## Section 5 Notices and Supports
User Guide

- Secondary Agent/Consultant

Environmental Protection Agency

Office of Pollution Prevention and Toxics

Delivery Order # GS00Q09BGD0022

Task Order # EP

- G11H

- 00154

Project # TDD 9.21

Version 1.0

December 22, 2014

### T able of Contents

Table of Contents

................................ ................................ ................................ ......................... i

List of Exhibits

................................ ................................ ................................ ............................ iv

1 Introduction

................................ ................................ ................................ ........................ 1

2 System Requirements

................................ ................................ ................................ ........ 2

2.1 Supported Browsers

................................ ................................ ................................ ..... 2

2.2 Screen Resolution

................................ ................................ ................................ ........ 2

3 Secondary Agent/Consultant Functions

................................ ................................ .............. 3

3.1 Log into Section 5 Notices and Supports Application

................................ .................... 4

3.2 Home Screen Navigation

................................ ................................ .............................. 5

3.3 Section 5 Notices and Supports Forms

................................ ................................ ......... 7

3.4 Create Passphrase

................................ ................................ ................................ ..... 10

3.5 Enter Passphrase

................................ ................................ ................................ ....... 12

3.6 Navigation Tree

................................ ................................ ................................ .......... 13

3.7 Action Bar

................................ ................................ ................................ ................... 21

3.8 Attach Documents

................................ ................................ ................................ ...... 23

3.9 Search Substance Registry Services

................................ ................................ .......... 28

3.10 Add Facility

................................ ................................ ................................ ................. 33

4 Create Joint/Letter of Support PMN Form

................................ ................................ ......... 36

4.1 Create Joint Submission

................................ ................................ ............................. 36

4.1.1 General Form Information (Joint PMN)

................................ ................................ . 36

4.1.2 Agent Information

................................ ................................ ................................ . 39

4.1.3 Technical Contact Information

................................ ................................ .............. 44

4.1.4 Chemical Identification

................................ ................................ .......................... 47

4.1.5 Class 1 or 2 Chemical Substances

................................ ................................ ....... 49

4.1.6 Class 2 Substances

................................ ................................ .............................. 55

4.1.7 Additional Chemical Information

................................ ................................ ........... 58

4.1.8 Polymer Identification Information

................................ ................................ ......... 63

4.1.9 Monomers and Other Reactants

................................ ................................ ........... 67

4.1.10 Production Volume and Hazard/Safety Information

................................ ............... 72

4.1.11 Use Information

................................ ................................ ................................ .... 75

4.1.12 Physical and Chemical Properties Worksheet

................................ ....................... 80

4.1.13 Physical and Chemical Properties Worksheet

– Continued (Optional)

.................. 88

4.1.14 Physical and Chemical Properties Worksheet

– Continued (Optional) Attach
Documents

................................ ................................ ................................ ........... 90

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant i4.1.1 5 Site Information

................................ ................................ ................................ ..... 94

4.1.16 Sites Controlled By Others

................................ ................................ .................... 9 5

4.1.17 Subm itter Operation Information

................................ ................................ ........... 97

4.1.18 Occupational Exposures

................................ ................................ ..................... 102

4.1.19 Environmental Releases

................................ ................................ ..................... 105

4.1.20 Industrial Sites Controlled By Others

................................ ................................ .. 110

4.1.21 Exposures/Releases

................................ ................................ ........................... 113

4.1.22 Byproduct Information

................................ ................................ ......................... 118

4.1.23 Optional Pollution Prevention

................................ ................................ .............. 119

4.1.24 Additional Attachments

................................ ................................ ....................... 122

4.1.25 Attachment Summary

................................ ................................ ......................... 124

4.1.26 Optional Cover Letter

................................ ................................ .......................... 126

4.1.27 Upload XML

................................ ................................ ................................ ........ 127

5 Create Biotechnology Joint/Letter of Support

................................ ................................ . 130

5.1 Joint and Letter of Support Process

................................ ................................ .......... 130

5.1.1 General Form Information

................................ ................................ ................... 130

5.1.2 Technical Contact Informa tion

................................ ................................ ............ 132

5.1.3 Optional Cover Letter

................................ ................................ .......................... 135

6 Create Bona Fide Letter o f Support

................................ ................................ ................ 137

6.1 Edit Bona Fide Form

................................ ................................ ................................ . 137

6.1.1 General Document Information

................................ ................................ ........... 137

6.1.2 Primary Contact Information

................................ ................................ ............... 138

6.1.3 Technical Contact Information

................................ ................................ ............ 140

6.1.4 Chemical Identification Information

................................ ................................ ..... 142

6.1.5 Class 1 or 2/Biotechnology Chemical Substances

................................ .............. 144

6.1.6 Class 2/Biotechnology Substances

................................ ................................ ..... 148

6.1.7 Polymer Identification Information

................................ ................................ ....... 150

6.1.8 Monomers and Other Reactants

................................ ................................ ......... 153

6.1.9 Use Information

................................ ................................ ................................ .. 156

6.1.10 Document Management

................................ ................................ ...................... 157

6.1.11 Optional Cover Letter

................................ ................................ .......................... 159

7 Preview

................................ ................................ ................................ .......................... 160

8 Validate

................................ ................................ ................................ .......................... 162

9 Submit to EPA via CDX

................................ ................................ ................................ .. 164

9.1 Submitting Official Information

................................ ................................ .................. 164

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant ii9.2 Submitting On Behalf Of Company

................................ ................................ ........... 166

9.3 Submission Process: Validation

................................ ................................ ................ 168

9.4 Cross

- Media Electronic Reporting Regulation (CROMERR) Certification

................. 170

9.5 CROMERR Login

................................ ................................ ................................ ..... 171

9.6 Cross

- Media Electronic Reporting Regulation (CROMERR) Security Question

........ 172

9.7 Submit to CDX

................................ ................................ ................................ .......... 173

9.8 Cross

- Media Electronic Reporting Regu lation (CROMERR) Submission

.................. 174

10 Download Copy of Record

................................ ................................ .............................. 176

11 Create an Amendment

................................ ................................ ................................ ... 178

12 Resources

................................ ................................ ................................ ...................... 180

Appendix A. Definitions, Acro nyms, and Abbreviations

................................ ........................... 183

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant iii

### List of Exhibit s

Exhibit 3

- 1: Section 5 Notices and Supports User Roles Matrix

................................ .................. 4

Exhibit 3

- 2: Chemical Information Submission System Screen

................................ ................... 5

Exhibit 3

- 3: Section 5 Notices and Supports Home Screen

................................ ......................... 7

Exhibit 3

- 4: Section 5 Notices and Supp orts Forms Screen

................................ ...................... 10

Exhibit 3

- 5: Create Passphrase Screen

................................ ................................ ..................... 12

Exhibit 3

- 6: Enter Passphrase Screen

................................ ................................ ....................... 13

Exhibit 3

- 7: Navigation Prompt

................................ ................................ ................................ .. 14

Exhibit 3

- 8: Premanufacture Notice Navigation Tree (Scroll 1)

................................ .................. 16

Exhibit 3

- 9: Premanufacture Notice Navigation Tree (Scroll 2)

................................ .................. 17

Exhibit 3

- 10: Premanufacture Notice Navigation Tree (Scroll 3)

................................ ................ 18

Exhibit 3

- 11: Premanufacture Notice Navigation Tree (Scroll 4)

................................ ................ 19

Exhibit 3

- 12: Biotechnology Nav igation Tree

................................ ................................ ............. 20

Exhibit 3

- 13: Bona Fide Navigation Tree (Class 1 or 2/Biotechnology Chemical Substances)

... 20

Exhibit 3

- 14: Bona Fide Navigation Tree (Polymer)

................................ ................................ ... 21

Exhibit 3

- 15: Action Bar

– Validate

................................ ................................ ............................ 22

Exhibit 3

- 16: Action Bar

– Save

................................ ................................ ................................ . 22

Exhibit 3

- 17: Action Bar

– Preview

................................ ................................ ............................ 22

Exhibit 3

- 18: Action Bar

– Submit

................................ ................................ .............................. 23

Exhibit 3

- 19: Help

– Links

................................ ................................ ................................ ......... 23

Exhibit 3

- 20: Section 5 Document Types and Subtypes

................................ ............................ 25

Exhibit 3

- 21: Attach Documents Pop

- Up Window (PMN or Biotechnology)

............................... 27

Exhibit 3

- 2 2: Attach Documents Pop

- Up Window (Bona Fide)

................................ .................. 28

Exhibit 3

- 23: Search Substance Registry Services Pop

- Up Window

................................ ......... 30

Exhibit 3

- 24: Chemical Not Found In Substance Registry Services Pop

- Up Window

................ 32

Exhibit 3

- 25: Add Facility Message Pop

- Up Window

................................ ................................ . 34

Exhibit 3

- 26: Add Facility Pop

- Up Window

................................ ................................ ................ 35

Exhibit 4

- 1: General Form Information Screen (Joint PMN)

................................ ....................... 39

Exhibit 4

- 2: Agent Information Screen (Joint PMN)

................................ ................................ ... 41

Exhibit 4

- 3: Add Agent Pop

- Up Window

................................ ................................ .................... 43

Exhibit 4

- 4: Technical Contact Information Screen (Joint PMN)

................................ ................ 45

Exhibit 4

- 5: Add Technical Contact Window

................................ ................................ .............. 47

Exhibit 4

- 6: Chemical Identification Screen (Joint PMN)

................................ ............................ 49

Exhibit 4

- 7: Class 1 or 2 Chemical Substances Screen (Joint PMN) (Scroll 1)

.......................... 53

Exhibit 4

- 8: Class 1 or 2 Chemical Substances Screen (Joint PMN) (Scroll 2)

.......................... 54

Exhibit 4

- 9: Class 2 Substances Screen (Joint PMN) (Scroll 1)

................................ ................. 57

Exhibit 4

- 10: Class 2 Substances Screen (Joint PMN) (Scroll 2)

................................ ............... 58

Exhibit 4

- 11: Additional Chemical Information Screen (Joint PMN) (Scroll 1)

............................ 62

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant ivExhibit 4

- 12: Additional Chemical Information Screen (Joint PMN) (Scroll 2)

............................ 63

Exhibit 4

- 13: Polymer Identification Info rmation Screen (Joint PMN) Scroll 1

............................ 66

Exhibit 4

- 14: Polymer Identification Information Screen (Joint PMN) Scroll 2

............................ 67

Exhibit 4

- 15: Monomers and Other Reactants Screen (Joint PMN) (Scroll 1)

............................ 71

Exhibit 4

- 16: Monomers and Other Reactants Screen (Joint PMN) (Scroll 2)

............................ 72

Exhibit 4

- 17: Production Volume and Hazard/Safety Information Screen (Joint PMN)

............... 75

Exhibit 4

- 18: Use Information Screen (Joint PMN) (Scroll 1)

................................ ..................... 79

Exhibit 4

- 19: Use Information Screen (Joi nt PMN) (Scroll 2)

................................ ..................... 80

Exhibit 4

- 20: Physical and Chemical Properties Worksheet Screen (Joint PMN) (Scroll 1)

....... 87

Exhibit 4

- 21: Physical and Chemical Properties Worksheet Screen (Joint PMN) (Scroll 2)

....... 88

Exhibit 4

- 22: Physical and Ch emical Properties Worksheet

– Continued (Optional) Screen (Joint PMN)

................................ ................................ ................................ ................................ ........ 90

Exhibit 4

- 23: Physical and Chemical Properties Worksheet

– Continued (Optional) Attach
Do cuments Window (Joint PMN) (Scroll 1)

................................ ................................ ............... 92

Exhibit 4

- 24: Physical and Chemical Properties Worksheet

– Continued (Optional) Attach Documents Window (Joint PMN) (Scroll 2)

................................ ................................ ............... 93

Exhibit 4

- 25: Submitter Controlled Site Information Screen (Joint PMN)

................................ ... 95

Exhibit 4

- 26: Sites Controlled By Others Screen (Joint PMN)

................................ .................... 97

Exhibit 4

- 27: Submitter Operation Information Screen (Joint PMN) (Scroll 1)

.......................... 101

Exhibit 4

- 28: Submitter Operation Information Screen (Joint PMN) (Scroll 2)

.......................... 102

Exhibit 4

- 29: Occupational Exposures Screen (Joint PMN)

................................ ..................... 105

Exhibit 4

- 30: Environmental Releases Screen (Joint PMN) (Scroll 1)

................................ ...... 109

Exhibit 4

- 31: Environmental Releases Screen (Joint PMN) (Scroll 2)

................................ ...... 110

Exhibit 4

- 32: Industrial Sites Controlled By Others Screen (Joint PMN)

................................ .. 113

Exhibit 4

- 33: Exposures/Releases Screen (Joint PMN) (Scroll 1)

................................ ............ 116

Exhibit 4

- 34: Exposures/Releases Screen (Joint PMN) (Scroll 2)

................................ ............ 11 8

Exhibit 4

- 35: Byproduct Information S creen (Joint PMN)

................................ ......................... 119

Exhibit 4

- 36: Optional Pollution Prevention Screen (Joint PMN)

................................ .............. 122

Exhibit 4

- 37: Additional Attachments Screen (Joint PMN)

................................ ....................... 124

Exhibit 4

- 38: Attachment Summary Screen (Joint PMN)

................................ ......................... 126

Exhibit 4

- 39: Optional Cover Letter Scree n (Joint PMN)

................................ .......................... 127

Exhibit 4

- 40: Upload XML Screen

................................ ................................ ........................... 129

Exhibit 5

- 1: General Form Information Screen (Joint Biotechnology)

................................ ...... 132

Exhibit 5

- 2: Technical Cont act Information Screen (Joint Biotechnology)

................................ 133

Exhibit 5

- 3: Add Technical Contact Window

................................ ................................ ............ 135

Exhibit 5

- 4 : Optional Cover Letter Screen

................................ ................................ ............... 136

Exhibit 6

- 1: General Document Information Screen (Letter of Support)

................................ ... 138

Exhibit 6

- 2: Primary Contact Information Screen

................................ ................................ ..... 140

Exhibit 6

- 3: Technical Contact Information Screen

................................ ................................ .. 142

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant vExhibit 6

- 4: Chemical Identification Information Screen

................................ ........................... 143

Exhibit 6

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

................................ .... 147

Exhibit 6

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

................................ ........... 149

Exhibit 6

- 7: Class 2 Substances Screen (Scroll 2)

................................ ................................ .. 150

Exhibit 6

- 8: Polymer Id entification Information Screen

................................ ............................ 153

Exhibit 6

- 9: Monomers and Other Reactants Screen

................................ .............................. 156

Exhibit 6

- 10: Use Information Screen

................................ ................................ ...................... 157

Exhibit 6

- 11: Document Management Screen

................................ ................................ ......... 158

Exhibit 6

- 12: Optional Cover Letter Screen

................................ ................................ ............. 159

Exhibit 7

- 1 : Preview Biotechnology Form Screen

................................ ................................ .... 160

Exhibit 7

- 2 : Preview Biotechnology Form PDF

................................ ................................ ........ 161

Exhibit 8

- 1: Section 5 Notices and Supports Validation Pop

- Up Window

................................ 163

Exhibit 9

- 1: Submitting Official Information Screen

................................ ................................ .. 166

Exhibit 9

- 2: Submitting On Behalf Of Company Screen

................................ ........................... 168

Exhibit 9

- 3: Submission Process: Validation Screen

................................ ............................... 169

Exhibit 9

- 4: Submission Process: PDF Generation Screen

................................ ..................... 170

Exhibit 9

- 5: Cross

- Media Electronic Reporting Regulation (CROMERR) Certification Screen

. 171

Exhibit 9

- 6: Cross

- Media Electronic Reporting Regulation (CROMERR) Login Scre en

........... 172

Exhibit 9

- 7: Cross

- Media Electronic Reporting Regulation (CROMERR) Security Question
Screen

................................ ................................ ................................ ................................ .... 173

Exhibit 9

- 8: Submit to CDX Screen

................................ ................................ ......................... 174

Exhibit 9

- 9: Cross

- Media Electronic Reporting Regulation (C ROMERR) Submission Screen

. 175

Exhibit 10

- 1: Download Copy of Record Screen

................................ ................................ ...... 176

Exhibit 10

- 2: Download Prompt Screen

................................ ................................ ................... 177

Exhibit 11

- 1: Section 5 Notices and Supports Form

– Amendment

................................ ......... 178

Exhibit 11

- 2: Unlock Prompt Mes sage

................................ ................................ .................... 179

Exhibit 12

- 1: Resources Screen (Scroll 1)

................................ ................................ ............... 181

Exhibit 12

- 2: Resources Screen (Scroll 2)

................................ ................................ ............... 182

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant vi

### Revision Log

Date Version
No. Description Author Reviewer Review
Date

09/20 /13 0.01 Initial Draft of User Guide C. Yeh

J. DeRosa A. Jaynes

J. Ritchey 09/20 /13

12/22/14 1 .0 Final Section 5 Notices and Supports Secondary Agent/Consultant User guide

Incorporated Release 1.00 enhancements, other OPPT

comments C. Yeh J. Bronick 12/22/14

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant vii

### 1 Introduction

This document presents the u ser g uide 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 Secondary Agent/Consultant user of the Section 5 Notices and Supports application

.
The Section 5 Notices and Supports application is the electronic, web

- based tool provided by

E nviron mental P rotection A gency (EPA) for the submission of Section 5 Notices and Supports
data. As a Secondary Agent/Consultant, you can create or modify a Joint Form /Letter of Support
for a Section 5 Notices and Supports form

. You can also delete Joint Section 5 Notices and Supports forms, submit amendments to Joint submissions and download the Copy of Record (CoR)

. You will not have t he ability to submit Joint Forms or Letters of Support , but may submit
amendments to these forms

. For questions concerning the Toxic Substances Control Act (TSCA) Section 5 Notices and Supports software requirements, please contact the Central Data Exchange (CDX) Help Desk

at helpdesk@epacdx.net or call 1

- 888

- 890

- 1995 between the hours of 8 am

– 6 pm Eastern
Standard Time (EST). For questions concerning the TSCA Section 5 Notices and Supports reporting requirements, please contact the TSCA Hotline at TSCA

- Hotline@epamail.epa.gov or call 2 02

- 554

- 1404 between the hours of 8:30 am

– 5:00 pm EST

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 1

### 2 System Requirements

To use the Section 5 Notices and Supports application to submit a Section 5 Notice s and Support s form

, the following are required :

• An e

- mail account

• JavaScript enabled web browser

• Internet access

• Adobe Ac robat 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/d l877

• 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

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 2

### 3 Secondary Agent/Consultant Functions

This section describes how to:

• Access the application

• Navigate the Section 5 Notices and Supports ‘ Home ’ screen

• Create, edit, amend, or delete the Section 5 Notices and Supports Letters of Supports and

Joint Submissions for a Premanufacture Notice (PMN) form , Biotechnology form

, and/or
Bona Fide

• Upload an extensible markup language (XML) file

• Download a Copy of Record
The Secondary Agent /Consultant is not responsible for the submission of original Letters of Support and/ or Joint forms for PMN, Biotechnology , or Bona Fide . The Secondary Agent/Consultant can creat e, edit, amend, or delete Joint Forms or Letters of Support

. The system uses Cross

- Media Electronic Reporting Regulation ( CROMERR ) encryption security during the submission signing process.

The Secondary Agent/Consultant can be responsible for receiving the unique identification number that will be sent after an original Section 5 Notices and Supports form was submitted and designated by the Primary A uthorized O fficial (AO) or Primary Agent/Consultant as pending a Joint Form and/or Letter of Support form

.
You can save the form at any point during the data entry process. T he save functionality will allow you to return to that same submission at any point in the future. You can print the submission at any point; however, the ‘ Not For Submission ’ watermark will be placed on the
form anytime the form is printed prior to actual submission

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 3Exhibit 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 A pplication

After you create an account in CDX

, click the ‘ Secondary Agent/Consultant ’ link for the Chemical Safety and Pesticide Programs (CSPP) data flow to navigate to the ‘ Chemical
Information Submission System ’ screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 4Exhibit 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, s elect ‘ TSCA Section 5 Notices and Supports

- ePMN ’ from the drop

- down menu and click the ‘ OK ’ button.

3.2 Home Screen Navigation

You can access the Section 5 Notices and Supports ‘ Home ’ screen by selecting ‘ TSCA Section 5 Notices and Supports

- ePMN ’ from the submission type drop

- down menu on the ‘ Chemical
Information Submission System ’ screen and clicking the ‘ OK ’ button.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 5The Section 5 Notices and Supports ‘ Home ’ screen is the first screen within the Section 5 Notices and Supports application. It provides yo u with links and tabs to access the ‘ Section 5 Notices and Supports Form s ’ and ‘ Resources ’ screens. To navigate to any of these screens, click
the corresponding screen lin k ( highlighted in blue text ), or click the screen tab (located within the application header ). The links and tabs provide the same functionality.

There is a ten (10) minute logout timer for this application; the application will automatically log

you out after ten minutes of inactivity and navigate you back to the CDX login screen

.

• Forms : Click the ‘ Forms ’ link or tab to navigate to the ‘ Section 5 Notices and Supports

Forms’ screen. You can 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 3.3

.

• Resources: Click the ‘ Resource s ’ link or tab to navigate to the ‘ Resources ’ screen. You can

find the Section 5 Notices and Supports user guide , as well as useful links for guidance
documents on the ‘ Resources ’ screen. For additional details about the ‘ Resources ’ screen, please refer to Section 12

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 6Exhibit 3

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

Exhibit 3

- 3 : Section 5 Notices and Supports Home Screen

Navigation: Click the ‘ Forms ’ link or tab to access the ‘ Section 5 Notices and Supports Forms ’

screen.

3.3 Section 5 Notices and Supports Form s

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.

Only one Section 5 Notices and Supports Form is created per form alias , which helps
differentiate between forms . Each column with in the table of the ‘Section 5 Notices and Supports

Forms’ screen can be sorted by clicking the individual column headers.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 7Start New Form : To create a new Section 5 Notices and Supports Joint Submission /Letter of Support

, click the ‘Start New Form’ button

. You will be required to enter the unique
identification number supplied by the Primary AO or Primary Agent/Consultant and create a passphrase that will be associated with you r particular form. Make sure to create a passphrase that you will remember, as i t cannot be retrieved or reset. Refer to Section 3.4 for further instructions on creating a new passphrase

. Edit a n ‘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. Refer to Section 11 for further instructions on viewing and modifying a form that is ‘In Progress.’

Amend a s ubmitted f orm : To edit an already submitted Section 5 Notices and Supports form (i.e., to create a n amendment ), you must first unlock the particular form by clicking the ‘ L ock ’
icon ( ) under the ‘Action’ column. You are 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 11 for f ur ther 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 within the ‘General Form Information

, ’ within a

PMN or Biotechnol ogy form or the ‘General Document Information’ screen within a Bona
Fide Notice . The ‘Alias’ column will display a default alias comprised of a form type , date
stamp and time stamp in the following format: Form Type

- YYYYMMDD

- HH:MM:SS Time

Zone if you accept the auto

- 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: ‘ Joint PMN

, ’ ‘ Joint Biotechnology

, ’ or ‘ Joint Bona
Fide

. ’

• Subtype: Thi s column will not populate for a Secondary Agent/Consultant

.

• Case Number: Displays the form case number pertaining to the reported chemical substance

or mixture after EPA receives the submission

. In all cases, the ‘XX’ represents the fiscal year
in which the form was submitted, and the ‘XXXX’ represents the order in which the form
was received. A consolidated submission will generate sequential case numbers for each
chemical identified within the form and will display all case numbers associated with that specific form . If the form has not been submitted and received, the ‘Case Number’ field
remains blank.

− A PMN submission can have the following case number formats : P

- XX

- XXXX for PMN,

SN

- XX

- XXXX for SNUN, L

- XX

- XXXX for LVE, LM

- XX

- XXXX for LVE
Modifications , X

- XX

- XXXX for LOREX, XM

- XX

- XXXX for LOREX Modifications, T

XX

- XXXX for TMEA, and I

- XX

- XXXX for Mock PMN notice types.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 8− 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 Notices will have a case number format of BF

- XX

- XXXX.

• 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 ‘ C opy of R ecord ’ icon ( ) to navigate to the ‘ Ent er Passphrase ’

screen , then the ‘Cross

- Media Electronic Reporting Regulation (CROMERR) Login’ screen to continue to the ‘Copy of Record’ screen. The ‘ C opy of R ecord ’ icon ( ) displays only after the form has been completed. Refer to Section 10 for further instructions on downloading the Copy of Record

. If you have just submitted via CDX, the ‘Copy of R ecord’

icon ( ) may take 15

- 20 minu tes to display. In addition , you must refresh the ‘Section 5 Notices and Supports Forms’ screen for the ‘Copy of R ecord’ icon ( ) to display

.

• Action: Displays a ‘Delete’ icon ( ) for all forms with a status of ‘In Progress.’ Click the

‘Delete’ icon to dele te a form. This column d isplays a ‘Lock’ icon ( ) for all forms that
have been submitted and are not ‘In Progress

. ’ You 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 as an amendment by a Secondary Agent/Consultant

.

• 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 , or portable document format (PDF)

. The export option s section will not display until a form is created.

• Start New Form: Click this button to start a new form and navigate to the ‘Create

Passphrase’ screen. This button is only available to Authorized Officials and Agents/Consultants

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 9Exhibit 3

- 4 shows a screen capture of the ‘Section 5 Notices and Supports Forms’ screen:

Exhibit 3

- 4 : Section 5 Notices and Supports Forms Screen

Nav igation: Click the ‘ Start New Form’ button to navigate to the ‘ Create Passphrase ’ screen.

3.4 Create Passphrase

To start a new Section 5 Notices and Supports Joint/Letter of Support for a PMN

, Biotechnology , or Bona Fide Notice , click the ‘Start New Form’ bu tton. The ‘ Create Passphrase ’

screen provides a text field for you to enter in the unique identification number supplied by the Primary AO or Primary Agent/Consultant and create a passphrase to associate that passphrase
with the 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 10If you forget the passphrase, you will not have access to t he 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 abl e to retrieve it or reset it to a new one

. Unique Identifier: Enter in the unique identifier that was provided by the Primary AO or Primary Agent/Consultant

. New Passphrase: To associate a passphrase with a form , enter a passphrase that is at least 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 sa me 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 December 22, 2014 Secondary Agent/Consultant 11Exhibit 3

- 5 shows a screen capture of the ‘Create Passphrase’ screen for a Secondary Agent/Consultant :

Exhibit 3

- 5 : Create Passphrase Screen

Navigation : Create a passphrase and click the ‘ Next ’ button to navigate to the ‘General Form
Information’ screen in a PMN or Biotechnology form

. Click the ‘Next’ button to navigate to the
‘General Document Information’ screen in a Bona Fide Notice.

3.5 Enter Passphrase

To edit a form click the ‘Alias’ link for a Section 5 Notices and Supports form with a status of

‘ In Progress ’ on the ‘Section 5 Notices and Supports Forms’ screen. The ‘ Enter Passphrase ’

screen requires you to enter the passphrase that is asso ciated with the form

. Enter Passphrase: Enter the passphrase that was originally created and associated with the
form

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 12Exhibit 3

- 6 shows a screen capture of the ‘ Enter Passphrase’ screen:

Exhibit 3

- 6 : Enter Passphrase Screen

Navigation: Enter the passphrase that was originally created and associated with the form and
click the ‘ Next ’ button to navigate to the ‘General Form Information’ screen in a PMN or Biotechnology form

. Click the ‘Next’ button to navigate to the ‘General Document Information’
screen in a Bona Fide Notice

. 3.6 Navigation Tree

The navigation t ree 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 t ree:

• Open and close the navigation tree: A navigation arrow that opens and closes the

navigation tree is located to the right of the navigation tree to provide more visual form space. Click the arrow ( ) on the open navigation tree to close the navigation tree and increase the space of the form content. Likewise, click the arrow ( ) on the closed navigation tree to open the navigation tree.

• Collapse and E xpand 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. Wh en 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 ti tle link to expand that section of the navigation tree. When you place your cursor over a folder title link, it will highlight in red.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 13• 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 navigatin g 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 navig ate to the requested screen without saving any of the data in the previous screen. Click the ‘Cancel’ button to close the prompt and remain on the current screen.

Exhibit 3

- 7 shows a screen capture of the navigation prompt window:

Exhibit 3

- 7 : Navigation Prompt

• Delete chemical folders : Click the ‘Delete’ icon ( ) that display s at the bottom of each

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 report is lost
and cannot be retrieved. Click the ‘Add Consol idated Chemical’ link and fill in all corresponding data to add a new chemical report

. This delete functionality is not applicable to the Biotechnology or Bona Fide Notice 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 attache d documents are removed from the copied chemical. This copy functionality is not a pplicable to the Biotechnology or Bona Fide Notice forms, and is unavailable when amending a PMN form

.

• Delete ‘ Submitted Controlled Operation s ’ or ‘ Operations Controlled By Others ’ : Click

the ‘Delete’ icon ( ) that displays at the bottom of each ‘Submitter Controlled Operation s ’
or ‘ Operations Controlled by Others ’ folder within the navigation tree to delete a specific operations folder . When a ‘Submitter Controlled Operat ion s ’ 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 Operation s ’ 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 a Biotechnology form or a Bona Fide Notice

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 14• Upload XML: The system display s an ‘Upload XML’ button in the navigation tree to allow a user to upload a n XML file into a PMN for m 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
functionali ty, refer to Section 4.1.27 for additional information.
Please note that in IE 7, the scroll bar within the navigation bar may freeze and portions of the scroll bar may be missing which can prevent you from using the n avigation 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 December 22, 2014 Secondary Agent/Consultant 15Exhibit 3

- 8 shows a screen capture of the ‘ PMN ’ navigation tree (S croll 1) :

Exhibit 3

- 8 : Premanufacture Notice Navigation Tree (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 16Exhibit 3

- 9 shows a screen capture of the ‘ PMN ’ navigation tree (S croll 2):

Exhibit 3

- 9 : Premanufacture Notice Navigat ion Tree (Scroll 2)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 17Exhibit 3

- 10 shows a screen capture of the ‘ PMN ’ navigation tree (S croll 3):

Exhibit 3

- 10 : Premanufacture Notice Navigation Tree (Scroll 3)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 18Exhibit 3

- 11 shows a screen capture of the ‘ PMN ’ navigation tree (Scroll 4):

Exhibit 3

- 11 : Premanufacture Notice Navigation Tree (Scroll 4)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 19Exhibit 3

- 12 shows a screen capture of the ‘ Biotech nology ’ navigation tree:

Exhibit 3

- 12 : Biotech nology Navigation Tree

Exhibit 3

- 13 shows a screen capture of the ‘ Bona Fide ’ navigation tree (Class 1 or

2 /Biotechnology chemical substance s ) :

Exhibit 3

- 13 : Bona Fide Navigation Tree (Class 1 or 2 /Biotechnology Chemical Substances)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 20Exhibit 3

- 14 shows a screen capture of the ‘ Bona Fide ’ navigation tree ( Polymer ):

Exhibit 3

- 14 : Bona Fide Navigation Tree (Polymer)

3.7 Action Bar

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

• 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 generate s
when you click the ‘ Validate ’ icon ( ) if you disable the pop

- up blocker within your
internet b rowser . 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 expand able / collapsible field set to save the information entered within the field set before the
‘Validate’ functionality initiate s

. Refer to Section 8 for more information on validating a
form

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 21The following exhibits

, Exhibit 3

- 15

, Exhibit 3

- 16

, Exhibit 3

- 17 , and Exhibit 3

- 18

, sh ow screen capture s for the action b ar:

Exhibit 3

- 15 : Action Bar

– Validate

• Save: Click the ‘ Save ’ icon ( ) at any stage of completing a Section 5 Notices and Supports

f

orm. 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 data entered. 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 info rmation 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. C lick the ‘X’ button in the upper right

- hand corner of the form in your
browser to close the form without saving.

Exhibit 3

- 16 : Action Bar

– Save

• Preview: Click the ‘ Preview ’ icon ( ) at any stage of compl eting a Section 5 Notices and

Supports f orm to preview the form . After you click the ‘ Preview ’ icon ( ), you will be given the option to view a regular version of the PDF (the confidential business information (CBI)
version of the form or the non

- CBI version of the form if the form contains no CBI) or a sanitized version of the PDF. Choosing either option will generate and display a watermarked

PDF 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

- 17 : Action Bar

– Preview

• Submit: As a Secondary Agent/Consultant you may click the ‘ S ubmit ’ icon ( ) to only

submit amendments to Joint Forms or Letters of Supports or after you or the Support have completed all sections of the Section 5 Notices and Supports submission process

. You do not have the ability to submit original Letters of Support for PMN, Bona Fide Notices, or Biotechnology forms.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 22Exhibit 3

- 18 : Action Bar

– Submit

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

.

• Help Links: You can click any of the ‘ Help ’ links , located at the bottom of each screen, at

any stage of completing a Section 5 Notices and Supports form

.

− If you click the ‘ CDX Homepage ’ link, the application takes you to the CDX Homepage.

− If you click the ‘ MyCDX Homepage ’ link, the application takes you to the CDX Login

screen

.

− 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

- 19 shows a screen capture of the ‘ Help’ links:

Exhibit 3

- 19 : Help

– Links

3.8 Attach Documents

The ‘Attach Document’ button displays on various screens within a Section 5 Notices and Supports form, and provides functionality for you to attach supporting documents where needed.
Click the ‘Attach Document’ button displayed on a screen to access the ‘A ttach 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 docume nt.

The system allows you to claim an uploaded document as CBI. If you claim a document as CBI, the system requires you to upload a sanitized version of the attached document. If you wish to change a CBI attachment to be non

- CBI by un

- checking the ‘CBI’ c heckbox, a warning appear s 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 applicat ion delete s 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 tab le 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. Click the ‘Delete’ icon ( ) locat ed
under the ‘Actions’ column to delete unwanted documents . To view, open, or edit previously

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 23attached documents, click the appropriate file name of the document within the ‘File Name’ column of the document table to view previously entered document inform ation.

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 additio nal information regarding d ocument types, refer to Exhibit 3

- 20 . This is a required
field.

• Subtype: Select the document type from the drop

- down menu of the document that you

upload. For additional information regarding document subtypes, refer to Exhibit 3

- 20 . This is a required field when displayed.

• Attachment: Click the ‘Browse’ button to generate the ‘File Upload’ window to search for a

particular file on your har d drive. The application prevents the upload of empty documents. The attached file can be one of the following file types: .pdf, .mol, .ppt, .pptx, .xls, .xlsx, .doc, .docx, .rtf, .txt, .gif, .jpg, .png, .bpm, .fas, .gbk, or .embl

.

• Description: Enter the d escription associated with the document. Submitters should not

include any CBI information in the description of the file information. 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.

• Sanit ized Attachment: Click the ‘Browse’ button to generate the ‘File Upload’ window to

search for a particular file 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, .jp g, .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 attac h 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 December 22, 2014 Secondary Agent/Consultant 24Exhibit 3

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

Exhibit 3

- 20 : Section 5 Document Types and Subtypes

Form Type Document Type Document Subtypes

PMN & Support Aquatic Ecotoxicity • Algae Toxicity

• Fish Acute Toxicity

• Fish Chronic Toxicity

• Invertebrate Acute Toxicity

• Invertebrate Chronic Toxicity

Chemical Structure Diagram • Not applicable (N/A)

Correspondence • N/A

Fate • BCF/BAF (bioconcentration factors / bioaccumulation factors)

• Biodegradation

• Fugacity

• Hydrolysis

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

• Partitioning (e.g., Koc, Kd, Kow, Koa, Henry’s law

constant)

• Photolysis

GPC • N/A

Genetic Toxicity • Chromosomal Aberrations Assay

• Genetic Mutation Assay

• Unscheduled DNA ( Deoxyribonucleic acid) Synthesis

Health Toxicity • Acute Toxicity

• Carcinogenicity

• Combined Repeated

Dose/Developmental/Reproductive Toxicity

• Dermal Irritation

• Developmental Toxicity

• Eye Irritation

• Immunotoxicity

• Neurotoxicity

• Pharmacokinetics/Metabolism

• Repeated

- Dose Toxicity

• Reproductive Toxicity

• Sensitization

IES Report • N/A

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 25Form Type Document Type Document Subtypes

Process Diagram

- Other • N/A

Process Diagram

– Submitter • N/A

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

• Technical Datasheet

Terrestrial Ecotoxicity • Avian Toxicity

• Invertebrate Toxicity

• Plant Toxicity

Biotechnology Published Literature • N/A

Regs and Certifications • N/A

ID • Identification (ID) Sequence Data

• Other ID Data

• Strain History

Construct • Construct Methodology

• Construct Data

• Gene Sequence Data

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 December 22, 2014 Secondary Agent/Consultant 26Exhibit 3

- 21 shows a screen capture of the ‘Attach Documents’ pop

- up window that displays within the majority of forms :

Exhibit 3

- 21 : Attach Documents Pop

- Up Window (PMN or Biotechnology)

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 December 22, 2014 Secondary Agent/Consultant 27Exhibit 3

- 21 shows a screen capture of the ‘Attach Documents’ pop

- up window for a Bona Fide
Notice :

Exhibit 3

- 22 : Attach Documents Pop

- Up Window (Bona Fide )

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 att achment process was initiated.

3.9 Search Substance Registry Services

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

. Search SRS: Click the ‘Search SRS’ button to generate the ‘Search Substance Registry Services’ window. You can search for the reported chemical(s) by either the ‘Chemical Abstracts Service Registry Number (CASRN)’ or ‘CA Index Name or Other Synonym.’ The application also offers the option of enter ing user

- specified chemical information by clicking the ‘Create

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 28New Chemical’ button. Click the ‘Create New Chemical’ button to generate the ‘Chemical Not Found In Substance Registry Services’ window and enter chemical information by filling in the
‘Chemic al 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 t he ‘OK’ button, the chemical information saves and populates into the chemical description table. The ‘Actions’ column of the chemical table allows you to delete chemicals that have been added.

The Section 5 Notices and Supports application contains functionality to prevent a user from adding duplicate chemicals within a multi

- component submission. The application checks chemicals in the following order :

• If both chemicals have CASRNs, they will be compared

.

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

.

• If neither chemical ha s a CASRN, their chemical names will be compared

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

- component submission.

Please note in IE 7, the CSPP logo might be misaligned in the ‘Search Substance Registry Services’ pop

- up 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: ‘Matc hes 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 Syno nym ’ for the desired chemical.

• Create New Chemical: Click the ‘Create New Chemical’ button to generate the ‘Chemical

Not Found In Substance Reg istry Services’ pop

- up window.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 29Exhibit 3

- 23 shows a screen capture of the ‘ Search Substance Registry Services’ pop

- up window:

Exhibit 3

- 23 : Search Substance Registry Services Pop

- Up Wind ow

Navigation: Click the ‘Search SRS ’ button on the ‘Search Substance Registry Services’ pop

- up 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 S ubstance R egistry S ervices ’ pop

- up window, close the ‘Search Substance Registry Services’ pop

- up window, and navigate back to the screen from which the SRS search
was initiated wh ere the chemical information will be populated.

If the chemical is not found in the ‘Search Substance Registry Services’ pop

- up window, click the ‘Create New Chemical’ button to generate the ‘Chemical Not Found In Substance Registry Services’ pop

- up window

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 30• CBI: Check the ‘CBI’ checkbox to claim the entered chemical as confidential. The ‘CBI’ checkbox will not be displayed on the ‘Chemical Not Found In Substance Registry Services’ window for the ‘Class 1 or 2 Chemical Substances,’ ‘Polymer Identification Information,’ or the ‘Monomers and Other Reactants’ screen.

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

• CASRN: Enter the CASRN, if available.

• Maximum Percent: Enter the maximum percentage for the impurity. This field is displayed

on ly in the ‘Chemical Not Found in Substance Registry Services’ pop

- up window on the
‘Additional Chemical Information’ screen within a PMN form.

• 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 31Exhibit 3

- 24 shows a screen capture of the ‘Chemical Not Found In Substance Registry Services’

pop

- up window:

Exhibit 3

- 24 : 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 b e 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 December 22, 2014 Secondary Agent/Consultant 323.10 Add Facilit y

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 ‘Submitter Site Identification’ screen within a Bona Fide form. The ‘ Add Facility ’ button is
used to generate the ‘Add Facility’ pop

- up window and select the applicable sites f or which you will be reporting. The ‘Add Facility’ drop

- down menu contains the sites that all AO users within the same organization are register ed 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 disp lays 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: ‘Se lect a site from the drop

- down menu below,’ ‘CBI,’ ‘Alias,’ ‘EPA Registry ID,’ ‘Facility Name,’ ‘Facility Address,’ ‘City,’ ‘State,’ and ‘Postal Code.’ Each individual site may be claimed as CBI.

• Select a site from the drop

- down menu below : Select a site that you will be reporting on

from the drop

- down menu.

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

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

pending for the form

.

• EPA Registry ID: Displays the EPA registry ID of the site selected from the drop

- down

menu.

• Facility Name: Displays the name of the site selected from the drop

- down menu.

• Facility Address: Displays the address of the site selected from the drop

- down m enu

.

• City: Displays the city of the site selected from the drop

- down menu

.

• State: Displays the state of the site selected from the drop

- down menu.

• Postal Code: Displays the postal code of the site selected from the drop

- down menu.

• Add Facility : Click the ‘Add Facility’ button to add the selected site to the main page from

which you are initiating the search.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 33E xhibit 3

- 25 shows a screen capture of the ‘ Add Facility ’ pop

- up window:

E xhibit 3

- 25 : Add Facility Message Pop

- Up Window

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 34Exhibit 3

- 26 shows a screen capture of the ‘Add Facility’ pop

- up window:

Exhibit 3

- 26 : Add Facility Pop

- Up Window

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 December 22, 2014 Secondary Agent/Consultant 35

### 4 Create Joint/Letter of Support PMN Form

Anyone who plans to manufacture or import a new chemical substance for a non

- exempt
commercial purpose is required by Section 5 of TSCA to provide EPA with notice before initiating the activity, known as a PMN form . This PMN must be submitted at least 90 days prior to the manufacture or import of the chemical.

The PMN j oint process will be a multis tep process with coordination needed on the behalf of Secondary AOs and Secondary Agents/Consultants . The Primary AO will first identify that a
Joint S ubmission and/ or Letter of Support (s) will supplement the original PMN form

. Based on the selection, the ‘Joint Submission’ folder and/or ‘Letter of Support’ folder generate s in the navigation tree . Each folder will contain a section for the Primary AO to enter contact
information and instruction information with the Joint and/or L etter of Support unique
identification number

.
When the Primary AO accesses the relevant ‘Joint’ or ‘Letter of Support’ folder in the original
PMN form

, the Primary AO will enter the Secondary Agent/Consultant ’s contact information on
the ‘Letter of Suppo rt Submitter Information’ screen , or the ‘Joint Submitter Information’ screen

. The email address entered on the ‘Letter of Support Submitter Information’ or ‘Joint Submitter
Information’ screen will be used to send the Secondary Agent/Consultant the unique
identification number via an un

- encrypted email sent by the Primary AO

. The ‘Joint Submission Information’ or ‘Letter of Support Submission Information’ screen in the ‘Joint’ or ‘Letter of Support’ folder displays the unique identification number that wil l be sent to the Secondary

A gent/Consultant by the Primary AO and a text box for the Primary AO to provide instructions
or information to the Secondary Agent/Consultant about what is to be filed.

The Secondary Agent/Consultant will register in CDX and access the Section 5 Notices and Supports application. Once you arrive at the ‘ Section 5 Notices and Supports Forms’ screen , click the ‘Start New Form’ button and navigate to the ‘Create Passphrase’ screen. For ‘Joint
PMN’ and ‘Let ter of Support’ forms

, the process of completing the form will work in the same way as the Primary AO , other than being able to enter a foreign address for a ‘Letter of Support’
submitter. Once the Secondary Agent/Consultant has created a new form and assi gned a passphrase, the Secondary Agent/Consultant may enter the required information within the form

. On the ‘ Create Passphrase’ screen, the Secondary Agent/Consultant will enter the unique
identification number sent via email from the Primary AO’s form . O nce the Secondary Agent/Consultant has entered the unique identification number , the Joint/Letter of Support form displays

.
4.1 Create Joint Submission

As a Secondary Agent/Consultant , you can create , modify, unlock, and/or delete Letter s of Support or Joint forms

.
4.1.1 General Form Information ( Joint PMN)

You can navigate to the ‘ General Form Information ’ screen by entering the unique identification
number provided by the Primary AO and creating a passphrase on the ‘Create Passphrase’

screen

. The ‘General Form Information’ screen provides fields for you to identify information that is specific to the form type of the original PMN form

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 36The ‘General Form Information ’ screen presents a list of text fields and checkboxes for you to input identifying information for the specific form . You will have the option to assign a ‘ Form Alias’ which you will use to identify the form . A form alias is helpful when a user or company has multiple forms and/or when you must differentiate betw een forms to the help desk. Upon navigating to the ‘General form Information’ screen, a default form alias generates in the following format: < Form Type

- YYYYMMDD

- HH:MM:SS Time Zone >

.
The ‘ General Form Information’ screen provides fields for you to enter in formation about other communications with EPA by entering a Toxic Substances ( TS ) number. The TS number is determined by the company to identify the form for both payments and connecting related submissions when additional communications (Letters of Suppor t, Joint Submissions, and corrections) are sent before a PMN/ Low Volume Exemption ( LVE ) 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. Com pany names, recognizable words and numerical
series are not recommended.

Test Data: The ‘Test Data’ section allows you to identify data that is included in the type of
notice the Primary AO selected from the ‘Type of Notice ’ drop

- down menu on the original PMN
form

. The following values 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.’ I f you check ‘Other Data

, ’ the system does not generate an additional text field
to enter in the other specific information. More often than not

, the remaining options under the

‘Test Data’ se ction provide sufficient information for information included in the PMN form.

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 to you, if these data are 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. Comple te 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).

• Form Alias: Enter the form alias. Upon navigating to the screen, the application displays an

auto

- generated editable form alias in the following format: <Form Type

- YYYYMMDD

HH:MM:SS Time Zone>. This is a required field.

• TS Number : Enter the TS number relating 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 numbe r 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 this form and should not be reused in a subsequent form

.

• Environmental fate data : Check the ‘Environmental fate data’ checkbox to indicate that the

form contains environmental fate data.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 37• 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.

• Te st 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 : C heck 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 data

.

• Other data : Check the ‘Other data’ checkbox to indicate that the form contains other types

of data.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 38Exhibit 4

- 1 shows a screen capture of the ‘ General Form Information ’ screen (Joint PMN ) :

Exhibit 4

- 1 : General Form Information Screen (Joint PMN )

Navigation: Click the ‘Next’ button to navigate to the ‘ Agent Information ’ screen

. You can also access this screen by clicking the ‘Agent Information’ link within the navigation tree.

4.1.2 Agent Information

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

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

The ‘Agent Information’ screen provides fields for you to enter information regarding all parties involved in representing the PMN form . The agent should be a person who can answer questions about the form. The ‘Agent Information’ screen displays an ‘Add Agent’ button that generates the ‘Add Agent’ pop

- up window for you to input the contact information on behalf of whom the
submission is being made. You will be able to enter multiple agents; if the agent is the same

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 39individual 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 fo r 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, wh ich 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 mul tiple 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: Indica tes 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 December 22, 2014 Secondary Agent/Consultant 40Exhibit 4

- 2 shows a screen capture of the ‘ Agent Information ’ screen (Joint PMN ):

Exhibit 4

- 2 : Agent Information Screen (Joint PMN )

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

tree.

4.1.2.1 Add Agent

Click the ‘Add Agent’ button to generate the ‘Add Agent’ pop

- up window. Enter agent information into the fields displayed on the ‘Add Agent’ pop

- up window. Click the ‘Cancel’ button to stop populating agent information. Click the ‘OK’ button after entering agent information to populate the information on the main ‘Agent Information’ screen.

The identification of an agent is optional.

• Copy CDX Registration: Click the ‘Copy CDX Registration’ button to display a prompt

confirming the import of CDX registration information and allow the system to populate the agent information fields with your contact information provided during CDX registration.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 41• Check here to claim this information as CBI: Chec k the ‘Check here to claim this
information as CBI’ checkbo x to claim agent information as confidential. If the ‘ Check here
to claim this information as CBI’ checkbox is checked before clicking the ‘Copy CDX Registration’ button, the ‘ Check here to claim t his information as CBI’ checkbox will become unchecked upon navigating back to the pop

- up window after copying CDX registration information. Check the ‘ Check here to claim this information as CBI’ checkbox after importing CDX registration information to cl aim 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 tit le.

• 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 age nt’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 f orm

.

• Phone Extension: Enter the agent’s daytime phone number extension. Click the ‘Copy CDX

Registration’ button to populate the fields with CDX registration information.

• Email Address: Enter the agent’s email address. The email address must follow the standard

email address format: John.Doe@abc.com

. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information.

• Mailing Address 1: Enter the first line of the agent’s mailing address. Click the ‘Copy CDX

Registration’ button to populate the fields with CDX registration information. This is a required field only if agent information will be added to the form.

• Mailing Address 2: Enter the second line of the agent’s mailing address. Click the ‘Copy

CDX Registration’ button to populate the fields with CDX registration information.

• City: Enter the city of the agent’s mailing address. Click the ‘Copy CDX Registrat ion’

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 Registr ation’ 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 selecte d 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 42required field only if agent information w ill 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
infor mation. This field is automatically set to ‘United States’ if a value is selected from the ‘State’ drop

- down menu. This is a required field only if agent information will be added to
the form

.

Exhibit 4

- 3 shows a screen capture of the ‘Add Agent’ pop

- up window:

Exhibit 4

- 3 : Add Agent Pop

- Up Window

Navigation: Click the ‘Cancel’ button or ‘X’ icon in the upper right

- hand corner to stop populating agent information and navigate back to the ‘Agent Information’ screen . Click the

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 43‘OK’ button to save the entered agent information and navigate back to the ‘Agent Information’

screen.

4.1.3 Technical Contact Information

You can access the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from the ‘Agent Information’ screen. You can also access this screen by clicking the ‘Technical Contact Information’ link within the navigation tre e.
The technical contact should be able to answer, or obtain answers to, questions related to the
chemical submitted to EPA within the PMN form. The technical contact does not have to physically work at the site reported on the form, but must be readily av ailable 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 Re gistration’ 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 th e 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 t hat 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: Indi cates 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 December 22, 2014 Secondary Agent/Consultant 44Exhibit 4

- 4 shows a screen capture of the ‘ Technical Contact Information ’ screen (Joint PMN ):

Exhibit 4

- 4 : Technical Contact Information Screen (Joint PMN )

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

4.1.3.1 Add Technical Contact

Click the ‘Add Technical Contact’ button to generate the ‘Add Technical Contact’ pop

- up window. Enter technical contact information into the fields displayed on the ‘Add Technical Contact’ pop

- up window. Click the ‘Cancel’ button to stop populating technical contact information. Click the ‘OK’ button to populate the entered technical contact information on the
‘Technical Contact Informatio n’ screen.

• Copy CDX Registration: Click the ‘Copy CDX Registration’ button to populate the fields

with your contact information provided during CDX registration. A prompt will display confirming the import of CDX registration information.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 45• Check here to cl aim 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 ‘ Check here to claim this information as CBI’ checkbox is checked before clicking the ‘Copy CDX Registration’ button, the ‘ Check here to claim this information as CBI’ checkbox will become unchecked upon navigating back to the pop

- up window after copying CDX registration information. To claim a technical contact as confidential, check the ‘ Check
here to claim this information as CBI’ checkbox after importing CDX registration
information.

• First Name: Enter the technical contact’s first name. Click the ‘Copy CDX Registration’

button to populate the fields with CDX registration information. Th is 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.

• C ompany 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 t he ‘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 wit h 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 requ ired 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 mailin g 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 Registr ation’ 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 regis tration information. This is a required field.

• Country: Displays ‘United States.’

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 46Exhibit 4

- 5 shows a screen capture of the ‘Add Technical Contact’ window:

Exhibit 4

- 5 : Add Technical Contact Window

Navigation: Click the ‘Cancel’ b utton or ‘X’ icon located 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
inform ation and navigate back to the ‘Technical Contact Information’ screen.

4.1.4 Chemical Identification

You can access the ‘Chemical Identification’ screen by clicking the ‘Next’ button from the

‘ Technical Contact Information ’ screen. You may also click the ‘Add Consolidated Chemical’ 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 fo rm for a class 1 or 2 chemical

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 47substance 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
acti on 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 allo ws 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: Selec t 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 ind icate 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 c hemical if the chemical type changes. Selecting either the ‘Class 1 or 2 Chemical Substance’ or ‘Polymer’ radio button is required.

• Chemical Alias: Enter the chemical alias to associate with a chemical. This field will auto

generate a chemical alias in the navigation tree upon leaving the screen if this field is left
blank. This field is required.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 48Exhibit 4

- 6 shows a screen capture of the ‘Chemical Identification’ screen (Joint PMN ):

Exhibit 4

- 6 : Chemical Identification Screen (Joint PMN )

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 wi thin the navigation tree.

If you selected the ‘Polymer’ radio button, click the ‘Next’ button to navi gate to the ‘Polymer
Identification Information’ screen. You can also navigate to this screen by clicking the ‘Polymer
Identification Information’ link wi thin the navigation tree.

4.1.5 Class 1 or 2 Chemical Substances

You can access the ‘Class 1 or 2 Chemical Substances’ screen if you selected the ‘Class 1 or 2
Chemical Substance’ radio button on the ‘Chemical Identification’ screen and clicked the ‘Next’
butt on. 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 che mical for which the PMN is to be filed. This screen will outline the unique

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 49chemical 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 ident ity.

For a single component submission, create the field set by clicking the ‘Add Chemical Component’ 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 Chemical Component’ button. Multi

- component chemical submissions occur when two or more chemicals are always generate d 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 tre e. 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, cl ick 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
ide ntity of the atoms and the nature and location of the bonds joining the atoms. Provide ionic charges and known stereo chemical details. Carbon atoms in ring systems do not need to be explicitly shown.

For a class 2 substance chemical structure diagram:

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

2) Describe the nature of the reaction or process.

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

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

Provide partial, complete, or representative structural diagrams to the extent possible. The diagram should indicate the characteristic or variable compositional structu ral 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 50‘Cancel’ link displays when the expandable/collapsible field set is open for editing. A confirmation message di splays to confirm the action.

• Edit: Click the ‘Edit’ link located in the upper right

- hand corner of the

expandable/collapsible f ield 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 o f 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 se ries 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 indicate s that some portions of the structure may
not be known and a ‘Class 2 Substances’ screen wil l 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’ subs tance. 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 ‘Cla ss 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.

• CBI: Check the ‘CBI’ chec kbox to claim the ‘Class of Substance’ as confidential.

• Search SRS: Click the ‘Search SRS’ button to generate the ‘Search Substance Registry

Services’ pop

- up window. Refer to Section 3.9 for additional details regarding the search SRS functionality.

• CASRN: Displays the CASRN of the chemical identified on the ‘Search Substance Registry

Services’ pop

- up window, if applicable.

• Chemical Name: Displays the chemical name of the chemical identified on the ‘Search

Substance Registry Services’ pop

- up window. For class 1 substances, a ‘Chemical Abstracts (CA) Index Name’ must be provided. For class 2 substances either a ‘CA Index Nam e’ or ‘CA Preferred Name’ must be provided, whichever is appropriate based on current CA nomenclature rules and conventions. This is a required field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 51• CBI: Check the ‘CBI’ checkbox to claim the ‘Chemical Name’ field as confidential and generate the ‘Gener ic 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 when displayed

.

• Method 1 (CAS Inventory Expert Service): Select the ‘Method 1 (CAS Inventory Expert

Service)’ radio button to identify the ID method as the CAS Inventory Expert Service (IES) method and generate the ‘IES Order #’ field. A copy of the identification report obtained
from the CAS I nventory 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, qualif ies as ‘Method 2.’ A single response option in the ‘B.1.c

. ID Method’ section is required.

• IES Order #: Enter the IES order number of the report. This field only displays when the

‘Method 1 (CAS Inventory Expert Service)’ radio button is selected.

• 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

s ystem will not allow subscripts and superscripts to be used.

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

• Attachments : Select the section of the page the file is associated with that you intend to

attach from the d rop

- down menu. This drop

- down menu contains the following values: ‘Chemical Structure Diagram’ and ‘ID Method.’ This is a required field to upload an
attachment.

• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up window. Refer to Section 3.8 for further details regarding the attach document functionality.

• Section: Displays the section associated with a document.

• File Name: Displays the file name and file extension of the file that is uploaded on the

‘Attach Documents’ pop

- up window.

• Descrip tion: 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 enti re document ro w 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 December 22, 2014 Secondary Agent/Consultant 52• Save: Click the button to save the information entered within the expandable/collapsible field

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

set.

Exhibit 4

- 7 shows a screen capture of the ‘Class 1 or 2 Chemical Substances’ screen (Joint

PMN ) ( S croll 1) :

Exhibit 4

- 7 : Class 1 or 2 Chemical Substances Screen (Joint PMN ) (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 53Exhibit 4

- 8 shows a screen capture of the ‘Class 1 or 2 Chemical Substances’ screen (Joint

PMN ) ( S croll 2) :

Exhibit 4

- 8 : Class 1 or 2 Chemical Substances Screen (Joint PMN ) (Scroll 2)

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 i n progress form

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 544.1.6 Class 2 Substances

You can navigate to 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 subst ance 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 Rea ction’ and ‘Range of Composition’ in text boxes. The ‘Nature of Reaction’ and ‘Range of Composition’ text fields 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 S RS’ button to generate the ‘Search Substance Registry

Services’ pop

- up window. Refer to Section 3.9 for additional details regarding the search

SRS functionality.

• Chemical Name: Displays the chemical name associated with a precursor substance. Click

the chemical name link to generate the ‘Search SRS’ pop

- up window to make edits.

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

• Actions: Click the ‘Delete’ icon ( ) to delete the entire chemical ro w 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.

• Att achments : 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 if you are uploading a document

.

• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up window and initiate the document upload process. Refer to Section 3.8 for further details regarding the attach document functionality.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 55• 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.’

• Action: Click the ‘Delete’ icon ( ) to delete the entire document ro w permanently from the

system; a warning message displays to confirm the deletion.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 56Exhibit 4

- 9 shows a screen capture of the ‘Class 2 Substances’ screen (Joint PMN) (Scroll 1):

Exhibit 4

- 9 : Class 2 Substances Screen (Joint PMN) (Scroll 1 )

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 57Exhibit 4

- 10 shows a screen capture of the ‘Class 2 Substances’ screen (Joint PMN) (Scroll 2):

Exhibit 4

- 10 : Class 2 Substances Screen (Joint PMN) (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.

4.1.7 Additional Chemical Information

Yo u 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 cli cking 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 re garding 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 December 22, 2014 Secondary Agent/Consultant 58An ‘Impurities’ table displays information reg arding 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 wil l also be able to enter a chemical using the ‘Chemical Name’ and ‘CASRN’ field (if applicable) on the ‘Chemical Not Found In Substance Registry Services’ pop

up window. If there are unidentified impurities, enter “unidentified.” You also have the option of claiming the chemical as confidential by checking the ‘CBI’ checkbox. A ‘Maximum %’ field is also displayed which captures the maximum percentage for the impurity. Documents may be attached for the ‘Impurities’ section if necessary

. A ‘Byproducts’ tabl e provides fields to capture information regarding the byproducts that may be produced from the manufacture of the respective chemical or polymer. C lick the ‘Search SRS’ button to access the ‘Search SRS’ pop

- up window and populate the ‘Byproducts’ table. Y ou will also be able to enter data and attach documents for the ‘Byproducts’ section. 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 ‘Byproduct s’ 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 canno t 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 th e 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 a document associated with the ‘Trade Identification’ section to provide additional trade names 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’ dr op

- 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 req uires 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 exten sion 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 59• B.3. Impurities

– Search SRS: Click the ‘Search SRS’ button to display the ‘Search Substance Registry Services’ pop

- up window. Refer to Section 3.9 for further details regarding the search SRS functionality.

• Impurity: Displays the name of the impurity. An impurity is a chemical substance th at you

did not intend to be pre sent 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 s uggestive 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 N umber 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 ( ) t o delete the entire impurity entry permanently from the

system; a warning message displays to confirm the deletion.

• B.7. Byproducts

- Search SRS: Click the ‘Search SRS’ button to generate the ‘Search

Substance Registry Services’ pop

- up window. Refer to Section 3.9 for further details regarding the search SRS functionality.

• Byproduct Name: Displays the name of the byproduct. Describe any byproducts resulting

from the manufacture, processing, use, or disposal of the new chemical substance. List any byproducts that you reasonably anticipate will result from the manufacture, processing, use and disposal of the new chemical substance at si tes 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 byproduct s 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’ i con ( ) to delete the entire byproduct en try permanently from

the system; a warning message displays to confirm the deletion.

• B.4. Synonyms

- CBI: Check the ‘CBI’ checkbox to claim the ‘Synon ym’ field set as

confidential.

• Synonym: Enter the synonym of th e 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 i n 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 valu e. If you click the ‘F orm’ icon

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 60( ), edit the entered values and click the ‘Next’ button without saving the changed value, an error will generate.

• Action s : Click the ‘Add’ icon ( ) to add a new text field to enter additional synonyms.

Click the ‘Save’ icon ( ) to save a che mical 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 i ndicate the CBI status of trade names. If you add a blank, editable line in this table and click the ‘Next’ button, no error w ill 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 enter ed 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.

• Action s : 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 m enu. 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 windo w. Refer to Section 3.8 for further details regarding the attach document functionality.

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

• File Name: Displays the file name and file extension of the file that is uploaded on the

‘Attach Documents’ pop

- up window.

• Description: Displays the description associated with a document.

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

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

• Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently

from the system; a warning message displays to confirm deletion of the documen t.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 61Exhibit 4

- 11 shows a screen capture of the ‘ Additional Chemical Information ’ screen (Joint PMN) (Scroll 1) :

Exhibit 4

- 11 : Additional Chemical Information Screen (Joint PMN ) (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 62Exhibit 4

- 12 shows a screen capture of the ‘ Additional Chemical Information ’ screen (Joint PMN) (Scroll 2) :

Exhibit 4

- 12 : Additional Chemical Information Screen (Joint PMN ) (Scroll 2)

Navigation: Click the ‘Next’ button to navigate to the ‘ Production Volume and Hazard /Safety
Information ’ screen. You can also access t his screen by clicking the ‘Production Volume and Hazard/Safety Information’ link within the navigation tree.

4.1.8 Polymer Identification Information

You can access the ‘Polymer Identification Information’ screen by clicking the ‘Next’ button
from the ‘Chemic al 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 Identificat ion’ screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 63The ‘Polymer Identification Information’ screen captures information describing the polymer(s) for which the PMN will be filed. This screen will outline the unique chemical properties that show the name, composition, and structure of the pol ymer. The system will provide fields for you to identify several key aspects concerning a polymer’s identity.

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

Click the ‘Add Ch emical Component ’ 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 chemica l
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 Chemical Component ’ button. Upon clicking the ‘Add Chemical Component ’ 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 Chemical Component ’ 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 Chemical Component ’ 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 informati on, by clicking the ‘ Add Chemical Component ’ button for each additional chemical that is part of the multi

- component mi xture. 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 fiel d 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 64• Collapse All: Click the ‘Collapse All’ link located at the upper right

- hand corner of the expandable/collapsible field sets to collapse a series of field sets.

• Search SRS: Click the button to generate the ‘Search SRS’ pop

- up window. Refer to Section

3.9 for additional details regarding the search SRS functionality.

• CASRN: Displays the CASRN of the chemical identified on the ‘Search SRS’ pop

- up

window, if applicable.

• Chemical Name: Displays the name of the chemical that has been identified on the ‘Search

SRS’ pop

- up window.

• CBI: Check the ‘CBI’ chec kbox 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.

• 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 consolida ted 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.

• 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.’

• Section: Displ ays the section of the page that the document will be associated. This drop

down menu contains the following values: ‘Chemical Structure Diagram’ and ‘ID Method.’

• Attach Document: Click the button to generate the ‘Attach Documents ’ pop

- up window.

Refer to Section 3.8 for additional details regarding the attach document functionality.

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

• File Name: Displays the file name and file extension of a document that is uploaded on the

‘Attach Documents’ window.

• Description: Displays the description of a document.

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

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

• Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently

from the system. A warning message di splays 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 bei ng able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 65Exhibit 4

- 13 shows a screen capture of the ‘Polymer Identification Information’ scre en (Joint PMN):

Exhibit 4

- 13 : Polymer Identification Information Screen (Joint PMN) Scroll 1

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 66Exhibit 4

- 14 shows a screen capture of the ‘Polymer Identification Information

– Chemical Claimed CBI’ screen (Joint PMN):

Exhibit 4

- 14 : Polymer Identification Information Screen (Joint PMN) 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.

4.1.9 Monomers and Other Reactants

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

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

Re actants.’

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 67In 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 specif ics

. 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 (M n ) and weight fractions below 500 and 1,000 Daltons. It may not be useful for all polymer evaluations; however, solubility problems and misleading cal ibration standards can lead to questionable GPC data. Correction estimates can be documented and presented in cases where only a soluble fraction of the polymer can be analyzed.

• Specify other method of measurement : Enter the method of measurement when you select

the ‘Other (Specify)’ radio button as the method of measurement. This is a required field when the ‘Other (Specify)’ radio button is selected.

• (i) lowest number avg. molecular weight: Enter the lowest number average molecular

weight; the entered v alue must be a positive numerical value and can contain decimal values.

• (ii) max. weight % below 500 molecular weight: Enter the maximum weight percentage

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

.

• (iii) max. weight % below 1000 molecular weight: Enter the maximum weight percentage

below 1,000 molecular weight; the value entered must be a positive numerical value greater than or equal to zero (0) but less than or equal to one hundred (100) and can contain decimal values. This value must be greater than or equal to the value specified in the ‘(ii) max. weight % below 500 molecular weight’ field. This is a required field if there are no pending Joint Submissions or Letters of Support

.

• Add Monomer: Click the 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
conf irmation 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 December 22, 2014 Secondary Agent/Consultant 6 8link displays when the expandable/col lapsible field set has been saved and the data is not currently editable.

• Delete: Click the ‘Delete’ icon ( ) located in the upper right

- hand corner of the

expandable/collapsible field set to delete the field set. A confirmation message displays to
confirm the deletion.

• Expand All: Click the ‘Expand All’ link located at the upper right

- hand corner of the

expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the ‘Collapse All’ link located at the upper right

- hand corner of the

expandable/collapsible field sets to collapse a series of field sets.

• Search SRS: Click the ‘Search SRS’ button to generate the ‘Search Substance Registry

Services’ pop

- up window. Refer to Section 3.9 for additional details regarding the search SRS functionality.

• 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 e qual 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 t he 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 t he ‘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) a nd 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 composit ion is a value that is less than or equal to 2 percent and asking you whether it should be included in the chemical identity. This is a required field , and the value must be greater than zero (0)

.

• CBI: Check the ‘CBI’ checkbox to claim the ‘Typical Compo sition’ 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 commer cial 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 f ield.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 69• 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 ( ) locat ed within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section
3.7 for more information regarding the save functionality in an expandable/collapsible field

set

.

• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up wind ow. Refer to Section 3.8 for additional details regarding the attach document functionality.

• File Name: Displays the file name and file extension of the document that is uploaded on the

‘Attach Documents’ pop

- up win dow. 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 st atus 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 December 22, 2014 Secondary Agent/Consultant 70Exhibit 4

- 15 shows a screen capture of the ‘Monomers and Other Reactants’ screen (Joint PMN) (Scroll 1):

Exhibit 4

- 15 : Monomers and Other Reactants Screen (Joint PMN) (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 71Exhibit 4

- 16 shows a screen capture of the ‘Monomers and Other Reactants’ screen (Joint PMN) (Scroll 2):

Exhibit 4

- 16 : Monomers and Other Reactants Screen (Joint PMN) (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.

4.1.10 Production Vol ume 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 72Production 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 ’ fields. The ‘Maximum first 12

- month production’ value should be less than or equa l to the ‘Maximum 12

- month production’ value. T he maximum volume should be 100,000,000,000,000 kg/year for either field. The entered value s will automatically display decimal points upon navigating away from the page . D ecimals are allowed up to the milligr am (.0000 0 1) . Estimates should be on a 100% new chemical substance basis. Your production volumes should be estimated as accurately as possible, but you are not bound to your estimates unless you check the ‘Binding’ checkbox. Include amounts you intend to produce for export. Provide an estimate of the first 12 months of production and the maximum production volume for any consecutive 12

- month period during the first 3 years of commercial manufacture. You may upload an attachment to enter additional producti on information.

Hazard Information: The ‘Hazard Information’ section captures information regarding hazards that the company chooses to disclose. In order for EPA to take respirator use into account when evaluating risks posed by a new chemical, the MSDS 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 MS DS 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 occupation al 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 w hen 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 uploade d.

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 r equirements of an LVE notice.

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

• Binding: Check the ‘Binding’ checkbox to claim the production volume information as

binding. This checkbox is enabled for LVE or LVE modifications only

.

• Maximum first 12

- month p roduction: 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 n ot have a pending Joint Submission and/or Letter of Support

.

• Maximum 12

- month p roduction: Enter the data associated with the production volume.

Provide an estimate of the maximum production volume for any consecutive 12

- month

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 73period during the first thre e (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 fiel d 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.

• Section: Select the section of the page with which the attached document is associated. This

drop

- down menu contains the following value: ‘Production Information Section ’ and ‘Hazard
Information Section .’

• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up window. Refer to Section 3.8 for additional details regarding the attach document functionality.

• Section: Displays the section with which the do cument 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 at tached 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 December 22, 2014 Secondary Agent/Consultant 74Exhibit 4

- 17 shows a screen capture of the ‘Production Volume and Hazard /Safety Information’ screen (Joint PMN ):

Exhibit 4

- 1 7 : Production Volume and Hazard /Safety Information Screen (Joint PMN )

Navigation: Click the ‘Next’ button to navigate to the ‘ Use Information ’ screen. You can also

access t his screen by clicking the ‘Use Information’ link within the navigation tree.

4.1.11 Use Information

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

The ‘Use I nformation’ screen is used to capture data about how the new chemical substance is
intended to be use d by function and application. Function refers to the chemical purpose for which the substance is designed and is often based on the physical and chemica l 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 scr een contains instructional text and an ‘Add Use’ button.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 75When you click the ‘Add Use’ button, an expandable/collapsible field set will open and display the ‘Use Information’ fields. Upon saving the entry, the expandable/collapsible field set collapses and displays the ‘Category of Use’ and ‘Production %’ values.

You will first enter a description for the ‘Category of Use’ field. Each use will center on the ‘Category of Use’ and the different variables surrounding it. The category of use information
should be specific enough to allow EPA reviewers to anticipate potential exposure patterns for the new substance (e.g. merely indicating “Dye” is not sufficient

– is it photographic dye, a reactive dye for nylon fibers, or a dye to be incorporated in a polymer ma king 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 gen eric use description will be available publicly.

The table capture s 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. ‘Production %’ is captured and must equal up to 100% for
all uses. The ‘Production %’ value can be declared CBI. The ‘% in Formulation’ valu e is captured for a use and can equal up to 100%. The ‘% in Formulation’ field may be claimed as

CBI.

The ‘% of substance expected’ per use is captured for the following categories: ‘Site Limited,’ ‘Consumer,’ ‘Industrial,’ and ‘Commercial.’ The ‘% of sub stance 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 n ew use information expandable/collapsible

field set.

• Cancel: Click the ‘Cancel’ link located in the upper right

- hand corner of the

expandable/collapsible field set to prevent edits from saving and to remove a field set. The
‘Cancel’ link displays when the expandable/collapsible field set is open for editing. A confirmation message displays to confirm the action.

• Edit: Click the ‘Edit’ link located in the upper right

- hand corner of the

expandable/collapsible field set to modify the information entered in the fields. The ‘Edit’

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

• Delete: Click the ‘Delete’ icon ( ) located in the upper right

- hand corner of the

expandable/collapsible field set to del ete 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 re quired field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 76• 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 confirma tion 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 whe n the ‘Category of Use’ field is claimed CBI. If you claim any category of use description as confidential, enter a generic description of that category. This field is required when the ‘Category of Use’ field is claimed CBI.

• Total Production for this Use %: Enter an estimate of the percent of total production for

the first three years devoted to each category of use for the specific chemical. The entered value must be a value greater than zero (0) but less than or equal to one hundred (100). This
field al lows 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

grea ter 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 zero e s. This field allows for decimal values. Break down the use(s) by percentage for the indicated end user categories. For example, site

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

• Consumer %: Enter the consumer percentage of substance expected per use for the

submitte d substance. Blank fields are recognized as zero e s. 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 con taining 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 zero e s. 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 77• Commercial % : Enter the commercial percentage o f substance expected per use for the submitted substance. Blank fields are recognized as zero e s. 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 d etails.

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 t he ‘CBI’ checkbox to claim the ‘ If you have pr ovided a ‘consumer’ use,

provide details’ information as confidential.

• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up window. Refer to Section 3.8 for additional details regarding the attach document functionality.

• File Name: Displays the file name and file extension of the file uploaded on the ‘Attach

Documents’ pop

- up window. Click the ‘File Name’ link to navigate to the ‘Attach Documents’ pop

- up window to make any edits.

• Description: Displays the description associated with a document.

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

• CBI: Indicates the CBI status of a document by displaying either a ‘Y’ o r an ‘N.’

• Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently

from the system. A warning message displays to confirm deletion of the document.

• Save: Click the button to save the information entered within the expandable/collapsible field

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

• Production Total: Displays the total production percentage for all uses.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 78Exhibit 4

- 18 shows a screen capture of the ‘ Use Information ’ screen (Joint PMN ) (Scroll 1) :

Exhibit 4

- 18 : Use Information Screen (Joint PMN ) (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 79Exhibit 4

- 19 shows a screen capture of the ‘Use Information’ screen (Joint PMN ) (Scroll 2) :

Exhibit 4

- 19 : Use Information Screen (Joint PMN ) (Scroll 2)

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.

4.1.12 Physical and Chemical Properties Worksheet

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 80The ‘Physical and Chemical Properties Worksheet’ screen is used to capture optional information about a chemical’s properties. EPA uses the chemical properties to determin e additional safety data about a chemical; t he 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 fro m soil,’ ‘pH @ concentration [concentration] ,’ ‘Flammab ility,’ ‘Explodability ,’ and ‘Ad sorption/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

- do wn menu and click the ‘Add Property’ button. The expandable/collapsible field set expand s and display s 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 t o accept ‘<’ or ‘>’ symbols. When all information is entered, click the ‘Save’ button. Each property may only be entered once per chemical.

You may also enter an option for ‘Other.’ The ‘Other’ option will allow you to enter a user

specified property and any relevant values. The property will capture the relevant values for the chemical and the property measurement can be identi fied 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, spectra l data , mass

s pectrometry (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 physiochemi cal data to aid in their risk
evaluations.

Indicate whether the value you provide is based on an actual test measurement ( ‘ Measured ’ ) or is
based on an estimate ( ‘Estimate’ ). Note that EPA staffers indicate that data qualifiers such as ‘negligible’ or ‘so luble’ 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 t o 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 81Please 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 o nce, 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)’ sc reen. 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 exp andable/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 uppe r 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/co efficient 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/Coe fficient

- Measured or Estimate : Indicate whether the property v alu e 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

‘Adsor ption/coefficient’ property as confidential.

• Boiling/sublimation temperature @

– Value : Enter the boiling/sublimation temperature in

°C of the chemical substance. This is a required field if the ‘Boiling/sublimation temperature

@ ’ property is selected.

• Boiling/sublimation temperature @ [pressure] torr: Enter the value of the pressure in torr

for which the boiling/sublimation of the chemical substance was determined. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Boil ing/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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 82from the drop

- down menu. This is a required field if the ‘Boiling/sublimation temperature @ ’ property is selected.

• Boi ling/sublimation temperature @

- CBI: Check the ‘CBI’ checkbox to claim the

‘B o iling/sublimation temperature @’ property as confidential.

• Density/relative density

- Valu e: 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 Est imate : 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 ‘D ensity/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 requir ed 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 r equired field if the ‘Dissociation constant’ property is selected.

• Dissociation constant

- CBI: Check the ‘CBI’ checkbox to claim the ‘D issociation constant ’

property as confidential.

• Explodability

- Value: Enter the explodability value of the chemical s ubstance. 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 o r Estimate : Indicate whether the property value is ‘Me asured’

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 ‘E xplodability ’ property as

conf idential.

• 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

‘F lammability ’ property is selected.

• Flam mability

- Measured or E stimate : 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 ‘F lammability ’ property is selected.

• Flammability

- CBI: Check the ‘CBI’ checkbox to claim the ‘F lammability ’ property as

confidential.

• Henry’s Law constant

- Value: Enter the Henry’s law constant value of the chemical

substance in atm

- m 3 /mole. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a requi red field if the ‘Henry’s Law constant’ property is selected.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 83• 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 re quired 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 Tem perature

- 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. T his is a required field if the ‘Melting Temperature’ property is selected.

• Melting Temperature

- CBI: Check the ‘CBI’ checkbox to claim the ‘M elting

T emperature ’ 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 ‘O ctanol/water partition coefficient ’ property is selected.

• Octanol/water partition coe fficient

- 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 ‘O ctanol/water partition coefficient ’ property
is selected.

• Octanol/water partition coefficient

- CBI: Check the ‘CBI’ checkbox to claim the

‘O ctanol/water partition coefficient ’ property as confidential.

• Particle size di stribution

- 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

‘P article size distribution ’ property is selected.

• Particle size dist ribution

- Me asured 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 ‘P article size distribution ’ property is selected.

• Particle size distribution

- CBI: Check the ‘CBI’ checkbox to claim the ‘P article size

distribution ’ property as confidential.

• Physical state of neat substance

- Value: Select the physical state of a neat substance of

chemicals, which can be either a ‘Solid,’ ‘Liquid,’ or ‘Gas.’ This is a required field if the

‘ Physical state of neat substance ’ property is selected.

• Physical state of neat s ubstance

- Measured or Estimate : Indicate whether the property

value is ‘Measured’ or based on an ‘Estimate ’ by selecting the approp riate value from the drop

- down menu. This is a required field if the ‘P hysical state of neat substance ’ property is
selected.

• Physical state of neat substance

- CBI: Check the ‘CBI’ checkbox to claim the ‘P hysical

state of neat substance ’ property as confi dential.

• pH @ concentration [concentration]: Enter the concentration at which the pH was

measured. This field allows for text. This is a required field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 84• pH @ concentration [concentration]

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

• pH @ concentration [conc entration]

- Measured or Estimate : Indicate whether the

property value is ‘Measured’ or based on an ‘Estimat e ’ 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.

• Solubil ity @ temperature solvent: Enter the temperature value in °C for which the

solubility was measured. This field allows text and is also able to accept ‘<’ or ‘>’ symbols. This is a required field.

• Solubility @ temperature solvent

- S olvent: 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 @ temp erature solvent

- V alue: Enter the solubility of the chemical substance in

g/L.

• Solubility @ t emperature solvent

- Measured or Estimate : Indicate whether the property

value is ‘Measured’ or based on an ‘Estimate ’ by selecting the appropriate value from th e drop

- down menu. This is a required field i f the ‘Solubility @ temperature solvent’ property is
selected.

• Solubility @ temperature solvent

- CBI: Check the ‘CBI’ checkbox to claim the ‘S olubility

@ temperature solvent ’ property as confidential.

• Solubilit y 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 ‘S olubility in W ater @ 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 @ t emperature

- Measur ed 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 ‘S olubility in W ater @ temperature ’ property is selected.

• Solubility in Water @ t emperature

- CBI: Check t he ‘CBI’ checkbox to claim the

‘S olubility in W ater @ 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 ‘S pectra ’ property as confidential.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 85• Vapor Pressure @ temperature : Enter the t emperature value in °C of the chemical for which the vapor pressure was measured. This is a re quired 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 v alue 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 t he ‘Vapor

Pressure @ temperature’ property as confidential.

• Volatili zation 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.

• Volatilizati on from water

- CBI : Check the ‘CBI’ checkbox to claim the ‘V olatilization

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 fro m 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 ‘V olatilization from

soil ’ property as confidential.

• Other : Enter any ‘Other’ pro perty that you may specify.

• Other

- Value : Enter an ‘Other’ property value. Value fields are able to accept ‘<’ or ‘>’

symbols. This is a required field if the ‘Other’ property was selected.

• Other

- Measured or Estimate : Indicate whether the property val ue is ‘Measured’ or based

on an ‘Estimate ’ by selecting the appropriate value from the drop

- down menu. This is a required field if the ‘Other’ property is selected.

• Other

- CBI: Check the ‘CBI’ checkbox to claim the property as confidential.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 86Exhibit 4

- 20 shows a screen capture of the ‘ Physical and Chemical Properties Worksheet’ screen (Joint PMN ) (Scroll 1) :

Exhibit 4

- 20 : Physical and Chemical Properties Worksheet Screen (Joint PMN ) (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 87Exhibit 4

- 21 shows a screen capture of the ‘Physical and Chemical Properties Worksheet’ screen (Joint PMN ) (Scroll 2):

Exhibit 4

- 21 : Physical and Chemical Properties Worksheet Screen (Joint PMN ) (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.

4.1.13 Physical and Chemical Properties Worksheet

– Continued (Optional)

You can navigate to the ‘Physical and Ch emical 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 December 22, 2014 Secondary Agent/Consultant 88screen. 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 particular attachments that refer to the chemical properties captured on
the ‘Physical and Ch emical 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
rele vant 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 CB I. 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 ‘A ttach Document’ button to generate the ‘Attach Documents’

pop

- up window. Refer to Section 3.8 for additional details regarding the attach document functionality.

• File Name: Displays the file name and file extension of the original file that is uploaded on

the ‘Attach Documents’ pop

- up window. Click the ‘File Name’ link to navigate to the ‘Attach Documents’ pop

- up window to make any edits.

• Propertie s: Displays the chemical properties associated with a document.

• Description: Displays the description associated with a document.

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

• CBI: Indicates the CBI status of the document by displ aying 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 December 22, 2014 Secondary Agent/Consultant 89Exhibit 4

- 23 shows a screen capture of the ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’ screen (Joint PMN ):

Exhibit 4

- 22 : Physical a nd Chemical Properties Worksheet

– Continued (Optional) Screen (Joint PMN )

Navigation: Click the ‘ Next’ button to navigate to the ‘ Site Information ’ screen if you have not
identified another chemical

. You can also access this screen by clicking the ‘Site Information’ link within the navigation tree. If you would like to add a consolidated chemical, click the ‘Add Consolidated Chemical’ link within the navigation tree.

4.1.14 Physical and Chemical Properties Worksheet

– Continued (Optional) Attach
Documents

You can navigate to the ‘ Attach Documents ’ window by clicking the ‘Attach Document’ button on the ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’ screen.

When attaching a document, the properties selected on the ‘Physical and Chemical Properties
Worksheet’ screen will display with checkboxes to allow the properties to which the attachment refers to be selected. Select the type and subtype for the attachment and the properties relevant t o the document, attach the document, and enter the number of pages.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 90The 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 associa ted with a document that are 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 driv e to be attached that can be associated with the physical/chemical properties previously identified on the ‘Physical and Chemical Properties Worksheet’ screen.

• Description: Enter the description associated with a document.

• Pages: Enter the number of page s a document contains.

• CBI: Check the ‘CBI’ checkbox to claim the document confidential.

• Sanitized Attachment: Click the ‘Browse’ button to generate the ‘File Upload’ window to

search for a particular file on your hard drive. F or 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 December 22, 2014 Secondary Agent/Consultant 91Exhibit 4

- 23 shows a screen capture of the ‘Physical and Chemical Properties Worksheet

– Continued (Optional) Attach Documents ’ window (Joint PMN ) (Scroll 1) :

Exhibit 4

- 23 : Physical and Chemical Properties Worksheet

– Continued (Optional) Attach Documents Window (Joint PMN ) (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 92Exhibit 4

- 24 shows a screen ca pture of the ‘Physical and Chemical Properties Worksheet

– Continued (Optional) Attach Documents’ window (Joint PMN ) (Scroll 2) :

Exhibit 4

- 24 : Physical and Chemical Properties Worksheet

– Continued (Optional) Attach Documents Window (Joint PMN ) (Scroll 2)

Navigation: Click the ‘Cancel’ or ‘X’ icon located in the upper right

- hand corner to stop the process of adding document information. Click the ‘OK’ button to save the entered information

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 93and navigate back to the ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’

screen.

4.1.15 Site Information

You can navigate to the ‘ Site Information ’ screen by clicking the ‘Next’ button from the ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’ screen. You can also access this screen by clicking the ‘Site Information’ link within the navigation tree.

The ‘Site Information’ screen captures information about the identification of submitter

controlled sites and sites controlled by others. If a user indicates there are submitter

- controlled sites, the ‘Submitter Operation Information,’ ‘Occupational Exposures,’ and ‘Environmental Releases’ screens are automatically generated within t he ‘Submitter Controlled Operations’ folder within the navigation tree. If a user indicates there are sites controlled by others, the ‘Industrial Sites Controlled By Others,’ ‘Exposures/Releases,’ and ‘Byproduct Information’ screens automatically generate within the ‘Operations Controlled By Others’ folder within the navigation tree upon clicking the ‘Next’ button. Toll manufacturing sites are considered sites controlled by the submitter.

• Do you have sites controlled by the submitter?: Select the ‘Yes’ radio button to indicate

that you have submitter controlled sites to identify; this response automatically generates the screens within the ‘Submitter Controlled Operations’ folder in the navigation tree upon clicking the ‘Next’ button. Se lect the ‘No’ radio button if you do not have any submitter

controlled sites to identify. An error message displays if a submitter

- controlled site displays within the navigation tree and the ‘No’ radio button is selected.

• Do you have sites controlled by o thers?: Select the ‘Yes’ radio button to indicate that you

have sites controlled by others to identify; this response automatically generates the screens within the ‘Operations Controlled by Others’ folder in the navigation tree upon clicking the
‘Next’ bu tton. 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 December 22, 2014 Secondary Agent/Consultant 94Exhibit 4

- 25 shows a screen capture of the ‘Submitter Controlled Site Information’ screen (Joint

PMN ):

Exhibit 4

- 25 : Submitter Controlled Site Information Screen (Joint PMN )

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

4.1.16 Sites Controlled By Others

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

The ‘Sites Controlled By Others’ screen captures information about known and/or unknown sites not controlled by the submitter. Complete the ‘Operations Controlled By Others’ section within the navigation tree for typical processing or use operations involving the new chemical substance at sites not controlled by the submitter. Importers do not have to complete this section for operations outside the U.S.; however, you must report any processing or use activities after import. Complete a se parate ‘Operations Controlled By Others’ section for each type of

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 95processing, 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 gener ate 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 display s 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 selec t ‘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 del eted.

• # 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 December 22, 2014 Secondary Agent/Consultant 96Exhibit 4

- 26 shows a screen capture of the ‘ Sites Controlled By Others ’ screen (Joint PMN ):

Exhibit 4

- 26 : Sites Controlled By Others Screen (Joint PMN )

Navigation: Click the ‘Add Operation’ link under the ‘Submitter Controlled Operations’ folder within the navigation tree to generate the submitter controlled operati on screens. You can access
this screen by clicking the ‘ Submitter Operation Inform ation’ link under the ‘Submitter Controlled Operations’ folder within the navigation tree.

4.1.17 Submitter Operation Information

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 97be able to enter an operation alias to iden tify 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 a re considered to be site s 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 operatio n 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 option s 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 s ame 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

acce ss 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 i n 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 s elect a site

from the drop

- down menu to add to the ‘Submitter Operation Information’ screen

. Refer to
Section 3.10 for additional details regarding the add facility functionality.

• Site Name: Displays the site name.

• Address: Displays the site address.

• City: Displays the site city.

• State: Displays the site state.

• Postal Code: Displays the site postal code.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 98• 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 ma nufacturing 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 ‘Proce ssing’ 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 ‘Continuou s’ 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: E nter 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/y ear: 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/ d ay: Enter the maximum number of kg of a chemical produced per day. This field

only displays when you select the ‘Continuou s’ radio button and is a required field. This field accepts decimal values.

• Hours/d ay: Enter the number of hours per day that the chemical is processed or

manufactured; this value cannot exceed 24. This field only displays when you select the
‘Continuous’ radio button and is a required field. This field accepts decimal values.

• Days/y ear: 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’ ra dio button, and is a required field. This field accepts decimal values.

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

• Process Description: Enter the process description. In the ‘Process Description’ text box, or

an attachment, address the following items: (1) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specify

– e.g., 5

- gallon pails, 55

- gallon drum, rail car, tank truck, etc.). (2) Provide the identity, the

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 99approximate 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, solve nts, catalysts, etc.), and of all products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. If releasing to two media at the same step, assign a second release number for the second medium. Either this field is required or a document must be attached.

• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up window. Refer to Section 3.8 for additional details regarding the attach document functionality.

• File Name: Displays the file name an d 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 December 22, 2014 Secondary Agent/Consultant 100Exhibit 4

- 27 shows a screen capture of the ‘ Submitter Operation Information ’ screen (Joint

PMN ) (Scroll 1) :

Exhibit 4

- 27 : Submitter Operati on Information Screen (Joint PMN ) (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 101Exhibit 4

- 28 shows a screen capture of the ‘Submitter Operation Information’ screen (Joint

PMN ) (Scroll 2) :

Exhibit 4

- 28 : Submitter Operation Information Screen (Joint PMN ) (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

tr ee.

4.1.18 Occupational Exposures

You can navigate to the ‘ Occupational Exposures ’ screen by clicking the ‘Next’ button from the

‘ Submitter Operation Information ’ screen. You can also access this screen by clicking the

‘ Occupational Exposures ’ link within the navigation tree

. Click the ‘Add’ button to generate an expandable/collapsible field set to enter occupational exposure information. The application displays fields for you to enter information for ‘Worker 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,

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 102the number of workers pote ntially exposed, and possible routes and duration of exposure to the PMN substance. Work with your plant engi neers to develop accurate data; r eview the CBI status of data you provide.

• Add: Click the ‘Add’ button to generate the ‘Occupational Exposure

– Sub mitter Controlled

Sites’ e xpandable/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 i n 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 de lete 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/collaps ible 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 w orker 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 d rop

- down menu will not populate. This is a required field.

• 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 pr otective equipment/engineering controls

information as confidential.

• Binding: Check the ‘Binding’ checkbox to claim the protective equipment/engineering

controls information as binding.

• Physical Fo rm(s) (5): Enter the physical forms(s) of the new chemical substance (e.g., solid,

crystal, granule, powder, or dust) and percentage of new chemical substance (if part of a mixture) at the time of exposure. Be as specific as possible on the physical form (e.g., is the PMN substance isolated as a crystalline or am orphous 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 103and % 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

bi nding.

• % New Substance (5): Enter the percentage of new chemical substance (if part of a mixture)

at the time of exposure. A value of zero (0) entered in this field will display an error. Please pay particular attention to the information within if this f ield 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 popul ated 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 max imum 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 dur ation 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 ma ximum duration values as confidential.

• Save: Click the ‘Save’ button to save the information entered in the ‘Occupational Exposure

– Submitter Controlled Sites’ 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 104Exhibit 4

- 29 shows a screen capture of the ‘ Occupational Exposures ’ screen (Joint PMN ):

Exhibit 4

- 29 : Occupational Exposures Screen (Joint PMN )

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.

4.1.19 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 en vironmental release and disposal status of a particular site. The information on exposure and environmental release is

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 105related to the flow diagram/process description on the ‘Submitter Operation Information’ screen. This page is duplicated and populated fo r each f low diagram supplied in the PMN (manufacturing, each processing description, and any use diagrams). The information provided
should focus on the PMN substan ce. 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 presen t 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 inf ormation 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 Site s’ e xpandable/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/collap sible 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 ‘Edi t’
link displays when the expandable/collapsible field set has been saved and the data is not currently editable.

• Delete: Click the ‘Delete’ icon ( ) located in the upper right

- hand corner of the

expandable/collapsible field set to delete the field set. A confirmation message displays to confirm the deletion. The ‘Delete’ icon ( ) displays when the user clicks the ‘Add’ button.

• Expand All: Click the ‘Expand All’ link located at the upper right

- hand corner of the

expandable/collapsible field sets to expand a series of field sets.

• Collapse All: Click the ‘Collapse All’ link located at the upper right

- hand corner of the

expandable/collapsible field sets to collapse a series of field sets.

• Release Number (1): Enter the number of each release point identified in the process

description on the ‘Submitter Operation Information’ screen. This is a required field.

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

• Amount of new su bstance r eleased to E nvironment (2a): Select the applicable radio

button and e nter 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 Ope ration Information’ screen . Include intermittent release estimates from cleaning of equipment and transportation containers, even if cleaned off

- site. Either the

‘Amoun t of new substance released to E nvironment’ or the ‘Amount of new substance
released to Control Technology’ field should be populated.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 106• Amoun t of new substance released to E nvironment kg/day: Select the radio button to claim that the amount of new substance released to the environment is measured in kilograms per day

.

• Amoun t of new substance released to E nvironment kg/batch: Select the radio button to

claim that the amount of new substance released to the environment is measured in kilograms per batch.

• Amoun t of new substance released to Control T echnology (2b): Enter the amount of new

subst ance 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.

• Amoun t of new substance released to Control T echno logy kg/day: Select the radio button

to claim that the amount of new substance released to control technology is me asured in kilograms per day.

• Amoun t of new substance released to Control T echnology kg/batch: Select the radio

button to claim that the amo unt 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 spe cify)) 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 fi eld.

• Binding: Check the ‘Binding’ checkbox to claim the control technology description as

binding.

• Release after Control Technology (5b): Enter the release after control technology. Estimate

the amount released to the environment after control technology (in kilograms per day). This is a required field.

• Save: Click the button to save the information entered within the expandable/collapsible field

set. You must click the button instead of the ‘Save’ icon ( ) located within the bottom
action bar to successfully save the information entered within the field set before being able

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 107to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section
3.7 for more information regarding the save functionality in an expandable/collapsible field

set.

• POTW Name: Enter the POTW name.

• POTW NPDES #: Enter the POTW National Pollutant Discharge Elimination System

(NPDES) number.

• POTW CBI: Check the ‘ CBI’ checkbox to claim the POTW as confidential.

• Navigable Waterway Name: Enter the navigable waterway name.

• Navigable Waterway NPDES #: Enter the navigable waterway NPDES number.

• Navigable Waterway CBI: Check the ‘CBI’ checkbox to claim the navigable w aterway 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 December 22, 2014 Secondary Agent/Consultant 108Exhibit 4

- 30 shows a screen capture of the ‘ Environmental Releases ’ screen (Joint PMN ) (Scroll 1) :

Exhibit 4

- 30 : Environmental Releases Screen (Joint PMN ) (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 109Exhibit 4

- 31 shows a screen capture of the ‘ Environmental Releases ’ screen (Joint PMN ) (Scroll 2) :

Exhibit 4

- 31 : Environmental Releases Screen (Joint PMN ) (Scroll 2)

Navigation: Click the ‘Save’ button within the ‘Environmental Release and Disposal

– Submitter Controlled Sites’ expandable/collapsible field set to save the information entered. 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.

4.1.20 Industrial Sites Controlled By Others

Click the ‘Add Operation’ link under the ‘Operations Controlled By Others’ folder within the navigation tree to generate the screens for an operation controlled by others. You can navigate to 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 110The ‘Industrial Sites Controlled By Others’ screen captures information about activities occurring at a particular site or grou p 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 si te(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 descr iption. 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 b y 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 Suppor t.

• Add Facility : Click the button to generate the ‘Add Facility’ pop

- up window and s elect a site

from the drop

- down menu to add to the ‘Industrial Sites Controlled By Others’ screen

. Refer

to Section 3.10 for additional details regarding the add facility functionality.

• Site Name: Displays the site name.

• Address: Displays the site address.

• City: Displays the site city.

• State: Displays the si te state.

• Postal Code: Displays the site postal code.

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

• Actions: Click the ‘Delete’ icon ( ) to delete a site from the table. A warning message

confirming deletion of the site displays.

• Select the chemical(s) that this submission pertains to : Displays all consolidated

chemicals in a PMN form.

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

(1) Diagram the major unit operation steps a nd 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 dia gram 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 w astes.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 111Include 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 su bstance. Either this field is required or a document must be attached.

• CBI: Check the ‘CBI’ checkbox to claim the operation description as confidential.

• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up window. Refer to Section 3.8 for additional details regarding the attach document functionality.

• File Name: Displays the file name and file extension of the document that was uploaded on

the ‘Attach Documents’ pop

- up window.

• Description: Displays the description associated with a document.

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

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

• Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently

from the system. A warning message displays to confirm deletion of the document.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 112Exhibit 4

- 32 shows a screen capture of the ‘ Industrial Sites Controlled By Others ’ screen (Joint

PMN ):

Exhibit 4

- 32 : Industrial Sites Controlled By Others Screen (Joint PMN )

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

4.1.21 Exposures / Releases

You can navigate to the ‘Exposures/Releases’ screen by clicking the ‘Next’ button from the ‘Industrial Sites Controlled By Others’ screen. You can also access this screen by clicking the ‘Exposures/Re leases’ link within the navigation tree under the ‘Operations Controlled By
Others’ folder.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 113The screen provides buttons to add expandable/collapsible field sets for worker exposure release information and environmental disposal information. The screen dis plays fields in the worker exposure expandable/collapsible field set to enter information for ‘Letter of Activity (1),’ ‘# Workers Exposed (2),’ ‘Duration of Exposure Hours/Day (4a),’ ‘Duration of Exposure Days/Year (4b),’ ‘Protective Equipment/Engineering Controls (6),’ ‘Physical Form (6),’ ‘% New Substance (6),’ and ‘% in Formulation (7).’ The screen displays fields in the environmental release expandable/collapsible field set to enter information for ‘Release Number (9),’ the
amount of the new substance released directly ‘to environment (10a),’ the amount of new substance released ‘into control technology (10b),’ ‘Media of Release (12),’ and ‘Control Technology (12).’

Information entered into the ‘Duration of Exposure Hours/Day (4a)’ and ‘Duration of Expo sure 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 s et. 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 se t 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

expand able/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 D ays/Year (4b): Enter an estimate of the typical duration of

exposure per worker in days/year. This field allows decimal values.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 114• CBI: Check the ‘CBI’ checkbox to claim the duration of exposure hours/day and days/year
as confidential.

• Protective Equipment/E ngineering Controls (6): Enter a description of any protective

equipment and engineering controls, if any, used to protect workers. Please pay particular attention to the information within if this field is populated via XML file. The information
contained within the ‘Protective Equipment/Engineering Controls/Physical Forms’ field in the thick client separates into two (2) separate fields, the ‘Protective Equipment/Engineering Controls’ and ‘Physical Forms’ field when these fields are populated via an XML f ile 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

attent ion 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 ‘P rotective 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 Formulatio n (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’ ic on ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section
3.7 for more information regarding the save functionality in an expandable/collapsible field

set.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 115Exhibit 4

- 33 shows a screen capture of the ‘ Exposures / Releases ’ screen (Joint PMN ) (Scroll 1) :

Exhibit 4

- 33 : Exposures / Releases Screen (Joint PMN ) (Scroll 1)

• Add: Click the ‘Add’ button to generate the environmental disposable

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 ‘ K g/day ’

radio button to indicate that the amount of substance released into environment measures in

k ilo g rams per day.

• Amt New Substance Released Directly into Environment kg/batch: Select the ‘ Kg/batch ’

radio button to indicate that the amount of substance released into environment measures in kilograms per batch.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 116• CBI: Check the ‘CBI’ checkbox to claim the amount new substance released directly into
environment as confidential.

• Amt New Substance Releas ed 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 tha t 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 contr ol technology measures in kilograms per batch.

• CBI: Check the ‘CBI’ checkbox to claim the amount new substance released directly into

control technology as confidential.

• Media of Release (12): Select a value from the drop

- down menu to capture the medi a of

release. The ‘Media of Release’ drop

- down menu contains the following values: ‘Fugitive Air,’ ‘Off

- Site Incineration,’ ‘POTW,’ ‘Stack Air,’ ‘Surface Water,’ and ‘Other,’ that will be
used to limit the release of the new substance to the environment.

• CBI: Check the ‘CBI’ checkbox to claim 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.

• CBI: Check the ‘CBI’ checkbox to clai m control technology information as confidential.

• Save: Click the ‘Save’ button to save the information entered into the ‘Environmental

Release’ expandable/collapsible field set. You must click this button instead of the ‘Save’
button located within the b ottom 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 117Exhibit 4

- 34 shows a screen capture of the ‘Exposures/Releases ’ screen (Scroll 2) (Joint PMN ):

Exhibit 4

- 34 : Exposures / Releases Screen (Joint PMN ) (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.

4.1.22 Byproduct Information

You can navigate to the ‘ Byproduct Information ’ screen by clicking the ‘Next’ button from the

‘ Exposures / Releases ’ screen. You can also access this screen by clicking the ‘ Byproduct
Information ’ link within the navigation tree

. The ‘Byproduct Information’ screen captures byproducts resulting from a particular site. The system displays fields to enter byproducts.

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 118• 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

- 35 shows a screen capture of the ‘ Byproduct Information ’ screen (Joint PMN ):

Exhibit 4

- 35 : Byproduct Information Screen (Joint PMN )

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

4.1.23 Optional Pollution Prevention

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 119The 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 appropr iate file name of the document
within the ‘File Name’ column of the attachment table.

The attachment table displays the file name and file extension of the document, the document description

, the number of the pages the document contains, and the CBI statu s 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 a ctivities surrounding manufacturing, processing, use, and disposal of the PMN substance. Include new information pertinent to pollution prevention, including source reduction, recycling activities and safer processes or products available due to the new ch emical 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
recl amation 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 em phasize 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 relati ve 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 ma terials 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 ch emical substance may be a substitute for an existing substance that poses a greater overall risk to human health or the environment.

EPA strongly encourages submitters to provide pollution prevention data in their notices, as this
information assists th e 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 li fe cycle of the PMN substance in your
evaluation. Also consider opportunities for product stewardship or other risk management

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 120controls 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 in dicate 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 b enefits:

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

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

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

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

(5) Does your manufacturing process eliminate or reduce the use/release of hazardous
substances?

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

Clicking the link displays additional information regarding the pollution information.

• Check here to claim this information as CBI: Check the ‘Check here to claim this

information as CBI’ checkbox to claim the pollution prevention information as confidential.

• Attach Docum ent: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up window. Refer to Section 3.8 for additional details regarding the attach document functionality.

• File Name: Displays the file name and file extension of a document that is uploaded on the

‘Attach Documents’ pop

- up window. Click the file name link to navigate to the ‘Attach

Documents ’ pop

- up window to make any edits.

• Description: Displays the description associated with a document.

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

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

• Actions: Cl ick 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 December 22, 2014 Secondary Agent/Consultant 121Exhibit 4

- 36 shows a screen capture of the ‘ Optional Pollution Prevention ’ screen (Joint PMN ):

Exhibit 4

- 36 : Optional Pollution Prevention Screen (Joint PMN )

Navigation: Click the ‘Next’ button to navigate to the ‘ Additional Attachments ’ screen. You can also access this screen by clicking the ‘Additional Attachments’ link within the navigation tree.

4.1.24 Additional Attachments

You can navigate to the ‘Additional Attachments’ screen by clicking the ‘Next’ button from the ‘Optional Pollution Prevention’ screen. You can also access this screen by clicking the ‘Additional Attachments’ link within the navigation tree.

The ‘Additional Attachments’ screen provides a table for you to add additional attachments that have not yet been incorporated into the form. This screen is used as a carryover where documents that did not have a suitable place in the application can be uploaded.

• 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 122• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up window. Refer to Section 3.8 for additional details regarding the attach document functionality.

• File Name: Displays the file name and file exten sion of a document that is uploaded on the

‘Attach Documents’ pop

- up window.

• Description: Displays the description associated with a document.

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

• Date: Displays the date a document was uploaded.

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

• Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently

from the system. A warning message displays to confirm the deletion.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 123Exhibit 4

- 37 shows a screen capture of the ‘ Additional Attachments ’ screen (Joint PMN ):

Exhibit 4

- 37 : Additional Attachments Screen (Joint PMN )

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

4.1.25 Attachment Summary

You can navigate to the ‘ Attachment Summary ’ scre en 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.

• Secti on: Displays the section of the PMN form the document is associated with

.

• File Name: Displays the file name and file extension of the documents that were uploaded on

the ‘Attach Documents’ pop

- up window.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 124• Description: Displays the description of a documen t that was uploaded on the ‘Attach Documents’ pop

- up window.

• Pages: Displays the number of pages in a document that was uploaded on the ‘Attach

Documents’ pop

- up window.

• Date: Displays the upload date of a document that was uploaded on the ‘Attach Docume nts’

pop

- up window.

• 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 December 22, 2014 Secondary Agent/Consultant 125Exhibit 4

- 38 shows a screen capture of the ‘ Attachment Summary ’ screen (Joint PMN ):

Exhibit 4

- 38 : Attachment Summary Screen (Joint PMN )

Navigation: Click the ‘Next’ button to navigate to the ‘ Optional Cover Letter ’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree.

4.1.26 Optional Cover Letter

You can navigate to the ‘Optional Cover Letter’ screen by clicking the ‘Next’ button from the

‘ Attachment Summary ’ screen. You can also access this screen by clicking the ‘Optional Cover
Letter’ link within the navigation tree

. The ‘Optional Cover Letter’ screen is used to communicate information with EPA that is not collected elsewhere in the form. The cover letter is used to give OPPT resources and special instructions regarding the application.

• Click here to claim this information as CBI: Check the ‘Click here to claim this

information as CBI’ checkbox to claim the information as confidential.

• Optional Cover Letter: Enter the description and any additional special instructions

regarding the form.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 126Exhibit 4

- 39 shows a screen capture of the ‘Optional Cover Letter’ screen (Joint PMN ):

Exhibit 4

- 39 : Optional Cover Letter Screen (Joint PMN )

Navigatio n: Click the ‘Validate’ icon ( ) located in the bottom action bar to validate the

submission. Click the ‘Save’ icon ( ) located in the bottom action bar to save the overall form. Click the ‘Preview’ icon ( ) to view a PDF preview of the form.

4.1.27 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 127form, which must be re

- attached. You must also add any sites ide ntified within the form to your CDX registration profile.

After uploading a file, click the ‘Preview’ icon ( ) located in the bottom action bar to view a PDF preview of the form ensuring that all the data has populated correctly and any other
information is displayed accurately. In particular, ensure that the ‘Letter of Activity (1),’ ‘Protective Equipment/Engineering Controls,’ ‘Physical Form,’ ‘Media of Release,’ ‘Control Technology,’ and ‘% New Substance’ fields of entry have been populated correctly.

P lease 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 f ile: Click the button to generate the ‘File Upload’ window to search for the ZIP copy of recor d 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 December 22, 2014 Secondary Agent/Consultant 128Exhibit 4

- 40 shows a screen capture of the ‘Upload XML’ screen:

Exhibit 4

- 40 : 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 129

### 5 Crea te Biotechnology Joint/Letter of Support

5.1 Joint and Letter of Support Process

The Biotechnology form is used as a way to collect information about “ intergeneric ” microorganisms that will be manufactured or imported into the United States. EPA collects the information provided in a Biotechnology form through a free text box and attachments. The Biotechnology form does not have a structured data format, but there are several types of Biotechnology notices that can be filed. The different types are as follows: Microbial Commercial Activity Notice ( MCAN )

, TSCA Experimental Release Application ( TERA ) , Tier I Exemption, Tier II Exemption, and Biotechnology Test Market Exemption (TME) forms.

The Joint and/or Letter of Support submitter will register in CDX as a Secondary Agent/Consultant and access the Section 5 Notices and Supports application. Once you arrive at the ‘Section 5 Notices and Supports Forms’ screen, click the ‘Start New Form’ button and enter in the unique identification number on the ‘Enter Passphrase’ screen sent via email by the Primary AO which will generate the appropriate form that you will be populating. The Joint Biotechnology form will contain the same screens listed for the primary Biotech nology form, except the Joint submitter will not be supplied the ‘Joint Folder.’ The secondary submission process will also be identical to the primary submission process

. 5.1.1 General Form Information

You can access the ‘General Form Information’ screen by creating a passphrase on t he ‘Create Passphrase’ screen or by entering a passphrase on the ‘Enter Passphrase’ screen.

The ‘General Form Information’ screen presents a list of text fields and drop

- down menus for you to input identifying information for the specific form. You will h ave the option to assign a ‘Form Alias’ by which you will use to 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 I nformation’ screen, the system will auto

- generate a default alias in the following format: < Form Type

- YYYYMMDD

- HH:MM:SS Time Zone >

. The system will provide a ‘TS Number’ field for you to enter a TS number to tie support
documents or Joint Submissions to t he original Biotechnology form. The TS number must be a six (6) character alphanumeric combination. The TS number should include two ( 2 )

, three ( 3 ) , or four ( 4 ) letters. Company names, recognizable words

, and numerical series are not
recommended

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

The ‘General Form Information’ screen displays the option to attach a docume nt by clicking the ‘Attach Document’ button. For more information regarding the attach document functionality, please refer to Section 3.8

.

• Form Alias: Enter the fo rm alias. Upon navigating to the screen, the system will auto

generate an editable alias comprised of Form Type

- YYYYMMDD

- HH:MM:SS Time Zone. This is a required field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 130• 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.

• Text/Comments: Enter a description of the form and/or attachment. This field is required if

an attachment is not provided.

• 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 individual toxicity s tudies, GPC data, spectra, exposure monitoring evaluations, physical and chemical properties data, Structure

- Activity Relationship (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, environmental toxicity, and
human health toxicit y. Please refer to Section 3.8 for additional details regarding the attach document functionality.

• File Name: Displays the file name and file extension of a document that is uploaded on the

‘Attach Documents’ pop

- up window.

• Description: Displays the description of a document.

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

• CBI: Indicates the CBI statu s 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 December 22, 2014 Secondary Agent/Consultant 131Exhibit 5

- 1 shows a screen capture of the ‘General Form Information’ screen (Joint Biotechnology) :

Exhibit 5

- 1 : General Form Information Scr een (Joint Biotech nology )

Navigation: Click the ‘Next’ button from the ‘General Form 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.

5.1.2 Technical Contact Information

You can access the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from
the ‘G eneral 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’ b utton to generate an ‘Add Technical Contact’ pop

- up window to

enter information into the text fields. The text fields can populate from your CDX r egistration
information by c licking the ‘Copy CDX Registration’ button. Check the ‘ Check here to claim

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 132this in formation as CBI’ checkbox to indicate that the information is confidential and will n ot 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 co ntact information by displaying

either a ‘Y’ or an ‘N.’

• Actions: Click the ‘Delete’ icon ( ) to delete the technical contact information from the

table. A warning message displays to confirm the deletion.

Exhibit 5

- 2 shows a screen capture of the ‘ Technical Contact Information ’ screen (Joint Biotechnology) :
Exhibit 5

- 2 : Technic al Contact Information Screen (Joint 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.

5.1.2.1 Add Technical Contact

You can access the ‘Add Technical Contact’ pop

- up window by clicking the ‘Add Technical
Contact’ button on the ‘Technical Contact Information’ screen

.

• Copy CDX Registration: Click the ‘Copy C DX Registration’ button to copy your

information from CDX registration; a message displays confirming the import of CDX registration information.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 133• Check here to claim this information as CBI: Check the ‘Check here to claim this
information as CBI’ checkbox to claim the technical contact information as confidential.

• First Name: Enter the technical contact’s first name. If you have clicked the ‘Copy CDX

Registration’ button, the fields populat e 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 requi red field.

• Phone Number: Enter the daytime U.S. phone number of the technical contact. Click the

‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field.

• Phone Extension: Enter the technical contact’s phone number extension if applicable.

• Email Address: Enter the technical contact’s email address. The email address must follow

the standard email address format: John.Doe@domain

. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration.

• Mailing Address 1: Enter the first line of the mailing add ress of the technical contact. 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 mailing address of the technical contact.

Click the ‘Copy CDX Registration’ button to populate the fields with information entered
durin g CDX registration.

• City: Enter the city of the mailing address of the technical contact. Click the ‘Copy CDX

Registration’ button to populate the fields with information entered during CDX registration. This is a required field.

• State: Select the stat e of the mailing address of the technical contact. 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 mailing address for the technical contact. 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 December 22, 2014 Secondary Agent/Consultant 134Exhibit 5

- 3 shows a screen capture of the ‘Add Technical Contact’ window:

Exhibit 5

- 3 : Add Technical C ontact Window

Navigation: Click the ‘ Cancel’ button or ‘X’ icon located in the upper

- right corner to stop the process of entering technical contact information. Click the ‘OK’ button to save the entered
contact information and return to the ‘Technical Contact Information’ screen

. 5.1.3 Optional Cover Letter

You can access the ‘Optional Cover Letter’ screen by clicking the ‘Next’ button from the

‘ Technical Contact Information’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ lin k 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 n ecessary instructions into the blank text field. The cover

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 135letter should be either fully CBI or non

- CBI to eliminate user error to promote transparency between the company and EPA.

• Check here to claim this information as CBI: Check the ‘Check here to claim this

information as CBI’ checkbox to claim the cover letter information as confidential.

• Optional Cover Letter: Enter the description and any additional special instructions

regarding the form.

Exhibit 5

- 4 shows a screen capture of the ‘ Optional Cover Letter ’ screen:
Exhibit 5

- 4 : 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 view a PDF preview of the form.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 136

### 6 Create Bona Fide Letter of Support

T he 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 cove red in a thirty (30) day period.

6.1 Edit Bona Fide Form

To create a new Bona Fide form, navigate to the ‘Section 5 Notices and Supports Forms’ screen
and click the ‘Start New Form’ button . Refer to Section 3.3 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen.

Refer to ( Exhibit 3

- 5 ) for additional details regarding the create passphrase process.

6.1.1 General Document Information

You can access the ‘ General Document Information ’ screen by entering the Unique Identification Number provided by the AO and creating a passphrase on the ‘Create Passphrase’

screen

. The ‘General Document Information’ screen provides fields f or you to identify information that is specific to the form type.

The ‘General Document Information’ screen presents a list of text fields and checkboxes that
allow you to input identifying info rmation for the specific form. You will have the option to

as sign a ‘Form Alias’ by which you will identify the form. A form alias is helpful if you or your company has multiple forms and/or when you must differentiate between forms to the help desk. If an alias is not entered, the system will provide a default alia s comprised of a form type and date and time stamp in the follo wing format: <Form Type

- YYYY

- MM

- DD

- HH:MM:SS Time

Zone >

.
You can indicate that a technical contact will be identified by checking the ‘Technical Contact’ checkbox. The technical contact must po ssess sufficient knowledge to answer any questions EPA may have about the chemical reported in the form . The application will generate a ‘Technical
Contact Information’ screen when you check the ‘Technical Contact’ checkbox.

• Form Alias: Enter the form ali as. Upon navigating to the screen, the screen will auto

generate an editable form alias in the following format: < Form Type

- YYYYMMDD

HH:MM:SS Time Zone >. This is a required field.

• I claim the entirety of the submission as CBI: Check the ‘I claim the entirety of the

submission as CBI’ checkbox to flag all data contained within the form as confidential

.

• Technical Contact: Check the ‘Technical Contact’ checkbox to generate a ‘Technical

Contact Information’ screen for you to enter contac t information about the technical contact associated with the reported chemical.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 137Exhibit 4

- 1 shows a screen capture of the ‘General Document Information’ screen (Letter of Support):

Exhibit 6

- 1 : General Document Information Screen (Let ter of Support)

Navigation: Click the ‘Next’ button to navigate to the ‘Primary Contact Information’ screen

. You can also access this screen by clicking the ‘Primary Contact Information’ link within the navigation tree.

6.1.2 Primary Contact Information

You can access the ‘Primary Contact Information’ screen by clicking the ‘Next’ button from the ‘General Document Information’ screen. You can also access this screen by clicking the ‘Primary Contact Information’ link within the navigation tree.

The data f ields 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 ‘Title’ field on this screen is not pre

- populated from CDX registration an d is a required field

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 138If you checked the ‘ I claim the entirety of the submission as CBI’ on the ‘General Document Information’ screen, all entered primary contact information is flagged as CBI.

The following fields are captured and displayed from the log ged in user’s CDX registration
information:

• Prefix: This field is pre

- populated with information from CDX registration information.
Select the primary contact’s prefix from the drop

- down menu , if necessary

.

• First Name: This field is pre

- populated with in formation from CDX registration
information. Edit the primary contact’s first name , if necessary . This is a required field.

• Middle Initial: This field is pre

- populated with information from CDX registration
information. Enter the primary contact’s middle initial , if necessary

.

• Last Name: This field is pre

- populated with information from CDX registration
information. Enter the primary contact’s last name , if necessary . This is a required field.

• Suffix: This field is pre

- populated with information from CD X registration information.
Select the primary contact’s suffix from the drop

- down menu , if necessary

.

• Title : Enter the primary contact’s job title. This is a required field.

• Company Name: This field is pre

- populated with information from CDX registration
information. Enter the primary contact’s company name , if necessary

.

• Phone Number : This field is pre

- populated with information from CDX registration
information. Enter the primary contact ’s daytime U.S. phone number if necessary ; dashes are not allowed. This is a required field.

• Phone Extension: This field is pre

- populated with information from CDX registration information. Enter the primary contact’s daytime U.S. phone number extension if applicable.

• Email Address: This field is pre

- populated with information from CDX registration
information. Enter the primary contact’s email address , if necessary . The email address
must follow the standard email address format: John.Doe@ABC.com . This is a required
field.

• Mailing Address 1: This field is pre

- populated with information from CDX registration
information. Enter the first line of the primary contact’s mailing address , if necessary

.

• Mailing Address 2: This field is pre

- populated with information from CDX registration
information. Enter the second line of the primary contact’s mailing address , if necessary

.

• City: This field is pre

- populated with information from CDX registration information. Enter the city of the primary contact’s mailing address , if necessary

.

• State: This field is pre

- populated with information from CDX registration information.
Select the state of the primary contact’s mailing address from the drop

- down menu if

necessary . T his is a required field.

• Postal Code : This field is pre

- populated with information from CDX registration
information. Enter the postal code of the primary contact’s mailing address , if necessary

.

• Country: This field is pre

- populated with information from CDX registration information. Select the country of the primary contact’s mailing address form the drop

down menu if necessary. This is a required field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 139Exhibit 6

- 2 shows a screen capture of the ‘Primary Contact Information’ screen:

Exhibit 6

- 2 : 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.

6.1.3 Technical Contact Information

If you indicated on the ‘General Document Information’ screen that technical contact information would be provid ed, then you can navigate to the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from the ‘Primary Contact Information’ screen. You can

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 140also 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 in to 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 tha t if you are using IE 7, there will be a spacing issue between the ‘Suffix’ drop

down menu and the ‘Title’ text field.

• Prefix: Select the technical contact’s prefix from the drop

- down menu.

• First Name: Enter the technical contact’s first name. This is a required field.

• Middle Initial: Enter the technical contact’s middle initial.

• Last Name: Enter the technical contact’s last name. This is a required field

.

• Suffix: Select the technical contact’s suffix from the drop

- down menu.

• Title: Enter the technical contact’s job title.

• Company Name: Enter the technical contact’s company name.

• Phone Number: Enter the technical contact’s daytime U.S. phone number; dashes are not allowed. This is a required field

.

• Phone Extension: Enter the technical contact’s phon e 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 technic al 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 December 22, 2014 Secondary Agent/Consultant 141Exhibit 6

- 3 shows a screen capture of the ‘Technical Contact Information’ screen:

Exhibit 6

- 3 : Technical Contact Information Screen

Navigation: Click t he ‘ Next ’ button to navigate to the ‘Chemical Identification Information’

screen. You can also access this screen if you click the ‘Chemical Identification Information’ link within the navigation tree.

6.1.4 Chemical Identification Information

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 142The ‘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 the selection that you designate, 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 substance. The user is required to select one of the two radio button options displayed in the ‘Chemical Type’ section.

• Polymer : Select the ‘Polyme r’ radio button to indicate that the chemical is a polymer. The

user is required to select one of the two options displayed in the ‘Chemical Type’ section.

• Chemical Alias: Enter the chemical alias to associate with a chemical.

Exhibit 6

- 4 shows a screen capture of the ‘Chemical Identification Information’ screen:

Exhibit 6

- 4 : Chemical Identification Information Sc reen

Navigation: If you selected the ‘Class 1 or 2 /Biotechnology Chemical S ubstance’ radio button,
click the ‘Next’ button to navigate to the ‘Class 1 or 2 /Biotechnology Chemical Substances’

screen. You can also access this screen by clicking the ‘Class 1 or 2 /Biotechnology Chemical Substances’ link within the navigation tree. If you selected the ‘Polymer’ radio button, click the

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 143‘Next’ button to navigate to the ‘Polymer Identification Information’ screen. You can also access this screen by clickin g the ‘Polymer Identification Information’ link within the navigation tree.

6.1.5 Class 1 or 2 /Biotechnology Chemical Substances

If you selected the ‘Class 1 or 2 /Biotechnology Chemical Substance’ radio button, click the ‘Next’ button to navigate to the ‘Class 1 or 2 /Biotechnology Chemical Substances’ screen.

The ‘Class 1 or 2 /Biotechnology Chemical Substances’ screen provides fields for you to enter information describing the chemical for the Bona Fide which is to be filed, including its name, composition, and structure.

You can add a chemical component by clicking the ‘Add New Chemical ’ button. Upon clicking
the ‘Add New Chemical ’ button, an expandable/collapsible field set generates that contains numerous fields to identify the chemical in question. You will be able to enter multiple chemical
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 descrip tion 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 d ocuments

. 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 /Biotech nology 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 en tered 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 se t 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: Cl ick 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 144structure may not be known and an additional screen will appear within the navig ation 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.’ I f you retrieve zero results, the system provides fields for you to enter the chemical information by filling in the ‘Chemical Name’ and the ‘Chemical Abstract Services Registry Number’ under the manual entry field set. The system provides functionality to enter the selected chemical by clicking the ‘OK’ button located at the bottom of the ‘Add Chemical ID’
window.

• Chemical Name: The system provides fields for you to identify the ‘Chemical Name’ and the

‘CASRN’ (if available). The system provides functional ity 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 w ithin the ‘Chemical Identification Information’ field set. After you attach the document(s), and click the ‘OK’ button, the ‘Attach IES Report’ pop

- up window
close s 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 th e file name link under the ‘File Name’ column to access or edit previously attached documents

.

• Molecular Formula: Enter a molecular formula in a text field using a free text format. This

field is optional.

• Chemical Structure Diagram: The system allows you to attach a chemical structure diagram.

This field is optional.

• Attach Chemical Structure: Click the ‘Attach Chemical Structure’ button within the

‘Chemical Identification Information’ field set to access the ‘Attach Chemical Structure’ pop

up window . You can attach the file(s) and enter a description of the document regarding the
chemical structure.

• File Name: Displays the file name and file extension of the file that is uploaded on the ‘Attach

Chemical Structure’ window.

• Description: Displays the descrip tion 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 145• Save: Click the button to save the information entered within the expandable/collapsible field set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section
3.7 for more information regarding the save functionality in an expandable/collapsibl e field

set.

Exhibit 6

- 5 shows a screen capture of the ‘Class 1 or 2 /Biotechnology Chemical Substances’

screen (Joint Bona Fide) (Scroll 1) :

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 146Exhibit 6

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

Navigation: If you selected the ‘Class 1’ radi o button and clicked the ‘Save’ button within the expandable/collapsible field set, click the ‘Next’ button to navigate to the ‘Use Information’

screen. You can al so access this screen by clicking the ‘Use Information’ link within the navigation tree. If you selected the ‘Class 2 /Biotechnology ’ radio button, clicked the ‘Save’ button within the expandable/collapsible field set, then click the ‘Next’ button to naviga te to the
‘Class 2 /Biotechnology Substances’ screen. You can also access this screen by clicking the
‘Class 2 /Biotechnology Substances’ link within the navigation tree.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 1476.1.6 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 b ar and clicking the ‘Class 2 /Biotechnology Substances’ link within the navigation tree.

The ‘Class 2 /Biotechnology Substances’ screen prov ides fields for you to enter information regarding a class 2 /biotechnology chemical substance. A class 2 /biotechnolog y 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

Nam e’ 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, alo ng with the respective CASRNs.

• Search SRS: Click the ‘Search SRS’ button to display the ‘Search Substance Registry

Services’ pop

- up window. Refer to Section 3.9 for additional details regarding the search SRS functionality.

• Chemical Name: Displays the chemical name associated with a precursor substance. Click

the ‘Chemical Name’ link to navigate to the ‘Search SRS’ pop

- up window for edits.

• CASRN: Displays the CAS RN 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 o f 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 Sec tion 3.8 for further details regarding the attach document functionality

.

• File Name: Displays the file name and file extension of the file that is uploaded on the

‘Attach Documents’ window.

• Description: Displays the descripti on 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 December 22, 2014 Secondary Agent/Consultant 148Exhibit 6

- 6 shows a screen capture of the ‘Class 2 /Biotechnology Substances’ screen (Scroll 1) :

Exhibit 6

- 6 : Class 2 /Biotechnology Substances Screen (Scr oll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 149Exhibit 6

- 7 7 shows a screen capture of the ‘Class 2 /Biotechnology Substances’ screen (Scroll 2):

Exhibit 6

- 7 : Class 2 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.

6.1.7 Polymer Identification Information

You can navigate to the ‘Polymer Identi fication 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 th e navigation tree.

Click the ‘Add New Chemical ’ button to create a chemical component. Upon clicking the ‘Add
New Chemical ’ button, an expandable/collapsible field set generates that contains numerous fields that pertain to the particular polymer. The sys tem provides numerous fields for you to enter multiple chemical components, each with unique information, by clicking the ‘Add New
Chemical ’ button for each chemical you wish to identify.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 150For 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

- c omponent 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
C hemical’ 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 I nformation’

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 d isplays 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 confirmat ion 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

I nformation ’ 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 ‘Ch emical 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: T he 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. When you select ‘Method 1 (CAS Inventory Expert Service),’ the system generates an ‘Attach IES Report’ button for you to attach an IES report.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 151If 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 th e ‘Attach

IES Report’ button within the ‘Polymer Identification I nformation ’ field set after selecting the ‘Method 1 (CAS Inventory Expert Service)’ radio button. After you attach the document(s), and click the ‘OK’ button, the ‘Attach IES Report’ pop

- up w indow will close and the document information will be displayed in a table format on the ‘Polymer Identification Information’ screen. The attachment table displays the file name of the

document and the user

- provided description of the document. Click the ‘ Delete’ icon ( )
located under the ‘Actions’ column to delete unwanted documents. Click the file name link
under the ‘File Name’ column to access or edit previously attached documents

.

• Chemical Structure Diagram: The system allows you to attach a chemical structure

diagram. This field is optional.

• Attach Chemical Structure: Click the ‘Attach Chemical Structure’ button within the

‘Polymer Identification I nformation ’ field set to access the ‘Attach Chemical Structure’ pop

up window . You can attach the file(s ) and enter a description of the document.

• File Name: Displays the file name and file extension of the document that is uploaded on the

‘Attach Chemical Structure’ window.

• Description: Displays the description of the chemical structure

• Actions: Click the ‘Delete’ icon ( ) to delete the entire attached chemical structure row

permanently from the system. A warning message displays to confirm the deletion.

• Save: Click the button to save the information entered within the expandable/collapsible field

set. Yo u 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.

Afte r the document is attached and you click the ‘OK’ button, the ‘Attach Chemical Structure’

pop

- up window closes and the document information will be displayed in a table format on the ‘Polymer Identification Information’ screen. The attachment table display s the file name of the document and provided description of the document. The system provides functionality for you to delete unwanted documents by clicking the ‘Delete’ icon ( ) located under the ‘Actions’
column. Click the appropriate file name of the do cument 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 December 22, 2014 Secondary Agent/Consultant 152Exhibit 6

- 8 8 shows a screen capture of the ‘Polymer Identification Information’ screen:

Exhibit 6

- 8 : 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.

6.1.8 Monomers and Other Reactants

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

. The ‘Monomers and Other Reactants’ screen is used to identify the chemical measurements and monomers that make up a polymer. The ‘Monomers and Other Reactants’ screen has an ‘Add

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 153Monomer’ button that allows you to identify the monomer(s) that make up th e 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 l ocated 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 seri es of field sets.

• Search SRS: Click the ‘Search SRS’ button to generate the ‘Search Substance Registry

Services’ pop

- up window. Refer to Section 3.9 for additional details regarding the search SRS functionality.

• CAS R egistry N umber : 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.

• Mono mer 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 gr eater 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 fiel d

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 December 22, 2014 Secondary Agent/Consultant 1543.7 for more information regarding the save functionality in an expandable/collapsible field

set.

• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up window. Refer t o Section 3.8 for additional details regarding the attach document functionality.

• File Name: Displays the file name and file extension of the file that is uploade d 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 t he 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 December 22, 2014 Secondary Agent/Consultant 155Exhibit 6

- 9 shows a screen capture of the ‘Monomers and Other Reactants’ screen:

Exhibit 6

- 9 : Monomers and Other Reactants Screen

Navigation: Click t he ‘Next’ button to navigate to the ‘Use Information’ screen. You can also access this screen by clicking the ‘Use Information’ link within the navigation tree.

6.1.9 Use Information

You can navigate to the ‘Use Information’ screen by clicking the ‘Next’ button from the ‘Class 1

or 2 /Biotechnology Chemical Substances’ screen, from the ‘Class 2 /Biotechnology Substances’

screen, or from the ‘Monomers and Other Reactants’ screen, depending o n 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 is used to capture data about the chemical substance’s intended
use. When you navigate to the screen, the screen contains a text box with instructional text that

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 156reads, ‘How will the substance be used?’ Enter the specific data for the chemical substance and
then advance to the next screen.

• How will the substance be used ? : Enter the data regarding how the chemical substance
is intended to be used. This is a required field.

Exhibit 6

- 10 0 shows a screen capture of the ‘Use Information’ screen:

Exhibit 6

- 10 : Use Information 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.

6.1.10 Document Management

You can navigate to the ‘Document Management’ screen by cli cking the ‘Next’ button from the

‘ Use Information ’ screen. You can also access this screen by clicking the ‘Document Management’ link within the navigation tree.

The ‘Document Management’ screen is used to attach required documents to the Bona Fide
form. You may attach three types of documents : ‘Spectrum of Substance,’ ‘Statement of Commercialization,’ and ‘Statement of Research and Development.’ The screen also allows the
user to attach ‘Other’ documents.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 157• Attach Document: Click the ‘Attach Document’ butto n to generate the ‘Attach Documents’

pop

- up window. Refer to Section 3.8 for additional details regarding the attach document functionality.

• Document Name: Displ ays the file name and file extension of the document uploaded on the

‘Attach Documents’ pop

- up window.

• Document Type: Displays the document type associated with the uploaded document.

• Action: Click the ‘Delete’ icon ( ) to delete the entire document row permanently from the

system. A warning message displays to confirm the deletion of the document.

Exhibit 6

- 11 shows a screen capture of the ‘Document Management’ screen:

Exhibit 6

- 11 : 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 1586.1.11 Optional Cover Letter

You can navigate to the ‘Optional Cover Letter’ screen by clicking the ‘Next’ button from the

‘ Document Management ’ screen. You can also access this screen by clicking the ‘Optional
Cover Letter’ link within the navigation tree

. The ‘Optional Cover Letter’ screen is used to communicate information with EPA that is not collected elsewhere in the form. The cover letter is used to g ive EPA resources and special instructions regarding the application.

• Optional Cover Letter: Enter any additional special instructions regarding the form.

Exhibit 6

- 12 shows a screen capture of the ‘Optional Cover Letter’ screen:

Exhibit 6

- 12 : Optional Cover Letter Screen

Navigation: Click the ‘Validate’ icon ( ) located in the bottom action bar to validate the form

. Click the ‘Save’ icon ( ) located in the bottom action bar to save the overall form. Click the ‘Preview’ icon ( ) located in the bottom action bar to view a PDF preview of the form.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 159

### 7 Preview

The system allows you to preview the form at any point duri ng the submission process. You can click the ‘Preview’ icon ( ) , located within the bottom action bar , to see a draft PDF version of
the form

. A prompt will display to allow you to select whether to view the ‘ Regular ’ or

‘ Sanitized ’ version of the PDF by c licking on the ‘Regular’ or ‘Sanitized’ buttons

. After you choose between the ‘Regular’ or ‘ Sanitized’ PDF, a draft watermarked PDF version of the form is generated

.
The watermark reads ‘Not for Submission’ and displays across each screen in the background. The form preview displays the entire form in a printable format. The preview functionality provides you with the flexibility to track the status and see the entire form in a single viewpoint.

Exhibit 7

- 1 shows a screen capture for the ‘Preview’ of the Biotech nology form:

Exhibit 7

- 1 : Preview Biotech nology Form Screen

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 160Exhibit 7

- 2 shows a screen capture for the ‘Preview’ of the Biotech nology Form PDF :

Exhibit 7

- 2 : Preview Biotech nology Form PDF

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 161

### 8 Validate

You can click the ‘Validate’ icon ( ) at any stage of completing a Section 5 Notices and Supports form. The ‘Section 5 Notices and Supports Validation’ pop

- up window displays when you click the ‘Validate’ icon ( ); please disable the pop

- up blocker withi n your internet browser. 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 Suppor ts form to find missing and invalid data.

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 Validatio n’ 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 : War nings 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

occu rred 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 re moved 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 top right of the ‘Section 5 Notices and Supports Validation’ pop

- up window.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 162Exhibit 8

- 1 show s a screen capture for the ‘ Section 5 Notices and Supports Validation’ window:

Exhibit 8

- 1 : Section 5 Notices and Supports Validation Pop

- Up W indow

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 163

### 9 Submit to EPA via CDX

As the Secondary Agent/Consultant , you have the ability to sign and submit a Section 5 Notices and Supports amendment to EPA

. You do not have the ability to submit original Joint Forms/Letters of Support. Y ou can save your form at any point during the data entry process. The save functionality will allow you to return to that same form at any point in the future.

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.

9.1 Submitting Official Information

Click the ‘ Submit ’ icon ( ) that is located in the bottom action b ar of the Section 5 Notices and Supports application to access the ‘Submitting Official Information’ screen. This screen only displays to Primary Authorized Officials or Agents/Consultants upon submiss ion.

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 a nd Supports ‘Home’ screen.

The following statement which displays to the Authorized Officials and Agents/Consultants must be confirmed before the system will allow you to move forward: “Please confirm that you are the legally responsible party from the su bmitting 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 as sociated with this statement, the application takes you back to the ‘Section 5 Notices and Supports Forms’ screen.

A ‘Submitting On Behalf Of’ checkbox will also be displayed on the screen. After you check the checkbox, click the ‘Next’ button to navigate to the ‘Submitting On Behalf Of’ screen. The ‘Submitting On Behalf Of’ checkbox is only displayed for amendments/revisions/updates/etc. to the original submission.

• Submitting On Behalf Of: This checkbox displays for original Support forms and

amendments/revisions/updates to an original submission.

• CBI: Check the ‘CBI’ checkbox to claim the submitting official’s information as

confidential.

• Please confirm that you are the legally responsible party from the submitting company:

Check the checkbo x 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 th e submitting official, which has been pre

populated from CDX registration information.

• Last Name: Displays the last name of the submitting official, which has been pre

- populated

from CDX registration information.

• Job Title: Displays the job title of the s ubmitting 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 1 64• Phone Number: Displays the phone number of the submitting official, which has been pre

populated from CDX registration information.

• Email Address: Displays the email address of the submitting official, which has been pre

populated from CDX registration information.

• Mailing Address 1: Displays the first line of the mailing address from CDX registration

information.

• Mailing Address 2: Displays the second line of the submitting official’s mailing address,

which has been pre

- populated from CDX registration information.

• City: Displays the city of the submitting official’s mailing add ress, which has been pre

populated from CDX registration information.

• State: Displays the state of the submitting official’s mailing address, which has been pre

populated from CDX registration information.

• Postal Code: Displays the postal code of the sub mitting official’s mailing address, which has

been pre

- populated fro m 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 December 22, 2014 Secondary Agent/Consultant 165Exhibit 9

- 1 shows a screen capture of the ‘Submitting Official Information’ screen:

Exhibit 9

- 1 : Submitting Official Information Screen

Navigation: Click the ‘Next’ button to continue with submitting the form and proceed to the
‘Submission Process: Validation’ screen

. 9.2 Submitting On Behalf Of Company

Click the ‘ Submit ’ icon ( ) that is located in the bottom action b ar of the Section 5 Notices and Supports application to access the ‘Submitting Official Information’ screen. This screen only displays for Support forms and amendments/revisions/updates/etc. to an original submission.

After checking the ‘Submittin g On Behalf Of’ checkbox on the ‘Submitting Official Information’ screen, you will be taken to the ‘Submitting On Behalf Of Company’ screen to enter in the company information that you are submitting the form on behalf of. Click the
‘Cancel’ button to navi gate to the form which you are submitting.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 166• CBI : Check the ‘CBI’ checkbox to claim the ‘Submitting On Behalf Of’ information as
confidential.

• Prefix: Select the prefix of the ‘Submitting On Behalf Of’ individual on whose behalf you

are submitting this form.

• First Name: Enter the first name of the ‘Submitting On Behalf Of’ individual on whose

behalf you are submitting this form. This is a required field

.

• Middle Initial: Enter the middle initial of the ‘Submitting On Behalf Of’ individual on

whose behalf you are submitting this form.

• Last Name: Enter the last name of the ‘Submitting On Behalf Of’ individual on whose

behalf you are submitting this form. T his is a required field.

• Suffix: Select the suffix of the ‘Submitting On Behalf Of’ individual on who behalf you are

submitting this form.

• Job Title: Enter the job title of the ‘Submitting On Behalf Of’ individual on whose behalf

you are submitting this form.

• Company Name: Enter the company name of the ‘Submitting On Behalf Of’ individual on

whose behalf you are submitting this form. This is a required field.

• Phone Number: Enter the phone number of the ‘Submitting On Behalf Of’ individual on

whose behal f you are submitting this form. This is a required field.

• Phone Extension: Enter the phone number extension of the ‘Submitting On Behalf Of’

individual on whose behalf you are submitting this form.

• Email Address: Enter the email address of the ‘Submittin g On Behalf Of’ individual on

whose behalf you are submitting this form. The email address must follow the standard email
address format: John.Doe@abc.com

.

• Mailing Address 1: Enter the first line of the mailing addr ess of the ‘Submitting On Behalf

Of’ individual on whose behalf you are submitting this form. This is a required field.

• Mailing Address 2: Enter the second line of the mailing address of the ‘Submitting On

Behalf Of’ individual on whose behalf you are sub mitting this form.

• City: Enter the city of the mailing address of the ‘Submitting On Behalf Of’ individual on

whose behalf you are submitting you are submitting this form. This is a required field.

• State: Select the state from the drop

- down menu of the m ailing address of the ‘Submitting

On Behalf Of’ individual on whose behalf you are submitting this form. This is a required field if the ‘Country’ field is set to ‘United States.’

• Postal Code: Enter the postal code of the ‘Submitting On Behalf Of’ individ ual on whose

behalf you are submitting this form. This is a required field.

• Country: Enter the country of the ‘Submitting On Behalf Of’ individual on whose behalf

you are submitting this form.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 167Exhibit 9

- 2 shows a screen capture of the ‘Submitting On Behalf Of Company’ screen:

Exhibit 9

- 2 : Submitting On Behalf Of Company Screen

Navigation: Click the ‘Next’ button to continue with submitting the form and proceed to the
‘Submission Process: Validation’ screen

. Click the ‘Cancel’ button to navigate back to the form from which you initiated the submission process.

9.3 Submission Process: Validation

Click the ‘ Submit ’ icon ( ) that is located in the bottom action b ar 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 informat ion entered within the Section 5 Notices and Supports form

. After a form is validated, the system will generate a PDF.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 168Exhibit 9

- 3 shows a screen capture of the ‘Submission Process: Validation’ screen:

Exhibit 9

- 3 : Submission Process: Validation Screen

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 169Exhibit 9

- 4 shows a screen capture of the ‘Submission Process: PDF Generation’ screen:

Exhibit 9

- 4 : Submission Process: PDF Generation Screen

Navigation: Click the ‘ Continue ’ button to continue with submitting the form and proceed to the

‘ Cross

- Media Electronic Reporting Regulation ( CROMERR ) Certification ’ screen

. 9.4 Cross

- Media Electronic Reporting Regulation ( CROMERR ) Certification

Click the ‘ Continue ’ button from 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 submission is CROMERR compliant. By clicking the ‘ I Certify ’ butto n on the ‘ Cross

- Media Electronic Reporting Regulation ( CROMERR ) Certification ’ screen, you authenticate all of the information
entered in the submission. Clicking the ‘ Cancel ’ button will allow you to navigate back to the Section 5 Notices and Supports app lication.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 170Exhibit 9

- 5 shows a screen capture for the ‘ Cross

- Media Electronic Reporting Regulation ( CROMERR ) Certification’ screen:

Exhibit 9

- 5 : 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

. 9.5 CROMERR Login

You ca n 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 :

• Password: Enter your CDX registration p assword

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 171Exhibit 9

- 6 shows a screen capture of the ‘ Cross

- Media Electronic Reporting Regulation ( CROMERR ) Login’ screen

. Exhibit 9

- 6 : Cross

- Media Electronic Reporting Regulation ( CROMERR ) Login Screen

Navigation: Enter your CDX registration password and click the ‘ Next ’ button to navigate to the

‘ Cross

- Media Electronic Reporting Regulation ( CROMERR ) Security Question ’ screen.

9.6 Cross

- Media Electronic Reporti ng 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 by 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 CD X registration

. 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 172Exhibit 9

- 7 shows a screen capture of the ‘ Cross

- Media Electronic Reporting Regulation ( CROMERR ) Security Question’ screen:

Exhibit 9

- 7 : Cross

- Media Elect ronic Reporting Regulation ( CROMERR ) Security Question Screen

Navigation: Answer the security question and click the ‘ Next ’ button to navigate to the ‘ Submit
to CDX ’ screen.

9.7 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 by clicking the ‘ Next ’ button.

On the ‘ Submit to CDX ’ screen, you will see a certification message. Read the m essage and acknowledge by clicking the ‘ Confirm ’ button. Once you have clicked the ‘ Confirm ’ button,

your form will be submitted to EPA via CDX.

This screen is only applicable to the original submissions (PMN, NOC, and Biotech nology ). This
screen will disp lay during the submission process for Joint Submissions and Letters of Support

. This screen is not applicable to Support forms and amendments to original submissions.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 173Exhibit 9

- 8 shows a screen capture of the ‘Submit to CDX’ screen:

Exhibit 9

- 8 : Submit to CDX Screen

Navigation: Click the ‘ Confirm ’ button to navigate to the ‘ Cross

- Media Electronic Reporting Regulation (CROMERR) Submission ’ screen.

9.8 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 EPA via CDX by clicking the ‘ Confirm ’
button.

On the ‘ Cross

- Media Electronic Reporting Regulation (CROMERR) Submission ’ screen, you will see a message indicating the submission has been successfully s ubmitted to EPA via CDX.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 174Exhibit 9

- 9 shows a screen capture of the ‘ Cross

- Media Electronic Reporting Regulation (CROMERR) Submission ’ screen:

Exhibit 9

- 9 : Cross

- Media Electronic Reporting Regulation (CROMERR) Submission
Screen

Navigation: Click the ‘Finish’ button to navigate back to the Section 5 Notices and Supports
‘Home’ s creen. 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 December 22, 2014 Secondary Agent/Consultant 175

### 10 Download Copy of Record

To download a Copy of R ecord , navigate to the ‘ Section 5 Notices and Supports Forms’ screen and l ocate a submission for which you have successfully completed and that has a status of

‘ Submitted

. ’

Click the ‘Copy of R ecord’ icon ( ) from the ‘ Section 5 Notices and Supports Forms’ screen. You will be taken to the ‘ Enter Passphrase ’ screen. The ‘Enter Passphrase’ screen requires you to enter the passphrase originally associated with the form. I f your passphrase is entered correctly

, you will be taken to the ‘Cross

- Media Electr onic 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 Rep orting Regulation ( CROMERR ) Security Question ’ screen. The

‘Cross

- Media Electronic Reporting Regulation ( CROMERR ) Security Question ’ screen randomly selects and displays one of the five CROMERR eSIG

- PIN questions that you answered
on the ‘ 20

- 5

- 1 Question ’ screen during CDX registration . Answer the CROMERR security question and click the ‘ OK ’ button. If your answer was successful

, you will be taken to the

‘ Download Copy of Record ’ screen

.

Exhibit 10

- 1 shows a screen capture of the ‘ Download Copy of Record’ screen:

Exhibit 10

- 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 176during the submission process, PDF version of the submission or the XML version of the Section

5 Notices a nd 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 associ ated with the case number, and click the ‘Next’ button. If the passphrase was correctly entered, the application will take you to the ‘CROMERR Login’ screen to enter the CDX password. If your login was successful, you will be taken to the ‘CROMERR Security Question’ screen. The ‘CROMERR Security Question’ screen randomly selects and displays one of the five CROMERR eSIG

- PIN questions that you answered on the 20

- 5

- 1 Question screen during the initial login to CDX. Answer the CROMERR security question and cli ck the ‘OK’ button. If your answer was successful, you will be taken to the ‘Download Copy of Record’ screen.

Exhibit 10

- 2 shows a screen capture of the ‘D ownload P rompt ’ screen :

Exhibit 10

- 2 : Download Prompt Screen

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 December 22, 2014 Secondary Agent/Consultant 177

### 11 Create an Amendment

To amend a submitted Joint /Letter of Support for a PMN

, Biotechnology , or Letter of Support
Bona Fide , navigate to the ‘ Section 5 Notices and Supports Forms’ screen and locate a form 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 a n amendment

.

Exhibit 11

- 1 shows a screen capture of the ‘ Section 5 Notices and Supports Forms ’ screen:

Exhibit 11

- 1 : Section 5 Notices and Supports Form

– Amendment

Navigation: After clicking the ‘Lock’ icon ( ), you will receive a prompt to confirm the
amendment process. If you do not want to continue with the amendment

, click the ‘ Cancel ’

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 178button to cancel the amendment process and return to the ‘ Section 5 Notices and Supports

Forms’ screen. Click the ‘ OK ’ button to close the prompt and continue with the amendment

.

Exhibit 11

- 2 shows a screen capture of the ‘Unlock Prompt’ mes sage:

Exhibit 11

- 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 ‘ General
Form Information ’ or ‘General Document Information ’ screen. Refer to Section 3.5 for further
instructions on the ‘ Enter Passphrase ’ screen.

After a submission has been unlocked , the ‘ Section 5 Noti ces and Supports Forms’ screen will
display a status of ‘ In Progress ’ under the ‘ Status ’ column, and an ‘Unlocked’ icon ( ) will display under the ‘ Action ’ column ; however

, you will not see these changes until you navigate
back to the ‘ Section 5 Notices and Supports Forms’ screen

. Refer to the following sections for additional instructions:

• Refer to Section 1 through Section 4.1.26 for instructions on editing a revised PMN form

.

• Refer to Section 1 through Section 5.1.3 for instructions on editing a revised

Biotechnology form.

• Refer to Section 1 through Section 6.1.11 for instruction s on editing a revised Bona Fide

form

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 179

### 12 Resources

You can access the ‘Resources’ screen by clicking the ‘ Resources ’ tab located at the top of the screen at any time during the submission process. You can also access the ‘Resources’ screen by clicking the ‘ Resources ’ link from the Section 5 Notices and Supports ‘ Home ’ screen. The

‘Resources’ screen provides you with links to the appropriate Section 5 Notices and Supports user guides as well as additional helpful links. Click the ‘ User Guide ’ link to access the Section 5 Notices and Supports user guide document

.

• Regulatory Impact Analysis for the Regulation of Microbial Products of Biotechnology:

Government Costs: Click this link to generate the ‘Regulatory Impact Analysis for the Regulation of Microbial Pr oducts 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 ‘P oints to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms’ PDF in a new browser window.

• CDX Ho mepage : Click this link to generate the CDX Homepage in a new browser window.

• TSCA Chemical Substances Inventory: Click this lin k 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

Progr am’ 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 December 22, 2014 Secondary Agent/Consultant 180Exhibit 12

- 1 shows a screen capture of the ‘ Resources ’ screen (Scroll 1) :

Exhibit 12

- 1 : Resources Screen (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 181Exhibit 12

- 2 shows a screen capture of the ‘Resources’ screen (Scroll 2):

Exhibit 12

- 2 : Resources Screen (Scroll 2)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 182

### Appendix A. Definitions, Acronyms

, and Abbreviations

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 Abstract s Service Registry Number

CDX Central Data Exchange

CFR Code of Federal Regulations

CoR Copy of Record

CROMERR Cross

- Media Electronic Reporting Regulation

CSPP Chemical Safety and Pesticide Programs

CSV Comma

- Separated Values

DNA Deoxyribonucleic Acid

EPA Environmental Protection Agency

EST Eastern Standard Time

ETI Environmental Technology Initiative

FR Federal Regulation

FRS Facility Registry System

GPC Gel

- permeation Chromatography

ID Identification

IE Internet Explorer

IES Inventory Expert Service

IH Industrial Hygienist

IR Infrared

KG Kilogram

LOREX Low Release/Low Exposure Exemption

LOS Letter of Support

LVE Low Volume Exemption

MCAN Microbial Commercial Activity Notice

MS Mass Spectrometry

MSDS Material Safety Data Sheet

NIOSH National Institute for Occupational Safety and Health

NMR Nuclear Magnetic Resonance

NOC Notice of Commencement

NPDES National Pollutant Discharge Elimination System

OPPT Office of Pollution Prevention and Toxics

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 22, 2014 Secondary Agent/Consultant 183PDF 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 December 22, 2014 Secondary Agent/Consultant 184