exhibit 3-5: Section 5 Notices and Supports Forms Screen Navigation: Select a form type from the ‘Form Type’ drop-down menu and click the ‘Start New Form’ button to navigate to the ‘Create Passphrase’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 13 3.5 Create Passphrase To start a new Section 5 Notices and Supports form, select a form type from the ‘Form Type’ drop-down menu, and click the ‘Start New Form’ button on the ‘Section 5 Notices and Supports Forms’ screen to navigate to the ‘Create Passphrase’ screen, which allows you to create a passphrase and associate that passphrase with your newly created form. The application uses the passphrase as an encryption key to protect the contents of the form. You are responsible for remembering the passphrase and distributing it to the appropriate individuals. If you forget the passphrase, you will not have access to the form and will not be able to view, print, submit, or make changes. If you lose or forget the passphrase, you must create a new form and passphrase. For security reasons, the system administrator does not have access to the passphrase and will not be able to retrieve it or reset it to a new one. New Passphrase: To associate a passphrase with a form, enter a passphrase that is at least eight (8) characters in length. To protect your account, your passphrase should contain a combination of letters and numbers. The passphrase you create may include spaces, but should not contain special characters (for example, +, ?, and *). You can associate the same passphrase with multiple forms. You will be responsible for remembering the passphrase and distributing it to only authorized Supports for an individual form. If you forget the passphrase, you will not be able to access the Section 5 Notices and Supports form to print, submit, or make changes. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 14 Exhibit 3-6 shows a screen capture of the ‘Create Passphrase’ screen for a Primary Authorized Official: Exhibit 3-6: Create Passphrase Screen Navigation: Create a passphrase and click the ‘Next’ button to navigate to the ‘General Form Information’ screen in a PMN, Biotechnology, NOC, or Support form. Click the ‘Next’ button to navigate to the ‘General Document Information’ screen in a Bona Fide Notice. Click the ‘Next’ button to navigate to the ‘Contact Information’ screen in an ACM form. 3.6 Attach Documents The ‘Attach Document’ button displays on various screens within a Section 5 Notices and Supports form, and provides functionality for you to attach supporting documents where needed. Click the ‘Attach Document’ button displayed on a screen to access the ‘Attach Documents’ pop-up window. You can attach a file and enter a description, number of pages, and indicate CBI status. There is no limit on the size of the file that can be attached; however, the application prevents a user from uploading an empty document. The system allows you to claim an uploaded document as CBI. If you claim a document as CBI, the system requires you to upload a sanitized version of the attached document. If you wish to TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 15 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. For additional information regarding document types, refer to Exhibit 3-7. This is a required field. • Subtype: Select the document subtype from the drop-down menu of the document that you upload. For additional information regarding document subtypes, refer to Exhibit 3-7. This is a required field when displayed. • Attachment: Click the ‘Browse’ button to generate the ‘File Upload’ window to search for a document on your hard drive. The application prevents the upload of empty documents. The attached file can be one of the following file types: .pdf, .ppt, .pptx, .xls, .xlsx, .doc, .docx, .rtf, .txt, .gif, .jpg, .png, .bpm, .fas, .gbk, or .embl. • Description: Enter a description associated with the attached document. Submitters should not include any CBI information in the document description. This is a required field. • Number of Pages: Enter the number of pages in a document. This is a required field. • Check to claim the attachment as CBI: Check the ‘CBI’ checkbox to claim the attached document as confidential. Un-checking the ‘CBI’ checkbox for a CBI document generates a warning notifying you that un-checking the CBI claim will delete the sanitized file. • Sanitized Attachment: Click the ‘Browse’ button to generate the ‘File Upload’ window to search for a document on your hard drive. The attached file can be one of the following file types: .pdf, .ppt, .pptx, .xls, .xlsx, .doc, .docx, .rtf, .txt, .gif, .jpg, .png, .bpm, .fas, .gbk, or .embl. For any attached document claimed as CBI, you will be required to attach a sanitized version of the document. • Cancel: Click the ‘Cancel’ button to cancel the attach document process. • OK: Click the ‘OK’ button to attach and link the document uploaded on the ‘Attach Documents window to the form. If a field is missing, a warning message will display notifying you that all attachments must be re-attached and the missing field must be populated. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 16 Exhibit 3-7 displays a table of the document types and subtypes for each Section 5 Notices and Supports form: Exhibit 3-7: Section 5 Document Types and Subtypes Form Type PMN & Support Document Type Document Subtypes 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 Genetic Toxicity • Chromosomal Aberrations Assay • Genetic Mutation Assay • Unscheduled DNA (Deoxyribonucleic acid) Synthesis TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 17 Form Type Document Type Health Toxicity Document Subtypes • Acute Toxicity • Carcinogenicity • Combined RepeatedDose/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 Biotechnology Terrestrial Ecotoxicity • Avian Toxicity • Invertebrate Toxicity • Plant Toxicity 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 TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 18 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 TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 19 Exhibit 3-8 shows a screen capture of the ‘Attach Documents’ pop-up window that displays within the majority of forms: Exhibit 3-8: Attach Documents Pop-Up Window 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 20 3.7 Enter Passphrase To edit a form click the ‘Alias’ link for a Section 5 Notices and Supports form with a status of ‘In Progress’ on the ‘Section 5 Notices and Supports Forms’ screen. The ‘Enter Passphrase’ screen requires you to enter the passphrase that is associated with the form. Enter Passphrase: Enter the passphrase that you originally created and associated with the form. Exhibit 3-9 shows a screen capture of the ‘Enter Passphrase’ screen: Exhibit 3-9: Enter Passphrase Screen Navigation: Enter the passphrase that you originally created and associated with the form and click the ‘Next’ button to navigate to the ‘General Form Information’ screen in a PMN, Biotechnology, NOC, or Support form. Click the ‘Next’ button to navigate to the ‘General Document Information’ screen in a Bona Fide Notice. Click the ‘Next’ button to navigate to the ‘Contact Information’ screen in an ACM form. 3.8 Navigation Tree The navigation tree is located on the left hand side of each screen. It allows you to navigate between the various screens within the application and the different sections of the form. You can perform the following functions using the navigation tree: • Open and close the navigation tree: A navigation arrow that opens and closes the navigation tree is located to the right of the navigation tree to provide more visual form space. Click the arrow ( ) on the open navigation tree to close the navigation tree and TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 21 increase the space of the form content. Likewise, click the arrow ( ) on the closed navigation tree to open the navigation tree. • Collapse and expand folders: Each section of the form falls under a collapsible folder within the navigation tree, which allows you to save space or easily view items in the navigation tree. When a folder is expanded, you can click the minus sign (-), the ‘Folder’ icon ( ), or the folder title link to collapse that section of the navigation tree. When a folder is collapsed, you can click the plus sign (+), the ‘Folder’ icon ( ), or the folder title link to expand that section of the navigation tree. When you place your cursor over a folder title link, it will highlight in red. • Navigate between screens: You can use the navigation tree to navigate between the various screens within the application and the different sections of the form. A ‘Form’ icon ( ) denotes each section of a form. Click a ‘Form’ icon ( ) or a section title link to navigate between screens. You are required to save all information entered on a particular screen before navigating to the next screen or all entered information will be lost. A prompt will appear after you click a link in the navigation tree indicating, ‘Are you sure you want to leave the current page? Any unsaved changes will be lost.’ Click the ‘OK’ button to navigate to the requested screen without saving any of the data in the previous screen. Click the ‘Cancel’ button to close the prompt and remain on the current screen. Exhibit 3-10 shows a screen capture of the navigation prompt pop-up window: Exhibit 3-10: Navigation Prompt Pop-Up Window • 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 22 • Delete chemical folders: Click the ‘Delete’ icon ( ) that displays at the bottom of each chemical folder within the navigation tree of a PMN form to delete specific chemical folders. When a chemical folder is deleted, all information entered within the deleted chemical folder is lost and cannot be retrieved. Click the ‘Add Consolidated Chemical’ link and fill in all corresponding data to add a new chemical report. This delete functionality is not applicable to the Biotechnology, NOC, Support, Bona Fide Notice, or ACM forms, and is unavailable when amending a PMN form. • Copy chemical folders: Click the ‘Copy’ icon ( ) that displays at the bottom of each chemical folder within the navigation tree of a PMN form to copy a specific chemical folder. When a chemical folder is copied, the chemical name, Chemical Abstracts Service Registry Number (CASRN), and attached documents are removed from the copied chemical. This copy functionality is not applicable to the Biotechnology, NOC, Support, Bona Fide, or ACM forms, and is unavailable when amending a PMN form. • Delete ‘Submitter Controlled Operations’ or ‘Operations Controlled By Others’ folders: Click the ‘Delete’ icon ( ) that displays at the bottom of each ‘Submitter Controlled Operations’ or ‘Operations Controlled by Others’ folder within the navigation tree to delete a specific operations folder. When a ‘Submitter Controlled Operations’ or ‘Operations Controlled by Others’ folder is deleted, all information entered within the deleted operation is lost and cannot be retrieved. Click the ‘Add Operation’ link under the appropriate operations folder and fill in all corresponding data to add a new ‘Submitter Controlled Operations’ or ‘Operation Controlled by Others’ folder. The delete functionality is not applicable while a user is navigating on a screen within the ‘Operations Controlled by Others’ folder. This delete functionality is not applicable to the Biotechnology, NOC, Support, Bona Fide Notices, or ACM forms. • Upload XML: The system displays an ‘Upload XML’ button in the navigation tree to allow a user to upload an XML file into a PMN form or joint PMN form, or to export an existing PMN form into an XML file format. A user may also upload eTSCA thick client files into a PMN form. If an XML file is uploaded into an existing form, the contents of that XML file overwrite the contents within the PMN form. For more information about the upload XML functionality, refer to Section 4.1.35. Please note that in IE 7, the scroll bar within the navigation tree may freeze or portions of the scroll bar may be missing which can prevent you from using the navigation tree. If the scroll bar freezes, click the ‘Previous’ and ‘Next’ buttons on a page to navigate, or click other links within the navigation tree to continue within the form. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 23 Exhibit 3-11 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 1): Exhibit 3-11: Premanufacture Notice Navigation Tree (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 24 Exhibit 3-12 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 2): Exhibit 3-12: Premanufacture Notice Navigation Tree (Scroll 2) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 25 Exhibit 3-13 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 3): Exhibit 3-13: Premanufacture Notice Navigation Tree (Scroll 3) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 26 Exhibit 3-14 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 4): Exhibit 3-14: Premanufacture Notice Navigation Tree (Scroll 4) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 27 Exhibit 3-15 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 5): Exhibit 3-15: Premanufacture Notice Navigation Tree (Scroll 5): TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 28 Exhibit 3-16 shows a screen capture of the Biotechnology navigation tree: Exhibit 3-16: Biotechnology Navigation Tree TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 29 Exhibit 3-17 shows a screen capture of the NOC navigation tree: Exhibit 3-17: Notice of Commencement (NOC) Navigation Tree Exhibit 3-18 shows a screen capture of the Support navigation tree: Exhibit 3-18: Support Navigation Tree TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 30 Exhibit 3-19 shows a screen capture of the Bona Fide navigation tree (Class 2 Substance): Exhibit 3-19: Bona Fide Navigation Tree (Class 2 Substance) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 31 Exhibit 3-20 shows a screen capture of the Bona Fide navigation tree (Polymer): Exhibit 3-20: Bona Fide Navigation Tree (Polymer) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 32 Exhibit 3-21 shows a screen capture of the ACM navigation tree: Exhibit 3-21: Alternative Control Measures (ACM) Navigation Tree 3.9 Action Bar The action bar is located at the bottom of the form on each screen. You can perform the following functions using the action bar: • Validate: Click the ‘Validate’ icon ( ) at any stage of completing a Section 5 Notices and Supports form. A ‘Section 5 Notices and Supports Validation’ pop-up window generates when you click the ‘Validate’ icon ( ) if you disable the pop-up blocker within your internet browser. The ‘Section 5 Notices and Supports Validation’ pop-up window displays a report of all warning messages and validation errors. On screens that display an expandable/collapsible field set, you must click the ‘Save’ button displayed within the expandable/collapsible field set to save the information entered within the field set before the ‘Validate’ functionality initiates. Refer to Section 11 for more information on validating a form. The following exhibits, Exhibit 3-22, Exhibit 3-23, Exhibit 3-24, and Exhibit 3-25 show screen captures for the action bar: Exhibit 3-22: Action Bar - Validate • 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 TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 33 within the expandable/collapsible field set to save the information entered before being able to click the ‘Save’ icon ( ) located within the action bar or use the ‘Previous’ and ‘Next’ buttons to navigate to another page. Click the ‘Previous’ and ‘Next’ buttons on a form to save the data entered within a form. Click the ‘X’ button in the upper right-hand corner of the form in your browser to close the form without saving. Exhibit 3-23: Action Bar - Save • Preview: Click the ‘Preview’ icon ( ) at any stage of completing a Section 5 Notices and Supports form to preview the form. After you click the ‘Preview’ icon ( ), you will be given the option to view a regular version of the PDF (the confidential business information (CBI) version of the form or the non-CBI version if the form contains no CBI) or a sanitized version of the PDF. Choosing either option will generate and display a watermarked PDF of the form in a separate tab of your internet browser. Please note that attachment header sheets no longer generate within the PDF. Exhibit 3-24: Action Bar - Preview • Submit: You can click the ‘Submit’ icon ( ) to submit a Section 5 Notices and Supports form after you and/or an assigned Support have completed all sections of a Section 5 Notices and Supports form. After you click the ‘Submit’ icon ( ) a pop-up message displays to confirm the submission process. The form validates during the submission process and displays any applicable warning or error messages. Refer to Section 11 for further instructions on validation errors. You can continue with the submission process only after clearing all validation errors. Validation warnings will not prevent you from submitting a form. Upon successful submission of the form, the application generates and sends an email indicating the successful submission of the form to the submitter’s email address. Refer to Section 12 for more information on submitting a Section 5 Notices and Supports form. Exhibit 3-25: Action Bar - Submit 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 34 • Help Links: You can click the ‘Help’ links, located at the bottom of each screen, at any stage of completing a Section 5 Notices and Supports form. − If you click the ‘CDX Homepage’ link, the application takes you to the CDX Homepage. − If you click the ‘MyCDX Homepage’ link, the application takes you to the CDX Login screen. − If you click the ‘EPA Homepage’ link, the application takes you to the EPA Homepage. − If you click the ‘Terms and Conditions’ link, the application takes you to the CDX Terms and Conditions screen. − If you click the ‘Privacy Notice’ link, the application takes you to the CDX Privacy and Security Notice screen. Exhibit 3-26 shows a screen capture of the action bar ‘Help’ links: Exhibit 3-26: Action Bar - Help Links 3.10 Search Substance Registry Services (SRS) The ‘Search SRS’ button displays on various screens within a Section 5 Notices and Supports form to identify chemicals that may be stored in SRS. Search SRS: Click the ‘Search SRS’ button to generate the ‘Search Substance Registry Services’ pop-up window. You can search for the reported chemical(s) by either the ‘Chemical Abstracts Service Registry Number (CASRN)’ or ‘CA Index Name or Other Synonym.’ The application also offers the option of entering user-specified chemical information by clicking the ‘Create New Chemical’ button. Click the ‘Create New Chemical’ button to generate the ‘Chemical Not Found In Substance Registry Services’ pop-up window and enter chemical information by filling in the ‘Chemical Name’ and ‘CASRN’ (if desired) field under the manual entry field set. The system allows you to enter each chemical by clicking the ‘OK’ button located at the bottom of the ‘Search SRS’ window. Once you enter all known chemical information and click the ‘OK’ button, the chemical information saves and populates into the chemical description table. The ‘Actions’ column of the chemical table allows you to delete chemicals that have been added. The Section 5 Notices and Supports application contains functionality to prevent a user from adding duplicate chemicals within a multi-component submission. The application checks chemicals in the following order: • If both chemicals have CASRNs, they will be compared. • If only one chemical has a CASRN, they will not be compared and are considered different. • If neither chemicals have CASRNs, their chemical names will be compared. An error message generates within the expandable/collapsible field set if a user attempts to add a duplicate chemical within a multi-component submission. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 35 Please note in IE 7, the CSPP logo might be misaligned in the ‘Search Substance Registry Services’ window. • CASRN: Enter the chemical abstracts service registry number of the chemical; this field accommodates dashes. Either the ‘CASRN’ or ‘CA Index Name or Other Synonym’ field is required when searching SRS. • CA Index Name or Other Synonym: Enter the chemical abstract ‘(CA) Index Name or Other Synonym’ of the chemical. This field displays the following options: ‘Matches Exactly,’ ‘Contains,’ and ‘Begins With.’ Either the ‘CASRN’ or ‘CA Index Name or Other Synonym’ field is required when searching SRS. • Search SRS: Click the ‘Search’ button to initiate the database search for the ‘CASRN’ or ‘CA Index Name or Other Synonym’ for the desired chemical. Refer to Section 3.10 for additional details regarding the search SRS functionality. • Create New Chemical: Click the ‘Create New Chemical’ button to generate the ‘Chemical Not Found In Substance Registry Services’ pop-up window. Exhibit 3-27 shows a screen capture of the ‘Search Substance Registry Services’ pop-up window: TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 36 Exhibit 3-27: Search Substance Registry Services Pop-Up Window Navigation: Click the ‘Search SRS’ button on the ‘Search Substance Registry Services’ window to initiate the database search for the ‘CASRN’ or ‘CA Index Name or Other Synonym.’ After SRS returns results, select the radio button associated to a chemical, click the ‘OK’ button on the ‘Search SRS’ window, close the ‘Search Substance Registry Services’ window, and navigate back to the screen from which the SRS search was initiated where the chemical information will be populated. If the chemical is not found in the ‘Search Substance Registry Services’ window, click the ‘Create New Chemical’ button to generate the ‘Chemical Not Found In Substance Registry Services’ pop-up window. • CBI: Check the ‘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’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 37 window for the ‘Class 1 or 2 Chemical Substances,’ ‘Polymer Identification Information,’ or the ‘Monomers and Other Reactants’ screen. • Chemical Name: Enter the chemical name. This is a required field. • CASRN: Enter the CASRN, if available. • Maximum Percent: Enter the maximum percentage for the impurity. This field displays only in the ‘Chemical Not Found In Substance Registry Services’ window on the ‘Additional Chemical Information’ screen. • Cancel: Click the ‘Cancel’ button to navigate back to the ‘Search Substance Registry Services’ pop-up window. • OK: Click the ‘OK’ button to enter the manually entered chemical information into the fields on the screen from which the SRS search was initiated. Exhibit 3-28 shows a screen capture of the ‘Chemical Not Found In Substance Registry Services’ pop-up window: TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 38 Exhibit 3-28: Chemical Not Found In Substance Registry Services Pop-Up Window 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 39 3.11 Add Facility The ‘Add Facility’ button displays on the ‘Submitter Operation Information’ screen and the ‘Industrial Sites Controlled By Others’ screen within a PMN form. This button also displays on the ‘Site Information’ screen within a NOC form and the ‘Submitter Site Identification’ screen within a Bona Fide Notice. The ‘Add Facility’ button is used to generate the ‘Add Facility’ popup window and select the applicable sites for which you will be reporting. The ‘Add Facility’ drop-down menu contains the sites that all AO users within the same organization are registered for within CDX registration; additional facilities can be added within CDX to further populate this drop-down menu. If you are not registered to any facilities within CDX registration, or you have finished identifying all possible sites, a message displays within a pop-up window notifying you to add additional sites within your CDX registration profile to add additional sites to a form. Click the ‘Add Facility’ button to generate the ‘Add Facility’ pop-up window which displays the following fields: ‘Select a site from the drop-down menu below,’ ‘CBI,’ ‘Alias,’ ‘EPA Registry ID,’ ‘Facility Name,’ ‘Facility Address,’ ‘City,’ ‘State,’ and ‘Postal Code.’ Each individual site may be claimed as CBI. • Select a site from the drop-down menu below: Select a single or multiple sites from the drop-down menu that you will be reporting on. • CBI: Check the ‘CBI’ checkbox to claim the facility information as confidential. • Alias: Enter the site alias. This is a required field if a Joint Submission or Letter of Support is pending for the form. • EPA Registry ID: Displays the EPA registry ID of the site selected from the drop-down menu. • Facility Name: Displays the name of the site selected from the drop-down menu. • Facility Address: Displays the address of the site selected from the drop-down menu. • City: Displays the city of the site selected from the drop-down menu. • State: Displays the state of the site selected from the drop-down menu. • Postal Code: Displays the postal code of the site selected from the drop-down menu. • Add Facility: Click the button to add the selected site to the main page from which you are initiating the search. • Cancel: Click the button to cancel the process of adding a site. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 40 Exhibit 3-29 shows a screen capture of the ‘Add Facility’ pop-up window: Exhibit 3-29: Add Facility Message Pop-Up Window TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 41 Exhibit 3-30 shows a screen capture of the ‘Add Facility’ pop-up window: Exhibit 3-30: Add Facility Pop-Up Window TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 42 Navigation: Click the ‘Add Facility’ button to add the selected site to the screen from which you initiated the site identification process. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 43 4 Create Premanufacture Notice (PMN) Form Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by Section 5 of TSCA to provide EPA with notice before initiating the activity, known as a PMN form. A PMN must be submitted at least ninety (90) days prior to the manufacture or import of the chemical. 4.1 Create PMN Form To create a new PMN form, navigate to the ‘Section 5 Notices and Supports Forms’ screen and select ‘Premanufacture Notice (PMN)’ from the ‘Form Type’ drop-down menu. Refer to Section 3.4 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen. Refer to Section 3.5 for additional details regarding the create passphrase process. 4.1.1 General Form Information You can navigate to the ‘General Form Information’ screen by clicking the ‘Start New Form’ button and creating a new passphrase, or by accessing a Section 5 Notices and Supports form that is in progress and entering the passphrase associated with the selected form. The ‘General Form Information’ screen provides fields to input identifying information for a form. You will have the option to assign a ‘Form Alias’ to identify the form. A unique form alias is helpful when a user or company has multiple forms and/or when you must differentiate between forms to the help desk. Upon navigating to the ‘General Form Information’ screen, the system auto-generates a default alias comprised of a form type, date stamp, and time stamp in the following format: . The application contains the following functionality and may generate additional screens for a PMN form based on the type of notice selected from the ‘Type of Notice’ drop-down menu on the ‘General Form Information’ screen: • If you select ‘Premanufacture Notice (PMN)’ or ‘Significant New Use Notice (SNUN)’ from the ‘Type of Notice’ drop-down menu, the ‘Payment ID’ and the ‘TS Number’ fields are required. Click the ‘Next’ button to navigate to the ‘User Fees Certification’ screen. • If you select ‘SNUN’ from the ‘Type of Notice’ drop-down menu, it is recommended that a cover letter be provided. Otherwise, a warning message will display during validation of the form. • If you are not filing a PMN or SNUN, click the ‘Next’ button to navigate to the ‘Agent Information’ screen. • If ‘Low Volume Exemption (LVE) @ 40 CFR 723.50(c)(1)’ or ‘LVE Modification’ is selected from the ‘Type of Notice’ drop-down menu, a ‘LVE Certification’ screen generates and displays during the submission process. The ‘LVE Modification’ form type requires only identification of a technical contact, and selection of a ‘Manufacture’ or ‘Import’ option. • If ‘Low Release/Low Exposure Exemption (LOREX) @ 40 CFR 723.50(c)(2)’ or ‘LOREX Modification’ is selected from the ‘Type of Notice’ drop-down menu, a ‘LOREX Certification’ screen generates and displays during the submission process. The ‘LOREX Modification’ form type requires only identification of a technical contact, and selection of a ‘Manufacture’ or ‘Import’ option. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 44 • If ‘Test Marketing Exemption Application (TMEA)’ is selected from the ‘Type of Notice’ drop-down menu, click the ‘Next’ button to navigate to the ‘Agent Information’ screen. The ‘TMEA’ form type requires only identification of a technical contact, and selection of a ‘Manufacture’ or ‘Import’ option. The ‘PMN Identification’ section provides fields for you to enter information regarding other communications with EPA by entering a ‘TS Number’ and ‘Payment ID.’ The TS number is determined by a company and is used to identify the form for both payments and connecting related submissions when additional communications (Letters of Support, Joint Submissions, and corrections) are sent before a PMN/LVE case number has been assigned. The TS number can be any six (6) character alphanumeric combination. The TS number should include two (2), three (3), or four (4) letters. Company names, recognizable words, and numerical series are not recommended. A unique identification number for the form will generate later if a Letter of Support or Joint Submission is being filed. The ‘Payment ID’ is a user supplied alphanumeric value that corresponds to the method of payment used to submit the user fee (e.g. a check number, a wire transfer number, or a Pay.gov transaction number). The ‘Payment ID’ is a required field when you are filing a PMN or SNUN. The ‘Test Data’ section provides checkboxes to identify data that is included in the notice selected from the ‘Type of Notice’ drop-down menu. The following values will display as checkboxes: ‘Environmental fate data,’ ‘Health effects data,’ ‘Environmental effects data,’ ‘Physical/Chemical properties,’ ‘Risk assessments,’ ‘Structure/Activity relationships,’ ‘Test data not in the possession or control of the submitter,’ and ‘Other data.’ You are required to submit all test data in your possession or control and to provide a description of all other data known to or reasonably ascertainable by you if the data is related to the health and environmental effects on the manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance. Standard literature citations may be submitted for data in the open scientific literature. Complete test data (written in English), not summaries of data, must be submitted if they do not appear in the open literature. You should clearly identify whether test data is on the substance or on an analog. In addition, the chemical composition of the tested material should be characterized. Data should be submitted according to the requirements of §720.50 of the Premanufacture Notification Rule (40 Code of Federal Regulations (CFR) Part 720). The ‘Identify whether any of the below options apply’ section provides checkboxes for you to indicate how interactions with other companies occur within the form. If the company is filing a Joint Submission, a ‘Joint Submission’ folder generates within the navigation tree for you to enter information concerning the Joint Submission. A unique identification number will be generated and sent to the joint submitter by the primary submitter and will link the two forms together. You will also be able to indicate that a Letter of Support submitted by a Secondary AO is expected with the original PMN form. • Form Alias: Enter the form alias. Upon navigating to the screen, the application displays an auto-generated editable form alias in the following format: . This is a required field. • Type of Notice: Select a value to indicate the type of notice for the PMN form. Valid values include: ‘Premanufacture Notice (PMN),’ ‘Significant New Use Notice (SNUN),’ ‘Test TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 45 Marketing Exemption Application (TMEA),’ ‘Low Volume Exemption (LVE) @ 40 CFR 723.50 (c)(1),’ ‘Low Release/Low Exposure Exemption (LOREX) @ 40 CFR 723.50(c)(2),’ ‘LVE Modification,’ ‘LOREX Modification,’ and ‘Mock Submission.’ Select ‘PMN’ if the application is for a standard, fine-product new chemical substance for placement on the TSCA inventory. Select ‘Significant New Use Notice’ for any notice that is marked in accordance with a Significant New Use Rule (SNUR). Select ‘TMEA’ for any notice submitted in accordance with the criteria listed in 40 CFR §720.38. A ‘Mock Submission’ is an enforcement case where the chemical was manufactured/imported in the past and is not currently being manufactured/imported by the company. This is a required field. • TS Number: Enter the TS number related to the PMN form; this field accepts any six (6) character alphanumeric combination. It is used by the financial institution that receives payment for EPA when it notifies the Agency that the fee has been received. The TS number should include two (2), three (3), or four (4) letters. Company names, recognizable words, and numerical series are not recommended. TS numbers should be unique to the submission and should not be reused in subsequent submissions. This field is required if ‘Premanufacture (PMN)’ or ‘Significant New Use Notice (SNUN)’ is selected from the ‘Type of Notice’ dropdown menu. • Payment ID: The ‘Payment ID’ can be entered as free text, but refers to a check number, wire transfer number, or a Pay.gov transaction number used to electronically transmit a fee. This field is required if either ‘Premanufacture (PMN)’ or ‘Significant New Use Notice (SNUN)’ is selected from the ‘Type of Notice’ drop-down menu. • Environmental fate data: Check the ‘Environmental fate data’ checkbox to indicate that the form contains environmental fate data. • Health effects data: Check the ‘Health effects data’ checkbox to indicate that the form contains health effects data. • Environmental effects data: Check the ‘Environmental effects data’ checkbox to indicate that the form contains environmental effects data. • Physical/Chemical properties: Check the ‘Physical/Chemical properties’ checkbox to indicate that the form contains physical/chemical properties data. • Test data not in the possession or control of the submitter: Check the ‘Test data not in the possession or control of the submitter’ checkbox to indicate that the form contains test data not in the possession or control of the submitter. • Risk assessments: Check the ‘Risk assessments’ checkbox to indicate that the form contains risk assessments data. • Structure/Activity relationships: Check the ‘Structure/Activity relationships’ checkbox to indicate that the form contains structure-activity relationships (SAR) data. • Other data: Check the ‘Other data’ checkbox to indicate that the form contains other types of data. • Check here if you are filing a joint PMN: Check the ‘Check here if you are filing a joint PMN’ checkbox to indicate that the form is pending a joint PMN form. A ‘Joint Submission’ folder generates within the navigation tree upon clicking the ‘Save’ icon located at the TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 46 bottom of the screen within the action bar or by clicking the ‘Next’ button on the ‘General Form Information’ screen. • Check here if you have a Letter of Support pending: Check the ‘Check here if you have a Letter of Support pending’ checkbox to indicate that the form is pending a Letter of Support. A ‘Letter of Support’ folder displays within the navigation tree upon clicking the ‘Save’ icon located at the bottom of the screen within the action bar or by clicking the ‘Next’ button on the ‘General Form Information’ screen. Exhibit 4-1 shows a screen capture of the ‘General Form Information’ screen (Scroll 1): Exhibit 4-1: General Form Information Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 47 Exhibit 4-2 shows a screen capture of the ‘General Form Information’ screen (Scroll 2): Exhibit 4-2: General Form Information Screen (Scroll 2) Navigation: If you are filing a ‘PMN’ or ‘SNUN,’ click the ‘Next’ button to navigate to the ‘User Fees Certification’ screen. You can also access this screen by clicking the ‘User Fees Certification’ link within the navigation tree for an in progress form. If you are not filing a ‘PMN’ or ‘SNUN,’ click the ‘Next’ button to navigate to the ‘Agent Information’ screen. You can also access this screen by clicking the ‘Agent Information’ link within the navigation tree for an in progress form. The ‘Save’ icon in the action bar or the ‘Next’ button must be clicked before the links within the navigation tree generate and are available to a user. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 48 4.1.2 User Fees Certification You can access the ‘User Fees Certification’ screen by selecting ‘Premanufacture Notice (PMN)’ or ‘Significant New Use Notice (SNUN)’ from the ‘Type of Notice’ drop-down menu and by clicking the ‘Next’ button from the ‘General Form Information’ screen. You can also access this screen by clicking the ‘User Fees Certification’ link within the navigation tree for an in progress form. The purpose of the ‘User Fees Certification’ screen is to inform EPA of how the user fees were paid. You will have three (3) options to select from to notify EPA which user fee was selected. A company will indicate whether ‘$100’ was submitted for a small business, ‘$1,000’ was submitted for an intermediate PMN, or ‘$2,500’ was submitted for a large business. You can find the specifics of which category to file under by reviewing 40 Code of Federal Regulations (CFR) Section 700. • The Company named in Part 1, Section A has remitted the fee of $2,500 specified in 40 CFR 700.45(b): Select this radio button to indicate that you have submitted a user fee in the amount of $2,500. One of the three user fee options must be selected. • The Company named in Part 1, Section A has remitted the fee of $1,000 for Intermediate PMN (defined @ 40 CFR 700.43) in accordance with 40 CFR 700.45(b): Select this radio button to indicate that you have submitted a user fee in the amount of $1,000. One of the three user fee options must be selected. • The Company named in Part 1, Section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b): Select this radio button to indicate that you have submitted a user fee in the amount of $100. One of the three user fee options must be selected. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 49 Exhibit 4-3 shows a screen capture of the ‘User Fees Certification’ screen: Exhibit 4-3: User Fees Certification Screen 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 TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 50 ‘PMN’ or ‘SNUN.’ You can also navigate to this screen by clicking the ‘Agent Information’ link within the navigation tree. The ‘Agent Information’ screen provides fields for you to enter information regarding all parties involved in representing the PMN form. The agent should be a person who can answer questions about the form. The ‘Agent Information’ screen displays an ‘Add Agent’ button that generates the ‘Add Agent’ pop-up window for you to input the contact information on behalf of whom the submission is being made. You will be able to enter multiple agents; if the agent is the same individual who is filling out the form, click the ‘Copy CDX Registration’ button to retrieve user information entered during CDX registration. The system provides a checkbox for you to claim entered contact information as confidential by checking the ‘Check here to claim this information as CBI’ checkbox. Each agent will have an individual CBI claim. You will be able to enter contact information for each agent, and click the ‘OK’ button, which will populate the agent table located on the ‘Agent Information’ screen. Click the ‘Delete’ icon ( ) 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 Primary Authorized Official December 15, 2014 51 Exhibit 4-4 shows a screen capture of the ‘Agent Information’ screen: Exhibit 4-4: Agent Information Screen Navigation: Click the ‘Add Agent’ button to begin the process of adding agent information. Click the ‘Next’ button to navigate to the ‘Technical Contact Information’ screen. You can also access this screen by clicking the ‘Technical Contact Information’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 52 4.1.3.1 Add Agent Click the ‘Add Agent’ button to generate the ‘Add Agent’ pop-up window. Enter agent information into the fields displayed on the ‘Add Agent’ pop-up window. Click the ‘Cancel’ button to stop populating agent information. Click the ‘OK’ button after entering agent information to populate the information on the main ‘Agent Information’ screen. The identification of an agent is optional. • Copy CDX Registration: Click the ‘Copy CDX Registration’ button to display a prompt confirming the import of CDX registration information and allow the system to populate the agent information fields with your contact information provided during CDX registration. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim agent information as confidential. If the ‘CBI’ checkbox is checked before clicking the ‘Copy CDX Registration’ button, the ‘CBI’ checkbox will become unchecked upon navigating back to the pop-up window after copying CDX registration information. Check the ‘CBI’ checkbox after importing CDX registration information to claim agent information as confidential. • First Name: Enter the agent’s first name. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field only if agent information will be added to the form. • Last Name: Enter the agent’s last name. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field only if agent information will be added to the form. • Position: Enter the agent’s job title. • Company Name: Enter the agent’s company name. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field only if agent information will be added to the form. • Phone Number: Enter the agent’s daytime phone number: U.S. or international. This field does not allow dashes. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field only if agent information will be added to the form. • Phone Extension: Enter the agent’s daytime phone number extension. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. • Email Address: Enter the agent’s email address. The email address must follow the standard email address format: John.Doe@abc.com. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. • Mailing Address 1: Enter the first line of the agent’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field only if agent information will be added to the form. • Mailing Address 2: Enter the second line of the agent’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 53 • City: Enter the city of the agent’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field only if agent information will be added to the form. • State: Select the state of the agent’s mailing address from the drop-down menu. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field only if agent information will be added to the form and if the ‘Country’ field is set to ‘United States.’ This field is disabled if a non-US country is selected from the ‘Country’ drop-down menu. • Postal Code: Enter the postal code of the agent’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field only if agent information will be added to the form and if the ‘Country’ field is set to ‘United States.’ • Country: Select the country of the agent’s mailing address from the drop-down menu. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This field is automatically set to ‘United States’ if a value is selected from the ‘State’ drop-down menu. This is a required field only if agent information will be added to the form. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 54 Exhibit 4-5 shows a screen capture of the ‘Add Agent’ pop-up window: TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 55 Exhibit 4-5: Add Agent Pop-Up Window Navigation: Click the ‘Cancel’ button or the ‘X’ icon in the upper right-hand corner to stop populating agent information and navigate back to the ‘Agent Information’ screen. Click the ‘OK’ button to populate the entered agent information and navigate back to the ‘Agent Information’ screen. 4.1.4 Technical Contact Information You can access the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from the ‘Agent Information’ screen. You can also access this screen by clicking the ‘Technical Contact Information’ link within the navigation tree. The technical contact should be able to answer, or obtain answers to, questions related to the chemical submitted to EPA within the PMN form. The technical contact does not have to TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 56 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 Primary Authorized Official December 15, 2014 57 Exhibit 4-6 shows a screen capture of the ‘Technical Contact Information’ screen: Exhibit 4-6: Technical Contact Information Screen Navigation: Click the ‘Add Technical Contact’ button to begin the process of adding technical contact information. Click the ‘Next’ button to navigate to the ‘Additional Submission Information’ screen. You can also access this screen by clicking the ‘Additional Submission Information’ link within the navigation tree. 4.1.4.1 Add Technical Contact Click the ‘Add Technical Contact’ button to generate the ‘Add Technical Contact’ pop-up window. Enter technical contact information into the fields displayed on the ‘Add Technical Contact’ pop-up window. Click the ‘Cancel’ button to stop populating technical contact information. Click the ‘OK’ button to populate the entered technical contact information on the main ‘Technical Contact Information’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 58 • Copy CDX Registration: Click the ‘Copy CDX Registration’ button to populate the fields with your contact information provided during CDX registration. A prompt will display confirming the import of CDX registration information. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the technical contact information as confidential. If the ‘CBI’ checkbox is checked before clicking the ‘Copy CDX Registration’ button, the ‘CBI’ checkbox will become unchecked upon navigating back to the pop-up window after copying CDX registration information. Check the ‘CBI’ checkbox after importing CDX registration information to claim a technical contact as confidential. • First Name: Enter the technical contact’s first name. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field. • Last Name: Enter the technical contact’s last name. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field. • Position: Enter the technical contact’s job title. • Company Name: Enter the technical contact’s company name. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field. • Phone Number: Enter the technical contact’s daytime phone number. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field. • Phone Extension: Enter the technical contact’s phone number extension. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. • Email Address: Enter the technical contact’s email address. The email address must follow the standard email address format: John.Doe@abc.com. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. • Mailing Address 1: Enter the first line of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field. • Mailing Address 2: Enter the second line of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. • City: Enter the technical contact’s U.S. city of the mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field. • State: Select the state of the technical contact’s mailing address from the drop-down menu. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field. • Postal Code: Enter the postal code of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field. • Country: Displays ‘United States.’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 59 Exhibit 4-7 shows a screen capture of the ‘Add Technical Contact’ pop-up window: Exhibit 4-7: Add Technical Contact Pop-Up Window 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 60 4.1.5 Additional Submission Information You can access the ‘Additional Submission Information’ screen by clicking the ‘Next’ button from the ‘Technical Contact Information’ screen. You can also access this screen by clicking the ‘Additional Submission Information’ link within the navigation tree. The ‘Additional Submission Information’ screen gathers information concerning the PMN form that references generic information allowing EPA to set a base point for the project. The ‘Prenotice Communication Number’ is a number given to a user during past communication with EPA. The ‘Prenotice Communication Number’ is required if you are filing a consolidated PMN. EPA must approve all consolidated PMN forms prior to submission. The system will require that you either enter a number into the text field or check the ‘None’ checkbox. You may declare the entered identification number(s) confidential by checking the ‘CBI’ checkbox. EPA uses the ‘Previously Submitted Notice Number’ to link past, current, and future forms. This number allows EPA to associate previous renditions of the current submission in the PMN process. The system will require that you either enter a case number into the text field or check the ‘None’ checkbox. You may declare the entered identification number(s) confidential by checking the ‘CBI’ checkbox. The ‘Bona Fide Intent Notice Number’ is listed to show the company previously contacted EPA to determine whether the chemical in question was previously listed on the TSCA inventory. The system will require that you either enter a number into the text field or check the ‘None’ checkbox. You may declare the entered identification number(s) confidential by checking the ‘CBI’ checkbox. On this screen, a company must also declare whether the newly registered chemical will be manufactured or imported. You will have the option to select ‘Manufacture’ and/or ‘Import’ and depending on whether the company only intends to do one of the available options, the system provides ‘Binding’ checkboxes to indicate a binding option. If the ‘Manufacture’ checkbox is checked, the screens within the ‘Submitter Controlled Operations’ folder automatically generates upon clicking the ‘Save’ button located in the bottom action bar. The binding option demonstrates that you intend to only do the one option selected and would be willing to legally bind to that situation if EPA chooses to regulate that chemical. The purpose of the binding option is to enable EPA (if necessary) to efficiently negotiate with a PMN submitter the development of §5(e) consent orders and promulgate SNUR for those new chemical substances that the Agency determines may present an unreasonable risk if certain control actions are not implemented. This option is intended to reduce delays that can slow the development of consent orders. At one time, SNUR were limited to environmental release activities and certain industrial, commercial, or consumer activities, but now they can include other important activities, such as protection in the workplace and hazard communications. Control measures instituted by the submitter to reduce exposures and/or releases of the substance may have a direct bearing on the Agency's conclusions regarding risk. Therefore, you may wish to indicate your willingness to be bound to certain submitted information on the form, which relates to the issue of potential risk such as use, production volume, protective equipment, engineering controls, and/or process description. By indicating your willingness to make these commitments, you would be indicating an interest in future negotiations if EPA deems them necessary. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 61 Please note that in IE 7, leaving an identification number field blank and clicking the ‘Save’ icon located within the ‘Actions’ column header associated with an identification number does not cause the empty field to turn yellow. In addition, entering identification numbers with incorrect formats into the ‘Previously Submitted Notice Number’ field does not cause the field to turn yellow. • Prenotice Communication Number – None: Check the ‘None’ checkbox for the ‘Prenotice Communication Number’ to indicate that there is no prenotice communication number. Check the ‘None’ checkbox to remove the ‘Prenotice Communication #’ fields and associated actions. Un-check the ‘None’ checkbox to re-generate a ‘Prenotice Communication Number’ field and enter a value. • Prenotice Communication Number: Enter the prenotice communication number to associate with a previous contact with EPA. Click the ‘Save’ icon ( ) to save an individual entry. Click the ‘Form’ icon ( ) 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 ( ) to save an individual entry. Click the ‘Form’ icon ( ) 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 ( ) to save an individual entry. Click the ‘Form’ icon ( ) that displays after saving to edit an individual entry. Click the ‘Delete’ icon ( ) to delete individual entries. Click the ‘Add’ icon ( ) to generate blank TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 62 text fields to provide additional entries. This field is required, or the ‘None’ checkbox must be checked. • Bona Fide Intent Notice Number – CBI: Check the ‘CBI’ checkbox to claim all identified bona fide intent notice numbers as confidential. • Manufacture: Check the ‘Manufacture’ checkbox to claim the intent to manufacture. The screens within the ‘Submitter Controlled Operations’ folder automatically generate when the ‘Manufacture’ checkbox is checked. • Binding: Check the ‘Binding’ checkbox to claim intent to manufacture information as binding. • Import: Check the ‘Import’ checkbox to claim the intent to import. • Binding: Check the ‘Binding’ checkbox to claim intent to import information as binding. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 63 Exhibit 4-8 shows a screen capture of the ‘Additional Submission Information’ screen: Exhibit 4-8: Additional Submission Information Screen 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 64 4.1.6 Chemical Identification You can access the ‘Chemical Identification’ screen by clicking the ‘Next’ button from the ‘Additional Submission Information’ screen. You may also click the ‘Add Consolidated Chemical’ link within the navigation tree access the ‘Chemical Identification’ screen. The ‘Chemical Identification’ screen identifies the type of chemical the submitter will be entering into the application. You will be able to file a PMN form for a class 1 or 2 chemical substance or a polymer. Based on your selection, the appropriate screens for the respective chemical will appear. If you select the ‘Class 1 or 2 Chemical Substance’ radio button, click the ‘Save’ icon ( ) within the bottom action bar, or click the ‘Next’ button to generate the ‘Class 1 or 2 Chemical Substances’ screen within the navigation tree. If you identify the chemical as a polymer by selecting the ‘Polymer’ radio button, click the ‘Save’ icon ( ) within the bottom action bar, or click the ‘Next’ button to generate the ‘Polymer Identification Information’ screen and the ‘Monomers and Other Reactants’ screen within the navigation tree. This screen provides a field to identify an alias for the chemical substance, and allows you to identify chemicals in a consolidated chemical submission. The chemical alias is required if a Joint Submission or Letter of Support is being filed and renames the chemical folder within the navigation tree. • Class 1 or 2 Chemical Substance: Select the ‘Class 1 or 2 Chemical Substance’ radio button to indicate that the chemical is a class 1 or 2 substance. If you select the ‘Polymer’ radio button after initially selecting the ‘Class 1 or 2 Chemical Substance’ radio button, the application generates a confirmation message warning you that you will lose all data for this chemical if the chemical type changes. Selecting either the ‘Class 1 or 2 Chemical Substance’ or ‘Polymer’ radio button is required. • Polymer: Select the ‘Polymer’ radio button to indicate that the chemical is a polymer. If you select the ‘Class 1 or 2 Chemical Substance’ radio button after initially selecting the ‘Polymer’ radio button, the application generates a confirmation message warning you that you will lose all data for this chemical if the chemical type changes. Selecting either the ‘Class 1 or 2 Chemical Substance’ or ‘Polymer’ radio button is required. • Chemical Alias: Enter the chemical alias to associate with a chemical. This field will autogenerate 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 65 Exhibit 4-9 shows a screen capture of the ‘Chemical Identification’ screen: Exhibit 4-9: Chemical Identification Screen 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 66 If you selected the ‘Polymer’ radio button, click the ‘Next’ button to navigate to the ‘Polymer Identification Information’ screen. You can also navigate to this screen by clicking the ‘Polymer Identification Information’ link within the navigation tree. 4.1.7 Class 1 or 2 Chemical Substances You can access the ‘Class 1 or 2 Chemical Substances’ screen if you selected the ‘Class 1 or 2 Chemical Substance’ radio button on the ‘Chemical Identification’ screen and clicked the ‘Next’ button. You can also access this screen by clicking the ‘Class 1 or 2 Chemical Substances’ link within the navigation tree for an in progress form. The ‘Class 1 or 2 Chemical Substances’ screen provides fields for you to enter information describing the chemical for which the PMN is to be filed. This screen will outline the unique chemical properties that show the name, composition, and structure of the chemical. The system provides fields for you to identify several key aspects concerning a chemical’s identity. For a single component submission, create the field set by clicking the ‘Add New Chemical’ button. Upon clicking the ‘Add New Chemical’ button, the application generates an expandable/collapsible field set containing numerous fields for you to enter information pertaining to that particular chemical. For a multi-component submission, create another field set by clicking the ‘Add New Chemical’ button. Multi-component chemical submissions occur when two or more chemicals are always generated together in a single pot and are never isolated. Upon clicking the ‘Add New Chemical’ button, the application generates a field set containing numerous fields for you to enter information pertaining to that particular chemical. Enter additional chemical components, each with unique identifying information, by clicking the ‘Add New Chemical’ button for each additional chemical that is part of the multi-component mixture. All multi-component chemicals will reside in one chemical folder in the navigation tree. Duplicate chemicals are not allowed within a multi-component submission. For a consolidated submission, create and identify chemicals in separate chemical folders by clicking the ‘Add Consolidated Chemical’ link within the navigation tree. If you select the ‘Class 1’ radio button on the ‘Class 1 or 2 Chemical Substances’ screen, click the ‘Next’ button to navigate to the ‘Additional Chemical Information’ screen. If you select the ‘Class 2’ radio button on the ‘Class 1 or 2 Chemical Substances’ screen, click the ‘Next’ button to navigate to the ‘Class 2 Substances’ screen. For a class 1 substance chemical structure diagram, provide a complete and correct chemical structure diagram. A class 1 structural diagram should clearly and completely indicate the identity of the atoms and the nature and location of the bonds joining the atoms. Provide ionic charges and known stereo chemical details. Carbon atoms in ring systems do not need to be explicitly shown. For a class 2 substance chemical structure diagram: 1) List the immediate precursor substances with their respective CASRN. 2) Describe the nature of the reaction or process. 3) Indicate the range of composition and the typical composition (where appropriate). TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 67 4) Provide a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained. Provide partial, complete, or representative structural diagrams to the extent possible. The diagram should indicate the characteristic or variable compositional structural components of the substance. If you are unsure of the exact structure, provide the best information you have and indicate that it is your best estimate of the chemical structure. • Add New Chemical: Click the button to generate the class 1 or 2 chemical substances expandable/collapsible field set. • Cancel: Click the ‘Cancel’ link located in the upper right-hand corner of the expandable/collapsible field set to prevent edits from saving and to remove a field set. The ‘Cancel’ link displays when the expandable/collapsible field set is open for editing. A confirmation message displays to confirm the action. • Edit: Click the ‘Edit’ link located in the upper right-hand corner of the expandable/collapsible field set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has been saved and the data is not currently editable. • Delete: Click the ‘Delete’ icon ( ) 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.1.a. Class of Substance: In section B.1.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.1.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.1.a. Class of Substance’ section is required. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 68 • CBI: Check the ‘CBI’ checkbox to claim the ‘Class of Substance’ as confidential. • Search SRS: Click the ‘Search SRS’ button to generate the ‘Search Substance Registry Services’ pop-up window. Refer to Section 3.10 for additional details regarding the search SRS functionality. • CASRN: Displays the CASRN of the chemical identified on the ‘Search Substance Registry Services’ pop-up window, if applicable. • Chemical Name: Displays the chemical name of the chemical identified on the ‘Search Substance Registry Services’ pop-up window. For class 1 substances, a ‘Chemical Abstracts (CA) Index Name’ must be provided. For class 2 substances either a ‘CA Index Name’ or ‘CA Preferred Name’ must be provided, whichever is appropriate based on current CA nomenclature rules and conventions. This is a required field. • CBI: Check the ‘CBI’ checkbox to claim the ‘Chemical Name’ field as confidential and generate the ‘Generic Chemical Name’ text field. • B.6. Generic Chemical Name: Enter the generic name to associate with a chemical. This field only displays when ‘CASRN’ and ‘Chemical Name’ are marked as ‘CBI.’ This is a required field if there is no pending Letter of Support or Joint Submission for the form. • Method 1 (CAS Inventory Expert Service): Select the ‘Method 1 (CAS Inventory Expert Service)’ radio button to identify the ID method as the CAS Inventory Expert Service (IES) method and generate the ‘IES Order #’ field. A copy of the identification report obtained from the CAS Inventory Expert Services must be submitted as an attachment to this notice; an IES report is required. For a consolidated submission, each chemical must be ‘Method 1’ except when the submission is pending a Letter of Support for that chemical. In the case of an LVE/LOREX modification form type, this ‘Method 1’ requirement is not applicable. A single response option in the ‘B.1.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.1.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.1.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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 69 • Attachments: Select the section of the page the file is associated with that you intend to attach from the drop-down menu. This drop-down menu contains the following values: ‘Chemical Structure Diagram’ and ‘ID Method.’ This is a required field to upload an attachment. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for further details regarding the attach document functionality. • Section: Displays the section associated with a document. • File Name: Displays the file name and file extension of the file that is uploaded on the ‘Attach Documents’ pop-up window. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire document row permanently from the system; a warning message displays to confirm the deletion of the document. • Save: Click the button to save the information entered within the expandable/collapsible field set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.9 for more information regarding the save functionality in an expandable/collapsible field set. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 70 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) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 71 Exhibit 4-11 shows a screen capture of the ‘Class1 or 2 Chemical Substances’ screen (Scroll 2): Exhibit 4-11: Class 1 or 2 Chemical Substances Screen (Scroll 2) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 72 Navigation: If you select the ‘Class 1’ radio button, click the ‘Next’ button to navigate to the ‘Additional Chemical Information’ screen. You can also access this screen by clicking the ‘Additional Chemical Information’ link within the navigation tree. If you select the ‘Class 2’ radio button, click the ‘Next’ button to navigate to the ‘Class 2 Substances’ screen. You can also access this screen by clicking the ‘Class 2 Substances’ link within the navigation tree for an in progress form. 4.1.8 Class 2 Substances You can access the ‘Class 2 Substances’ screen by clicking the ‘Next’ button from the ‘Class 1 or 2 Chemical Substances’ screen when you select the ‘Class 2’ radio button for the ‘Class of Substance’ field. You can also access this screen by clicking the ‘Class 2 Substances’ link within the navigation tree for an in progress form. The ‘Class 2 Substances’ screen captures information regarding a class 2 chemical substance. A class 2 chemical substance is a substance that may not have a defined chemical structure that has been identified. This screen provides fields to identify specific elements in the creation of the chemical using the following fields: ‘Precursor Substances,’ ‘Nature of Reaction,’ and ‘Range of Composition.’ Enter precursor substances by searching SRS or using manual entry when the substance is not in SRS. The selected substances will display in a table listing the ‘Chemical Name’ and ‘CASRN.’ The system provides fields to capture ‘Nature of Reaction’ and ‘Range of Composition’ in text boxes. The ‘Nature of Reaction’ and ‘Range of Composition’ text boxes can be claimed as CBI. • B.1.e.1. Precursor Substances: This table captures the chemicals identified as immediate precursor substances, along with the respective CASRNs, if applicable. • CBI: Check the ‘CBI’ checkbox to claim the precursor substances information as confidential. • Search SRS: Click the ‘Search SRS’ button to generate the ‘Search Substance Registry Services’ pop-up window. Refer to Section 3.10 for additional details regarding the search SRS functionality. • Chemical Name: Displays the chemical name associated with a precursor substance. Click the chemical name link to generate the ‘Search SRS’ pop-up window to make edits. • CASRN: Displays the CASRN, if applicable, associated with a precursor substance. • Actions: Click the ‘Delete’ icon ( ) to delete the entire chemical row permanently from the system; a warning message displays to confirm the deletion of the chemical. • B.1.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.1.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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 73 • 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.1.e.1. Precursor Substances,’ ‘B.1.e.2. Nature of Reaction,’ and ‘B.1.e.3. Range of Composition.’ This is a required field. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window and initiate the document upload process. Refer to Section 3.6 for further details regarding the attach document functionality. • Section: Displays the section associated with a document. • File Name: Displays the file name and file extension of a file that is uploaded on the ‘Attach Documents’ window. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire document row permanently from the system; a warning message displays to confirm the deletion. Exhibit 4-12 shows a screen capture of the ‘Class 2 Substances’ screen (Scroll 1): TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 74 Exhibit 4-12: Class 2 Substances Screen (Scroll 1) Exhibit 4-13 shows a screen capture of the ‘Class 2 Substances’ screen (Scroll 2): TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 75 Exhibit 4-13: Class 2 Substances Screen (Scroll 2) Navigation: Click the ‘Next’ button to navigate to the ‘Additional Chemical Information’ screen. You can also access this screen by clicking the ‘Additional Chemical Information’ link within the navigation tree. 4.1.9 Additional Chemical Information You can navigate to the ‘Additional Chemical Information’ screen by selecting the ‘Class 1’ radio button on the ‘Class 1 or 2 Chemical Substances’ screen and clicking the ‘Next’ button, by clicking the ‘Next’ button on the ‘Class 2 Substances’ screen, or clicking the ‘Next’ button from the ‘Monomers and Other Reactants’ screen. You can also access this screen by clicking the ‘Additional Chemical Information’ link within the navigation tree. The ‘Additional Chemical Information’ screen captures information regarding the chemicals produced as byproducts and impurities when a chemical is manufactured. This screen also captures other names for the chemical at hand in the ‘Synonyms’ and ‘Trade Identification’ tables. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 76 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’ popup window. If there are unidentified impurities, enter “unidentified.” You also have the option of claiming the chemical as confidential by checking the ‘CBI’ checkbox. A ‘Maximum %’ field is also displayed which captures the maximum percentage for the impurity. Documents may be attached for the ‘Impurities’ section if necessary. A ‘Byproducts’ table provides fields to capture information regarding the byproducts that may be produced from the manufacture of the respective chemical or polymer. Click the ‘Search SRS’ button to access the ‘Search SRS’ pop-up window and populate the ‘Byproducts’ table. You may associate a CASRN with a byproduct (if applicable) and check the ‘CBI’ checkbox to claim a byproduct as confidential. Documents may be attached for the ‘Byproducts’ section if necessary. A ‘Synonyms’ table provides fields to capture the synonyms that the respective chemical or polymer may be referred to in the documentation. A maximum of five synonyms can be entered in the table. The search SRS functionality cannot be used to populate the ‘Synonyms’ table. You may attach documents associated with the ‘Synonyms’ section to provide additional synonyms if necessary. A ‘Trade Identification’ table provides fields to capture information about the trade names by which the respective chemical or polymer may be referred in documentation. There is no limit to the number of trade names that may be added. You may attach documents associated with the ‘Trade Identification’ section to provide additional information if necessary. The ‘Attach Documents’ pop-up window provides fields to upload documents related to the ‘Impurities,’ ‘Byproducts,’ ‘Synonyms,’ and/or ‘Trade Identification’ section(s). Select the section of the page the document is associated with from the ‘Section’ drop-down menu, and click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window and attach a document. The system provides a ‘CBI’ checkbox to claim the uploaded document as confidential. If you claim a document as CBI, the system requires you to upload the sanitized version of the attached document. If the sanitized version of the document is not provided, the Section 5 Notices and Supports form will fail validation upon navigating away from the ‘Attach Documents’ window. To view or edit previously attached documents, click the appropriate file name of the document within the ‘File Name’ column of the attachments table. The attachments table displays the section of the page the document is associated with, the file name and file extension of the document, the document description, the number of pages in the document, and if the document was claimed CBI. Click the ‘Delete’ icon ( ) located under the ‘Actions’ column to delete unwanted documents. Click a file name link in the ‘File Name’ column to generate the ‘Attach Documents’ pop-up window to view and/or edit an attached document. • B.3. Impurities – Search SRS: Click the ‘Search SRS’ button to display the ‘Search Substance Registry Services’ pop-up window. Refer to Section 3.10 for further details regarding the search SRS functionality. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 77 • 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 3.10 for further details regarding the search SRS functionality. • Byproduct Name: Displays the name of the byproduct. Describe any byproducts resulting from the manufacture, processing, use, or disposal of the new chemical substance. List any byproducts that you reasonably anticipate will result from the manufacture, processing, use and disposal of the new chemical substance at sites under your control. Click the ‘Byproduct Name’ link to generate the ‘Search Substance Registry Services’ pop-up window to view and/or edit byproduct information. Provide the specific chemical name, CAS numbers if they can be determined, and the confidential status of the byproducts formed. If no byproducts are formed, enter “None” or leave the section blank. • CASRN: Displays the CASRN for the byproduct (if applicable). • CBI: Indicates the CBI status of the byproduct by displaying either a ‘Y’ or an ‘N.’ • Action: Click the ‘Delete’ icon ( ) 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 ( ), edit the entered values and click the ‘Next’ button without saving the changed value, an error will generate. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 78 • Actions: Click the ‘Add’ icon ( ) to add a new text field to enter additional synonyms. Click the ‘Save’ icon ( ) to save a chemical synonym. Click the ‘Form’ icon ( ) 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 ( ), change the entered value(s) and click the ‘Next’ button without saving the changed value(s), an error message will generate. • Actions: Click the ‘Add’ icon ( ) to add a new text field to enter additional trade identification names. Click the ‘Save’ icon ( ) to save a trade identification name. Click the ‘Form’ icon ( ) to edit a trade identification name. Click the ‘Delete’ icon ( ) to delete a previously added trade identification name. • Attachments: Select the section of the page with which the document is associated from the drop-down menu. This drop-down menu contains the following values: ‘Byproducts Section,’ ‘Impurities Section,’ ‘Synonyms Section,’ and ‘Trade Identification Section.’ • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for further details regarding the attach document functionality. • Section: Displays the section of the page with which the document is associated. • File Name: Displays the file name and file extension of the file that is uploaded on the ‘Attach Documents’ pop-up window. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Action: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system; a warning message displays to confirm deletion of the document. Exhibit 4-14 shows a screen capture of the ‘Additional Chemical Information’ screen (Scroll 1): TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 79 Exhibit 4-14: Additional Chemical Information Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 80 Exhibit 4-15 shows a screen capture of the ‘Additional Chemical Information’ screen (Scroll 2): Exhibit 4-15: Additional Chemical Information Screen (Scroll 2) Navigation: Click the ‘Next’ button to navigate to the ‘Production Volume and Hazard/Safety Information’ screen. You can also access this screen by clicking the ‘Production Volume and Hazard/Safety Information’ link within the navigation tree. 4.1.10 Polymer Identification Information You can access the ‘Polymer Identification Information’ screen by clicking the ‘Next’ button from the ‘Chemical Identification’ screen if you select the ‘Polymer’ radio button. You can also access this screen by clicking the ‘Polymer Identification Information’ link within the navigation tree after selecting the ‘Polymer’ radio button on the ‘Chemical Identification’ screen. The ‘Polymer Identification Information’ screen captures information describing the polymer(s) for which the PMN will be filed. This screen outlines the unique chemical properties that show the name, composition, and structure of the polymer. The system will provide fields for you to identify several key aspects concerning a polymer’s identity. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 81 To reference a monomer cleared with an LVE, comments should be included in an attachment (for example, on a reaction scheme). Click the ‘Add New Chemical’ button to create a chemical field set. Upon clicking the ‘Add New Chemical’ button, an expandable/collapsible field set generates that contains numerous fields that pertain to the particular polymer. You are able to enter multiple chemical substances, each with unique information, by clicking the ‘Add New Chemical’ button for each chemical you wish to identify. For a single component submission, create the field set by clicking the ‘Add New Chemical’ button. Upon clicking the ‘Add New Chemical’ button, the application generates a field set containing numerous fields that captures information pertaining to that particular chemical. For a multi-component submission, click the ‘Add New Chemical’ button to create a field set. Multi-component chemical submissions occur when two or more chemicals always generate together in a single pot and are never isolated. Upon clicking the ‘Add New Chemical’ button, the application generates a field set that provides numerous fields to enter information pertaining to that particular chemical. Enter additional chemical substances, each with unique identifying information, by clicking the ‘Add New Chemical’ button for each additional chemical that is part of the multi-component mixture. All multi-component chemicals will reside in one chemical folder in the navigation tree. For a consolidated submission, create separate chemical folders by clicking the ‘Add Consolidated Chemical’ link within the navigation tree. A form may contain a maximum of six (6) separate chemical folders. • Add New Chemical: Click the ‘Add New Chemical’ button to generate a polymer identification information expandable/collapsible field set. • Cancel: Click the ‘Cancel’ link located in the upper right-hand corner of the expandable/collapsible field set to prevent edits from saving and to remove a field set. The ‘Cancel’ link displays when the expandable/collapsible field set is open for editing. A confirmation message displays to confirm the action. • Edit: Click the ‘Edit’ link located in the upper right-hand corner of the expandable/collapsible field set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has been saved and the data is not currently editable. • 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 3.10 for additional details regarding the search SRS functionality. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 82 • CASRN: Displays the CASRN of the chemical identified on the ‘Search SRS’ pop-up window, if applicable. • Chemical Name: Displays the name of the chemical that has been identified on the ‘Search SRS’ pop-up window. • CBI: Check the ‘CBI’ checkbox to identify the chemical as confidential. • Generic chemical name: Enter the generic name to associate with a chemical. This field displays when ‘Chemical Name’ and ‘CASRN’ are claimed CBI. This is a required field if there is no pending Letter of Support or Joint Submission for the form. • Method 1 (CAS Inventory Expert Service): Select the ‘Method 1 (CAS Inventory Expert Service)’ radio button to identify the ID method as the ‘CAS Inventory Expert Service’ method. Submit a copy of the identification report obtained from the CAS Inventory Expert Services as an attachment to this notice. For a consolidated submission, each chemical must be ‘Method 1’ except when the submission is pending a Letter of Support for that chemical. Select the ‘Method 1 (CAS Inventory Expert Service)’ radio button to generate the ‘IES Order #’ field. A single response option in the ‘ID Method’ section is required if there is no pending Letter of Support or Joint Submission for the form. • IES Order #: Select the ‘Method 1 (CAS Inventory Expert Service)’ radio button to generate this field. Enter the IES order number. This is a required field if the ‘Method 1 (CAS Inventory Expert Service)’ radio button is selected. • Method 2 (Other Method): Select the ‘Method 2 (Other Method)’ radio button to identify the ID method as ‘Other Method.’ An alternative method of providing a name, such as a STN database report or a CAS Client Services report, qualifies as ‘Method 2.’ If the chemical is pending a Letter of Support, the method can only be ‘Method 2.’ A single response option in the ‘ID Method’ section is required if there is no pending Letter of Support or Joint Submission for the form. • Attachments: Select the section of the page with which the document is associated from the drop-down menu. This drop-down menu contains the following values: ‘Chemical Structure Diagram’ and ‘ID Method.’ It is required that a document be attached for the ID Method if there is no pending Letter of Support or Joint Submission for the form. • Attach Document: Click the button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for additional details regarding the attach document functionality. • Section: Displays the section of the page with which the file is associated. • File Name: Displays the file name and file extension of a document that is uploaded on the ‘Attach Documents’ window. • Description: Displays the description of a document. • Pages: Displays the number of pages in a document. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm the deletion. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 83 • Save: Click the button to save the information entered within the expandable/collapsible field set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.9 for more information regarding the save functionality in an expandable/collapsible field set. Exhibit 4-16 shows a screen capture of the ‘Polymer Identification Information’ screen (Scroll 1): Exhibit 4-16: Polymer Identification Information Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 84 Exhibit 4-17 shows a screen capture of the ‘Polymer Identification Information’ screen (Scroll 2): Exhibit 4-17: Polymer Identification Information Screen (Scroll 2) 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 and Other Reactants You can navigate to the ‘Monomers and Other Reactants’ screen by clicking the ‘Next’ button from the ‘Polymer Identification Information’ screen. You can also access this screen by clicking the ‘Monomers and Other Reactants’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 85 The ‘Monomers and Other Reactants’ screen is used to identify the chemical measurements and monomers that make up a polymer. The screen is divided into two sections to identify different elements describing a polymer: ‘Polymer Weight Information’ and ‘Monomers and Other Reactants.’ In the ‘Monomers and Other Reactants’ section, enter the typical weight percent of each monomer or other reactant in the polymer. Enter the maximum weight percent of each monomer or other reactant that may be present as a residual in the polymer as manufactured for commercial purposes. The maximum residual should be less than the typical composition. Do not use parts per million (ppm) units (1 ppm = 0.0001 wt%). To reference a monomer cleared with an LVE, include an attachment detailing any specifics. Please note that in IE 7, the % symbols that display to the right of the ‘max. weight % below 500 molecular weight’ and ‘max weight % below 1000 molecular weight’ fields might be slightly misaligned. • CBI: Check the ‘CBI’ checkbox to claim the ‘Polymer Weight Information’ section as confidential. • Method of Measurement: Only a single response option can be selected for ‘Method of Measurement;’ valid values include ‘GPC’ and ‘Other (Specify).’ Gel-permeation chromatography (GPC) is a well-established method for establishing the number average molecular weight (Mn) and weight fractions below 500 and 1,000 Daltons. It may not be useful for all polymer evaluations; however, solubility problems and misleading calibration standards can lead to questionable GPC data. Correction estimates can be documented and presented in cases where only a soluble fraction of the polymer can be analyzed. This is a required field if there is no pending Letter of Support or Joint Submission for the form. • Specify other method of measurement: Enter the method of measurement when you select the ‘Other (Specify)’ radio button as the method of measurement. This is a required field when the ‘Other (Specify)’ radio button is selected. • (i) lowest number avg. molecular weight: Enter the lowest number average molecular weight; the entered value must be a positive numerical value and can contain decimal values. This is a required field if there is no pending Letter of Support or Joint Submission. • (ii) max. weight % below 500 molecular weight: Enter the maximum weight percentage below 500 molecular weight; the value entered must be a positive numerical value greater than or equal to zero (0), but less than or equal to one hundred (100) and can contain decimal values. This value must be less than or equal to the value specified in the ‘(iii) max. weight % below 1000 molecular weight’ field. This is a required field if there are no pending Joint Submissions or Letters of Support. • (iii) max. weight % below 1000 molecular weight: Enter the maximum weight percentage below 1,000 molecular weight; the value entered must be a positive numerical value greater than or equal to zero (0) but less than or equal to one hundred (100) and can contain decimal values. This value must be greater than or equal to the value specified in the ‘(ii) max. weight % below 500 molecular weight’ field. This is a required field if there are no pending Joint Submissions or Letters of Support. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 86 • Add Monomer: Click the ‘Add Monomer’ button to generate the monomer expandable/collapsible field set. • Cancel: Click the ‘Cancel’ link located in the upper right-hand corner of the expandable/collapsible field set to prevent edits from saving and to remove a field set. The ‘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 3.10 for additional details regarding the search SRS functionality. • Monomer or Other Reactant: Displays the monomer or other reactant name; this field populates based on information entered on the ‘Search SRS’ pop-up window. This is a required field. • Include in Identity: Check the ‘Include in Identity’ checkbox to claim the value for ‘Monomer or Other Reactant’ as part of the monomer identification. This checkbox is most applicable for monomers that are less than or equal to 2% since the monomer is not considered to be included in the identity unless this checkbox is checked. This checkbox appears when a value of ‘2’ or less is entered into the ‘Typical Composition’ text field. • CBI: Check the ‘CBI’ checkbox to claim the monomer or other reactant name and CASRN as confidential. • CAS Registry Number: Displays the CASRN for the specified monomer; this field populates based on information entered on the ‘Search SRS’ pop-up window. • Chemical Name: Displays the name of the chemical identified on the ‘Search SRS’ pop-up window. • Typical Composition: Enter the typical composition value that a monomer contributes to a polymer; the value entered must be a positive numerical value greater than zero (0) and less than or equal to one hundred (100) and can contain decimal values. If the value entered is less than or equal to ‘2’ a warning will be displayed in the global ‘Validate’ function or during the submission process indicating that the typical composition is a value that is less than or equal to 2 percent and asking you whether it should be included in the chemical identity. This is a required field, and the value must be greater than zero (0). TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 87 • CBI: Check the ‘CBI’ checkbox to claim the ‘Typical Composition’ and ‘Include In Identity’ fields as confidential. • Maximum Residual: Enter the maximum residual value. Indicate the maximum weight percent of each monomer or other reactant that may be present as a residual in the polymer as manufactured for commercial purposes. Enter a percent value less than or equal to the maximum weight; do not use ppm units (1 ppm = 0.0001 wt%). The value entered must be a positive numerical value that is less than or equal to the typical composition value. This is a required field. • CBI: Check the ‘CBI’ checkbox to claim the ‘Maximum Residual’ field as confidential. • Save: Click the button to save the information entered within the expandable/collapsible field set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.9 for more information regarding the save functionality in an expandable/collapsible field set. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for additional details regarding the attach document functionality. • File Name: Displays the file name and file extension of the document that is uploaded on the ‘Attach Documents’ pop-up window. Click the file name link to navigate to the ‘Attach Documents’ pop-up window to make any edits. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm the deletion of the document. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 88 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) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 89 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) Navigation: Click the ‘Next’ button to navigate to the ‘Additional Chemical Information’ screen. You can also access this screen by clicking the ‘Additional Chemical Information’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 90 4.1.12 Production Volume and Hazard/Safety Information You can navigate to the ‘Production Volume and Hazard/Safety Information’ screen by clicking the ‘Next’ button from the ‘Additional Chemical Information’ screen. You can also access this screen by clicking the ‘Production Volume and Hazard/Safety Information’ link within the navigation tree. The ‘Production Volume and Hazard/Safety Information’ screen collects different information regarding a chemical’s production and hazard elements. Production Volume: The ‘Production Volume’ section captures information about production for the respective chemical or polymer for the ‘Maximum first 12-month production’ and the ‘Maximum 12-month production.’ The ‘Maximum first 12-month production’ value should be less than or equal to the ‘Maximum 12-month production’ value. The maximum volume may not exceed 100,000,000,000,000 kg/year for either field. The entered values will automatically display decimal points upon navigating away from the page. Decimals are allowed up to the milligram (.000001). Estimates should be on a 100% new chemical substance basis. Your production volumes should be estimated as accurately as possible, but you are not bound to your estimates unless you check the ‘Binding’ checkbox and are creating an LVE or LVE modification submission. Include amounts you intend to produce for export. Provide an estimate of the first 12 months of production and the maximum production volume for any consecutive 12-month period during the first three (3) years of commercial manufacture. You may upload an attachment to enter additional production information. Hazard Information: The ‘Hazard Information’ section captures information regarding hazards that the company chooses to disclose. For EPA to take respirator use into account when evaluating risks posed by a new chemical, the MSDS (material safety data sheet) for the substance must specify a respirator that is appropriate for the types of anticipated exposures. For the same reason, all respirators must be certified by the National Institute for Occupational Safety and Health (NIOSH), and be referenced in the MSDS as “NIOSH certified” respirators. If any type of risk assessment is prescribed to determine personal protective equipment (PPE) requirements, such risk assessment must be performed by a qualified Industrial Hygienist (IH) or other authorized occupational safety and health specialist. Engineering controls are the preferred methods for managing workplace exposures to hazards. If these controls are inadequate or lacking, personal protective equipment must be used. For EPA to take glove use into account when evaluating risks posed by a new chemical, the MSDS for the substance must specify gloves that are impervious to the substances of concern, as well as suitable for the type of tasks. Close-fitting goggles or a full-face piece facemask are preferred for vapor, mist, or fume exposures, or wherever workplace contaminants can readily bypass loose-fitting equipment. The information is collected in a file attachment. The system will display instructional text for you to identify which forms should be uploaded. Provide the MSDS for the PMN substance or intermediate or product mixture (that contains it) as an attachment to the PMN. Also, include hazard warning statements or labels, if relevant. The personal protection requirements of the MSDS become integral requirements of an LVE notice. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 91 • CBI: Check the ‘CBI’ checkbox to claim the production volume information as confidential. • Binding: Check the ‘Binding’ checkbox to claim the production volume information as binding. This checkbox is enabled for LVE or LVE modifications only. • Maximum first 12-month production: Provide an estimate of the first 12 months of production. The entered value must be a numerical value and must be greater than zero but less than 100,000,000,000,000 kg/year. This field accepts decimals to the milligram and is a required field if you do not have a pending Joint Submission and/or Letter of Support. • Maximum 12-month production: Enter the data associated with the production volume. Provide an estimate of the maximum production volume for any consecutive 12-month period during the first three (3) years of commercial manufacture. The entered value must be a numerical value and must be greater than zero but less than 100,000,000,000,000 kg/year. This value must be greater than or equal to the ‘Maximum first 12-month production’ value. This field accepts decimals to the milligram and is a required field if you do not have a pending Joint Submission and/or Letter of Support. • Binding: Check the ‘Binding’ checkbox to claim the hazard information as binding. • Attachments: Select the section of the page with which the attached document is associated. This drop-down menu contains the following value: ‘Production Information Section’ and ‘Hazard Information Section.’ • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for additional details regarding the attach document functionality. • Section: Displays the section with which the document is associated. • File Name: Displays the file name and file extension of the file that is uploaded on the ‘Attach Documents’ pop-up window. Click the file name link to navigate to the ‘Attach Documents’ pop-up window to make any edits. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm the deletion. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 92 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 Navigation: Click the ‘Next’ button to navigate to the ‘Use Information’ screen. You can also access this screen by clicking the ‘Use Information’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 93 4.1.13 Use Information You can navigate to the ‘Use Information’ screen by clicking the ‘Next’ button from the ‘Production Volume and Hazard/Safety Information’ screen. You can also access this screen by clicking the ‘Use Information’ link within the navigation tree. The ‘Use Information’ screen captures data about how the new chemical substance is intended to be used by function and application. Function refers to the chemical purpose for which the substance is designed and is often based on the physical and chemical properties of the substance. Application refers to how the substance is used in particular processes or products. An example of a function and application would be as a dispersive dye for finishing polyester fibers. When you navigate to the screen, the screen contains instructional text and an ‘Add Use’ button. When you click the ‘Add Use’ button, an expandable/collapsible field set opens and displays the ‘Use Information’ fields. Upon saving the entry, the expandable/collapsible field set collapses and displays the ‘Category of Use’ and ‘Production %’ values. You will first enter a description for the ‘Category of Use’ field. Each use will center on the ‘Category of Use’ and the different variables surrounding it. The category of use information should be specific enough to allow EPA reviewers to anticipate potential exposure patterns for the new substance (e.g. merely indicating “Dye” is not sufficient – is it photographic dye, a reactive dye for nylon fibers, or a dye to be incorporated in a polymer making film?). LVE notices limit you to your stated category of use(s), so make sure your description fully encompasses all intended uses for any LVE. When you claim the ‘Category of Use’ as CBI, you are required to enter a ‘Generic Use Description.’ The generic use description will be available publicly. The table captures the different elements of use that the PMN form captures. The ‘Production %’ and ‘% in Formulation’ values will be captured to indicate how the product will be used and at what percent in that use. Each use must capture the percent of the production and percent in formulation for each category of use. The ‘Production %’ must equal up to 100% for all uses if there is no pending Letter of Support or Joint Submission for the form, and the field can be declared CBI. The ‘% in Formulation’ value can equal up to 100%, and the field can be declared CBI. The ‘% of substance expected’ per use is captured for the following categories: ‘Site Limited,’ ‘Consumer,’ ‘Industrial,’ and ‘Commercial.’ The ‘% of substance expected’ value must total 100%. The ‘% of substance expected’ values can be claimed as CBI or listed as binding. These use types are used to determine the risks that the chemical will place on society. • Add Use: Click the ‘Add Use’ button to add a new use information expandable/collapsible field set. • 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’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 94 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. • Category of Use: Enter the category of use for the specific chemical substance by function and application. This is a required field. • CBI: Check the ‘CBI’ checkbox to claim the category of use information as confidential and generate the ‘Generic Use Description’ field. Claiming the ‘Category of Use’ field as CBI and then un-checking the ‘CBI’ checkbox generates a confirmation message that all attached documents will be deleted. • Binding: Check the ‘Binding’ checkbox to claim the category of use information as binding. • C.2.b. Generic Use Description: Enter the generic use description of the chemical. This field displays when the ‘Category of Use’ field is claimed CBI. If you claim any category of use description as confidential, enter a generic description of that category. This field is required when the ‘Category of Use’ field is claimed CBI. • Total Production for this Use %: Enter an estimate of the percent of total production for the first three years devoted to each category of use for the specific chemical. The entered value must be a value greater than zero (0) but less than or equal to one hundred (100). The ‘Production %’ must equal up to 100% for all uses if there is no pending Letter of Support or Joint Submission for the form. This field allows for decimal values. This is a required field. • CBI: Check the ‘CBI’ checkbox to claim the ‘Total Production for this Use’ information as confidential. • In Formulation %: Estimate the percent of the new substance as formulated in mixture, suspensions, emulsions, solutions, or gels as manufactured for commercial purposes at sites under your control associated with each category of use. The entered value must be a value greater than zero (0) but less than or equal to one hundred (100) and can include decimal values. This is a required field. • CBI: Check the ‘CBI’ checkbox to claim the ‘Percentage in Formulation’ information as confidential. • CBI: Check the ‘CBI’ checkbox to claim the percentage of substance expected per use information as confidential. • Binding: Check the ‘Binding’ checkbox to claim the percentage of substance expected per use information as binding. • Site Limited %: Enter the site limited percentage of substance expected per use for the submitted substance. Blank fields are recognized as zeroes. This field allows for decimal values. Break down the use(s) by percentage for the indicated end user categories. For TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 95 example, site-limited means the substance will only be used on the adjacent property unit where manufactured and will not intentionally be removed from the site except for waste disposal. • Consumer %: Enter the consumer percentage of substance expected per use for the submitted substance. Blank fields are recognized as zeroes. This field allows for decimal values. Break down the use(s) by percentage for the indicated end user categories. Consumer use means that private individuals will use the chemical substance or products containing the substance for personal use or enjoyment. • Industrial %: Enter the industrial percentage of substance expected per use for the submitted substance. Blank fields are recognized as zeroes. This field allows for decimal values. Break down the use(s) by percentage for the indicated end user categories. Industrial use means that the chemical substance or product containing the substance will be used at the locations of other manufacturers or processors. • Commercial %: Enter the commercial percentage of substance expected per use for the submitted substance. Blank fields are recognized as zeroes. This field allows for decimal values. Break down the use(s) by percentage for the indicated end user categories. Indicate percentage of product volume expected for the listed “use” sectors. Commercial use refers to the chemical substance or product containing the chemical substance being used by a company to provide a consumer service. • If you have provided a “consumer” use, provide details: Enter consumer use details. Provide a detailed description of the use(s) of this chemical substance in consumer products. In addition, include estimates of the concentration of the new chemical substance as expected in consumer products and describe the chemical reactions by which this substance loses its identity in the consumer product. This is a required field if the ‘Consumer % of substance expected per use’ field is populated and is a value greater than zero (0). • CBI: Check the ‘CBI’ checkbox to claim the ‘If you have provided a ‘consumer’ use, provide details’ information as confidential. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for additional details regarding the attach document functionality. • File Name: Displays the file name and file extension of the file uploaded on the ‘Attach Documents’ pop-up window. Click the ‘File Name’ link to navigate to the ‘Attach Documents’ pop-up window to make any edits. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm deletion of the document. • 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 Authorized Official December 15, 2014 96 3.9 for more information regarding the save functionality in an expandable/collapsible field set. • Production Total: Displays the total production percentage for all uses. This value must be equal to 100, unless a Joint Submission or Letter of Support is pending, in which case the total value requirement is not immediately applicable. Exhibit 4-21 shows a screen capture of the ‘Use Information’ screen (Scroll 1): Exhibit 4-21: Use Information Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 97 Exhibit 4-22 shows a screen capture of the ‘Use Information’ screen (Scroll 2): Exhibit 4-22: Use Information Screen (Scroll 2) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 98 Navigation: Click the ‘Next’ button to navigate to the ‘Physical and Chemical Properties Worksheet’ screen. You can also access this screen by clicking the ‘Physical and Chemical Properties Worksheet’ link within the navigation tree. 4.1.14 Physical and Chemical Properties Worksheet You can navigate to the ‘Physical and Chemical Properties Worksheet’ screen by clicking the ‘Next’ button from the ‘Use Information’ screen. You can also access this screen by clicking the ‘Physical and Chemical Properties Worksheet’ link within the navigation tree. The ‘Physical and Chemical Properties Worksheet’ screen is used to capture optional information about a chemical’s properties. EPA uses the chemical properties to determine additional safety data about a chemical; the properties are used to determine potential risks and exposures of the chemicals. The properties for a chemical are captured in an expandable/collapsible field set format. The following categories may apply to a chemical: ‘Physical state of neat substance,’ ‘Vapor Pressure @ temperature,’ ‘Density/relative density,’ ‘Solubility @ temperature ___ solvent ___,’ ‘Solubility in water @ temperature ___,’ ‘Melting temperature,’ ‘Boiling/sublimation temperature @ ____,’ ‘Spectra,’ ‘Dissociation constant,’ ‘Particle size distribution,’ ‘Octanol/water partition coefficient,’ ‘Henry’s Law constant,’ ‘Volatilization from water,’ ‘Volatilization from soil,’ ‘pH @ concentration [concentration],’ ‘Flammability,’ ‘Explodability,’ and ‘Adsorption/coefficient.’ All of the properties will capture the relevant values for a chemical. Each property may be claimed individually as CBI. To enter physical/chemical property information, select a physical/chemical property from the drop-down menu and click the ‘Add Property’ button. The expandable/collapsible field set expands and displays all fields that should be entered for that property. You are then able to enter all relevant information regarding that property. Value fields are able to accept ‘<’ or ‘>’ symbols. When all information is entered, click the ‘Save’ button. Each property may only be entered once per chemical. You may also enter an option for ‘Other.’ The ‘Other’ option will allow you to enter a userspecified 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 99 Indicate whether the value you provide is based on an actual test measurement (‘Measured’) or is based on an estimate (‘Estimate’). Note that EPA staffers indicate that data qualifiers such as ‘negligible’ or ‘soluble’ are not useful descriptions. You are not required to generate the listed test data if you do not have it. Physical/chemical properties data may be so unique that they could in the future link the PMN substance to a commercial product or may tend to identify unique classes of chemical substance, and therefore some data elements may represent confidential business information. Review the CBI status of each entry carefully, and avoid making unsupportable claims. Please note that in IE 7, all physical/chemical properties you wish to add must be identified before navigating away from this page; otherwise, the properties are removed from the ‘Add Property’ drop-down menu. In addition, you will be able to add the ‘Henry’s Law constant’ property more than once, and the chemical property fields located within the expandable/collapsible fields sets on this page will be disorganized. After clicking the ‘Next’ button, you will navigate to the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ screen. After clicking the ‘Previous’ button, the physical/chemical properties have been removed from the ‘Add Property’ drop-down menu. • Add Property: Click the ‘Add Property’ button to add and open a new ‘Property’ expandable/collapsible field set for a selected property. • Cancel: Click the ‘Cancel’ link located in the upper right-hand corner of an expandable/collapsible field set to prevent edits from saving and to remove a field set. The ‘Cancel’ link displays when an expandable/collapsible field set is open for editing. A confirmation message displays to confirm the action. • Edit: Click the ‘Edit’ link located in the upper right-hand corner of an expandable/collapsible field set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has been saved and the data is not currently editable. • Delete: Click the ‘Delete’ icon ( ) 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 100 • Boiling/sublimation temperature @ – Value: Enter the boiling/sublimation temperature in °C of the chemical substance. This is a required field if the ‘Boiling/sublimation temperature @’ property is selected. • Boiling/sublimation temperature @ [pressure] torr: Enter the value of the pressure in torr for which the boiling/sublimation of the chemical substance was determined. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Boiling/sublimation temperature @’ property is selected. • Boiling/sublimation temperature @ - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Boiling/sublimation temperature @’ property is selected. • Boiling/sublimation temperature @ - CBI: Check the ‘CBI’ checkbox to claim the ‘Boiling/sublimation temperature @’ property as confidential. • Density/relative density - Value: Enter the density/relative density value of the chemical substance in g/cm3. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Density/relative density’ property is selected. • Density/relative density - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Density/relative density’ property is selected. • Density/relative density - CBI: Check the ‘CBI’ checkbox to claim the ‘Density/relative density’ property as confidential. • Dissociation constant - Value: Enter the dissociation constant value of the chemical substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Dissociation constant’ property is selected. • Dissociation constant - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Dissociation constant’ property is selected. • Dissociation constant - CBI: Check the ‘CBI’ checkbox to claim the ‘Dissociation constant’ property as confidential. • Explodability - Value: Enter the explodability value of the chemical substance. This field allows text or numbers to be entered and is also able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Explodability’ property is selected. • Explodability - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Explodability’ property is selected. • Explodability - CBI: Check the ‘CBI’ checkbox to claim the ‘Explodability’ property as confidential. • Flammability - Value: Enter the flammability value of the chemical substance. This field allows text and is also able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Flammability’ property is selected. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 101 • Flammability - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Flammability’ property is selected. • Flammability - CBI: Check the ‘CBI’ checkbox to claim the ‘Flammability’ property as confidential. • Henry’s Law constant - Value: Enter the Henry’s law constant value of the chemical substance in atm-m3/mole. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Henry’s Law constant’ property is selected. • Henry’s Law constant - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Henry’s Law constant’ property is selected. • Henry’s Law - CBI: Check the ‘CBI’ checkbox to claim the ‘Henry’s Law constant’ property as confidential. • Melting Temperature - Value: Enter the melting temperature of the chemical substance in °C. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Melting Temperature’ property is selected. • Melting Temperature - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Melting Temperature’ property is selected. • Melting Temperature - CBI: Check the ‘CBI’ checkbox to claim the ‘Melting Temperature’ property as confidential. • Octanol/water partition coefficient - Value: Enter the octanol/water partition coefficient value of the chemical substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Octanol/water partition coefficient’ property is selected. • Octanol/water partition coefficient - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Octanol/water partition coefficient’ property is selected. • Octanol/water partition coefficient - CBI: Check the ‘CBI’ checkbox to claim the ‘Octanol/water partition coefficient’ property as confidential. • Particle size distribution - Value: Enter the particle size distribution value of the chemical substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Particle size distribution’ property is selected. • Particle size distribution - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Particle size distribution’ property is selected. • Particle size distribution - CBI: Check the ‘CBI’ checkbox to claim the ‘Particle size distribution’ property as confidential. • Physical state of neat substance - Value: Select the physical state of a neat substance of chemicals, which can be either a ‘Solid,’ ‘Liquid,’ or ‘Gas.’ This is a required field if the ‘Physical state of neat substance’ property is selected. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 102 • Physical state of neat substance - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Physical state of neat substance’ property is selected. • Physical state of neat substance - CBI: Check the ‘CBI’ checkbox to claim the ‘Physical state of neat substance’ property as confidential. • pH @ concentration [concentration]: Enter the concentration at which the pH was measured. This field allows for text. This is a required field if the ‘pH @ concentration [concentration]’ property is selected. • pH @ concentration [concentration] - Value: Enter the pH value. This field allows text and is also able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘pH @ concentration [concentration]’ property is selected. • pH @ concentration [concentration] - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘pH @ concentration [concentration]’ property is selected. • pH @ concentration [concentration] - CBI: Check the ‘CBI’ checkbox to claim the ‘pH @ concentration [concentration]’ property as confidential. • Solubility @ temperature solvent: Enter the temperature value in °C for which the solubility was measured. This field allows text and is also able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Solubility @ temperature solvent’ property is selected. • Solubility @ temperature solvent - Solvent: Enter the solvent that will be used for the chemical substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Solubility @ temperature solvent’ property is selected. • Solubility @ temperature solvent - Value: Enter the solubility of the chemical substance in g/L. • Solubility @ temperature solvent - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Solubility @ temperature solvent’ property is selected. • Solubility @ temperature solvent - CBI: Check the ‘CBI’ checkbox to claim the ‘Solubility @ temperature solvent’ property as confidential. • Solubility in Water @ temperature: Enter the temperature value in °C of the chemical for which the solubility in water was measured. This is a required field if the ‘Solubility in Water @ temperature’ property is selected. • Solubility in Water @ temperature - Value: Enter the solubility in water of the chemical substance in g/L. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Solubility in Water @ temperature’ property is selected. • Solubility in Water @ temperature - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 103 from the drop-down menu. This is a required field if the ‘Solubility in Water @ temperature’ property is selected. • Solubility in Water @ temperature - CBI: Check the ‘CBI’ checkbox to claim the ‘Solubility in Water @ temperature’ property as confidential. • Spectra - Value: Enter the spectra value of the chemical substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the spectra property is selected. • Spectra - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Spectra’ property is selected. • Spectra - CBI: Check the ‘CBI’ checkbox to claim the ‘Spectra’ property as confidential. • Vapor Pressure @ temperature: Enter the temperature value in °C of the chemical for which the vapor pressure was measured. This is a required field if the ‘Vapor Pressure @ temperature’ property is selected. • Vapor Pressure @ temperature - Value: Enter the value of the Vapor Pressure in torr units of the chemical substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Vapor Pressure @ temperature’ property is selected. • Vapor Pressure @ temperature - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Vapor Pressure @ temperature’ property is selected. • Vapor Pressure @ temperature - CBI: Check the ‘CBI’ checkbox to claim the ‘Vapor Pressure @ temperature’ property as confidential. • Volatilization from water - Value: Enter the volatilization from water value of the chemical substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Volatilization from water’ property is selected. • Volatilization from water - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Volatilization from water’ property is selected. • Volatilization from water - CBI: Check the ‘CBI’ checkbox to claim the ‘Volatilization from water’ property as confidential. • Volatilization from soil - Value: Enter the volatilization from soil value. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Volatilization from soil’ property is selected. • Volatilization from soil - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Volatilization from soil’ property is selected. • Volatilization from soil - CBI: Check the ‘CBI’ checkbox to claim the ‘Volatilization from soil’ property as confidential. • Other: Enter any ‘Other’ property that you may specify. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 104 • Other - Value: Enter an ‘Other’ property value. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Other’ property was selected. • Other - Measured or Estimate: Indicate whether the property value is ‘Measured’ or based on an ‘Estimate’ by selecting the appropriate value from the drop-down menu. This is a required field if the ‘Other’ property is selected. • Other - CBI: Check the ‘CBI’ checkbox to claim the property as confidential. Exhibit 4-23 shows a screen capture of the ‘Physical and Chemical Properties Worksheet’ screen (Scroll 1): Exhibit 4-23: Physical and Chemical Properties Worksheet Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 105 Exhibit 4-24 shows a screen capture of the ‘Physical and Chemical Properties Worksheet’ screen (Scroll 2): Exhibit 4-24: Physical and Chemical Properties Worksheet Screen (Scroll 2) Navigation: Click the ‘Next’ button to navigate to the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ screen. You can also access this screen by clicking the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ link within the navigation tree. 4.1.15 Physical and Chemical Properties Worksheet – Continued (Optional) You can navigate to the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ screen by clicking the ‘Next’ button from the ‘Physical and Chemical Properties Worksheet’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 106 screen. You can also access this screen by clicking the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ link within the navigation tree. The ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ screen is used to capture all the studies and attachments that refer to the chemical properties captured on the ‘Physical and Chemical Properties Worksheet’ screen. When you first access the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ screen, instructional text, an ‘Attach Document’ button, and an attachments table displays. When you attach a document, the properties that were selected on the ‘Physical and Chemical Properties Worksheet’ screen will be listed with checkboxes in the ‘Attach Documents’ window for you to select which properties an attachment is associated with. Check the properties that are relevant to the document, and then select a type and subtype value for the document. You will be able to attach a document, enter a description of the document, and list the number of pages. The system provides functionality to claim an uploaded document as CBI. If a document is claimed as CBI, the system requires you to upload the sanitized version of the attached document. To view, open, or edit previously attached documents, click the appropriate file name of the document within the ‘File Name’ column of the attachment table. The attachment table displays the ‘File Name,’ ‘Properties,’ ‘Description,’ ‘Pages,’ ‘CBI,’ and ‘Actions’ columns. Click the ‘Delete’ icon ( ) located under the ‘Actions’ column to delete unwanted documents. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for additional details regarding the attach document functionality. • File Name: Displays the file name and file extension of the original file that is uploaded on the ‘Attach Documents’ pop-up window. Click the ‘File Name’ link to navigate to the ‘Attach Documents’ pop-up window to make any edits. • Properties: Displays the chemical properties associated with a document. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm the deletion. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 107 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 Navigation: Click the ‘Next’ button to navigate to the ‘Site Information’ screen if you have not identified another chemical. You can also access this screen by clicking the ‘Site Information’ link within the navigation tree. If you would like to add a consolidated chemical, click the ‘Add Consolidated Chemical’ link within the navigation tree. 4.1.16 Physical and Chemical Properties Worksheet – Continued (Optional) Attach Documents You can navigate to the ‘Attach Documents’ window by clicking the ‘Attach Document’ button on the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ screen. When attaching a document, the properties selected on the ‘Physical and Chemical Properties Worksheet’ screen will display with checkboxes to allow the properties to which the attachment TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 108 refers to be selected. Select the type and subtype for the attachment and the properties relevant to the document, attach the document, and enter the number of pages. The system allows the uploaded document to be claimed as CBI. If a document is claimed as CBI, the system requires the sanitized version of the attached document to be uploaded. To access or edit previously attached documents, click the appropriate file name of the document within the ‘File Name’ column of the attachment table. • Type: Select the document type from the drop-down menu. • Subtype: Select the document subtype from the drop-down menu. • Chemical Properties: Displays the physical and/or chemical properties identified on the ‘Physical and Chemical Properties Worksheet’ screen that can be potentially associated with a document. Check the appropriate chemical properties that are associated with a document that is being attached. These checkboxes are enabled only if ‘Physical Chemical Property’ is selected from the ‘Type’ drop-down menu. • Attachment: Displays the ‘Browse’ button to search for and identify documents on your local hard drive to be attached that can be associated with the physical/chemical properties identified on the ‘Physical and Chemical Properties Worksheet’ screen. • Description: Enter the description associated with a document. • Pages: Enter the number of pages a document contains. • CBI: Check the ‘CBI’ checkbox to claim the document as confidential. • Sanitized Attachment: Click the ‘Browse’ button to generate the ‘File Upload’ window to search for a particular file on your hard drive. For any attached document claimed as CBI, you are required to attach a sanitized version of the document. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 109 Exhibit 4-26 shows a screen capture of the ‘Attach Documents’ pop-up window (Scroll 1) from the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ screen: Exhibit 4-26: Physical and Chemical Properties Worksheet - Continued (Optional) Attach Documents Pop-Up Window (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 110 Exhibit 4-27 shows a screen capture of the ‘Attach Documents’ pop-up window (Scroll 2) on the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ screen: Exhibit 4-27: Physical and Chemical Properties Worksheet - Continued (Optional) Attach Documents Pop-Up Window (Scroll 2) Navigation: Click the ‘Cancel’ button or ‘X’ icon located in the upper right-hand corner to stop the process of adding document information. Click the ‘OK’ button to save the entered TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 111 information and navigate back to the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ screen. 4.1.17 Site Information You can navigate to the ‘Site Information’ screen by clicking the ‘Next’ button from the ‘Physical and Chemical Properties Worksheet – Continued (Optional)’ screen. You can also access this screen by clicking the ‘Site Information’ link within the navigation tree. The ‘Site Information’ screen captures information about the identification of submittercontrolled sites and sites controlled by others. If a user indicates there are submitter-controlled sites, the ‘Submitter Operation Information,’ ‘Occupational Exposures,’ and ‘Environmental Releases’ screens are automatically generated within the ‘Submitter Controlled Operations’ folder within the navigation tree. If a user indicates there are sites controlled by others, the ‘Industrial Sites Controlled By Others,’ ‘Exposures/Releases,’ and ‘Byproduct Information’ screens automatically generate within the ‘Operations Controlled By Others’ folder within the navigation tree upon clicking the ‘Next’ button. Toll manufacturing sites are considered sites controlled by the submitter. • Do you have sites controlled by the submitter?: Select the ‘Yes’ radio button to indicate that you have submitter controlled sites to identify; this response automatically generates the screens within the ‘Submitter Controlled Operations’ folder in the PMN navigation tree upon clicking the ‘Next’ button. Select the ‘No’ radio button if you do not have any submittercontrolled sites to identify. An error message displays if a submitter-controlled site displays within the navigation tree and the ‘No’ radio button is selected. • Do you have sites controlled by others?: Select the ‘Yes’ radio button to indicate that you have sites controlled by others to identify; this response automatically generates the screens within the ‘Operations Controlled by Others’ folder in the PMN navigation tree upon clicking the ‘Next’ button. Select the ‘No’ radio button if you do not have any sites controlled by others to identify. An error message displays if a site controlled by others displays within the navigation tree and the ‘No’ radio button is selected. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 112 Exhibit 4-28 shows a screen capture of the ‘Site Information’ screen: Exhibit 4-28: Site Information Screen Navigation: Click the ‘Next’ button to navigate to the ‘Sites Controlled By Others’ screen. You can also access this screen by clicking the ‘Sites Controlled By Others’ link within the navigation tree. 4.1.18 Sites Controlled By Others You can navigate to the ‘Sites Controlled By Others’ screen by clicking the ‘Next’ button from the ‘Site Information’ screen. You can also access this screen by clicking the ‘Sites Controlled By Others’ link within the navigation tree. The ‘Sites Controlled By Others’ screen captures information about known and/or unknown sites not controlled by the submitter. Complete the ‘Operations Controlled By Others’ section within the navigation tree for typical processing or use operations involving the new chemical substance at sites not controlled by the submitter. Importers do not have to complete this section for TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 113 operations outside the U.S.; however, you must report any processing or use activities after import. Complete a separate ‘Operations Controlled By Others’ section for each type of processing, or use operation involving the new chemical substance. If the same operation is performed at more than one site, describe the typical operation common to these sites. The screen first captures whether there is any data for other controlled sites. If there is no data for sites controlled by others, the screen will not update and the option of selecting the ‘Next’ button is available. If there is data for sites controlled by others, an additional question will appear. The screen then captures whether site-specific data for the chemical is known for ‘Sites Controlled By Others.’ If you indicate that there is site-specific data by selecting the ‘Yes’ radio button, the screen will generate a text field to enter the ‘# of unknown sites’ and a ‘CBI’ checkbox to claim the number of unknown sites as confidential. If there is no site-specific data, the screen displays a text box to capture the number of unknown sites. Please note that in IE 7, after adding a site, the ‘# of unknown sites’ text box label disappears but the text field and ‘CBI’ checkbox are still displayed. • Do you have any sites controlled by others for which you have information to report?: If you select ‘Yes’ the screen will display the question ‘Do you have site-specific information?’ If you select ‘No’ only the listed navigation options will display. If an operation controlled by others displays within the navigation tree, the ‘Yes’ radio button must be selected for this question. • Do you have site-specific information?: If you select ‘Yes’ the screen generates fields to capture specific site information. If you select ‘No,’ an error message displays indicating that any other sites you have will be deleted. • # of unknown sites: Enter the number of unknown sites; zero (0) is an acceptable value. This is a required field. • CBI: Check the ‘CBI’ checkbox to claim the number of unknown sites as confidential. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 114 Exhibit 4-29 shows a screen capture of the ‘Sites Controlled By Others’ screen: Exhibit 4-29: Sites Controlled By Others Screen Navigation: Click the ‘Next’ button to navigate to the ‘Submitter Operation Information’ screen. You can also click the ‘Add Operation’ link under the ‘Submitter Controlled Operations’ folder within the navigation tree to generate the submitter controlled operation screens or click the ‘Submitter Operation Information’ link under the ‘Submitter Controlled Operations’ folder within the navigation tree. 4.1.19 Submitter Operation Information You can navigate to the ‘Submitter Operation Information’ screen by clicking the ‘Next’ button from the ‘Sites Controlled By Others’ screen. You can also access this screen by clicking the ‘Submitter Operation Information’ link under the ‘Submitter Controlled Operations’ folder TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 115 within the navigation tree. You can add additional sites by clicking the ‘Add Operation’ link within the navigation tree under the ‘Submitter Controlled Operations’ folder. The ‘Submitter Operation Information’ screen captures information about an operation that occurs at a particular site or group of sites. You are asked a series of questions, and based on the responses, a series of fields displays regarding a specific operation. The guided approach is designed to eliminate errors and ensure the completion of all relevant sections for a site. You will be able to enter an operation alias to identify the operation. Importers are not required to complete this section for operations outside the U.S.; however, any industrial processing or use operation that takes place after import must be described. It should be noted that Toll manufacturing sites are considered to be sites controlled by the submitter. You will first be asked to select the site(s) and chemical(s) for the operation and will then select the applicable operation type checkboxes. If you select an option other than ‘Use’ for the operation type, you will be asked whether the chemical is manufactured or processed as a ‘batch’ or ‘continuous’ process. Based on the property selected, fill in the relevant information. If you select the ‘Use’ operation type, then there will be no further options on this screen. The follow-up screens are used to capture specific information about the operation type process. The system provides a text box for describing the process description. Additional process information may also be included in an attachment. In the process description, include the following information: (1) Diagram the major unit operation steps and chemical conversions. Include interim storage and specify transport containers (e.g., 5-gallon pails, 55-gallon drum, rail car, tank truck, etc.). (2) Provide the identity, approximate weight (by kilograms (kg) kg/day or kg/batch on a new chemical substance basis), and entry point of all starting materials, feedstocks (including reactants, solvents, catalysts, etc.), products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. If releasing to two media at the same step, assign a second release number for the second medium. You may claim the process description or attachment as CBI. If an attached document is claimed as CBI, the system requires a sanitized version of the attached document to be uploaded. To access or edit previously attached documents, click the file name of the document within the ‘File Name’ column of the document table. The document table displays the file name and file extension of the document, the document description, the number of pages in the document, and whether a sanitized copy of the document was attached. Click the ‘Delete’ icon ( ) under the ‘Actions’ column to delete unwanted documents. • Operation Alias: Enter the operation alias. This field makes it easier to distinguish between operations in the navigation tree when there is more than one operation. This is a required field if the form is pending a Joint Submission or a Letter of Support. • Add Facility: Click the button to generate the ‘Add Facility’ pop-up window and select a site from the drop-down menu to add to the ‘Submitter Operation Information’ screen. Refer to Section 3.11 for additional details regarding the add facility functionality. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 116 • Site Name: Displays the site name. • Address: Displays the site address. • City: Displays the site city. • State: Displays the site state. • Postal Code: Displays the site postal code. • CBI: Indicates the CBI status of the site by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete a site from the table. A warning message displays to confirm the deletion of the site. • Select the chemical(s) that this submission pertains to: Displays all consolidated chemicals in a PMN submission with associated checkbox(es). • CBI: Check the ‘CBI’ checkbox to claim the operation type as confidential. • Manufacturing: Check the ‘Manufacturing’ checkbox to indicate that manufacturing is taking place at the site. Checking the ‘Manufacturing’ checkbox generates the ‘Is it batch or continuous’ radio buttons. • Processing: Check the ‘Processing’ checkbox to indicate that processing is taking place at the site. Checking the ‘Processing’ checkbox generates the ‘Is it batch or continuous’ radio buttons. • Use: Check the ‘Use’ checkbox to indicate that chemical use is taking place at the site. • CBI: Check the ‘CBI’ checkbox to claim the amount and duration information as confidential. • Is it batch or continuous?: Select the ‘Batch’ radio button to indicate that the chemical is produced in a batch process. Select the ‘Continuous’ radio button to indicate that the chemical is produced on a continuous basis. Either the ‘Batch’ or ‘Continuous’ radio button is required to be selected. • Max kg/batch: Enter the maximum number of kilograms produced per batch. This field only displays when you select the ‘Batch’ radio button and is a required field. This field accepts decimal values. • Hours/batch: Enter the hours of manufacturing or processing time needed per batch. This field only displays when you select the ‘Batch’ radio button and is a required field. This field accepts decimal values. • Batches/year: Enter the number of batches produced per year. This field only displays when you select the ‘Batch’ radio button and is a required field. This field accepts decimal values. • Max kg/day: Enter the maximum number of kg of a chemical produced per day. This field only displays when you select the ‘Continuous’ radio button and is a required field. This field accepts decimal values. • Hours/day: Enter the number of hours per day that the chemical is processed or manufactured; this value cannot exceed 24. This field only displays when you select the ‘Continuous’ radio button and is a required field. This field accepts decimal values. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 117 • 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., 5gallon pails, 55-gallon drum, rail car, tank truck, etc.). (2) Provide the identity, the approximate weight (by kg/day or kg/batch on a 100% new chemical substance basis), and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc.), and of all products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. If releasing to two media at the same step, assign a second release number for the second medium. Either this field is required or a document must be attached. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for additional details regarding the attach document functionality. • File Name: Displays the file name and file extension of the file that is uploaded on the ‘Attach Documents’ pop-up window. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm the deletion. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 118 Exhibit 4-30 shows a screen capture of the ‘Submitter Operation Information’ screen (Scroll 1): Exhibit 4-30: Submitter Operation Information Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 119 Exhibit 4-31 shows a screen capture of the ‘Submitter Operation Information’ screen (Scroll 2): Exhibit 4-31: Submitter Operation Information Screen (Scroll 2) 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 120 4.1.20 Occupational Exposures You can navigate to the ‘Occupational Exposures’ screen by clicking the ‘Next’ button from the ‘Submitter Operation Information’ screen. You can also access this screen by clicking the ‘Occupational Exposures’ link within the navigation tree. Click the ‘Add’ button to generate an expandable/collapsible field set to enter occupational exposure information. The application displays fields for you to enter information for ‘Worker Category (1),’ ‘Worker Activity (1),’ ‘Protective Equipment/Engineering Controls (3),’ ‘Physical Form(s) (5),’ ‘% New Substance (5),’ ‘# Workers Exposed (8),’ ‘Maximum Duration Hours/Day (10),’ and ‘Maximum Duration Days/Year (11).’ EPA is attempting to estimate exposure levels, the number of workers potentially exposed, and possible routes and duration of exposure to the PMN substance. Work with your plant engineers to develop accurate data; review the CBI status of data you provide. Information entered into the ‘Maximum Duration Hours/Day (10)’ and ‘Maximum Duration Days/Year (11)’ fields must be a positive whole number or decimal. The system does not allow special characters to be saved in these fields. If further explanation is required regarding duration of exposure, please provide this in an attachment. • Add: Click the ‘Add’ button to generate the ‘Occupational Exposure – Submitter Controlled Sites’ expandable/collapsible field set. • Cancel: Click the ‘Cancel’ link located in the upper right-hand corner of the expandable/collapsible field set to prevent edits from saving and remove the field set. The ‘Cancel’ link displays when the expandable/collapsible field set is open for editing. A confirmation message displays to confirm the action. • 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 121 • User Defined Worker Activity: Enter the worker activity in which workers may be exposed to a chemical substance. This field displays only for certain worker activity values. • Protective Equipment/Engineering Controls (3): Enter the protective equipment/engineering controls used to protect workers. This is a required field. • CBI: Check the ‘CBI’ checkbox to claim the protective equipment/engineering controls information as confidential. • Binding: Check the ‘Binding’ checkbox to claim the protective equipment/engineering controls information as binding. • Physical Form(s) (5): Enter the physical forms(s) of the new chemical substance (e.g., solid, crystal, granule, powder, or dust) at the time of exposure. Be as specific as possible on the physical form (e.g., is the PMN substance isolated as a crystalline or amorphous powder, wet cake, flake solid, granular solid, or a fused solid?). If data on particle size of solids are available, it should be included as an attachment. For wet cakes, a percent moisture estimate may prevent EPA from making an estimate that is too conservative. Please pay particular attention to the information within if this field is populated via XML file. The information contained within the ‘Physical Forms and % New Substance’ field in the thick client separates into two (2) separate fields, the ‘Physical Form(s)’ field and ‘% New Substance’ field when these fields are populated via an XML file generated from the ePMN thick client. This is a required field. • Binding: Check the ‘Binding’ checkbox to claim the physical form(s) information as binding. • % New Substance (5): Enter the percentage of new chemical substance (if part of a mixture) at the time of exposure. A value of zero (0) entered in this field will display an error. Please pay particular attention to the information if this field is populated via XML file. The information contained within the ‘Physical Forms and % New Substance’ field in the thick client separates into two (2) separate fields, the ‘Physical Form(s)’ field and ‘% New Substance’ field when these fields are populated via an XML file generated from the ePMN thick client. This is a required field that accepts decimal values. • Binding: Check the ‘Binding’ checkbox to claim the percentage new substance information as binding. • # Workers Exposed (8): Enter the number of workers exposed. Estimate the maximum number of all workers involved in each activity for all sites combined. This is a required field. • CBI: Check the ‘CBI’ checkbox to claim the number of workers exposed as confidential. • Hours/Day (10): Enter the maximum duration occupational exposure occurs for the activity for any worker in hours per day; this field allows decimal values. A value of zero (0) entered in this field will display an error. This is a required field. • Days/Year (11): Enter the maximum duration occupational exposure occurs for the activity for any worker in days per year; this field allows decimal values. A value of zero (0) entered in this field will display an error. This is a required field. • CBI: Check the ‘CBI’ checkbox to claim the maximum duration values as confidential. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 122 • Save: Click the button to save the information entered within the expandable/collapsible field set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.9 for more information regarding the save functionality in an expandable/collapsible field set. Exhibit 4-32 shows a screen capture of the ‘Occupational Exposures’ screen (Scroll 1): Exhibit 4-32: Occupational Exposures Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 123 Exhibit 4-33 shows a screen capture of the ‘Occupational Exposures’ screen (Scroll 2): Exhibit 4-33: Occupational Exposures Screen (Scroll 2) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 124 Navigation: Click the ‘Next’ button to navigate to the ‘Environmental Releases’ screen. You can also access this screen by clicking the ‘Environmental Releases’ link within the navigation tree. 4.1.21 Environmental Releases You can navigate to the ‘Environmental Releases’ screen by clicking the ‘Next’ button from the ‘Occupational Exposures’ screen. You can also access this screen by clicking the ‘Environmental Releases’ link within the navigation tree. The ‘Environmental Releases’ screen captures information about the environmental release and disposal status of a particular site. The information on exposure and environmental release is related to the flow diagram/process description on the ‘Submitter Operation Information’ screen. This page is duplicated and populated for each flow diagram supplied in the PMN (manufacturing, each processing description, and any use diagrams). The information provided should focus on the PMN substance. EPA reviewers pay particular attention to human exposure and environmental release date under their TSCA mandate to protect against unreasonable risks from new chemical substances. In the absence of this information, EPA will make its own estimates of worker exposure and environmental release, which are usually conservative. You should present data that is accurate and as complete as possible. The page displays an ‘Add’ button to add an expandable/collapsible field set to enter ‘Environmental Release and Disposal – Submitter Controlled Sites’ information. The page displays fields to enter information for ‘Release Number,’ the amount of the new substance released ‘to environment’ and the amount of new substance released ‘to control technology,’ ‘Media of Release,’ ‘Control Technology Description,’ and ‘Release after Control Technology.’ You will be asked to enter information concerning the release to water, such as Publicly Owned Treatment Works (POTW), navigable waterways, and others. • Add: Click the ‘Add’ button to generate the ‘Environmental Release and Disposal – Submitter Controlled Sites’ expandable/collapsible field set. • 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 125 • CBI: Check the ‘CBI’ checkbox to claim the release number information as confidential. • Amount of new substance released to Environment (2a): Select the applicable radio button and enter the amount of new substance released to environment. Release estimates should be consistent with the release levels shown on the preceding flow diagram on the ‘Submitter Operation Information’ screen. Include intermittent release estimates from cleaning of equipment and transportation containers, even if cleaned off-site. Either the ‘Amount of new substance released to Environment’ or the ‘Amount of new substance released to Control Technology’ field should be populated. • Amount of new substance released to Environment kg/day: Select the radio button to claim that the amount of new substance released to the environment is measured in kilograms per day. • Amount of new substance released to Environment kg/batch: Select the radio button to claim that the amount of new substance released to the environment is measured in kilograms per batch. • Amount of new substance released to Control Technology (2b): Enter the amount of new substance released to control technology. Release estimates should be consistent with the release levels shown on the proceeding flow diagram on the ‘Submitter Operation Information’ screen. Include intermittent release estimates from cleaning of equipment and transportation containers, even if cleaned off-site. Either the ‘Amount of new substance released to environment’ or the ‘Amount of new substance released to Control Technology’ field should be populated. • Amount of new substance released to Control Technology kg/day: Select the radio button to claim that the amount of new substance released to control technology is measured in kilograms per day. • Amount of new substance released to Control Technology kg/batch: Select the radio button to claim that the amount of new substance released to control technology is measured in kilograms per batch. • Media of Release (4): Identify the media of release (i.e., stack air, fugitive air, surface water, on-site or off-site land or incineration, POTW, or other (please specify)) to which the new substance will be released from that release point from the drop-down menu. This is a required field. • CBI: Check the ‘CBI’ checkbox to claim the media of release as confidential. • If Other, specify: Enter the other media of release when you select ‘Other’ from the ‘Media of Release’ drop-down menu. • Control Technology Description (5a): Enter the control technology description. Describe control technology, if any, and control efficiency used to limit the release of the new substance to the environment. For releases disposed of on land, characterize the disposal method and state whether it is approved for disposal of Resource Conservation and Recovery Act (RCRA) hazardous waste. For each site, describe any additional disposal methods that will be used and whether the waste is subject to secondary or tertiary on-site treatment. Indicate if you want this information to bind. Check the ‘CBI’ checkbox if the information is confidential. This is a required field. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 126 • 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 this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.9 for more information regarding the save functionality in an expandable/collapsible field set. • POTW Name: Enter the POTW (publicly owned treatment works) name. • POTW NPDES #: Enter the POTW National Pollutant Discharge Elimination System (NPDES) number. • POTW CBI: Check the ‘CBI’ checkbox to claim the POTW as confidential. • Navigable Waterway Name: Enter the navigable waterway name. • Navigable Waterway NPDES #: Enter the navigable waterway NPDES number. • Navigable Waterway CBI: Check the ‘CBI’ checkbox to claim the navigable waterway as confidential. • Other (Specify) Name: Enter the name of the other destination of release to water. • Other (Specify) CBI: Check the ‘CBI’ checkbox to claim the other destination of release to water as confidential. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 127 Exhibit 4-34 shows a screen capture of the ‘Environmental Releases’ screen (Scroll 1): Exhibit 4-34: Environmental Releases Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 128 Exhibit 4-35 shows a screen capture of the ‘Environmental Releases’ screen (Scroll 2): Exhibit 4-35: Environmental Releases Screen (Scroll 2) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 129 Navigation: Click the ‘Next’ button to navigate to the ‘Industrial Sites Controlled By Others’ screen. You can also access this screen by clicking the ‘Industrial Sites Controlled By Others’ link within the navigation tree. Click the ‘Add Operation’ link under the ‘Operations Controlled By Others’ folder within the navigation tree to generate the screens for an operation controlled by others. 4.1.22 Industrial Sites Controlled By Others Click the ‘Add Operation’ link under the ‘Operations Controlled By Others’ folder within the navigation tree to generate the screens for an operation controlled by others. You can navigate to this screen by clicking the ‘Next’ button from the ‘Environmental Releases’ screen. You can also access this screen by clicking the ‘Industrial Sites Controlled By Others’ link within the navigation tree under the ‘Operations Controlled by Others’ folder. The ‘Industrial Sites Controlled By Others’ screen captures information about activities occurring at a particular site or group of sites. You will be able to enter an operation alias to identify the operation. Importers are not required to complete this section for operations outside the U.S.; however, any industrial processing or use operation that takes place after import must be described. You will first be asked to select the site(s) and chemical(s) for the operation. You will then proceed to the next screen to enter resources concerning the operation. The system provides a field to add an operation process description. The site(s) and chemical(s) for the operation must be identified. The system then navigates to the next screen to enter resources concerning the operation. The ‘Industrial Sites Controlled By Others’ screen also displays a field to add an operation process description. In the operation description, include the following information: (1) Diagram the major unit operation steps and chemical conversions, including interim storage and specify transport containers (e.g., 5-gallon pails, 55-gallon drums, rail cars, tank trucks, etc.). On the diagram, identify by letter and briefly describe each worker activity. (2) Either in the diagram or in the text field, provide the identity, the approximate weight (by kg/day or kg/batch, on a 100% new chemical substance basis), and entry point of all feedstocks (including reactants, solvents and catalysts, etc.), products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) Either in the diagram or in the text field, identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. • Operation Alias: Enter the operation alias. This is a required field if the form is pending a Joint Submission or a Letter of Support. • Add Facility: Click the button to generate the ‘Add Facility’ pop-up window and select a site from the drop-down menu to add to the ‘Industrial Sites Controlled By Others’ screen. Refer to Section 3.11 for additional details regarding the add facility functionality. • Site Name: Displays the site name. • Address: Displays the site address. • City: Displays the site city. • State: Displays the site state. • Postal Code: Displays the site postal code. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 130 • 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 intermittent releases, to the environment of the new chemical substance. Either this field is required or a document must be attached. • CBI: Check the ‘CBI’ checkbox to claim the operation description as confidential. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for additional details regarding the attach document functionality. • File Name: Displays the file name and file extension of the document that was uploaded on the ‘Attach Documents’ pop-up window. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm deletion of the document. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 131 Exhibit 4-36 shows a screen capture of the ‘Industrial Sites Controlled By Others’ screen (Scroll 1): TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 132 Exhibit 4-36: Industrial Sites Controlled By Others Screen (Scroll 1) Exhibit 4-37 shows a screen capture of the ‘Industrial Sites Controlled By Others’ screen (Scroll 2): TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 133 Exhibit 4-37: Industrial Sites Controlled By Others Screen (Scroll 2) Navigation: Click the ‘Next’ button to navigate to the ‘Exposures/Releases’ screen. You can also access this screen by clicking the ‘Exposures/Releases’ link within the navigation tree. 4.1.23 Exposures/Releases You can navigate to the ‘Exposures/Releases’ screen by clicking the ‘Next’ button from the ‘Industrial Sites Controlled By Others’ screen. You can also access this screen by clicking the ‘Exposures/Releases’ link within the navigation tree under the ‘Operations Controlled By Others’ folder. The screen provides buttons to add expandable/collapsible field sets for worker exposure release information and environmental disposal information. The screen displays fields in the worker exposure expandable/collapsible field set to enter information for ‘Letter of Activity (1),’ ‘# Workers Exposed (2),’ ‘Duration of Exposure Hours/Day (4a),’ ‘Duration of Exposure Days/Year (4b),’ ‘Protective Equipment/Engineering Controls (6),’ ‘Physical Form (6),’ ‘% New Substance (6),’ and ‘% in Formulation (7).’ The screen displays fields in the environmental TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 134 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 TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 135 contained within the ‘Protective Equipment/Engineering Controls/Physical Forms’ field in the thick client separates into two (2) separate fields, the ‘Protective Equipment/Engineering Controls’ and ‘Physical Forms’ field when these fields are populated via an XML file generated from the ePMN thick client. • CBI: Check the ‘CBI’ checkbox to claim the protective equipment/engineering controls information as confidential. • Physical Form (6): Enter a description of physical forms of exposure. Please pay particular attention to the information populated in this field if this field is populated via XML file. The information contained within the ‘Protective Equipment/Engineering Controls/Physical forms’ field in the thick client separates into two (2) separate fields, the ‘Protective Equipment/Engineering Controls’ and ‘Physical Forms’ field when these fields are populated via an XML file generated from the ePMN thick client. • % New Substance (6): Describe percentage of new chemical substance (if in mixture). • % in Formulation (7): Estimate the percent of the new substance as formulated when packaged or used as a final product. • Save: Click the button to save the information entered within the expandable/collapsible field set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.9 for more information regarding the save functionality in an expandable/collapsible field set. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 136 Exhibit 4-38 shows a screen capture of the ‘Exposures/Releases’ screen (Scroll 1): Exhibit 4-38: Exposures/Releases Screen (Scroll 1) • 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 137 • Amt New Substance Released Directly into Environment Kg/Batch: Select the ‘Kg/Batch’ radio button to indicate that the amount of substance released into environment measures in kilograms per batch. • Amt New Substance Released Directly into Control Technology (10b): Estimate the amount of the new substance released into control technology in Kg/Day or Kg/Batch. • Amt New Substance Released Directly into Control Technology Kg/Day: Select the ‘Kg/Day’ radio button to indicate that the amount of substance released into control technology measures in kilograms per day. • Amt New Substance Released Directly into Control Technology Kg/Batch: Select the ‘Kg/Batch’ radio button to indicate that the amount of substance released into control technology measures in kilograms per batch. • Media of Release (12): Select a value from the drop-down menu to capture the media of release. The ‘Media of Release’ drop-down menu contains the following values: ‘Fugitive Air,’ ‘Off-Site Incineration,’ ‘On-site Incineration,’ ‘On-site WWT,’ ‘POTW,’ ‘Stack Air,’ ‘Surface Water,’ and ‘Other,’ that will be used to limit the release of the new substance to the environment. Please pay particular attention to the information within if this field is populated via XML file. The information contained within the ‘Media of Release & Control Technology’ field in the thick client separates into two (2) separate fields, the ‘Media of Release’ drop-down menu and ‘Control Technology’ field when these fields are populated via an XML file generated from the ePMN thick client. • If Other, specify: Enter the other media of release. • CBI: Check the ‘CBI’ checkbox to claim the media of release as confidential. • Control Technology (12): Enter the control technology, if any, which will be used to limit the release of the new substance to the environment. Please pay particular attention to the information within if this field is populated via XML file. The information contained within the ‘Media of Release & Control Technology’ field in the thick client separates into two (2) distinct fields, the ‘Media of Release’ drop-down menu and ‘Control Technology’ field when these fields are populated via an XML file generated from the ePMN thick client. • Save: Click the button to save the information entered within the expandable/collapsible field set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.9 for more information regarding the save functionality in an expandable/collapsible field set. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 138 Exhibit 4-39 shows a screen capture of the ‘Exposures/Releases’ screen (Scroll 2): Exhibit 4-39: Exposures/Releases Screen (Scroll 2) Navigation: Click the ‘Next’ button to navigate to the ‘Byproduct Information’ screen. You can also access this screen by clicking the ‘Byproduct Information’ link within the navigation tree. 4.1.24 Byproduct Information You can navigate to the ‘Byproduct Information’ screen by clicking the ‘Next’ button from the ‘Exposures/Releases’ screen. You can also access this screen by clicking the ‘Byproduct Information’ link under the ‘Operations Controlled By Others’ folder within the navigation tree. The ‘Byproduct Information’ screen captures byproducts resulting from a particular site. The system displays fields to enter byproducts. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 139 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 ( ) 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 ( ) to edit a saved byproduct. ) Exhibit 4-40 shows a screen capture of the ‘Byproduct Information’ screen: Exhibit 4-40: Byproduct Information Screen Navigation: Click the ‘Next’ button to navigate to the ‘Optional Pollution Prevention’ screen. You can also access this screen by clicking the ‘Optional Pollution Prevention’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 140 4.1.25 Optional Pollution Prevention You can navigate to the ‘Optional Pollution Prevention’ screen by clicking the ‘Next’ button from the ‘Byproduct Information’ screen. You can also access this screen by clicking the ‘Optional Pollution Prevention’ link within the navigation tree. The ‘Optional Pollution Prevention’ screen provides fields for companies to enter data about their pollution prevention efforts. The company has the option of entering information as a free text field or as an attachment. The company can claim the information as confidential by checking the ‘CBI’ checkbox. The system allows an uploaded document to be claimed as CBI. If a document is claimed as CBI, the system requires the sanitized version of the attached document to be uploaded. To access or edit previously attached documents, click the appropriate file name of the document within the ‘File Name’ column of the document table. The attachment table displays the file name and file extension of the document, the document description, the number of pages the document contains, and the CBI status of the document. Click the ‘Delete’ icon ( ) located within the ‘Actions’ column to delete unwanted documents. You may provide information not reported elsewhere in this form regarding your efforts to reduce or minimize potential risks associated with activities surrounding manufacturing, processing, use, and disposal of the PMN substance on the ‘Optional Pollution Prevention’ screen. Include new information pertinent to pollution prevention, including source reduction, recycling activities and safer processes or products available due to the new chemical substance. Source reduction includes the reduction in the amount or toxicity of chemical wastes by technological modification, process and procedure modification, product reformulation, and/or raw materials substitution. Recycling refers to the reclamation of useful chemical components from wastes that would otherwise be treated or released as air emissions or water discharges, or land disposal. Quantitative or qualitative descriptions of pollution prevention, source reduction and recycling should emphasize potential risk reduction in addition to compliance with existing regulatory requirements. EPA is interested in the information to assess overall net reductions in toxicity or environmental releases and exposures, not the shifting of risks to other media (e.g., air to water) or non-environmental areas (e.g., occupational or consumer exposure). To the extent known, information about the technology being replaced will assist EPA in its relative risk determination. In addition, information on the relative cost or performance characteristics of the PMN substance to potential alternatives may be provided. Describe the expected net benefits, such as: (1) An overall reduction in risk to human health or the environment; (2) A reduction in the generation of waste materials through recycling, source reduction or other means; (3) A reduction in the use of hazardous starting materials, reagents, or feedstocks; (4) A reduction in potential toxicity, human exposure and/or environmental release; or (5) The extent to which the new chemical substance may be a substitute for an existing substance that poses a greater overall risk to human health or the environment. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 141 EPA strongly encourages submitters to provide pollution prevention data in their notices, as this information assists the Agency in balancing the benefits of a PMN substance against its unique risks. While Agency staffers frequently receive information on the benefits of the PMN substance with respect to its use(s), data on pollution prevention effects are rarely included. This section should be utilized to indicate to EPA benefits in terms of the raw materials incorporated, the manufacturing process, emission reductions, less toxic waste byproducts, or lower risks upon end use and disposal. You should consider the entire life cycle of the PMN substance in your evaluation. Also consider opportunities for product stewardship or other risk management controls that could significantly reduce risk characteristics of the new substance (e.g., disposal techniques that can be easily implemented and substantially reduce waste toxicity). Initiatives in the New Chemicals Program such as Environmental Technology Initiative (ETI) for Chemicals, and the Pollution Prevention Recognition Project, are geared towards incorporating this type of information into the Agency’s risk management decision making and recognizing innovative chemical design or technological innovation that shows potential for environmental and human health benefits. Describe any pollution prevention benefits here, and indicate if this information is confidential business information. Attempt to quantify the expected benefits to the extent possible and avoid exaggeration and highly speculative statements. The following questions can be used to assess pollution prevention benefits: (1) Are there pollution prevention benefits associated with the new PMN chemical? (2) Does it allow reduction of elimination of (more) toxic solvents? (3) Does it reduce disposal to land, or in safer forms, compared to the chemistry it replaces? (4) Can it be recycled more easily than existing materials? (5) Does your manufacturing process eliminate or reduce the use/release of hazardous substances? • Please click here to review additional information that should be included on this page: Click the link to display additional information regarding the pollution information. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the pollution prevention information as confidential. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for additional details regarding the attach document functionality. • File Name: Displays the file name and file extension of a document that is uploaded on the ‘Attach Documents’ pop-up window. Click the file name link to navigate to the ‘Attach Documents’ pop-up window to make any edits to an attached document. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 142 • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm the deletion. Exhibit 4-41 shows a screen capture of the ‘Optional Pollution Prevention’ screen: Exhibit 4-41: Optional Pollution Prevention Screen Navigation: Click the ‘Next’ button to navigate to the ‘Additional Attachments’ screen. You can also access this screen by clicking the ‘Additional Attachments’ link within the navigation tree. 4.1.26 Additional Attachments You can navigate to the ‘Additional Attachments’ screen by clicking the ‘Next’ button from the ‘Optional Pollution Prevention’ screen. You can also access this screen by clicking the ‘Additional Attachments’ link within the navigation tree. The ‘Additional Attachments’ screen provides a table for you to add additional attachments that have not been incorporated into the form. This screen allows documents that did not have a suitable place in the application to be uploaded. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 143 • Please click here to view a list of commonly attached documents and where they should be attached: Click the link to display a list of documents and where they should be attached. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for additional details regarding the attach document functionality. • File Name: Displays the file name and file extension of a document that is uploaded on the ‘Attach Documents’ pop-up window. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • Date: Displays the date a document was uploaded. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Action: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm the deletion. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 144 Exhibit 4-42 shows a screen capture of the ‘Additional Attachments’ screen: Exhibit 4-42: Additional Attachments Screen Navigation: Click the ‘Next’ button to navigate to the ‘Attachment Summary’ screen. You can also access this screen by clicking the ‘Attachment Summary’ link within the navigation tree. 4.1.27 Attachment Summary You can navigate to the ‘Attachment Summary’ screen by clicking the ‘Next’ button from the ‘Additional Attachments’ screen. You can also access this screen by clicking the ‘Attachment Summary’ link within the navigation tree. The ‘Attachment Summary’ screen displays a summary of the documents attached to the PMN form. The attachment table displays the section of the form a document is associated with, file name and file extension of a document, the document description, number of pages in a document, date attached, and whether the document is CBI. • Section: Displays the section of the PMN form that the attached document is associated. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 145 • File Name: Displays the file name and file extension of a document that is uploaded on the ‘Attach Documents’ pop-up window. • Description: Displays the description of a document that was uploaded on the ‘Attach Documents’ pop-up window. • Pages: Displays the number of pages a document contains. • Date: Displays the upload date of a document that was uploaded on the ‘Attach Documents’ pop-up window. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ Exhibit 4-43 shows a screen capture of the ‘Attachment Summary’ screen: Exhibit 4-43: Attachment Summary Screen Navigation: Click the ‘Next’ button to navigate to the ‘Optional Cover Letter’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 146 4.1.28 Optional Cover Letter You can navigate to the ‘Optional Cover Letter’ screen by clicking the ‘Next’ button from the ‘Attachment Summary’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree. The ‘Optional Cover Letter’ screen is used to communicate information with EPA that is not collected elsewhere in the form. The cover letter is used to give OPPT resources and special instructions regarding the application. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the information as confidential. • Optional Cover Letter: Enter the description and any additional special instructions regarding the form. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 147 Exhibit 4-44 shows a screen capture of the ‘Optional Cover Letter’ screen: Exhibit 4-44: Optional Cover Letter Screen Navigation: If you are not filing a Joint or Letter of Support submission, please refer to Section 3.9 for the functionality available within the bottom action bar. If you are submitting a Joint Submission, click the ‘Next’ button to navigate to the ‘Joint Submitter Information’ screen. You can also access this screen by clicking the ‘Joint Submitter Information’ link within the navigation tree. If you have a Letter of Support pending and are not submitting a Joint Submission, click the ‘Next’ button to navigate to the ‘Letter of Support Submitter Information’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 148 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 Primary Authorized Official December 15, 2014 149 Exhibit 4-45 shows a screen capture of the ‘Joint Submitter Information’ screen: Exhibit 4-45: Joint Submitter Information Screen Navigation: Click the ‘Next’ button to navigate to the ‘Joint Submission Information’ screen. You can also access this screen by clicking the ‘Joint Submission Information’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 150 4.1.30 Joint Submission Information You can access the ‘Joint Submission Information’ screen by clicking the ‘Next’ button from the ‘Joint Submitter Information’ screen. You can also access this screen by clicking the ‘Joint Submission Information’ link within the navigation tree. The ‘Joint Submission Information’ screen is used as a communication point between two companies. The ‘Joint Submission Information’ screen displays fields that capture information to pass to the joint submitter. A text box captures information to send to the joint submitter in an unencrypted email sent by the primary submitter. A ‘Unique Identifier for Joint Submissions’ box will also display on this screen. The unique identification number auto-generates when a user declares a joint submission is being established. Joint Submission Process: When you designate that a Joint Submission is being filed, you will be asked to enter all the information within the ‘Joint Submission’ folder. When the primary submitter navigates to the ‘Joint Submission Information’ screen, the primary submitter must send an email to the joint submitter identified on the ‘Joint Submitter Information’ screen. The email will contain the unique identification number that will link the two forms. When the joint submitter accesses the ‘Section 5 Notices and Supports Forms’ screen and creates a new form, the joint submitter will be prompted to enter the unique identification number on the ‘Create Passphrase’ screen. Once the unique identification number has been entered, the system will link the primary and joint forms. The original notice will not undergo a review process until all forms are received. • Joint Submission Information Instructions: Enter the information that the primary submitter is sending to the joint submitter. • Joint Submission Informational Text: Displays instructional text provided by OPPT, the unique identification number automatically generated for the form, and provides functionality to email the unique identification number to the joint submitter by clicking the ‘Notify the Secondary Submitter of the Joint Submission’ link. • Unique Identification Number: The unique identification number is a random, autogenerated 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 Authorized Official December 15, 2014 151 Exhibit 4-46 shows a screen capture of the ‘Joint Submission Information’ screen: Exhibit 4-46: Joint Submission Information Screen Navigation: Click the ‘Notify the Secondary Submitter of the Joint Submission’ link to access the unique identifier notification pop-up window. Click the ‘Next’ button to navigate to the ‘Letter of Support Submitter Information’ screen if you are submitting a Letter of Support. You can also access this screen by clicking the ‘Letter of Support Submitter Information’ link within the navigation tree. A warning generates on this screen after clicking the ‘Next’ or ‘Previous’ button if you have not sent an email notification to the Joint Submitter. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 152 4.1.31 Notify Joint Submitter of Joint Submission Information You can access the unique identifier notification window by clicking the ‘Notify the Secondary Submitter of the Joint Submission’ link from the ‘Joint Submission Information’ screen. The unique identifier notification window is used to provide the unique identification number to the joint submitter. The unique identifier notification window displays a ‘CC’ field for you to add other email addresses to the notification (including the original submitter), a ‘To’ field, and an ‘Additional Comments’ text box. • Chemical Checkbox (es): The chemical(s) identified within a form displays on the unique identifier notification pop-up window. Check the checkbox (es) for the chemical(s) identified within the form for which the secondary submitter should provide supporting information. • From: Displays the email address of the user that created the form. • CC: This editable field automatically populates with the email address of the user that created the original form and the email address (es) of the technical contact(s) identified within the form. • To: Contains instructional text for you to enter multiple email addresses. Contains the editable email address of the joint submitter specified on the ‘Joint Submitter Information’ screen; this email address will be pre-populated upon navigating to the window. Enter any additional email addresses to which the email should be sent. • Subject: Displays ‘YYYY Primary PMN.’ • Message: Contains a pre-determined message that will display in the email sent to a joint submitter. • Additional Comments: Enter any other additional comments or instructions that should be passed onto the joint submitter. • Send: Click the ‘Send’ button to generate and send the email to the email addresses identified in the ‘CC’ and ‘To’ fields. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 153 Exhibit 4-47 shows a screen capture of the Joint Submission unique identifier notification pop-up window (Scroll 1): Exhibit 4-47: Joint Submission Unique Identifier Notification Pop-Up Window (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 154 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) Navigation: Click the ‘Send’ button to send the email to the joint submitter and navigate back to the ‘Joint Submission Information’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 155 4.1.32 Letter of Support Submitter Information Click the ‘Next’ button from the ‘Joint Submission Information’ screen to access the ‘Letter of Support Submitter Information’ screen if a Letter of Support is pending. You can also access this screen by clicking the ‘Letter of Support Submitter Information’ link within the navigation tree. If you are only filing a Letter of Support, click the ‘Next’ button from the ‘Optional Cover Letter’ screen to navigate to the ‘Letter of Support Submitter Information’ screen. Click the ‘Add Letter of Support’ link within the navigation tree to add extra Letters of Support. The ‘Letter of Support Submitter Information’ screen captures contact information for the Letter of Support submitter who will enter separate information for the PMN form. The unique identification number will be sent to the Letter of Support submitter via the email address provided. An unlimited number of Letters of Support can be identified for each form. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the Letter of Support submitter contact information as confidential. • First Name: Enter the Letter of Support submitter’s first name. This is a required field. • Last Name: Enter the Letter of Support submitter’s last name. This is a required field. • Position: Enter the Letter of Support submitter’s job title. • Company Name: Enter the Letter of Support submitter’s company name. This is a required field. • Phone Number: Enter the Letter of Support submitter’s daytime phone number; U.S. or international. This field does not accept dashes. This is a required field. • Phone Extension: Enter the Letter of Support submitter’s phone number extension if applicable. • Email Address: Enter the Letter of Support submitter’s email address. The email address must follow the standard email address format: John.Doe@abc.com. This is not a required field, but is suggested for this contact. • Mailing Address 1: Enter the first line of the Letter of Support submitter’s mailing address. This is a required field. • Mailing Address 2: Enter the second line of the Letter of Support submitter’s mailing address. • City: Enter the city of the Letter of Support submitter’s mailing address. This is a required field. • State: Select the state of the Letter of Support submitter’s mailing address from the dropdown menu. This is a required field if ‘United States’ is selected from the ‘Country’ dropdown menu. • Postal Code: Enter the postal code of the Letter of Support submitter’s mailing address. This is a required field if the ‘Country’ field is set to ‘United States.’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 156 • Country: Select the country of the Letter of Support submitter’s mailing address from the drop-down menu. This is a required field. Exhibit 4-49 shows a screen capture of the ‘Letter of Support Submitter Information’ screen: Exhibit 4-49: Letter of Support Submitter Information Screen TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 157 Navigation: Click the ‘Next’ button to navigate to the ‘Letter of Support Submission Information’ screen. You can also access this screen by clicking the ‘Letter of Support Submission Information’ link within the navigation tree. 4.1.33 Letter of Support Submission Information You can navigate to the ‘Letter of Support Submission Information’ screen by clicking the ‘Next’ button from the ‘Letter of Support Submitter Information’ screen. You can also access this screen by clicking the ‘Letter of Support Submission Information’ link within the navigation tree. The ‘Letter of Support Submission Information’ screen is used as a communication point between two companies. The ‘Letter of Support Submission Information’ screen displays fields that capture information to pass onto the Letter of Support submitter. A text box captures information to send to the Letter of Support submitter in an email sent by the primary submitter. A ‘Unique Identifier for Letter of Support Submissions’ box will also display on this screen. The unique identification number generates when you declare a Letter of Support is being established. Letter of Support Submission Process: When you designate that a Letter of Support is pending, you will be asked to enter all the information within the ‘Letter of Support’ folder. When the primary submitter chooses to, the system will send an email to the Letter of Support submitter designated on the ‘Letter of Support Submitter Information’ screen. The email will contain the unique identification number that will link the two forms. When the Letter of Support submitter accesses the ‘Section 5 Notices and Supports Forms’ screen and clicks the ‘Start New Form’ button, the Letter of Support submitter will be prompted to enter the unique identification number on the ‘Create Passphrase’ screen. Once the unique identification number has been entered, the system will link the primary form and Letters of Support. Click the ‘Add Letter of Support’ link within the navigation tree to add extra Letters of Support as needed. • Letter of Support Submission Information Instructions: Enter the information that the primary submitter is sending to the Letter of Support submitter. • Letter of Support Submission Informational Text: Displays instructional text provided by EPA, the unique identification number generated for the form, and provides functionality to email the unique identification number to the Letter of Support submitter by clicking the ‘Notify the Secondary Submitter of the letter of support submission’ link. • Unique Identification Number: The unique identification number is a random number autogenerated to pass on to the Letter of Support submitter to create a Letter of Support. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 158 Exhibit 4-50 shows a screen capture of the ‘Letter of Support Submission Information’ screen: Exhibit 4-50: Letter of Support Submission Information Screen Navigation: Click the ‘Notify the Secondary Submitter of the letter of support submission’ link to navigate to the unique identifier notification window. Click the ‘Add Letter of Support’ link to file two or more Letters of Support. Click the ‘Next’ button to navigate to the ‘Letter of Support TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 159 Submitter Information’ screen if additional Letters of Support are identified. A warning generates on this screen after clicking the ‘Next’ or ‘Previous’ button (which may be present depending on the presence of multiple Letters of Support) if you have not sent an email notification to the Letter of Support submitter. Refer to Section 3.9 for the functionality available within the bottom action bar. 4.1.34 Notify Secondary Submitter of Letter of Support Information You can access the unique identifier notification window by clicking the ‘Notify the Secondary Submitter of the letter of support submission’ link from the ‘Letter of Support Submission Information’ screen. The unique identifier notification window is used to notify the Letter of Support submitter of the unique identification number. The unique identifier notification window displays a ‘CC’ field for you to add other email addresses to the notification (including the original submitter), a ‘To’ field, and an ‘Additional Comments’ text box. • 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 Primary Authorized Official December 15, 2014 160 Exhibit 4-51 shows a screen capture of the Letter of Support unique identifier notification pop-up window: TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 161 Exhibit 4-51: Letter of Support Unique Identifier Notification Pop-Up Window Navigation: Click the ‘Send’ button to send the email to the Letter of Support submitter and navigate back to the ‘Letter of Support Submission Information’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 162 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. If you upload an XML file into a pre-populated form, the XML file overwrites the contents of the pre-populated form. In addition, uploading any file removes the attached documents within a form, which must be re-attached. You must also add any sites identified within the form to your CDX registration profile. After uploading a file, click the ‘Preview’ icon ( ) located in the bottom action bar to view a PDF preview of the form ensuring that all the data has populated correctly and any other information is displayed accurately. In particular, review the ‘Letter of Activity (1),’ ‘Protective Equipment/Engineering Controls,’ ‘Physical Form,’ ‘Media of Release,’ ‘Control Technology,’ and ‘% New Substance’ fields of entry to confirm that they have been populated correctly. Please note that in IE 7, if an upload fails, the action bar at the bottom of the screen might be misaligned when the ‘Upload XML’ screen reloads. • Upload archive file: Click the button to generate the ‘File Upload’ window to search for the ZIP copy of record archive file populated with PMN information. The copy of record archive file must contain the XML form in a file labeled ‘formdata.xml.’ The application processes the ZIP copy of record archive file and displays any applicable error messages. • Export XML: Click the button to generate the XML file of the current PMN form that a user can download. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 163 Exhibit 4-52 shows a screen capture of the ‘Upload XML’ screen: Exhibit 4-52: Upload XML Screen Navigation: Click the ‘Validate’ icon ( ) located in the bottom action bar to validate the form. Click the ‘Save’ icon ( ) located in the bottom action bar to perform a global save on the form. Click the ‘Preview’ icon ( ) located in the bottom action bar to view a PDF preview of the form. Click the ‘Submit’ icon ( ) located in the bottom action bar to begin the submission process. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 164 5 Create Biotechnology Form The Biotechnology form is used to collect information about “intergeneric” microorganisms that will be manufactured or imported into the United States. EPA collects the information provided in a Biotechnology form through a free text box and attachments. The Biotechnology form does not have a structured data format, but there are several types of Biotechnology notices that can be filed. The different types are as follows: ‘Microbial Commercial Activity Notice (MCAN),’ ‘TSCA Experimental Release Application (TERA),’ ‘Tier I Exemption,’ ‘Tier II Exemption,’ and ‘Biotechnology Test Market Exemption (TME)’ forms. All the forms have the same upload requirements, and EPA will retain responsibility for verifying the correct information is received. 5.1 Create Biotechnology Form To create a new Biotechnology form, navigate to the ‘Section 5 Notices and Supports Forms’ screen and select ‘Biotechnology’ from the ‘Form Type’ drop-down menu. Refer to Section 3.4 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen. Refer to Section 3.5 for additional details regarding the create passphrase process. 5.1.1 General Form Information You can access the ‘General Form Information’ screen by creating a passphrase on the ‘Create Passphrase’ screen or by entering the passphrase on the ‘Enter Passphrase’ screen. The ‘General Form Information’ screen presents a list of text fields and drop-down menus for you to input identifying information for the specific form. You will have the option to assign a ‘Form Alias’ to help you identify the form. A form alias is helpful when a user or company has multiple forms and/or when you must differentiate between forms to the help desk. Upon navigating to the ‘General Form Information’ screen, the system auto-generates a default alias in the following format: . Select the submission type from the ‘Type of Submission’ drop-down menu. The ‘Type of Submission’ drop-down menu displays the following values: • MCAN (Microbial Commercial Activity Notice) • TERA (TSCA Experimental Release Application) • Tier I Exemption • Tier II Exemption • Biotechnology TME (Text Market Exemption) The system will provide a ‘TS Number’ field for you to enter a TS number to tie support forms or Joint Submissions to the original Biotechnology form. The TS number must be a six (6) character alphanumeric combination and should include two (2), three (3), or four (4) letters. Company names, recognizable words, and numerical series are not recommended. The ‘Text/Comments’ text box captures information regarding the submission/attachment. A ‘CBI’ checkbox displays above the ‘Text/Comments’ text box to claim the information as confidential. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 165 The ‘General Form Information’ screen displays the option to attach a document by clicking the ‘Attach Document’ button. For more information regarding the attach document functionality, please refer to Section 3.6. • Form Alias: Enter a custom form alias, if applicable. Upon navigating to the screen, the system auto-generates an editable alias comprised of . This is a required field. • Type of Submission: Select the submission type from the drop-down menu. This drop-down menu contains the following values: ‘MCAN (Microbial Commercial Activity Notice),’ ‘TERA (TSCA Experimental Release Application),’ ‘Tier I Exemption,’ ‘Tier II Exemption,’ and ‘Biotechnology TME (Test Market Exemption).’ • TS Number: Enter the TS number. The TS number can be any six (6) character alphanumeric combination and should include two (2), three (3), or four (4) letters. Company names, recognizable words and numerical series are not recommended. This field is required if ‘MCAN’ is selected from the ‘Type of Submission’ drop-down menu, but is also required regardless of the submission type if a Letter of Support is pending, and/or if a joint Biotechnology form is being filed. • Text/Comments: Enter a description of the form and/or attachment. • CBI: Check the ‘CBI’ checkbox to claim the ‘Text/Comments’ information as confidential. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Upload attachments including published literature, regulations and certifications, ID data, construct data, effects data, MSDS, manufacturing details, use details, inactivation data, and/or other types of documents. At least one document is required to be uploaded even if a Letter of Support or Joint Submission is claimed. Please refer to Section 3.6 for additional details regarding the attach document process. • File Name: Displays the file name and file extension of a document that is uploaded on the ‘Attach Documents’ pop-up window. • Description: Displays the description of a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm the deletion. • Check here if you are filing a consolidated Biotechnology form: Check the ‘Check here if you are filing a consolidated Biotechnology form’ checkbox to indicate you will be submitting a consolidated form. This field is required if a value is entered in the ‘Number of Microorganisms’ text field. This field is non-editable when creating a Biotechnology amendment. • Number of Microorganisms: Enter the number of microorganisms in a consolidated submission; this number should be a value from two (2) through twenty (20). This field is required if the ‘Check here if you are filing a consolidated Biotechnology form’ checkbox is checked. This field is non-editable when creating a Biotechnology amendment. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 166 • 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) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 167 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) Navigation: If you are filing a joint Biotechnology form, click the ‘Next’ button to navigate to the ‘Joint Submitter Information’ screen. You can also access this screen by clicking the ‘Joint Submitter Information’ link within the navigation tree after clicking the ‘Save’ icon within the bottom action bar. If you are filing a Letter of Support and not a joint Biotechnology form, click the ‘Next’ button to navigate to the ‘Letter of Support Submitter Information’ screen. You can also access this screen by clicking the ‘Letter of Support Submitter Information’ link within the navigation tree after clicking the ‘Save’ icon within the bottom action bar. Click the ‘Next’ button to navigate to the ‘Technical Contact Information’ screen if you are not filing either a Letter of Support or a Joint Biotechnology form. You can also navigate to this screen by clicking the ‘Technical Contact Information’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 168 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 Primary Authorized Official December 15, 2014 169 Exhibit 5-3 shows a screen capture of the ‘Joint Submitter Information’ screen: Exhibit 5-3: Joint Submitter Information Screen (Biotechnology) Navigation: Click the ‘Next’ button to navigate to the ‘Joint Submission Information’ screen. You can also access this screen by clicking the ‘Joint Submission Information’ link within the navigation tree. 5.1.3 Joint Submission Information You can access the ‘Joint Submission Information’ screen by clicking the ‘Next’ button from the ‘Joint Submitter Information’ screen. You can also access this screen by clicking the ‘Joint Submission Information’ link within the navigation tree. The ‘Joint Submission Information’ screen is used as a communication point between two companies. The ‘Joint Submission Information’ screen displays fields that capture information to pass to the joint submitter. A text box captures information to send to the joint submitter in an unencrypted email sent by the primary submitter. A ‘Unique Identifier for Joint Submissions’ box will also display on this screen. The unique identification number auto-generates when a user declares a joint submission is being established. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 170 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 autogenerated to pass on to the joint submitter to create a joint submission. Exhibit 5-4 shows a screen capture of the ‘Joint Submission Information’ screen: Exhibit 5-4: Joint Submission Information Screen (Biotechnology) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 171 Navigation: If you are filing a Letter of Support, click the ‘Next’ button to navigate to the ‘Letter of Support Submitter Information’ screen. You can also access this screen by clicking the ‘Letter of Support Submitter Information’ link within the navigation tree. If you are not filing a Letter of Support, click the ‘Next’ button to navigate to the ‘Technical Contact Information’ screen. You can also navigate to this screen by clicking the ‘Technical Contact Information’ link within the navigation tree. 5.1.4 Notify Secondary Submitter of Joint Submission Information You can access the unique identifier notification pop-up window by clicking the ‘Notify the Secondary Submitter of the Joint Submission’ link from the ‘Joint Submission Information’ screen. The unique identifier notification pop-up window is used to notify the secondary submitter of the unique identification number. The unique identifier notification window displays a ‘CC’ field to add other email addresses to the notification (including the original submitter), a ‘To’ field, and an ‘Additional Comments’ text box. • From: Displays the email address of the original submitter. • CC: Contains the email address from CDX registration information, and the editable email address of the technical contact. • To: Contains instructional text to enter multiple email addresses. Contains the editable email address of the joint submitter specified on the ‘Joint Submitter Information’ screen; this email address will be automatically populated upon navigating to the window. • Subject: Displays ‘YYYY Biotechnology.’ • Message: Displays a pre-determined message that will display in the email sent to a secondary submitter. • Additional Comments: Enter any other additional comments or instructions that should be passed onto the secondary submitter. • Send: Click the button to generate and send an email to the email addresses identified in the ‘CC’ and ‘To’ fields. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 172 Exhibit 5-5 shows a screen capture of the ‘Unique Identifier Notification’ pop-up window: Exhibit 5-5: Unique Identifier Notification Pop-Up Window Navigation: Click the ‘Send’ button to send the email to the Joint Submitter and navigate back to the ‘Joint Submission Information’ screen. Click the ‘X’ button in the upper right-hand corner to cancel the process of notifying a Joint Submitter and navigate back to the ‘Joint Submission Information’ screen. 5.1.5 Letter of Support Submitter Information You can access the ‘Letter of Support Submitter Information’ screen by clicking the ‘Next’ button from the ‘General Form Information’ screen if you are not filing a Joint Submission. You can also access this screen by clicking the ‘Next’ button from the ‘Joint Submission Information’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 173 screen. You can also access this screen by clicking the ‘Letter of Support Submitter Information’ link within the navigation tree when you have indicated that a Letter of Support form will be filed. Click the ‘Add Letter of Support’ link within the navigation tree to add a Letter of Support. The system will allow an unlimited number of Letters of Support to be filed. Remove a Letter of Support by clicking the ‘Remove’ link ( ) within the navigation tree. The ‘Letter of Support Submitter Information’ screen presents a list of text fields and drop-down menus used to enter contact information for the Letter of Support submitter who will be submitting separate information for the Biotechnology form. The provided email address will be used to send the Letter of Support submitter the unique identification number to create the Letter of Support at the discretion of the primary submitter. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the Letter of Support submitter information as confidential. When you claim the Letter of Support submitter contact information as CBI, you are stating that the information is confidential and should not be released to the public. • First Name: Enter the Letter of Support submitter’s first name. This is a required field. • Last Name: Enter the Letter of Support submitter’s last name. This is a required field. • Position: Enter the Letter of Support submitter’s job title. • Company Name: Enter the Letter of Support submitter’s company name. This is a required field. • Phone Number: Enter the Letter of Support submitter’s phone number. This is a required field. • Phone Extension: Enter the Letter of Support submitter’s phone number extension if applicable. • Email Address: Enter the Letter of Support submitter’s email address. The email address must follow the standard email address format: John.Doe@abc.com. • Mailing Address 1: Enter the first line of the Letter of Support submitter’s mailing address. This is a required field. • Mailing Address 2: Enter the second line of the Letter of Support submitter’s mailing address. • City: Enter the city of the mailing address of the Letter of Support submitter. This is a required field. • State: Select the state of the mailing address of the Letter of Support submitter from the drop-down menu. This is a required field if the ‘Country’ field is set to ‘United States.’ • Postal Code: Enter the postal code of the mailing address for the Letter of Support submitter. • Country: Select the country of the mailing address for the Letter of Support submitter. This is a required field. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 174 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) 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 TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 175 to enter information to pass to the secondary submitter. A text box is used to send information in an email to the secondary submitter. A ‘Unique Identifier for Letter of Support Submissions’ box will also display on this screen. The unique identifier auto-generates when a Letter of Support submission is being established. Letter of Support Submission Process: A field titled ‘Special Information’ will be used to send information to the Joint Submitter in an email sent at the discretion of the primary submitter. When the secondary submitter accesses the ‘Section 5 Notices and Supports Forms’ screen and creates a new form, the secondary submitter will be prompted to enter the unique identifier on the ‘Create Passphrase’ screen. Once the unique identifier has been entered, the application will tie the two forms together. • Letter of Support Submission Information Instructions: Enter the information that the primary submitter is sending to the Letter of Support submitter. • Letter of Support Submission Informational Text: Displays instructional text provided by EPA, the unique identification number generated for the form, and provides functionality to email the unique identification number to the Letter of Support submitter by clicking the ‘Notify the Secondary Submitter of the Letter of Support submission’ link. • Unique Identification Number: The unique identification number is a random number autogenerated to pass on to the Letter of Support submitter to create a Letter of Support. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 176 Exhibit 5-7 shows a screen capture of the ‘Letter of Support Submission Information’ screen: Exhibit 5-7: Letter of Support Submission Information Screen (Biotechnology) 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 177 5.1.7 Notify Secondary Submitter of Letter of Support Information You can access the unique identifier notification pop-up window by clicking the ‘Notify the Secondary Submitter of the Letter of Support submission’ link from the ‘Letter of Support Submission Information’ screen. The unique identifier notification pop-up window is used to notify the secondary submitter of the unique identification number. The unique identifier notification window displays a ‘CC’ field to add other email addresses to the notification (including the original submitter), a ‘To’ field, and an ‘Additional Comments’ text box. • From: Displays the email address of the original submitter. • CC: This editable text field automatically populates with the email address from CDX registration information, and the email address of the technical contact. • To: Contains instructional text to enter multiple email addresses. Contains the editable email address of the joint submitter specified on the ‘Joint Submitter Information’ screen; this email address automatically populates upon navigating to the window. • Subject: Displays ‘YYYY Biotechnology.’ • 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 Primary Authorized Official December 15, 2014 178 Exhibit 5-8 shows a screen capture of the unique identifier notification pop-up window: Exhibit 5-8: Unique Identifier Notification Pop-Up Window Navigation: Click the ‘Send’ button to send the email to the secondary submitter and navigate back to the ‘Letter of Support Submission Information’ screen. Click the ‘X’ in the upper righthand corner to cancel the unique identification number notification process and navigate back to the ‘Letter of Support Submission Information’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 179 5.1.8 Technical Contact Information You can access the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from the ‘General Form Information’ screen if you are not filing a Joint Submission or Letter of Support. You can also access this screen by clicking the ‘Next’ button from the ‘Joint Submission Information’ screen if you are not filing a Letter of Support. You can also navigate to the ‘Technical Contact Information’ screen by clicking the ‘Technical Contact Information’ link within the navigation tree. The ‘Technical Contact Information’ screen displays an ‘Add Technical Contact’ button. Click the ‘Add Technical Contact’ button to generate an ‘Add Technical Contact’ pop-up window to enter information into the text fields. Click the ‘Copy CDX Registration’ button to populate the text fields using your CDX registration information. Check the ‘Check here to claim this information as CBI’ checkbox to indicate that the information is confidential and will not be released to the public. • Add Technical Contact: Click the ‘Add Technical Contact’ button to generate the ‘Add Technical Contact’ pop-up window. • Last Name: Displays the last name of the reported technical contact. • First Name: Displays the first name of the reported technical contact. • Address: Displays the address of the reported technical contact. • CBI: Indicates the CBI status of the reported technical contact information by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) 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 Primary Authorized Official December 15, 2014 180 Exhibit 5-9 shows a screen capture of the ‘Technical Contact Information’ screen: Exhibit 5-9: Technical Contact Information Screen (Biotechnology) Navigation: Click the ‘Next’ button from the ‘Technical Contact Information’ screen to navigate to the ‘Optional Cover Letter’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree. 5.1.8.1 Add Technical Contact You can access the ‘Add Technical Contact’ pop-up window by clicking the ‘Add Technical Contact’ button on the ‘Technical Contact Information’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 181 • Copy CDX Registration: Click the ‘Copy CDX Registration’ button to copy your information from CDX registration; a message displays confirming the import of CDX registration information. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the technical contact information as confidential. • First Name: Enter the technical contact’s first name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Last Name: Enter the technical contact’s last name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Position: Enter the technical contact’s job title. • Company Name: Enter the technical contact’s company name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Phone Number: Enter the daytime U.S. phone number of the technical contact; this must be at least 10 characters long and does not accept dashes. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Phone Extension: Enter the technical contact’s phone number extension if applicable. • Email Address: Enter the technical contact’s email address. The email address must follow the standard email address format: John.Doe@abc.com. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. • Mailing Address 1: Enter the first line of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Mailing Address 2: Enter the second line of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. • City: Enter the city of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • State: Select the state of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Postal Code: Enter the postal code of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Country: Displays ‘United States.’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 182 Exhibit 5-10 shows a screen capture of the ‘Add Technical Contact’ pop-up window: Exhibit 5-10: Add Technical Contact Pop-Up Window Navigation: Click the ‘Cancel’ button to stop populating technical contact information and navigate back to the ‘Technical Contact Information’ screen. Click the ‘OK’ button to save and populate the entered technical contact information and navigate back to the ‘Technical Contact Information’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 183 5.1.9 Optional Cover Letter You can access the ‘Optional Cover Letter’ screen by clicking the ‘Next’ button from the ‘Technical Contact Information’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree. The ‘Optional Cover Letter’ screen is used to communicate information to EPA not collected elsewhere in the form. The cover letter is used to give OPPT resources and special instructions regarding the application; enter any necessary instructions into the blank text field. The cover letter should be either fully CBI or non-CBI to eliminate user error to promote transparency between the company and EPA. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the cover letter information as confidential. • Optional Cover Letter: Enter the description and any additional special instructions regarding the form. Exhibit 5-11 shows a screen capture of the ‘Optional Cover Letter’ screen: Exhibit 5-11: Optional Cover Letter Screen TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 184 Navigation: Click the ‘Validate’ icon ( ) located in the bottom action bar to validate the form. Click the ‘Save’ icon ( ) located in the bottom action bar to perform a global save on the form. Click the ‘Preview’ icon ( ) located in the bottom action bar to view a PDF preview of the form. Click the ‘Submit’ icon ( ) located in the bottom action bar to begin the submission process. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 185 6 Create Notice of Commencement (NOC) Form The Notice of Commencement (NOC) form allows industry users to notify EPA when a new chemical or microorganism, submitted under a Biotechnology or PMN form, has already started manufacture or import. A NOC form cannot be submitted before the chemical or microorganism has gone through the review period by EPA. The NOC must be submitted within thirty (30) days after the start date of the first manufacture or import. 6.1 Create NOC Form To create a new NOC form, navigate to the ‘Section 5 Notices and Supports Forms’ screen and select ‘Notice of Commencement (NOC)’ from the ‘Form Type’ drop-down menu and click the ‘Start New Form’ button. Refer to Section 3.4 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen. Refer to Section 3.5 for additional details regarding the create passphrase process. 6.1.1 General Form Information You can access the ‘General Form Information’ screen by creating a passphrase on the ‘Create Passphrase’ screen or entering the passphrase on the ‘Enter Passphrase’ screen. The ‘General Form Information’ screen provides fields to identify information that notifies EPA of the form alias, case number, and manufacture or import information. The ‘General Form Information’ screen presents a list of text fields and drop-down menus to capture information about the originally filed form. The ‘Manufacture/Import Information’ field presents radio buttons for you to state whether the company intends to manufacture or import the new chemical substance. When a manufacture/import radio button is selected, a calendar widget appears for you to enter the date of commencement. • Form Alias: Enter a custom form alias, if applicable. Upon navigating to the screen, the system auto-generates an editable form alias in the following format: . This is a required field. • Case Number: Enter the case number pertaining to the reported chemical substance or mixture. The case number must be in the following format: P-XX-0999 for Premanufacture Notice cases or J-XX-0999 for MCAN Biotechnology cases where ‘XX’ indicates the fiscal year in which the case number is generated, and the leading ‘0’ is required. This is a required field. • First Commercial Manufacture: Enter the date for the first commercial manufacture. Select the ‘First Commercial Manufacture’ radio button to generate a date field and calendar widget to select the appropriate date. If you select a future date past the current date, an error displays when navigating away from the screen. Either the ‘First Commercial Manufacture’ radio button or the ‘First Commercial Importation’ field is required. • First Commercial Importation: Enter the date for the first commercial importation. Select the ‘First Commercial Importation’ radio button to generate a date field and calendar widget to select the appropriate date. If you select a future date past the current date, an error displays when navigating away from the screen. Either the ‘First Commercial Manufacture’ or the ‘First Commercial Importation’ field is required. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 186 Exhibit 6-1 shows a screen capture of the ‘General Form Information’ screen: Exhibit 6-1: General Form Information Screen (NOC) Navigation: Click the ‘Next’ button to navigate to the ‘Technical Contact Information’ screen. You can also access this screen by clicking the ‘Technical Contact Information’ link within the navigation tree. 6.1.2 Technical Contact Information You can access the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from the ‘General Form Information’ screen. You can also access this screen by clicking the ‘Technical Contact Information’ link within the navigation tree. The ‘Technical Contact Information’ screen displays an ‘Add Technical Contact’ button. Click the ‘Add Technical Contact’ button to generate an ‘Add Technical Contact’ pop-up window to enter technical contact information into the list of text fields. Click the ‘Copy CDX Registration’ button to populate the text fields with your contact information entered during CDX registration. Check the ‘Check here to claim this information as CBI’ checkbox to claim the technical contact information as confidential to indicate that the information will not be released to the public. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 187 • Add Technical Contact: Click the ‘Add Technical Contact’ button to generate the ‘Add Technical Contact’ pop-up window. • Last Name: Displays the technical contact’s last name. • First Name: Displays the technical contact’s first name. • Address: Displays the technical contact’s address. • CBI: Indicates the technical contact’s CBI status by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the technical contact. A warning message displays to confirm the deletion of the technical contact. Exhibit 6-2 shows a screen capture of the ‘Technical Contact Information’ screen: Exhibit 6-2: Technical Contact Information Screen (NOC) Navigation: Click the ‘Next’ button to navigate to the ‘Chemical Information’ screen. You can also access this screen by clicking the ‘Chemical Information’ link within the navigation tree. 6.1.2.1 Add Technical Contact Click the ‘Add Technical Contact’ button to begin the process of adding technical contacts. • Copy CDX Registration: Click the ‘Copy CDX Registration’ button to import contact information from CDX registration; a confirmation will display. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 188 • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the technical contact information as confidential. • First Name: Enter the technical contact’s first name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Last Name: Enter the technical contact’s last name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Company Name: Enter the technical contact’s company name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Phone Number: Enter the technical contact’s daytime U.S. phone number; this must be at least 10 characters long and does not accept dashes. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Phone Extension: Enter the technical contact’s phone number extension, if applicable. • Email Address: Enter the technical contact’s email address. The email address must follow the standard email address format: John.Doe@abc.com. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. • Mailing Address 1: Enter the first line of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Mailing Address 2: Enter the second line of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. • City: Enter the city of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • State: Select the state of the technical contact’s mailing address from the drop-down menu. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Postal Code: Enter the postal code of the technical contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Country: Displays ‘United States.’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 189 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) Navigation: Click the ‘Cancel’ button or ‘X’ icon at the top left corner of the window to return to the ‘Technical Contact Information’ screen without saving the technical contact information. Click the ‘OK’ button to save the entered technical contact information and return to the ‘Technical Contact Information’ screen. 6.1.3 Chemical Information You can access the ‘Chemical Information’ screen by clicking the ‘Next’ button from the ‘Technical Contact Information’ screen. You can also access this screen by clicking the ‘Chemical Information’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 190 The ‘Chemical Information’ screen provides fields to identify the chemical the submitter has begun to manufacture or import. The ‘Specific Chemical Identity’ section provides fields to input information describing the chemical for which the NOC is to be filed. This screen outlines the unique chemical properties and displays the name and CASRN of the chemical. Most of the chemicals submitted under a NOC will not be found in the ‘Search Substance Registry Services’ window, and a new chemical will have to be created. To create a new chemical, click the ‘Search SRS’ button, found in the ‘Chemical Information’ screen, and then the ‘Create New Chemical’ button to generate the ‘Chemical Not Found In Substance Registry Services’ pop-up window. If you claim a chemical as CBI, the ‘Generic Chemical Name’ text box generates. A ‘CBI Substantiation’ folder displays within the navigation tree upon navigating away from the screen. If you claim chemical identity as confidential, you must provide a generic chemical name for your substance that reveals the specific chemical identity of the new chemical substance to the maximum extent possible. Please note that EPA will be closely assessing the generic name at this time; please make sure that your generic name is a good generic name that only hides the proprietary parts of the chemical information. • Add New Chemical: Click the ‘Add New Chemical’ button to generate the ‘Specific Chemical Identity’ expandable/collapsible field set. At least one chemical is required. • Search SRS: Click the ‘Search SRS’ button to generate the ‘Search SRS’ window. Refer to Section 3.10 for additional details regarding the search SRS functionality. • CASRN: Displays the CASRN of the chemical being reported, if applicable. • Chemical Name: Displays the chemical name of the substance being reported. • CBI: Check the ‘CBI’ checkbox to claim the ‘Specific Chemical Identity’ information as confidential and generate the ‘Generic Chemical Name’ text box. If you claim the chemical as confidential, a ‘CBI Substantiation’ folder displays within the navigation tree after clicking the ‘Next’ button from the ‘Chemical Information’ screen. • Generic Chemical Name: Enter the generic name to associate with a chemical. This field displays only when the ‘Specific Chemical Identity’ is claimed CBI. This is a required field if there is no pending Letter of Support or Joint Submission for the form. • Save: Click the button to save the information entered within the expandable/collapsible field set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.9 for more information regarding the save functionality in an expandable/collapsible field set. • Cancel: Click the ‘Cancel’ link located in the upper right-hand corner of the expandable/collapsible field set to prevent edits from saving and to remove a field set. The ‘Cancel’ link displays when the expandable/collapsible field set is open for editing. A confirmation message displays to confirm the action. • Edit: Click the ‘Edit’ link located in the upper right-hand corner of the expandable/collapsible field set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has been saved and the data is not currently editable. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 191 • 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. • Expand All: Click the ‘Expand All’ link located at the upper right-hand corner of the expandable/collapsible field sets to expand a series of field sets. • Collapse All: Click the ‘Collapse All’ link located at the upper right-hand corner of the expandable/collapsible field sets to collapse a series of field sets. • Substance Identity Confidentiality Status: You will only be able to select a single radio button. If you claim the chemical as CBI, after clicking the ‘Save’ button in the ‘Specific Chemical Identity’ expandable/collapsible field set, the system enables the first radio button and disables the second and third radio buttons. If you do not claim the chemical as CBI, after clicking the ‘Save’ button in the ‘Specific Chemical Identity’ expandable/collapsible field set, the system disables the first radio button and enables the second and third radio button options. This section displays the following options: o I wish to claim the substance identity confidential and the substantiation to support this claim is attached. Failure to submit the required substantiation in accordance with 40 CFR 720.85(b) will result in waiver of your claim. o I previously claimed the substance identity as confidential and hereby relinquish that claim. o I did not claim the substance identity as confidential in my original PMN submission. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 192 Exhibit 6-4 shows a screen capture of the ‘Chemical Information’ screen (Scroll 1): Exhibit 6-4: Chemical Information Screen (Scroll 1) (NOC) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 193 Exhibit 6-5 shows a screen capture of the ‘Chemical Information’ screen (Scroll 2): Exhibit 6-5: Chemical Information Screen (Scroll 2) (NOC) Navigation: Click the ‘Next’ button to navigate to the ‘Site Information’ screen. You can also access this screen by clicking the ‘Site Information’ link within the navigation tree. 6.1.4 Site Information You can access the ‘Site Information’ screen by clicking the ‘Next’ button from the ‘Chemical Information’ screen. You can also access this screen by clicking the ‘Site Information’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 194 The ‘Site Information’ screen identifies the site at which the manufacture or import of the chemical occurs. You are able to identify sites via the ‘Add Site’ pop-up window. To do so, click the ‘Add Site’ button. You must select a site before moving on to the ‘CBI Substantiation Part 1’ screen or to the ‘Optional Cover Letter’ screen. • Add Site: Click the ‘Add Site’ button to generate the ‘Add Site’ pop-up window. Refer to Section 3.11 for additional details regarding the add site functionality. • Registry ID: Displays the EPA registry ID of the site. • Site Name: Displays the site name associated with a site. • Address: Displays the site address of a site. • CBI: Indicates the CBI status of a site by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the site row permanently from the system. A confirmation prompt displays to confirm the deletion. Exhibit 6-6 shows a screen capture of the ‘Site Information’ screen: Exhibit 6-6: Site Information Screen (NOC) Navigation: If you claimed a chemical as CBI, click the ‘Next’ button to navigate to the ‘CBI Substantiation Part 1’ screen. You can also access this screen by clicking the ‘CBI Substantiation Part 1’ link within the navigation tree. If you did not claim a chemical as CBI, click the ‘Next’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 195 button to navigate to the ‘Optional Cover Letter’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree. 6.1.5 CBI Substantiation Part 1 You can access the ‘CBI Substantiation Part 1’ screen by clicking the ‘Next’ button from the ‘Site Information’ screen if a chemical was claimed CBI on the ‘Chemical Information’ screen. You can also access this screen by clicking the ‘CBI Substantiation Part 1’ link within the navigation tree. The ‘CBI Substantiation Part 1’ screen presents substantiation questions that require you to provide answers into the text fields as free text or enter ‘N/A’ if the question does not apply. The ‘CBI Substantiation Part 1’ screen consists of questions A through D, which read as follows: • (A) What harmful effects to your competitive position, if any, do you think would result if EPA publishes on the Inventory the identity of the chemical substance? How could a competitor use such information given the fact that the identity of the substance otherwise would appear on the inventory of chemical substances with no link between the substance and your company or industry? How substantial would the harmful effects of disclosure be? What is the causal relationship between the disclosure and the harmful effects?: Enter the answer to substantiation question A. This is a required field. • (B) For what period of time should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?: Enter the answer to substantiation question B. This is a required field. • (C) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential for purposes of the Inventory?: Enter the answer to substantiation question C. This is a required field. • (D) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone?: Enter the answer to substantiation question D. This is a required field. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 196 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) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 197 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) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 198 Navigation: Click the ‘Next’ button to navigate to the ‘CBI Substantiation Part 2’ screen. You can also access this screen by clicking the ‘CBI Substantiation Part 2’ link within the navigation tree. 6.1.6 CBI Substantiation Part 2 You can access the ‘CBI Substantiation Part 2’ screen by clicking the ‘Next’ button from the ‘CBI Substantiation Part 1’ screen. You can also access this screen by clicking the ‘CBI Substantiation Part 2’ link within the navigation tree. The ‘CBI Substantiation Part 2’ screen presents substantiation questions that require answers to be entered into the text fields as free text or enter ‘N/A’ if the question does not apply. The ‘CBI Substantiation Part 2’ screen consists of questions E through H, which read as follows: • (E) Is the fact that someone is manufacturing or importing this chemical substance for commercial purposes available to the public, e.g. in technical journals or other publications; in libraries; or in State, local or Federal agency public files?: Enter the answer to substantiation question E. This is a required field. • (F) What measures have you taken to prevent undesired disclosure of the fact that you are manufacturing or importing this substance for a commercial purpose?: Enter the answer to substantiation question F. This is a required field. • (G) To what extent has the fact that you are manufacturing or importing this chemical substance for a commercial purpose been disclosed to others? What precautions have you taken in regard to these disclosures? Has this information been disclosed to the public, or to competitors?: Enter the answer to substantiation question G. This is a required field. • (H) In what form does this particular chemical substance leave the site of manufacture, e.g. as part of a product, in effluent or emission stream? If so, what measures have you taken to guard against discovery of its identity?: Enter the answer to substantiation question H. This is a required field. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 199 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) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 200 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) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 201 Navigation: Click the ‘Next’ button to navigate to the ‘CBI Substantiation Part 3’ screen. You can also access this screen by clicking the ‘CBI Substantiation Part 3’ link within the navigation tree. 6.1.7 CBI Substantiation Part 3 You can access the ‘CBI Substantiation Part 3’ screen by clicking the ‘Next’ button from the ‘CBI Substantiation Part 2’ screen. You can also access this screen by clicking the ‘CBI Substantiation Part 3’ link within the navigation tree. The ‘CBI Substantiation Part 3’ screen presents substantiation questions that require answers to be entered into the text fields as free text or enter ‘N/A’ if the question does not apply. The ‘CBI Substantiation Part 3’ screen consists of questions I through L, which read as follows: • (I) If the chemical substance leaves the site of manufacture in a product that is available to either the public or your competitors, can they identify the substance by analyzing the product?: Enter the answer to substantiation question I. This is a required field. • (J) For what purpose do you manufacture or import the substance?: Enter the answer to substantiation question J. This is a required field. • (K) Has EPA, another Federal agency, or any Federal court made any persistent confidentiality determinations regarding this chemical substance? If so, copies of such determinations must be included in the substantiation.: Enter the answer to substantiation question K. This is a required field. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window and attach supporting documentation for substantiation question K. Refer to Section 3.6 for additional details regarding the attach document functionality. • File Name: Displays the file name and file extension of the file that is uploaded on the ‘Attach Documents’ pop-up window. • Description: Displays the description associated with a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) 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 Authorized Official December 15, 2014 202 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) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 203 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) Navigation: Click the ‘Next’ button from the ‘Site Information’ screen if a chemical was not claimed CBI, or the ‘CBI Substantiation Part 3’ screen to navigate to the ‘Optional Cover Letter’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 204 6.1.8 Optional Cover Letter If you are not claiming a chemical as CBI on the ‘Chemical Information’ screen, click the ‘Next’ button from the ‘Site Information’ screen to navigate to the ‘Optional Cover Letter’ screen. If you did claim a chemical as CBI on the ‘Chemical Information’ screen, click the ‘Next’ button from the ‘CBI Substantiation Part 3’ screen to navigate to the ‘Optional Cover Letter screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree. The ‘Optional Cover Letter’ screen is used to communicate information to EPA not collected elsewhere in the form. The cover letter is used to give OPPT resources and special instructions regarding the application. The cover letter should be either fully CBI or non-CBI to eliminate user error and to promote transparency between the company and EPA. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the cover letter as confidential. • Cover Letter: Enter any additional information or special instructions associated with the form. Exhibit 6-13 shows a screen capture of the ‘Optional Cover Letter’ screen: Exhibit 6-13: Optional Cover Letter Screen (NOC) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 205 Navigation: Click the ‘Validate’ icon ( ) located in the bottom action bar to validate the form. Click the ‘Save’ icon ( ) located in the bottom action bar to save the overall form. Click the ‘Preview’ icon ( ) to generate a PDF preview of the form. Click the ‘Submit’ icon ( ) located in the bottom action bar to begin the submission process. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 206 7 Create Support Form The Section 5 Notices and Supports application allows support forms to be submitted such as ‘Amendment,’ ‘Other Correspondence,’ ‘Suspension Request,’ ‘Transfer of Ownership,’ ‘Withdrawal Requests,’ and ‘Test Data.’ Support forms are filed separately from PMN forms due to access restrictions and/or to provide information not included in the original PMN. The Support form is used to supplement the original PMN by providing additional data that was not provided originally, withdraw a PMN application, or provide data that was requested later. 7.1 Create Support Form To create a new Support form, navigate to the ‘Section 5 Notices and Supports Forms’ screen and select ‘Support’ from the ‘Form Type’ drop-down menu. Refer to Section 3.4 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen. Refer to Section 3.5 for additional details regarding the create passphrase process. 7.1.1 General Form Information You can access the ‘General Form Information’ screen by entering a passphrase on the ‘Enter Passphrase’ screen or creating a passphrase on the ‘Create Passphrase’ screen. The ‘General Form Information’ screen provides a list of text fields and drop-down menus for you to input information about the originally filed form. Please note that if you are using IE 7, the action bar icons may be misaligned and hovering over the ‘Next’ button on this screen causes the button to move. • Form Alias: Enter the form alias. Upon navigating to the screen, the system auto-generates an editable form alias comprised of . This is a required field. • Case Number: Enter the case number that connects to the original submission in the system. This is a type-ahead field that displays the forms that have been submitted under the same organization. If the case number is in the application, the remaining fields on the ‘General Form Information’ screen will populate. In the case of legacy submissions, case numbers must be manually entered. The case number must be in one of the following formats: P-XXXXXX 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-XXXXXX for TERA, G-XX-XXXX for Tier-I, H-XX-XXXX for Tier-II, or BF-XX-XXXX for Bona Fide. This field does not accept -0000 as a case number suffix. This is a required field. • TS Number: Enter the TS number; this field accepts any six (6) character alphanumeric combination. This value is determined by the company in order to identify the form for both payments and connecting related submissions (Letters of Support, Joint Submissions and corrections). This field will auto-populate if the ‘Case Number’ field is linked to a form that is recognized by the application. The TS number should include two (2), three (3), or four (4) letters. Company names, recognizable words and numerical series are not recommended. • Type of Support: Select the type of support from the drop-down menu. This field contains the following values: ‘Amendment,’ ‘Suspension Request,’ ‘Test Data,’ ‘Transfer of TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 207 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 ( ) to save an individual EPA/contractor entry. Click the ‘Form’ icon ( ) 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 ‘CBI’ checkbox to claim the support description or explanation of support as confidential. • Description or Explanation of Support: Enter the support description or explanation of support. Either the ‘Description or Explanation of Support’ field is required, or an attached document is required. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window and attach documents describing the Support form. Attachments that are uploaded include individual toxicity studies, GPC data, spectra, exposure monitoring evaluations, physical and chemical properties data, SAR modeling, test samples characterization data, explanatory comments, etc. Analytical tests should be provided with their complete data set. For example, provide a GPC test report with time interval data and all graphs. For ease of review, group attachments by type of data, e.g., physical/chemical properties, fate information. Refer to Section 3.6 for additional details regarding the attach document functionality. • File Name: Displays the file name and file extension of a file that is uploaded on the ‘Attach Documents’ pop-up window. • Description: Displays the description of a file that is uploaded on the ‘Attach Documents’ pop-up window. • Subtype: Displays the subtype of a document. • Pages: Displays the number of pages a document contains. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm the deletion. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 208 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) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 209 Exhibit 7-2 shows a screen capture of the ‘General Form Information’ screen (Scroll 2) for a Support form: Exhibit 7-2: General Form Information Screen (Scroll 2) (Support) 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. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 210 • Click here to copy your information from CDX Registration: Click the ‘Copy CDX Registration’ button to import your CDX registration information. A prompt will generate to confirm the import of registration information. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the original submitter contact information as confidential. • First Name: Enter the original submitter’s first name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Last Name: Enter the original submitter’s last name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Position: Enter the original submitter’s job title. • Company Name: Enter the original submitter’s company name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Phone Number: Enter the original submitter’s daytime phone number; U.S. or international. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Phone Extension: Enter the original submitter’s phone number extension, if applicable. • Email Address: Enter the original submitter’s email address. The email address must follow the standard email address format: John.Doe@abc.com. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. • Mailing Address 1: Enter the first line of the original submitter’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Mailing Address 2: Enter the second line of the original submitter’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. • City: Enter the city of the original submitter’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • State: Select the original submitter’s state from the drop-down menu. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Postal Code: Enter the postal code of the original submitter’s mailing address for the original submitter. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Country: Displays ‘United States.’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 211 Exhibit 7-3 shows a screen capture of the ‘Original Submitter Information’ screen: Exhibit 7-3: Original Submitter Information Screen (Support) 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 generate a PDF preview of the form. Click the ‘Submit’ icon ( ) located in the bottom action bar to initiate the submission process. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 212 8 Create Bona Fide Form The purpose of the Bona Fide module is to receive an official determination from EPA as to whether a substance is on the TSCA inventory. Submitters may attempt to avoid submitting a PMN by completing a Bona Fide form to establish that the chemical already exists on the inventory. The Bona Fide process is covered in a thirty (30) day period. 8.1 Create Bona Fide Form To create a new Bona Fide form, navigate to the ‘Section 5 Notices and Supports Forms’ screen and select ‘Bona Fide’ from the ‘Form Type’ drop-down menu. Refer to Section 3.4 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen. Refer to Section 3.5 for additional details regarding the create passphrase process. 8.1.1 General Document Information You can access the ‘General Document Information’ screen by clicking the ‘Start New Form’ button and creating a new passphrase, or by accessing a Section 5 Notices and Supports Bona Fide form that is ‘In Progress’ and entering the passphrase associated with the selected form. The ‘General Document Information’ screen presents text fields and checkboxes for you to input identifying information for the specific form. You will have the option to assign a ‘Form Alias’ by which the form can be identified. The form alias is helpful when you or the company has multiple forms and/or when a user must differentiate between forms to the help desk. If a form alias is not entered, the system will provide a default alias comprised of a form type and date and time stamp in the following format: . You can claim the entirety of the form as CBI. The entire form will be claimed as CBI if you check the ‘I claim the entirety of the submission as CBI’ checkbox. The entire form will be considered non-CBI if you leave the ‘I claim the entirety of the submission as CBI’ checkbox unchecked. You can indicate that a technical contact will be identified by checking the ‘Technical Contact’ checkbox. The technical contact must possess sufficient knowledge to answer any questions EPA may have about the chemical reported in the form. The application generates a ‘Technical Contact Information’ screen when you check the ‘Technical Contact’ checkbox. You can indicate that a Letter of Support is expected to be filed by a secondary submitter by checking the ‘Letter of Support’ checkbox. The Secondary Authorized Official will have a unique identification number that will link the forms. The unique identification number will be sent to the Letter of Support submitter, via email. At submission of the primary Bona Fide form, the unique identification number will link the two forms together. The information submitted in both forms will be kept separate, but linked, by the system. The Primary and Secondary AO will only be able to view information submitted by their own company. • Form Alias: Enter the form alias. Upon navigating to the screen, the screen auto-generates an editable form alias comprised of . This is a required field. • I claim the entirety of this submission as CBI: Check the ‘I claim the entirety of this submission as CBI’ checkbox to flag all data contained within the form as confidential. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 213 • 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) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 214 Exhibit 8-2 shows a screen capture of the ‘General Document Information’ screen (Scroll 2): Exhibit 8-2: General Document Information Screen (Scroll 2) Navigation: Click the ‘Next’ button to navigate to the ‘Primary Contact Information’ screen. You can also access this screen by clicking the ‘Primary Contact Information’ link within the navigation tree. 8.1.2 Primary Contact Information You can access the ‘Primary Contact Information’ screen by clicking the ‘Next’ button from the ‘General Document Information’ screen. You can also access this screen by clicking the ‘Primary Contact Information’ link within the navigation tree. The data fields on the ‘Primary Contact Information’ screen are pre-populated based on information entered during CDX registration. All fields are editable allowing for necessary updates. The ‘Job Title’ field on this screen is not pre-populated from CDX registration and is a required field. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 215 If you checked the ‘I claim the entirety of the submission as CBI’ checkbox on the ‘General Document Information’ screen, all entered primary contact information is flagged as CBI. The following fields are captured and displayed from the logged in user’s CDX registration information: • • • • • • • • • • • • • • • • Prefix: Select the primary contact’s prefix from the drop-down menu. First Name: Enter the primary contact’s first name. This is a required field. Middle Initial: Enter the primary contact’s middle initial. Last Name: Enter the primary contact’s last name. This is a required field. Suffix: Select the primary contact’s suffix from the drop-down menu. Title: Enter the primary contact’s job title. This is a required field. Company Name: Enter the primary contact’s company name. Phone Number: Enter the primary contact’s daytime phone number; dashes are not allowed. This is a required field. Phone Extension: Enter the extension to the primary contact’s daytime phone number. Email Address: Enter the primary contact’s email address. The email address must follow the standard email address format: John.Doe@ABC.com. This is a required field. Mailing Address 1: Enter the first line of the primary contact’s mailing address. This is a required field. Mailing Address 2: Enter the second line of the primary contact’s mailing address. City: Enter the city of the primary contact’s mailing address. State: Select the state of the primary contact’s mailing address from the drop-down menu. The state field is required if the user selects ‘United States’ from the ‘Country’ drop-down menu. Postal Code: Enter the postal code of the primary contact’s mailing address. This is a required field. Country: Select the country of the primary contact’s mailing address. This is a required field. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 216 Exhibit 8-3 shows a screen capture of the ‘Primary Contact Information’ screen: Exhibit 8-3: Primary Contact Information Screen Navigation: Click the ‘Next’ button to navigate to the ‘Technical Contact Information’ screen if you checked the ‘Technical Contact’ checkbox on the ‘General Document Information’ screen. You can also access this screen by clicking the ‘Technical Contact Information’ link within the navigation tree. Click the ‘Next’ button to navigate to the ‘Statement of Intent’ screen if you left the ‘Technical Contact’ checkbox unchecked on the ‘General Document Information’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 217 You can also access this screen by clicking the ‘Statement of Intent’ link within the navigation tree. 8.1.3 Technical Contact Information If you indicated on the ‘General Document Information’ screen that technical contact information would be provided, click the ‘Next’ button from the ‘Primary Contact Information’ screen to navigate to the ‘Technical Contact Information’ screen. You can also access this screen by clicking the ‘Technical Contact Information’ link within the navigation tree. The technical contact is a subject matter expert (SME) who is capable of answering questions related to the chemical submitted to EPA within the Bona Fide form. The technical contact does not have to work at the port or site reported on the form but must possess sufficient knowledge to answer EPA’s questions pertaining to the chemical reported in the form. The text fields on the ‘Technical Contact Information’ screen will be blank upon accessing the screen. To add information, you will enter data into the blank text boxes for the listed text fields. If you checked the ‘I claim the entirety of the submission as CBI’ checkbox on the ‘General Document Information’ screen, all entered technical contact information will be flagged as CBI. Please note that if you are using IE 7, there will be a spacing issue between the ‘Suffix’ dropdown 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 Authorized Official December 15, 2014 218 Exhibit 8-4 shows a screen capture of the ‘Technical Contact Information’ screen (Scroll 1): Exhibit 8-4: Technical Contact Information Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 219 Exhibit 8-5 shows a screen capture of the ‘Technical Contact Information’ screen (Scroll 2): Exhibit 8-5: Technical Contact Information Screen (Scroll 2) Navigation: Click the ‘Next’ button to navigate to the ‘Statement of Intent’ screen. You can also access this screen by clicking the ‘Statement of Intent’ link within the navigation tree. 8.1.4 Statement of Intent You can access the ‘Statement of Intent’ screen by clicking the ‘Next’ button from the ‘Primary Contact Information’ if you left the ‘Technical Contact’ checkbox unchecked on the ‘General Document Information’ screen. You can also navigate to this screen by clicking the ‘Next’ button on the ‘Technical Contact Information’ screen if you checked the ‘Technical Contact’ checkbox on the ‘General Document Information’ screen. You can also access this screen by clicking the ‘Statement of Intent’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 220 The ‘Statement of Intent’ screen requires you to indicate whether your intent is to manufacture and/or import the chemical substance for which you are requesting a TSCA inventory determination from EPA. You must indicate the activities of ‘Manufacture’ and/or ‘Import’ by checking the provided checkboxes. If you indicate that you intend to manufacture the chemical substance, a prompt to identify the ‘Site of Manufacture’ after clicking the ‘Add Site’ button on the ‘Submitter Site Identification’ screen will display. Similarly, if you indicate that you intend to import the chemical substance, a prompt to identify a ‘Port of Entry’ after clicking the ‘Add Site’ button on the ‘Submitter Site Identification’ screen will display. On this screen, you are required to enter the date you expect to submit a Section 5 notification if the result is that the chemical is not found on the inventory. If you checked the ‘I claim the entirety of the submission as CBI’ checkbox on the ‘General Document Information’ screen, all information entered on the ‘Statement of Intent’ screen will be flagged as CBI. • Manufacture: Check the ‘Manufacture’ checkbox to indicate the chemical substance will be manufactured. Either the ‘Manufacture’ or ‘Import’ checkbox is required to be checked. • Import: Check the ‘Import’ checkbox to indicate the chemical substance will be imported. Either the ‘Manufacture’ or ‘Import’ checkbox is required to be checked. • Date of expected Section 5 notification if the result is that the chemical is not on the inventory: Enter the date you are expecting to submit a Section 5 notification if the result is that the chemical is not found on the inventory. This data can be entered in any format (e.g. ‘Quarter 1 of 2014,’ ‘10/01/14’). This is a required field. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 221 Exhibit 8-6 shows a screen capture of the ‘Statement of Intent’ screen: Exhibit 8-6: Statement of Intent Screen Navigation: Click the ‘Next’ button to navigate to the ‘Letter of Support Submitter Information’ screen if you checked the ‘Letter of Support’ checkbox on the ‘General Document Information’ screen. You can also access this screen by clicking the ‘Letter of Support Submitter Information’ link within the navigation tree. Click the ‘Next’ button to navigate to the ‘Chemical Identification Information’ screen if the ‘Letter of Support’ checkbox was not checked on the ‘General Document Information’ screen. 8.1.5 Letter of Support Submitter Information You can access the ‘Letter of Support Submitter Information’ screen by clicking the ‘Next’ button from the ‘Statement of Intent’ screen if you checked the ‘Letter of Support’ checkbox on TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 222 the ‘General Document Information’ screen. You can also access this screen by clicking the ‘Letter of Support Submitter Information’ link within the navigation tree. The ‘Letter of Support Submitter Information’ screen captures contact information regarding the Letter of Support submitter who will provide additional, separate information regarding the Bona Fide form. The email address provided for the Letter of Support submitter will be used to send the unique identification number, which is used to link the primary and secondary submissions, to the Letter of Support submitter. If you checked the ‘I claim the entirety of the submission as CBI’ checkbox on the ‘General Document Information’ screen, all information entered on the ‘Letter of Support Submitter Information’ screen will be flagged as CBI. • Prefix: Select the Letter of Support submitter’s prefix from the drop-down menu. • First Name: Enter the Letter of Support submitter’s first name. This is a required field. • Middle Initial: Enter the Letter of Support submitter’s middle initial. • Last Name: Enter the Letter of Support submitter’s last name. This is a required field. • Suffix: Select the Letter of Support submitter’s suffix from the drop-down menu. • Title: Enter the Letter of Support submitter’s job title. • Company Name: Enter the Letter of Support submitter’s company name. This is a required field. • Phone Number: Enter the Letter of Support submitter’s U.S. or international daytime phone number; dashes are not allowed. This is a required field. • Phone Extension: Enter the Letter of Support submitter’s U.S. or international daytime phone number extension. • Email Address: Enter the Letter of Support submitter’s email address. The email address must follow the standard email address format: John.Doe@ABC.com. This is a required field. • Mailing Address 1: Enter the first line of the Letter of Support submitter’s mailing address. This is a required field. • Mailing Address 2: Enter the second line of the Letter of Support submitter’s mailing address. • City: Enter the city of the Letter of Support submitter’s mailing address. This is a required field. • State: Select the state of the Letter of Support submitter’s mailing address from the dropdown menu. This is a required field when the ‘Country’ field is identified as ‘United States.’ • Postal Code: Enter the postal code of the Letter of Support submitter’s mailing address. This is a required field. • Country: Select the country of the Letter of Support submitter’s mailing address from the drop-down menu. This is a required field. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 223 Exhibit 8-7 shows a screen capture of the ‘Letter of Support Submitter Information’ screen: Exhibit 8-7: Letter of Support Submitter Information Screen Navigation: Click the ‘Next’ button to navigate to the ‘Letter of Support Submission Information’ screen. You can also access this screen by clicking the ‘Letter of Support Submission Information’ link within the navigation tree. 8.1.6 Letter of Support Submission Information You can access the ‘Letter of Support Submission Information’ screen by clicking the ‘Next’ button from the ‘Letter of Support Submitter Information’ screen. You can also access this TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 224 screen by clicking the ‘Letter of Support Submission Information’ link within the navigation tree. The ‘Letter of Support Submission Information’ screen is used as a communication point between two companies. The ‘Letter of Support Submission Information’ screen displays a comment box for you to enter information that will be passed on to the Letter of Support submitter. A text field captures information to send to the Letter of Support submitter in an email sent by the primary submitter. A ‘Unique Identification Number for Letter of Support Submissions’ box will also display on this screen. The unique identification number generates when you declare a Letter of Support submission is being established. Letter of Support Submission Process: When you designate that a Letter of Support submission is being filed, you will be asked to enter all the information within the ‘Letter of Support Submission’ folder. The forms from the primary submitter will be linked, but not combined by the system. When the primary submitter chooses to notify the Letter of Support submitter of the unique identification number, the system will send an email to the Letter of Support submitter designated on the ‘Letter of Support Submitter Information’ screen. The email will contain the ‘Unique Identifier Number’ that will link the two forms. When the Letter of Support submitter accesses the ‘Section 5 Notices and Supports Forms’ screen and creates a form to be filed, the user will be prompted to enter the unique identification number on the ‘Create Passphrase’ screen. Once the unique identification number has been entered, the system will link the primary and Letter of Support forms. You may add additional Letters of Supports by clicking the ‘Add Letter of Support’ link within the navigation tree. • Letter of Support Submission Information Instructions: Enter the information that the Primary AO is sending to the Letter of Support submitter. • Letter of Support Submission Informational Text: Displays instructional text provided by OPPT, the unique identifier number generated for the form, and allows you to email the unique identifier number to the Letter of Support submitter by clicking the ‘Notify the Secondary Submitter of the letter of support submission’ link. • Unique Identification Number: The unique identification number is a random number autogenerated to pass on to the Letter of Support submitter to create a Letter of Support submission. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 225 Exhibit 8-8 shows a screen capture of the ‘Letter of Support Submission Information’ screen: Exhibit 8-8: Letter of Support Submission Information Screen TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 226 Navigation: Click the ‘Notify the Secondary Submitter of the letter of support submission’ link to access the ‘Unique Identifier Notification’ pop-up window. Click the ‘Next’ button to navigate to the ‘Chemical Identification Information’ screen. You can also access the ‘Chemical Identification Information’ screen by clicking the ‘Chemical Identification Information’ link within the navigation tree. 8.1.7 Notify Secondary Submitter of Letter of Support Information You can access the ‘Unique Identifier Notification’ pop-up window by clicking the ‘Notify the Secondary Submitter of the letter of support submission’ link from the ‘Letter of Support Submission Information’ screen. The ‘Unique Identifier Notification’ pop-up window is used to notify the Secondary Submitter of the ‘Unique Identifier Number.’ The ‘Unique Identifier Notification’ pop-up window displays a ‘CC’ field for you to add other email addresses to the notification (including the original submitter), a ‘To’ field, and an ‘Additional Comments’ text box. • From: Displays the email address of the logged in user that created the form. • CC: Contains instructional text for a user to enter multiple email addresses. This will automatically populate with the email address of the logged in user, and the email address of the technical contact. • To: Contains the editable email address of the Letter of Support submitter specified on the ‘Letter of Support Submitter Information’ screen; this email address will be automatically populated upon navigating to the window. • Subject: Displays ‘YYYY Bona Fide.’ • Message: Displays a pre-determined message in the email sent to a Letter of Support submitter. • Additional Comments: Enter any other additional comments or instructions to be passed onto the Letter of Support submitter. • Send: Click the ‘Send’ button to generate and send the email to the email addresses identified in the ‘CC’ and ‘To’ fields. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 227 Exhibit 8-9 shows a screen capture of the ‘Notify Letter of Support Submitter’ pop-up window: TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 228 Exhibit 8-9: Notify Letter of Support Submitter Pop-Up Window Navigation: Click the ‘Send’ button to send the email to the Letter of Support submitter and navigate back to the ‘Letter of Support Submission Information’ screen. Click the ‘X’ button in the upper right-hand corner to cancel the unique identifier notification process. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 229 8.1.8 Chemical Identification Information You can navigate to the ‘Chemical Identification Information’ screen by clicking the ‘Next’ button from the ‘Statement of Intent’ screen if you left the ‘Letter of Support’ checkbox unchecked on the ‘General Document Information’ screen. You can also access the ‘Chemical Identification Information’ screen from the ‘Letter of Support Submission Information’ screen if you checked the ‘Letter of Support’ checkbox on the ‘General Document Information’ screen. You can also access this screen by clicking the ‘Chemical Identification Information’ link within the navigation tree. The ‘Chemical Identification Information’ screen identifies the type of chemical the submitter will be entering into the application. You will be able to file a Bona Fide form for a class 1 or 2/Biotechnology chemical substance or a polymer. Based on your selection, the appropriate screens for the respective chemical will appear. This screen also provides a text field for you to identify an alias for the chemical substance. • Class 1 or 2/Biotechnology Chemical Substance: Select the ‘Class 1 or 2/Biotechnology Chemical Substance’ radio button to indicate that the chemical is a class 1 or 2/biotechnology substance. If you select the ‘Polymer’ radio button after initially selecting the ‘Class 1 or 2/Biotechnology Chemical Substance’ radio button, the application generates a notification message warning you that you will lose all data for this chemical if the chemical type changes. The user is required to select one of the two radio button options displayed in the ‘Chemical Type’ section. • Polymer: Select the ‘Polymer’ radio button to indicate that the chemical is a polymer. If you select the ‘Class 1 or 2/Biotechnology Chemical Substance’ radio button after initially selecting the ‘Polymer’ radio button, the application generates a notification message warning you that you will lose all data for this chemical if the chemical type changes. The user is required to select one of the two radio button options displayed in the ‘Chemical Type’ section. • Chemical Alias: Enter the chemical alias to associate with a chemical. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 230 Exhibit 8-10 shows a screen capture of the ‘Chemical Identification Information’ screen: Exhibit 8-10: Chemical Identification Information Screen Navigation: If you selected the ‘Class 1 or 2/Biotechnology Chemical Substance’ radio button, click the ‘Next’ button to navigate to the ‘Class 1 or 2/Biotechnology Chemical Substances’ screen. If you selected the ‘Polymer’ radio button, click the ‘Next’ button to navigate to the ‘Polymer Identification Information’ screen. 8.1.9 Class 1 or 2/Biotechnology Chemical Substances If you selected the ‘Class 1 or 2/Biotechnology Chemical Substance’ radio button, click the ‘Next’ button to navigate to the ‘Class 1 or 2/Biotechnology Chemical Substances’ screen. The ‘Class 1 or 2/Biotechnology Chemical Substances’ screen provides fields for you to enter information describing the chemical for the Bona Fide which is to be filed, including its name, composition, and structure. You can add a chemical component by clicking the ‘Add New Chemical’ button. Upon clicking the ‘Add New Chemical’ button, an expandable/collapsible field set generates that contains TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 231 numerous fields to identify the chemical in question. You will be able to enter multiple chemical substances, each with unique information, by clicking the ‘Add New Chemical’ button for each chemical substance you wish to identify. After the document(s) is/are attached and you have clicked the ‘OK’ button, the ‘Attach Chemical Structure’ pop-up window closes and the document information will be displayed in a table format on the ‘Class 1 or 2/Biotechnology Chemical Substances’ screen. The attachment table displays the file name of the document and user-provided description of the document. Click the ‘Delete’ icon ( ) 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 TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 232 selected chemical by clicking the ‘OK’ button located at the bottom of the ‘Add Chemical ID’ window. • Chemical Name: The system provides fields for you to identify the ‘Chemical Name’ and the ‘CASRN’ (if available). The system provides functionality for you to search for the chemical substance using the ‘Add Chemical ID’ search or manually enter the chemical information in the ‘Add Chemical ID’ pop up. • ID Method: The system shall require that you identify which ID method was used to determine the chemical identity. If you select ‘Method 1,’ you are required to attach an IES report. You can also select ‘Method 2 (Other Method).’ • Attach IES Report: To access the ‘Attach IES Report’ pop-up window, click the ‘Attach IES Report’ button that displays within the ‘Chemical Identification Information’ field set. After you attach the document(s), and click the ‘OK’ button, the ‘Attach IES Report’ pop-up window closes and the document information displays in a table format on the ‘Class 1 or 2/Biotechnology Chemical Substances’ screen. The document attachment table displays the file name of the document(s) and the user-provided description of the document(s). Click the ‘Delete’ icon ( ) 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’ popup 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 3.9 for more information regarding the save functionality in an expandable/collapsible field set. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 233 Exhibit 8-11 shows a screen capture of the ‘Class 1 or 2/Biotechnology Chemical Substances’ screen (Scroll 1): Exhibit 8-11: Class 1 or 2/Biotechnology Chemical Substances Screen (Scroll 1) Navigation: If you selected the ‘Class 1’ radio button, click the ‘Save’ button within the expandable/collapsible field, then click the ‘Next’ button to navigate to the ‘Use Information’ screen. If you selected the ‘Class 2/Biotechnology’ radio button, click the ‘Save’ button within the expandable/collapsible field set, then click the ‘Next’ button to navigate to the ‘Class 2/Biotechnology Substances’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 234 8.1.10 Class 2/Biotechnology Substances You can navigate to the ‘Class 2/Biotechnology Substances’ screen by clicking the ‘Next’ button from the ‘Class 1 or 2/Biotechnology Chemical Substances’ screen when you select the ‘Class 2/Biotechnology’ radio button. You can also access this screen by clicking the ‘Save’ icon ( ) within the action bar and clicking the ‘Class 2/Biotechnology Substances’ link within the navigation tree. The ‘Class 2/Biotechnology Substances’ screen provides fields for you to enter in information regarding a class 2/biotechnology chemical substance. A class 2/biotechnology chemical substance is a substance that may not have a defined chemical structure that has been identified. This screen provides fields for you to identify specific elements in the creation of the chemical using the following fields: ‘Precursor Substances,’ ‘Nature of Reaction,’ and ‘Range of Composition (Optional).’ You will be able to enter precursor substances by searching SRS or by the manual entry fields when the substance is not in SRS. The substances will display in a table listing the ‘Chemical Name’ and CASRN. The system provides fields for you to capture ‘Nature of Reaction’ and ‘Range of Composition’ in text boxes. • Precursor Substances: This table captures the chemicals identified as immediate precursor substances, along with the respective CASRNs. • Search SRS: Click the ‘Search SRS’ button to display the ‘Search Substance Registry Services’ pop-up window. Refer to Section 3.10 for additional details regarding the search SRS functionality. • Chemical Name: Displays the chemical name associated with a precursor substance. Click the ‘Chemical Name’ link to navigate to the ‘Search SRS’ pop-up window for edits. • CASRN: Displays the CASRN associated with a precursor substance. • Action: Click the ‘Delete’ icon ( ) to delete the entire chemical row permanently from the system. A warning message will display to confirm the deletion of the chemical. • Nature of Reaction: Enter the ‘Nature of Reaction’ description. This is a required field. • Range of Composition: Enter the ‘Range of Composition’ description. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window and upload a document. Refer to Section 3.6 for further details regarding the attach document functionality. • File Name: Displays the file name and file extension of the file that is uploaded on the ‘Attach Documents’ window. • Description: Displays the description associated with a document. • Action: Click the ‘Delete’ icon ( ) 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 Primary Authorized Official December 15, 2014 235 Exhibit 8-12 shows a screen capture of the ‘Class 2/Biotechnology Substances’ screen (Scroll 1): Exhibit 8-12: Class 2/Biotechnology Substances Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 236 Exhibit 8-13 shows a screen capture of the ‘Class 2/Biotechnology Substances’ screen (Scroll 2): Exhibit 8-13: Class 2/Biotechnology Substances Screen (Scroll 2) Navigation: Click the ‘Next’ button to navigate to the ‘Use Information’ screen. You can also access this screen by clicking the ‘Use Information’ link within the navigation tree. 8.1.11 Polymer Identification Information You can navigate to the ‘Polymer Identification Information’ screen by clicking the ‘Next’ button from the ‘Chemical Identification Information’ screen when you select the ‘Polymer’ radio button. You can also access this screen by clicking the ‘Polymer Identification Information’ link within the navigation tree after clicking the ‘Save’ icon within the bottom action bar. Click the ‘Add New Chemical’ button to create a chemical substance. Upon clicking the ‘Add New Chemical’ button, an expandable/collapsible field set generates that contains numerous fields that pertain to the particular polymer. The system provides numerous fields for you to TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 237 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 chemical substance using the ‘Add Chemical ID’ search or manually enter the chemical information in the ‘Add Chemical ID’ pop up. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 238 • 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’ popup 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 3.9 for more information regarding the save functionality in an expandable/collapsible field set. After the document is attached and you click the ‘OK’ button, the ‘Attach Chemical Structure’ pop-up window closes and the document information displays in a table format on the ‘Polymer Identification Information’ screen. The attachment table displays the file name of the document and provided description of the document. Click the ‘Delete’ icon ( ) located under the ‘Actions’ column to delete unwanted documents. Click the appropriate file name of the document within the ‘File Name’ column of the attachment table to access or edit previously attached documents. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 239 Exhibit 8-14 shows a screen capture of the ‘Polymer Identification Information’ screen: Exhibit 8-14: Polymer Identification Information Screen Navigation: Click the ‘Next’ button to navigate to the ‘Monomers and Other Reactants’ screen. You can also access this screen by clicking the ‘Monomers and Other Reactants’ link within the navigation tree. 8.1.12 Monomers and Other Reactants You can navigate to the ‘Monomers and Other Reactants’ screen by clicking the ‘Next’ button from the ‘Polymer Identification Information’ screen. You can also access this screen by clicking the ‘Monomers and Other Reactants’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 240 The ‘Monomers and Other Reactants’ screen is used to identify the chemical measurements and monomers that make up a polymer. The ‘Monomers and Other Reactants’ screen has an ‘Add Monomer’ button that allows you to identify the monomer(s) that make up the polymer composition. • Add Monomer: Click the ‘Add Monomer’ button to generate an expandable/collapsible field set. • Cancel: Click the ‘Cancel’ link located in the upper right-hand corner of the expandable/collapsible field set to prevent edits from saving and to remove a field set. The ‘Cancel’ link displays when the expandable/collapsible field set is open for editing. A confirmation message displays to confirm the action. • Edit: Click the ‘Edit’ link located in the upper right-hand corner of the expandable/collapsible field set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has been saved and the data is not currently editable. • Delete: Click the ‘Delete’ icon ( ) located in the upper right-hand corner of the expandable/collapsible field set to delete the field set. A confirmation message displays to confirm the deletion. • Expand All: Click the ‘Expand All’ link located at the upper right-hand corner of the expandable/collapsible field sets to expand a series of field sets. • Collapse All: Click the ‘Collapse All’ link located at the upper right-hand corner of the expandable/collapsible field sets to collapse a series of field sets. • Search SRS: Click the ‘Search SRS’ button to generate the ‘Search Substance Registry Services’ pop-up window. Refer to Section 3.10 for additional details regarding the search SRS functionality. • CAS Registry Number: Displays the CASRN for the specified monomer; this field populates based on information entered on the ‘Search Substance Registry Services’ pop-up window. This is a required field. • Monomer or Other Reactant: Displays the monomer or other reactant name; this field populates based on information entered on the ‘Search Substance Registry Services’ pop-up window. This is a required field. • Include in Identity: Check the ‘Include in Identity’ checkbox to claim the value for ‘Monomer or Other Reactant’ as part of the monomer identification. • Typical Composition: Enter the ‘Typical Composition’ value that a monomer contributes to a polymer; the value entered must be a positive numerical value greater than zero (0) and less than or equal to 100 with up to three decimal points. If the value entered is less than or equal to ‘2’ a warning will be displayed in the global ‘Validate’ function or during the submission process indicating that the ‘Typical Composition’ is a value that is less than or equal to 2% and asking the user whether it should be included in the ‘Chemical Identity.’ This is a required field. • Save: Click the button to save the information entered within the expandable/collapsible field set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 241 action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.9 for more information regarding the save functionality in an expandable/collapsible field set. • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window. Refer to Section 3.6 for additional details regarding the attach document functionality. • File Name: Displays the file name and file extension of the file that is uploaded on the ‘Attach Documents’ pop-up window. Click the file name link to navigate to the ‘Attach Documents’ pop-up window to make any edits. • Description: Displays the description associated with a document. • Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A warning message displays to confirm the deletion of the document. Exhibit 8-15 shows a screen capture of the ‘Monomers and Other Reactants’ screen: TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 242 Exhibit 8-15: Monomers and Other Reactants Screen Navigation: Click the ‘Next’ button to navigate to the ‘Use Information’ screen. You can also access this screen by clicking the ‘Use Information’ link within the navigation tree. 8.1.13 Use Information You can navigate to the ‘Use Information’ screen by clicking the ‘Next’ button from the ‘Class 1 or 2 Chemical Substances’ screen, from the ‘Class 2 Substances’ screen, or from the ‘Monomers and Other Reactants’ screen, depending on the choice made on the ‘Chemical Identification Information’ screen. You can also access this screen by clicking the ‘Use Information’ link within the navigation tree. The ‘Use Information’ screen captures data about the chemical substance’s intended use. When you navigate to the screen, the screen contains a text box with instructional text that reads, ‘How will the substance be used?’ Enter the specific data for the chemical substance and then advance to the next screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 243 • How will the substance be used?: Enter data regarding how the chemical substance is intended to be used. This is a required field. Exhibit 8-16 shows a screen capture of the ‘Use Information’ screen: TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 244 Exhibit 8-16: Use Information Screen Navigation: Click the ‘Next’ button to navigate to the ‘Submitter Site Identification’ screen. You can also access this screen by clicking the ‘Submitter Site Identification’ link within the navigation tree. 8.1.14 Submitter Site Identification You can navigate to the ‘Submitter Site Identification’ screen by clicking the ‘Next’ button from the ‘Use Information’ screen. You can also access this screen by clicking the ‘Submitter Site Identification’ link within the navigation tree. The ‘Submitter Site Identification’ screen captures information about the identification of the sites of manufacture and/or the port of entry. The system requires you to select from the ‘Site of Manufacture or Import’ drop-down menu when both the ‘Manufacture’ and ‘Import’ checkboxes are checked on the ‘Statement of Intent’ screen. List all of the sites of manufacture and/or the ports of entry that are controlled by the submitter on this screen; at least one site is required. • Add Site: Click the ‘Add Site’ button to display the ‘Add Site’ pop-up window. Refer to Section 3.11 for additional details regarding the add site functionality. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 245 • 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. Exhibit 8-17 shows a screen capture of the ‘Submitter Site Identification’ screen: TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 246 Exhibit 8-17: Submitter Site Identification Screen 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 Primary Authorized Official December 15, 2014 247 • Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop-up window to upload documents. Refer to Section 3.6 for additional details regarding the attach document functionality. • Document Name: Displays the document name and file extension of the document uploaded on the ‘Attach Documents’ pop-up window. • Document Type: Displays the document type associated with the uploaded document. • Action: Click the ‘Delete’ icon ( ) to delete the entire document row permanently from the system. A warning message displays to confirm the deletion of the document. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 248 Exhibit 8-18 shows a screen capture of the ‘Document Management’ screen: Exhibit 8-18: Document Management Screen Navigation: Click the ‘Next’ button to navigate to the ‘Optional Cover Letter’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree. 8.1.16 Optional Cover Letter You can navigate to the ‘Optional Cover Letter’ screen by clicking the ‘Next’ button from the ‘Document Management’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree. The ‘Optional Cover Letter’ screen is used to communicate information with EPA that is not collected elsewhere in the form. The cover letter is used to give EPA resources and special instructions regarding the application. • Optional Cover Letter: Enter any additional special instructions regarding the form. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 249 Exhibit 8-19 shows a screen capture of the ‘Optional Cover Letter’ screen: Exhibit 8-19: Optional Cover Letter Screen 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 generate a PDF preview of the form. Click the ‘Submit’ icon ( ) located in the bottom action bar to initiate the submission process. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 250 9 Create Alternative Control Measures (ACM) Form The Section 5 Notices and Supports application allows ACM forms to be submitted. The ACM form is used to report proposed alternative control measures for published significant new use rules (SNURs). 9.1 Create Alternative Control Measures Form To create a new ACM form, navigate to the ‘Section 5 Notices and Supports Forms’ screen and select ‘Alternative Control Measures (ACM)’ from the ‘Form Type’ drop-down menu. Refer to Section 3.4 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen. Refer to Section 3.5 for additional details regarding the create passphrase process. 9.1.1 Contact Information You can access the ‘Contact Information’ screen by entering the passphrase on the ‘Enter Passphrase’ screen or creating a passphrase on the ‘Create Passphrase’ screen. The ‘Contact Information’ screen provides an ‘Add Contact’ button and a contact information table for you to identify a point of contact who is working for a U.S. based company. Please note that if you using IE 7 to view this screen, the ‘Form Alias’ text field label displays under the form alias header at the top of the screen. • Form Alias: Enter a custom alias to differentiate the ACM 721.30 form, if applicable. The system auto-generates a default alias consisting of the form type and date stamp in the following format: . The form alias is an editable field that may be changed at any time. This is a required field. • Add Contact: Click the button to generate the ‘Add Contact’ window, which allows a user to enter information for a point of contact. At least one contact is required. • Last Name: Displays the last name of the contact identified on the ‘Add Contact’ pop-up window. • First Name: Displays the first name of the contact identified on the ‘Add Contact’ pop-up window. • Address: Displays the mailing address of the contact identified on the ‘Add Contact’ pop-up window. • CBI: Indicates the CBI status of a contact by displaying either a ‘Y’ or an ‘N.’ • Actions: Click the ‘Delete’ icon ( ) to delete a contact from the table. A warning message displays to confirm deletion of the contact. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 251 Exhibit 9-1 shows a screen capture of the ‘Contact Information’ screen: Exhibit 9-1: Contact Information Screen (ACM) Navigation: Click the ‘Add Contact’ button to begin the process of adding contact information. Click the ‘Next’ button to navigate to the ‘Attachments’ screen. You can also access this screen by clicking the ‘Attachments’ link within the navigation tree. 9.1.1.1 Add Contact You can access the ‘Add Contact’ pop-up window by clicking the ‘Add Contact’ button on the ‘Contact Information’ screen. The ‘Add Contact’ pop-up window displays fields for you to enter information regarding the point of contact. Please note that if you are using IE 7 to view this pop-up window, the ‘Copy CDX Registration’ button and ‘Help’ button are misaligned. • Click here to copy your information from CDX Registration: Click the ‘Copy CDX Registration’ button to populate the fields with your contact information provided during CDX registration. A prompt will display confirming the import of CDX registration information. • Check here to claim this information as CBI: Check the ‘Check here to claim this information as CBI’ checkbox to claim the contact information as confidential. If the ‘CBI’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 252 checkbox is checked before clicking the ‘Copy CDX Registration’ button, the ‘CBI’ checkbox becomes unchecked upon navigating back to the screen after copying CDX registration information. Check the ‘CBI’ checkbox after importing CDX registration information to claim a contact as confidential. • First Name: Enter the contact’s first name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Last Name: Enter the contact’s last name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Company Name: Enter the contact’s company name. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Phone Number: Enter the contact’s daytime phone number; dashes are not allowed. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Phone Extension: Enter the contact’s phone number extension, if applicable. • Email Address: Enter the contact’s email address. The email address must follow the standard email address format: John.Doe@abc.com. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Mailing Address 1: Enter the first line of the contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Mailing Address 2: Enter the second line of the contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. • City: Enter the contact’s U.S. city of the mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • State: Select the state of the contact’s mailing address from the drop-down menu. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Postal Code: Enter the postal code of the contact’s mailing address. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field. • Country: Displays ‘United States.’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 253 Exhibit 9-2 shows a screen capture of the ‘Add Contact’ pop-up window: Exhibit 9-2: Add Contact Pop-Up Window (ACM) Navigation: Click the ‘Cancel’ button or the ‘X’ icon to stop populating contact information. Click the ‘OK’ button to save the entered contact information and navigate back to the ‘Contact Information’ screen. 9.1.2 Attachments You can access the ‘Attachments’ screen by clicking the ‘Next’ button from the ‘Contact Information’ screen. You can also access this screen by clicking the ‘Attachments’ link within the navigation tree. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 254 The ‘Attachments’ screen provides an ‘Attach Document’ button for you to upload documentation that fulfills the specified requirements, and a text field to provide the 40 CFR 721 citation to which the documentation refers. • Attach Document: Click the ‘Attach Document’ button to attach documents that fulfill the outlined requirements in the instructional text. At least one document is required. Refer to Section 3.6 for additional information regarding the attach document functionality. • File Name: Displays the file name and file extension of a document. • Description: Displays the description of a document. • Pages: Displays the number of pages a document contains. • Date: Displays the date that a document was uploaded on the ‘Attach Documents’ pop-up window. • CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’ • Action: Click the ‘Delete’ icon ( ) to remove the attached document row. A warning message displays to confirm deletion of the document. • ACM Citation at 40 CFR 721: Enter the ACM citation reference that the uploaded documents support. This field allows up to seven (7) numeric characters; letters or other characters are not allowed. This is a required field. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 255 Exhibit 9-3 shows a screen capture of the ‘Attachments’ screen: Exhibit 9-3: Attachments Screen (ACM) Navigation: Click the ‘Validate’ icon ( ) in the bottom action bar to validate the form. Click the ‘Save’ icon ( ) 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 Primary Authorized Official December 15, 2014 256 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 of the ‘Preview EPMN Form’ screen: Exhibit 10-1: Preview EPMN Form Screen TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 257 Exhibit 10-2 shows a screen capture for the ‘Preview’ of the Biotechnology form: Exhibit 10-2: Preview Biotechnology Form PDF TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 258 Exhibit 10-3 shows a screen capture for the ‘Preview’ of the NOC form: Exhibit 10-3: Preview NOC Form PDF TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 259 Exhibit 10-4 shows a screen capture for the ‘Preview’ of the Support form: TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 260 Exhibit 10-4: Preview Support Form PDF TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 261 11 Validate You can click the ‘Validate’ icon ( ) at any stage of completing a Section 5 Notices and Supports form. The ‘Section 5 Notices and Supports Validation’ pop-up window displays when you click the ‘Validate’ icon ( ). Disable the pop-up blocker within your internet browser so that the ‘Section 5 Notices and Supports Validation’ pop-up window displays correctly. The ‘Section 5 Notices and Supports Validation’ pop-up window displays a report of all validation errors and warning messages. During the validation process, the application validates each screen of the Section 5 Notices and Supports form to find missing and invalid data. Please note in IE 7, the ‘Help’ button aligns to the right side of the ‘Section 5 Notices and Supports Validation’ pop-up window. Validation Errors: Errors are denoted by an ‘Error’ icon ( ) and can be fixed by clicking the error link. The links will display the Screen Title Name (e.g., Chemical Identification) and the associated error. After you click a link, the main application screen will display the section where the error occurred so you can easily fix the error. Once you have fixed the error(s), click the ‘Validate’ icon ( ) again to refresh the ‘Section 5 Notices and Supports Validation’ pop-up window. If the information you fixed passes validation, the error will be removed from the ‘Section 5 Notices and Supports Validation’ pop-up window. You must fix all validation errors to submit the form to CDX successfully. Warning Messages: Warnings are denoted by a ‘Warning’ icon ( ) and can be fixed by clicking the warning link. The links will display the Screen Title and the associated warning. After you click a link, the main application screen will display the section where the warning occurred so you can easily fix the warning. Once you have fixed the warning(s), click the ‘Validate’ icon ( ) again to refresh the ‘Section 5 Notices and Supports Validation’ pop-up window. If the information you fixed passes validation, the warning will be removed from the ‘Section 5 Notices and Supports Validation’ pop-up window. You can pass validation and continue to submit a form to CDX with active warning messages. You can close the ‘Section 5 Notices and Supports Validation’ pop-up window by clicking the ‘X’ button located at the upper right-hand corner of the window. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 262 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 TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 263 12 Submit to EPA via CDX As a Primary AO, you have the ability to sign and submit a Section 5 Notices and Supports form to EPA via CDX. You can save your form at any point during the data entry process. Any assigned Supports for your form cannot submit the Section 5 Notices and Supports form. The save functionality will allow you to return to that same form at any point in the future. Once you complete all required information and correct all items failing validation, the system will allow the Section 5 Notices and Supports form to be successfully submitted. 12.1 Submitting Official Information Click the ‘Submit’ icon ( ) that is located in the bottom action bar of the Section 5 Notices and Supports application to access the ‘Submitting Official Information’ screen. This screen only displays to a Primary AO upon submission. After clicking the ‘Submit’ icon ( ), the system requires you to review your contact information provided during CDX registration. The system also requires you to identify your job title. Click the ‘Home’ button to navigate to the Section 5 Notices and Supports ‘Home’ screen. The following statement which displays to the Primary AO and Secondary AO must be confirmed before the system will allow you to move forward: “Please confirm that you are the legally responsible party from the submitting company.” If you check this checkbox associated with the statement, the application navigates to either the appropriate certification screen or the ‘Cross-Media Electronic Reporting Regulation (CROMERR)’ screen. If you do not check the checkbox associated with this statement, the application takes you back to the ‘Section 5 Notices and Supports Forms’ screen. Please note in IE 7, the ‘Cancel’ and ‘Next’ buttons will be misaligned in the center of the ‘Submitting Official Information’ screen. • CBI: Check the ‘CBI’ checkbox to claim the submitting official’s information as confidential. • Please confirm that you are the legally responsible party from the submitting company: Check the checkbox to confirm that the individual submitting the form has permission to do so. • First Name: Displays the first name of the submitting official, which has been pre-populated from CDX registration information. • Middle Initial: Displays the middle initial of the submitting official, which has been prepopulated from CDX registration information. • Last Name: Displays the last name of the submitting official, which has been pre-populated from CDX registration information. • Job Title: Enter the job title of the submitting official. This is a required field. • Company Name: Displays the company name of the submitting official, which has been pre-populated from CDX registration information. • Phone Number: Displays the phone number of the submitting official, which has been prepopulated from CDX registration information. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 264 • Email Address: Displays the email address of the submitting official, which has been prepopulated 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 prepopulated from CDX registration information. • State: Displays the state of the submitting official’s mailing address, which has been prepopulated from CDX registration information. • Postal Code: Displays the postal code of the submitting official’s mailing address, which has been pre-populated from CDX registration information. • Country: Displays the country of the submitting official’s mailing address, which has been pre-populated from CDX registration information. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 265 Exhibit 12-1 shows a screen capture of the ‘Submitting Official Information’ screen: Exhibit 12-1: Submitting Official Information Screen Navigation: Click the ‘Next’ button to continue with submitting the form and navigating to the ‘Submission Process: Validation’ screen or a certification screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 266 12.2 LVE Certification Click the ‘Next’ button from the ‘Submitting Official Information’ screen to access the ‘LVE Certification’ screen. This screen displays when ‘LVE’ or ‘LVE Modification’ is selected from the ‘Type of Notice’ drop-down menu on the ‘General Form Information’ screen for a PMN form. If the notice type is not ‘LVE’ or ‘LVE Modification,’ click the ‘Next’ button to navigate to the ‘Submission Process: Validation’ screen or a different certification screen. Exhibit 12-2 shows a screen capture of the ‘LVE Certification’ screen: Exhibit 12-2: LVE Certification Screen Navigation: Click the ‘I Certify’ button to continue with submitting the form and navigate to the ‘Submission Process: Validation’ screen. Click the ‘Cancel’ button to stop the submission process. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 267 12.3 LOREX Certification Click the ‘Next’ button on the ‘Submitting Official Information’ screen to access the ‘LOREX Certification’ screen. This screen displays when ‘LOREX’ or ‘LOREX Modification’ is selected from the ‘Type of Notice’ drop-down menu on the ‘General Form Information’ screen for a PMN form. Exhibit 12-3 shows a screen capture of the ‘LOREX Certification’ screen: Exhibit 12-3: LOREX Certification Screen Navigation: Click the ‘I Certify’ button to continue with submitting the form and proceed to the ‘Submission Process: Validation’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 268 12.4 Submission Process: Validation Click the ‘Submit’ icon ( ) that is located in the bottom action bar of the Section 5 Notices and Supports form to begin the submission process and access the ‘Submission Process: Validation’ screen. The first step in the submission process will validate the information entered within the Section 5 Notices and Supports form. After a form is validated, the system will generate a PDF. Exhibit 12-4 shows a screen capture of the ‘Submission Process: Validation’ screen: Exhibit 12-4: Submission Process: Validation Screen TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 269 Exhibit 12-5 shows a screen capture of the ‘Submission Process: PDF Generation’ screen: Exhibit 12-5: Submission Process: PDF Generation Screen Navigation: Click the ‘View PDF’ button to generate and view a PDF of the form. Click the ‘Continue’ button to continue with submitting the form and proceed to the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Certification’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 270 12.5 Cross-Media Electronic Reporting Regulation (CROMERR) Certification Click the ‘Continue’ button on the ‘Submission Process: PDF Generation’ screen to access the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Certification’ screen. CROMERR provides the legal framework for electronic reporting under all of EPA’s environmental regulations. After clicking the ‘Continue’ button, the system requires you to certify that the form is CROMERR compliant. By clicking the ‘I Certify’ button on the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Certification’ screen, you authenticate all of the information entered in the form. Click the ‘Cancel’ button to navigate back to the Section 5 Notices and Supports application. Exhibit 12-6 shows a screen capture for the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Certification’ screen: Exhibit 12-6: Cross-Media Electronic Reporting Regulation (CROMERR) Certification Screen Navigation: Click the ‘I Certify’ button to continue with submitting the form and proceed to the ‘CROMERR Login’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 271 12.6 Cross-Media Electronic Reporting Regulation (CROMERR) Login You can access the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Login’ screen by clicking the ‘I Certify’ button on the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Certification’ screen. To proceed with the submission, log into CDX using the credentials you provided during CDX registration: • Please login with your CDX password: Enter your CDX registration password. Exhibit 12-7 shows a screen capture of the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Login’ screen: Exhibit 12-7: Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen Navigation: Enter your CDX registration password and click the ‘Next’ button to navigate to the ‘CROMERR Security Question’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 272 12.7 Cross-Media Electronic Reporting Regulation (CROMERR) Security Question You can access the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Security Question’ screen by entering your CDX registration password on the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Login’ screen and clicking the ‘Next’ button. The ‘Cross-Media Electronic Reporting Regulation (CROMERR) Security Question’ screen randomly selects and displays one of the five CROMERR eSIG-PIN questions you answered on the ‘20-5-1 Question’ screen during the initial login to CDX. eSIG-PIN Authorization Code: Provide one of the five secret answers to the questions that were pulled from the list of 20 CDX security questions. Exhibit 12-8 shows a screen capture of the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Security Question’ screen: Exhibit 12-8: Cross-Media Electronic Reporting Regulation (CROMERR) Security Question Screen Navigation: Answer the security question and click the ‘Next’ button to navigate to the ‘Submit to CDX’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 273 12.8 Submit to CDX You can access the ‘Submit to CDX’ screen after answering the 20-5-1 security question on the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Security Question’ screen and clicking the ‘Next’ button. On the ‘Submit to CDX’ screen, you will see a certification message. Read the message and acknowledge by clicking the ‘Confirm’ button. Once you have clicked the ‘Confirm’ button, your form will be submitted to CDX. This screen is only applicable to the original forms (PMN, NOC, Biotechnology, Bona Fide, and ACM). This screen will display during the submission process for joint submissions and Letters of Support. This screen is not applicable to Support forms and amendments to original submissions. Exhibit 12-9 shows a screen capture of the ‘Submit To CDX’ screen: Exhibit 12-9: Submit To CDX Screen Navigation: Click the ‘Confirm’ button to navigate to the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Submission’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 274 12.9 Cross-Media Electronic Reporting Regulation (CROMERR) Submission You can access the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Submission’ screen by acknowledging the certification to submit to CDX by clicking the ‘Confirm’ button on the ‘Submit to CDX’ screen. On the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Submission’ screen, you will see a message indicating the form has been successfully submitted to CDX. Exhibit 12-10 shows a screen capture of the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Submission’ screen: Exhibit 12-10: Cross-Media Electronic Reporting Regulation (CROMERR) Submission Screen 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.’ TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 275 13 Download Copy of Record To download a Copy of Record, navigate to the ‘Section 5 Notices and Supports Forms’ screen and locate a form alias for which you have successfully completed a submission and which has a status of ‘Submitted.’ Click the ‘Copy of Record’ icon ( ) from the ‘Section 5 Notices and Supports Forms’ screen to navigate to the ‘Enter Passphrase’ screen to login into CDX. The ‘Enter Passphrase’ screen requires you to enter the passphrase originally associated with the form. If your passphrase is entered correctly, you will access the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Login’ screen where you are required to enter your credentials you provided during CDX registration. Once you have provided the correct CDX password, click the ‘Next’ button to navigate to the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Security Question’ screen. The ‘Cross-Media Electronic Reporting Regulation (CROMERR) Security Question’ screen randomly selects and displays one of the five CROMERR eSIG-PIN questions that you answered on the 20-5-1 Question screen during CDX registration. Answer the CROMERR security question and click the ‘OK’ button. If your answer was successful, you will be taken to the ‘Download Copy of Record’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 276 Exhibit 13-1 shows a screen capture of the ‘Download Copy of Record’ screen: Exhibit 13-1: Download Copy of Record Screen The ‘Download Copy of Record’ screen displays the ‘File Name’ and ‘Action’ columns in a table format. Click the ‘Copy of Record’ icon ( ) to download the individual files uploaded during the submission process, PDF version of the submission or the XML version of the Section 5 Notices and Supports form. When you click the ‘Copy of Record’ icon ( ), the system will allow you to view or download the individual files that were uploaded during the submission process. After you click the ‘Copy of Record’ icon ( ), enter the passphrase associated with the case number, and click the ‘Next’ button. If the passphrase was correctly entered, the application will take you to the ‘CROMERR Login’ screen to enter the CDX password. If your login was successful, you will access the ‘CROMERR Security Question’ screen. The ‘CROMERR Security Question’ screen randomly selects and displays one of the five CROMERR eSIG-PIN questions that you answered on the 20-5-1 Question screen during the initial login to CDX. Answer the CROMERR security question and click the ‘OK’ button. If your answer was successful, you will navigate to the ‘Download Copy of Record’ screen. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 277 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 If you click the ‘Copy of Record’ icon ( ) you will download: • A PDF version of the Section 5 Notices and Supports form • An XML version of the Section 5 Notices and Supports form • The documents attached to a Section 5 Notices and Supports form TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 278 14 Create An Amendment To amend a submitted Section 5 Notices and Supports form, navigate to the ‘Section 5 Notices and Supports Forms’ screen and locate a submission that you previously submitted with a status of ‘Submitted.’ In addition to displaying a status of ‘Submitted’ under the ‘Status’ column, the ‘Lock’ icon ( ) will be displayed under the ‘Action’ column. Click the ‘Lock’ icon ( ) under the ‘Action’ column to start an amendment. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 279 Exhibit 14-1 shows a screen capture of the ‘Section 5 Notices and Supports Forms’ screen: Exhibit 14-1: Section 5 Notices and Supports Forms Screen - Amendment Navigation: After clicking the ‘Lock’ icon ( ), a prompt will display to confirm the amendment process. If you do not want to continue with the amendment, click the ‘Cancel’ button to cancel the amendment process and return to the ‘Section 5 Notices and Supports Forms’ screen. Click the ‘OK’ button to close the prompt and continue with the amendment. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 280 Exhibit 14-2 shows a screen capture of the ‘Unlock Prompt’ message: Exhibit 14-2: Unlock Prompt Message After you click the ‘OK’ button, you will be taken to the ‘Enter Passphrase’ screen. You must enter the passphrase originally associated with the submission to start the amendment process. After you enter the passphrase and click the ‘Next’ button, you will be taken to the first screen in the specific Section 5 Notices and Supports form. Refer to Section 3.7 for further instructions on the ‘Enter Passphrase’ screen. After a submission has been unlocked, the ‘Section 5 Notices and Supports Forms’ screen will display a status of ‘In Progress’ under the ‘Status’ column, and the ‘Unlocked’ icon ( ) will display under the ‘Action’ column; however, you will not see these changes until you navigate back to the ‘Section 5 Notices and Supports Forms’ screen. • Refer to Section 1 through Section 4.1.35 for instructions on editing a revised PMN form. • Refer to Section 1 through Section 5.1.9 for instructions on editing a revised Biotechnology form. • Refer to Section 1 through Section 6.1.8 for instructions on editing a revised NOC form. • Refer to Section 1 through Section 7.1.2 for instructions on editing a revised Support form. • Refer to Section 1 through Section 8.1.16 for instructions on editing a revised Bona Fide form. • Refer to Section 1 through Section 9.1.2 for instructions on editing a revised ACM form. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 281 15 Resources You can access the ‘Resources’ screen by clicking the ‘Resources’ tab located at the top of the screen at any time during the submission process. You can also access the ‘Resources’ screen by clicking the ‘Resources’ link from the Section 5 Notices and Supports ‘Home’ screen. The ‘Resources’ screen provides you with links to the appropriate Section 5 Notices and Supports user guides as well as additional helpful links. Click the ‘User Guide’ link to access the Section 5 Notices and Supports user guide document. • Regulatory Impact Analysis for the Regulation of Microbial Products of Biotechnology: Government Costs: Click this link to generate the ‘Regulatory Impact Analysis for the Regulation of Microbial Products of Biotechnology: Government Costs’ screen in a new browser window. • Microbial Products of Biotechnology: Final Rule (62 FR 17910): Click this link to generate the ‘Microbial Products of Biotechnology: Final Rule (62 FR 17910)’ screen in a new browser window. • Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms: Click this link to generate the ‘Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms’ PDF in a new browser window. • CDX Homepage: Click this link to generate the CDX Homepage in a new browser window. • TSCA Chemical Substances Inventory: Click this link to generate the ‘TSCA Chemical Substances Inventory’ screen in a new browser window. • Substance Registry Services (SRS): Click this link to generate the ‘Substance Registry Services (SRS)’ screen in a new browser window. • Facility Registry System (FRS): Click this link to generate the ‘Facility Registry System (FRS)’ screen in a new browser window. • CAS Inventory Expert Services: Click this link to generate the ‘CAS Inventory Expert Services (IES)’ screen in a new browser window. • National Pollutant Discharge Elimination System (NPDES): Click this link to generate the ‘National Pollutant Discharge Elimination System (NPDES)’ screen in a new browser window. • New Chemicals Program Homepage: Click this link to generate the ‘New Chemicals Program’ screen in a new browser window. • Status of Section 5 Notices: Click this link to generate the ‘Status of Section 5 Notices’ screen in a new browser window. TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 282 Exhibit 15-1 shows a screen capture of the ‘Resources’ screen (Scroll 1): Exhibit 15-1: Resources Screen (Scroll 1) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 283 Exhibit 15-2 shows a screen capture of the ‘Resources’ screen (Scroll 2): Exhibit 15-2: Resources Screen (Scroll 2) TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 284 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 TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 285 Acronym Full Name OPPT Office of Pollution Prevention and Toxics PDF Portable Document Format PMN Premanufacture Notice POTW Publicly Owned Treatment Works PPE Personal Protective Equipment PPM Parts Per Million RCRA Resource Conservation and Recovery Act SAR Structure-Activity Relationship SDS Safety Data Sheet SME Subject Matter Expert SNUN Significant New Use Notice SNUR Significant New Use Rule SRS Substance Registry Services STN Scientific and Technical Information Network TERA TSCA Experimental Release Application TME Test Market Exemption TMEA Test Marketing Exemption Application TS Toxic Substances TSCA Toxic Substances Control Act UV Ultraviolet XML Extensible Markup Language TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide Primary Authorized Official December 15, 2014 286
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