## Section 5 Notices and Supports
User Guide

- Secondary Authorized
Official

Environmental Protection Agency

Office of Pollution Prevention and Toxics

Manage Toxic Substance s

Delivery Order # GS00Q09BGD0022

Task Order # EP

- G11H

- 00154

Project # TDD 9.21

Version 1.0

December 17, 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 Authorized Official Functions

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

3.1 Log into Section 5 Notices and Supports Application

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

3.2 Home Screen Navigation

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

3.3 User Management

................................ ................................ ................................ ........ 8

3.4 Section 5 Notices and Supports Forms

................................ ................................ ......... 9

3.5 Create Passphrase

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

3.6 Enter Passphrase

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

3.7 Navigation Tree

................................ ................................ ................................ .......... 15

3.8 Action Bar

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

3.9 Attach Documents

................................ ................................ ................................ ...... 24

3.10 Search Substance Registry Services

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

3.11 Add Facility

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

4 PMN Secondary User

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

4.1 Create Joint Submission

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

4.1.1 General Form Information (Joint PMN)

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

4.1.2 Agent Information

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

4.1.3 Technical Contact Information

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

4.1.4 Chemical Identification

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

4.1.5 Class 1 or 2 Chemical Substances

................................ ................................ ....... 46

4.1.6 Class 2 Substances

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

4.1.7 Additional Chemical Information

................................ ................................ ........... 56

4.1.8 Polymer Identification Information

................................ ................................ ......... 61

4.1.9 Monomers and Other Reactants

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

4.1.10 Production Volume and Hazard/Safety Information

................................ ............... 70

4.1.11 Use Information

................................ ................................ ................................ .... 73

4.1.12 Physical and Chemical Properties Worksheet

................................ ....................... 78

4.1.13 Physical and Chemical Properties Worksheet

– Continued (Optional)

.................. 86

OPPT MTS Section 5 Notices and Supports User Guide December 17, 2014 Secondary Authorized Official i4.1.14 Physical and C hemical Properties Worksheet

– Continued (Optional) Attach
Documents

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

4.1.15 Site Information

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

4.1.16 Sites Controlled By Others

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

4.1.17 Submitter Operation Information

................................ ................................ ........... 96

4.1.18 Occupational Exposures

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

4.1.19 Environmental Releases

................................ ................................ ..................... 104

4.1.20 Industrial Sites Controlled By Others

................................ ................................ .. 108

4.1.21 Exposures/Releases

................................ ................................ ........................... 111

4.1.22 Byproduct Information

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

4.1.23 Optional Pollution Prevention

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

4.1.24 Additional Attachments

................................ ................................ ....................... 120

4.1.25 Attachment Summary

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

4.1.26 Optional Cover Letter

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

4.1.27 Upload XML

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

5 Biotechnology Secondary User

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

5.1 Joint and Letter of Support Process

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

5.1.1 General Form Information

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

5.1.2 Technical Contact Information

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

5.1.3 Optional Cover Letter

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

6 Bona Fide Form Secondary User

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

6.1 Edit Bona Fide Form

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

6.1.1 General Document Information

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

6.1.2 Primary Contact Infor mation

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

6.1.3 Technical Contact Information

................................ ................................ ............ 141

6.1.4 Chemical Identification Information

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

6.1.5 Class 1 or 2/Biotechnology Chemical Substance

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

6.1.6 Class 2/Biotechnology Substances

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

6.1.7 Polymer Identif ication Information

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

6.1.8 Monomers and Other Reactants

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

6.1.9 U se Information

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

6.1.10 Document Management

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

6.1.11 Optional Cover Letter

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

7 Preview

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

8 Validate

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

OPPT MTS Section 5 Notices and Supports User Guide December 17, 2014 Secondary Authorized Official ii9 Submit to EPA via CDX

................................ ................................ ................................ .. 165

9.1 Submitting Official Information

................................ ................................ .................. 165

9.2 Submitting On Behalf Of

................................ ................................ ........................... 167

9.3 Submission Process: Validation

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

9.4 Cross

- Media Electronic Reporting Regulation (CROMERR) C ertification

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

9.5 Cross

- Media Electronic Reporting Regulation (CROMERR) Login

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

9.6 Cross

- Media Electronic Reporting Regulation (CROMERR) Security Question

........ 172

9.7 Submit to CDX

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

9.8 Cross

- Media Electronic Reporting Regulation (CROMERR) Submission

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

10 Download Copy of Record

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

11 Create an Amendment

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

12 Resources

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

Appendix A

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

OPPT MTS Section 5 Notices and Supports User Guide December 17, 2014 Secondary Authorized Official 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: User Management Screen

................................ ................................ ........................ 9

Exhibit 3

- 5: Section 5 Notices and Supports Forms Screen

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

Exhibit 3

- 6: Create Passphrase Screen

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

Exhibit 3

- 7: Enter Passphrase Screen

................................ ................................ ....................... 15

Exhibit 3

- 8: Navigation Prompt Pop

- Up Win dow

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

Exhibit 3

- 9: Premanufacture Notice Navigation Tree (Scroll 1)

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

Exhibit 3

- 10: Premanufacture Notice Navigation Tree (Scroll 2)

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

Exhibit 3

- 11: Premanufacture No tice Navigation Tree (Scroll 3)

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

Exhibit 3

- 12: Biotechnology Navigation Tree

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

Exhibit 3

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

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

Exhibit 3

- 14: Bona Fide Navigation Tree (Polymer)

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

Exhibit 3

- 15: Action Bar

– Validate

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

Exhibit 3

- 16: Action Bar

– Save

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

Exhibit 3

- 17: Action Bar

– Preview

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

Exhibit 3

- 18: Action Bar

– Submit

................................ ................................ .............................. 24

Exhibit 3

- 19: Action Bar

– Help Links

................................ ................................ ........................ 24

Exhibit 3

- 20: Attach Documents Pop

- Up Window

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

Exhibit 3

- 21: Search Substance Registry S ervices Pop

- Up Window

................................ ......... 29

Exhibit 3

- 22: Chemical Not Found In Substance Registry Services Pop

- Up Window

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

Exhibit 3

- 23: Add Facility Pop

- Up Window

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

Exhibit 4

- 1: General Form Information Screen (Joint Submission)

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

Exhibit 4

- 2: Agent Information Screen (Joint Submission)

................................ ......................... 38

Exhib it 4

- 3: Add Agent Pop

- Up Window

................................ ................................ .................... 40

Exhibit 4

- 4: Technical Contact Information Screen (Joint Submission)

................................ ...... 42

Exhibit 4

- 5: Add Technical Contact Pop

- Up Window

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

Exhibit 4

- 6: Chemical Identification Screen (Joint Submission)

................................ ................. 46

Exhibit 4

- 7: Class 1 or 2 Chemi cal Substances Screen (Joint Submission)

............................... 52

Exhibit 4

- 8: Class 2 Substances Screen (Joint Submission) (Scroll 1)

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

Exhibit 4

- 9: Class 2 Substances Screen (Joint Submission) (Scroll 2)

................................ ...... 56

Exhibit 4

- 10: Additional Chemical Information Screen (Joint Submission) (Scroll 1)

.................. 60

Exhibit 4

- 1 1: Additional Chemical Information Screen (Joint Submission) (Scroll 2)

.................. 61

Exhibit 4

- 12: Monomers and Other Reactants Screen (Joint Submission) (Scroll 1)

................. 69

Exhibit 4

- 13: Monomers and Other Reactants Screen (Joint Submission) (Scroll 2)

................. 70

Exhibit 4

- 14: Production Volume and Hazard/Safety Information Screen (Joint Submission)

.... 73

OPPT MTS Section 5 Notices and Supports User Guide December 17, 2014 Secondary Authorized Official ivExhibit 4

- 15: Use Information Screen (Joint Submission) (Scroll 1)

................................ ........... 77

Exhibit 4

- 16: Use Information Screen (Joint Submission) (Scroll 2)

................................ ........... 78

Exhibit 4

- 17: Physical and Chemical Properties Worksheet Screen (Joint Submission) (Scroll 1)

................................ ................................ ................................ ................................ .............. 85

Exhibit 4

- 18: Physical and Chemical Properties Worksheet Screen (Joint Submission) (Scroll 2)

................................ ................................ ................................ ................................ .............. 86

E xhibit 4

- 19: Physical and Chemical Properties Worksheet

– Continued (Optional) Screen (Joint Submission)

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

Exhibit 4

- 20: Physical and Chemical Properties Workshee t

– Continued (Optional) Attach Documents Pop

- Up Window (Joint Submission) (Scroll 1)

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

Exhibit 4

- 21: Physical and Chemical Properties Worksheet

– Continued (Opt ional) Attach Documents Pop

- Up Window (Joint Submission) (Scroll 2)

................................ ........................ 91

Exhibit 4

- 22: Site Information Screen (Joint Submission)

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

Exhibit 4

- 23: Sites Controlled By Others Screen (Joint Submission)

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

Exhibit 4

- 24: Submitter Opera tion Information Screen (Joint Submission) (Scroll 1)

................. 99

Exhibit 4

- 25: Submitter Operation Information Screen (Joint Submission) (Scroll 2)

............... 100

Exhibit 4

- 26: Occupational Exposures Screen (Joint Submission)

................................ ........... 103

Exhibit 4

- 27: Environmental Releases Screen (Joint Submission)

................................ ........... 107

Exhibit 4

- 28: Industrial Sites Controlled By Others Screen (Joint Submission)

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

Exhibit 4

- 29: Exposures/Releases Screen (Joint Submission) (Scroll 1)

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

Exhibit 4

- 30: Exposures/Releases Screen (Joint Submission) (Scroll 2)

................................ . 115

Exhibit 4

- 31: Byproduct Information Screen (Joint Submission)

................................ .............. 117

Exhibit 4

- 32: Optional Pollution Prevention Screen (Joint Submission)

................................ ... 120

Exhibit 4

- 33: Additional Attachments Screen (Joint Submission)

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

Exhibit 4

- 34: Attachment Summary Screen (Joint Submission)

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

Exhibit 4

- 35: Optional Cover Letter Screen (Joint Submission)

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

Exhibit 4

- 36: Upload XML Screen

................................ ................................ ........................... 128

Exhibit 5

- 1 General Form Information Screen (Joint Biotechnology)

................................ ....... 131

Exhibit 5

- 2: Technical Contact Information Screen (Joint Biotechnology)

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

Exhibit 5

- 3: Add Technical Contact Pop

- Up 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 Cont act Information Screen

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

Exhibit 6

- 3: Technical Contact Information Screen

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

Exhibit 6

- 4: Chemical Identification Information Screen

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

Exhibit 6

- 5: Polymer Identification Information Screen

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

Exhibit 6

- 6: Monomers and Other Reactants Screen

................................ .............................. 155

Exhibit 6

- 7: Use Information Screen

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

Exhibit 6

- 8: Document Management Screen

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

Exhibit 6

- 9: Optional Cover Letter Screen

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

OPPT MTS Section 5 Notices and Supports User Guide December 17, 2014 Secondary Authorized Official vExhibit 7

- 1 : Preview Biotechnology Form Screen

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

Exhibit 7

- 2 : Preview Biotechnology Form PDF

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

Exhibit 8

- 1: Section 5 Notices and Supports Validation Pop

- Up Window

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

Exhibit 9

- 1: Submitting Official Information Screen

................................ ................................ .. 167

Exhibit 9

- 2: Submitting On Behalf Of Screen

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

Exhibit 9

- 3: Submission Process: Validation Screen

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

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 (CROMERR) 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

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

Exhibit 11

- 2: Unlock Prompt Message

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

Exhibit 12

- 1: Resources Screen (Scroll 1)

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

Exhibit 12

- 2: Resources Screen (Scroll 2)

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

OPPT MTS Section 5 Notices and Supports User Guide December 17, 2014 Secondary Authorized Official 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 S. Young

J. Ritchey 09/20 /13

12/ 17 /14 1.0 Final Section 5 Notices and Supports Secondary AO User Guide
Incorporated OPPT comments give n on 11/07/2013

Incorporated Release 1.00 enhancements, other OPPT

comments C. Yeh J. Bronick 12/ 17 /14

OPPT MTS Section 5 Notices and Supports User Guide December 17, 2014 Secondary Authorized Official 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 forms application submission process

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

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

- based tool provided by the

E nvironmental P rotection A gency (EPA) for the submission of Section 5 Notices and Supports
data. As a Secondary AO, you can create or modify a Joint Submission/Letter of Support for a
Section 5 Notices and Supports form as well as submit it to the Central Data Exchange ( CDX )

. You can also delete Section 5 Notices and Supports forms, submit amendments to Joint forms

, and download the Copy of Record (CoR)

. For questions concerning the Tox ic Substances Control Act (TSCA) Section 5 Notices and Supports software requirements, please contact the CDX Help Desk at helpdesk@epacdx.net or call 1

- 888

- 890

- 1995 between the hours of 8 am

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

- Hotline@epamail.epa.gov or call 202

- 554

- 1404 between the
hou rs of 8:30 am

– 5:00 pm EST.

OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 1

### 2 System Requirements

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

• An e

- mail account

• JavaScript enabled web browser

• Internet access

• Adobe Acrobat Reader 5.0 or higher

• CDX username and password

2.1 Supported Browsers

• Internet Explorer (IE) 7 or above (Internet Explorer 8 or higher is recommended; issues

found using IE 7 will be resolved on a case

- by

- case basis during post

- production and known
issues within IE 7 are identified wi thin the appropriate sections of this guide)

− Go to the following link to download:

http://windows.microsoft.com/en

- US/internet

- explorer/downloads/ie

• Mozilla Firefox 3. 0 or above

− Go to the following link to download:

http://www.mozilla.com/en

- US/firefox/all

- older.html

• Safari 4 or above

− Go to the following link to download:

http://support.apple.com/kb/dl877

• Google Chrome

− Go to the following link to download:

http://www.google.com/chrome

• Opera

− Go to the following link to download:

http://www.opera.com/download

2.2 Screen Resolution

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 2

### 3 Secondary Authorized Official Functions

This section describes how to:

• Access the a pplication

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

• Assign Support s to complete a Letter of Support or Joint Submission

• Start , complete, and submit the Section 5 Notices and Supports Letters of Supports and Joint

Submissions for a Prema nufacture Not ice (PMN), Biotech nology

, or Letter of Support for a
Bona Fide

• Upload an Extensible Markup Language (XML) file

• Download a Copy of Record

• Create a n amendment for Joint Submissions and/or Letter of Supports
The Secondary AO has the ability to submit Joint Submissions and/or L etters of S upport, and is legally responsible for the information submitted to EPA. The Secondary AO is typically a senior official with management responsibility for the person(s) completing the form. The Secondary AO can create

, delete, and unlock submitted Joint Submissions and or/Letters of Support for creating amendments . The Secondary AO is responsible for restricting the Secondary Support’s (and other authorized individuals) access to select forms by using the user

managemen t functionality within the system. The system uses Cross

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

The Secondary AO creates a new J oint Submission or L etter of S upport and delegates to the

S econdary Support to fill out required sections of the form.

The Secondary AO is responsible for receiving the unique identification number that will be sent after an original PMN , Biotechnology, or Bona Fide form is submitted and designated by the Primary Submitter as a Joint Form and/or Letter of Support form . The Joint Submission or Letter of Support will not be created until the Secondary AO creates a passphrase for a form. To link
the Joint Form to the primary form , a user will enter the unique identif ication number

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

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 3Exhibit 3

- 1 displays a table of the capabil ities 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 Authorized Officia l’ link for the Chemical Safety and Pesticide Programs (CSPP) data flow to navigate to the ‘ Chemical
Information Submission System ’ screen.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 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, select ‘ TSCA Section 5 Notices and Supports

– ePMN ’ from the submission type drop

- down menu and click the ‘ OK ’
button.

3.2 Home Screen Navigation

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

– ePMN ’ from the submission type drop

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 5The Section 5 Notices and Supports ‘Home’ screen is the first screen within the Section 5 Notices and Supports application. It provides you with links and tabs to access the ‘Section 5 Notices and Supports Forms,’ ‘User Management,’ and ‘Resources’ screens. To navigate to any of these screens, click the corresponding screen link (highlighted in blue text), or click the screen tab (located within the application header). The links and tabs provide the same functionality.

There is a ten (10) minute logout timer for this application; the application will aut omatically log you out after ten minutes of inactivity and navigate you back to the CDX login screen.

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

Forms’ screen. You can create

, modify , or delete a Section 5 Not ices 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 Error! Reference
source not fou nd.

.

• User Management: Click the ‘User Management’ link or tab to navigate to the ‘User

Management’ screen. You can manage the access rights of Supports per form alias using the ‘User Manage ment’ screen. For additional details about the ‘User Management’ screen, please refer to Section Error! Reference source not found.

.

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

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

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 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 ‘ User Management ’ link or tab to access the ‘ User Management ’ screen and assign Supports

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 73.3 User Management

You can access the ‘User Management’ screen by clicking the ‘User Management’ link on the Section 5 Notices and Supports ‘Home’ screen or by clicking the ‘User Management’ ta b from the application header.

On the ‘ User Management ’ screen, y ou have the ability to assign one or more Supports to have access to modify any of the Section 5 Notices and Support forms you have created. You can also assign different Supports to fill out the Section 5 Notices and Supports submission for each form
alias.

Form Alias : A form alias will not be available in this menu until it has been created. Select a
form alias from the drop

- down menu to begin assigning Supports

. Once a form alias has been selected, the ‘ Assign Users ’ group box will update to display only the Supports who have identified you as their AO during CDX registration

. Form Information: This box shows information pertaining to the form you selected from the ‘Form Alias’ drop

- down menu.

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

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

form.

• F orm Type: Displays the type of form, which may include ‘Primary PMN,’

‘Biotechnology,’ or ‘Bona Fide.’

• Form Subtype: This value will be blank for Secondary AOs since this value is disjointed

from the form information displayed.

• Last Modified: Displays the date the form was last modified.
Assign Users: This box shows all the Supports you can assign to complete a Section 5 Notices and Supports form for the form alias selected. To move Supports from the ‘ Unassigned ’ group box to the ‘ Assigned ’ group box

, highlight the individual or multiple Support ( s ) and click the

‘ add >> ’ button.

• Unassigned: This box/field contains the registered Supports associated with the AO who

could potentially be assigned to access and edit the selected form

. To move Supports fro m the ‘Unassigned’ group box to the ‘Assigned’ group box, highlight an individual or multiple Support(s) and click the ‘add >>’ button. To highlight multiple Supports hold down the <Ctrl> key on your keyboard while clicking each Support . To highlight multi ple consecutive Supports, hold down the <Shift> key on your keyboard while clicking the first and last Support s in the list

.

• Assigned: This box/field contains the registered Supports given permission, by the AO , to

access and edit the selected form. This group box shows all the Supports that are assigned to complete the Section 5 Notices and Supports form for a single form alias . To move Supports
from the ‘ Assigned ’ group box to the ‘ Unassigned ’ group box highlight individual or multiple Supports and click the ‘ << remove ’ button. To highlight multiple Supports hold down the <Ctrl> key on your keyboard and click each Support . To highlight multiple
consecutive Supports hold down the <Shift> key on your keyboard and click the first and last Support s in the lis t

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 8• Add >>: Click the button to move Supports from the ‘Unassigned’ box to the ‘Assigned’
box.

• << Remove: Click the button to move Supports from the ‘Assigned’ box to the ‘Unassigned’

box.

When you have finished assigning the Supports

, click the ‘ Save ’ butt on that displays after selecting a form to save the selection.

Exhibit 3

- 4 shows a screen capture of the ‘User Management’ screen:

Exhibit 3

- 4 : User Management Screen

Navigation: Click the ‘ Forms ’ tab located within the application header to navigate to the

‘ Section 5 Notices and Supports Forms ’ screen and start a new form

. 3.4 Section 5 Notices and Supports Form s

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 9Only one Section 5 Notices and Supports form is created per form alias . Each column with in the
table of the ‘Section 5 Notices and Supports Forms’ screen can be sorted by clicking the
individual column headers.

Start New Form : To create a new Section 5 Notices and Supports 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 your particular form. Make sure to create a passphrase that you will remember, as it cannot be retrieved or reset. Refer to Se ction 3.5 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 that has a status of ‘ In P rogress. ’ You will be required to enter the passphrase associated with that particular form to access and edit the form. Refer to Section 0 for fur ther instructions on viewing and modifying a form that is ‘In Progress.’

Amend a s ubmitted form : To edit an already submitted Section 5 Notices and Supports form (i.e., to create an amendment ), you must first unlock the particular form by clicking the ‘ Lock ’
icon ( ) under the ‘Action’ column. You are required to enter the passphrase associated with that particular submission to gain access and amend the submission . All changes that are made
will be submitted as an amendment . Refer to Section 0 for fur 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 provided on the ‘General Form Information,’ ‘General

Document Information,’ or ‘Contact Information’ screen. The ‘Alias’ column will display a default alias comprised of a form type, date stamp, and time stamp in the following for mat: <Form Type

- YYYYMMDD

- HH:MM:SS Time Zone> if you accept the system

- generated ‘Form Alias’ on the first screen in a Section 5 Notices and Supports form. A form alias is helpful when a user or company has multiple forms and/or when you must differentiate
between forms. Click the form alias link to navigate to the ‘Enter Passphrase’ screen to
access a form.

• Type: Displays the form type pertaining to the reported chemical substance or mixture. This

column can contain the following values: ‘ Joint PMN, ’ ‘ Joint Biotechnology, ’ or ‘ Joint Bona
Fide. ’

• Subtype: This column will not populate for a Secondary Authorized Official.

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

or mixture after EPA receives the submission. A consolidated submission will generate sequential case numbers for each chemical identified within the form. Case numbers will not be sequential for joint consolidated submissions. If the form has not been submitted and received, the field remains blank.

• 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 10• Submission Date: Displays the date the form was submitted to EPA via CDX. This date populates only after the form has been submitted.

• Copy of Record: Click the ‘Copy of R ecord’ icon ( ) to navigate to the ‘Enter Passphrase’

screen , then the ‘Cross

- Media Electronic Reporting Regulation (CROMERR) Login’ screen

to continue to the ‘Copy of Record’ screen. The ‘Copy of 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 minutes 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 delete a form. This column d isplays a ‘Lock’ icon ( ) for all forms that have been submitted. Only an AO can unlock a form by clicking the ‘Lock’ icon ( ) and
unlocking the form. The form will remain unlocked and display the ‘Unlocked’ icon ( ) until the form is resubmitted by a Secondary AO.

• Export Opti ons: 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), XML , or Portable Document Format (PDF). The expo rt options 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 11Exhibit 3

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

Exhibit 3

- 5 : Section 5 Notices and Supports Forms Screen

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

3.5 Create Passphrase

To start a new Section 5 Notices and Supports Joint/Letter of Support PMN, Biotechnology, or Bona Fide form, click the ‘Start New Form’ button. The ‘ Create Passphrase ’ screen provides a
text field for you to enter in the unique identifier supplied by the Primary AO and c reate a passphrase to associate that passphrase with the form.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 12The 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 individu als.

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

. Unique Identifier: Enter 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 same passphrase with multiple
forms

. You will be responsible for remembering the passphrase and distributing it to only
authorized Supports for an individual form . If you forget the passphrase, y ou will not be

able to access the Section 5 Notices and Supports form to print, submit, or make changes.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 13Exhibit 3

- 6 shows a screen capture of the ‘Create Passphrase’ screen for a Secondary Authorized
Official:

Exhibit 3

- 6 : Create Passphrase Screen

Naviga tion: Enter a ‘Unique Identifier ,’ c reate 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 B ona F ide form.

3.6 Enter Passphrase

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

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

screen requires you to enter the passphrase that is associated with the form

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

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 14Exhibit 3

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

Exhibit 3

- 7 : Enter Passphrase Screen

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

. 3.7 Navigation Tree

The navigation t ree is located on each screen on the left hand side. 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. Likewis e, 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. When a folder is expanded, you can click the minus sign (

- ), the ‘Folder’ icon ( ), or the fo lder title link to collapse that section of the navigation tree. When a folder is collapsed, you can click the plus sign (+), the ‘Folder’ icon ( ), or the folder title link to expand that section of the navigation tree. When you place your cursor over a f older title link, it will highlight in red.

• Navigate between screens: You can use the navigation tree to navigate between the various

screens within the application and the different sections of the form. A ‘Form’ icon ( )

denotes each section of a form. Click a ‘Form’ icon ( ) or a section title link to navigate between screens. You are required to save all information entered on a particular screen

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 15before navigating to the next screen or all entered information will be lost. A prompt will appear after yo u click a link in the navigation tree indicating, ‘Are you sure you want to leave the current page? Any unsaved changes will be lost.’ Click the ‘OK’ button to navigate to the requested screen without saving any of the data in the previous screen. Click th e ‘Cancel’ button to close the prompt and remain on the current screen.

Exhibit 3

- 8 shows a screen capture of the navigation prompt pop

- up window:

Exhibit 3

- 8 : Navigation Prompt Pop

- Up Window

• Delete c hemical f olders: To delete specific chemical folders, a ‘Delete’ icon ( ) displays at the bottom of each chemical folder within the navigation tree of a PMN form. When a chemical folder is deleted, all information entered within the deleted chemical folder is lost and cannot be retrieved. You can add a new chemical folder by c licking the ‘Add Consolidated Chemical’ link, and filling in all corresponding data. This delete functionality is not applicable to the Biotechnology or Bona Fide form.

• Copy c hemical folders: To copy a specific chemical folder, click the ‘Copy’ icon ( ) t hat

displays at the bottom of each chemical folder within the navigation tree of a PMN form. When a chemical folder is copied, the chemical name, Chemical Abstracts Service Registry Number (CASRN), and attached documents are removed from the copied chemica l. This copy functionality is not a pplicable to the Biotechnology or Bona Fide module.

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

the ‘Delete’ icon ( ) that displays a t the bottom of each ‘Submitter Controlled Op erations’ or ‘Operations Controlled by Others’ folder within the navigation tree to delete a specific operations folder . When a ‘Submitter Controlled Operations’ or ‘Operations Controlled by Others’ folder is deleted, all information entered within the del eted operation is lost and
cannot be retrieved. Click the ‘Add Operation’ link under the appropriate operations folder and fill in all corresponding data to add a new ‘Submitter Controlled Operations’ or ‘Operation Controlled by Others’ folder. The delete functionality is not applicable while a user is navigating on a screen within the ‘Operations Controlled by Others’ folder. This delete functionality is not applicable to the Biotechnology or Bona Fide module within the Section 5 Notices and Supports appli cation.

• Upload XML: The system displays an ‘Upload XML’ button in the navigation t ree to allow

a user to upload an XML file into a PMN form or j oint 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
overwrites the contents within the PMN form. For more information about the upload XML functionality, refer to Section 4.1.27

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 16Please note that in IE 7, the scroll bar within the navigation tree may freeze or portions of the scroll bar may be missing which can prevent you from using the navigation tree . If the scroll bar freezes, click the ‘Previous’ and ‘Next’ buttons on a page to navigate, or click other links within the navigation tree to continue within the form.

Exhibit 3

- 9 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 1) :

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 17Exhibit 3

- 9 : Premanufacture Notice Navigation Tree (Scroll 1)

Exhibit 3

- 10 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 2):

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 18Exhibit 3

- 10 : Premanufac ture Notice Navigation Tree (Scroll 2)

Exhibit 3

- 11 shows a screen capture of the Premanufacture Notice navigation tree (Scroll 3):

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 19Exhibit 3

- 11 : Premanufacture Notice Navigation Tree (Scroll 3)

Exhibit 3

- 12 shows a screen capture of the Biotech nology n avigation tree:

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 20Exhibit 3

- 12 : Biotech nology Navigation Tree

Exhibit 3

- 13 shows a screen capture of the Bona Fide navigation tree (Class 1 or 2 chemical substances):

Exhibit 3

- 13 : Bona Fide Navigation Tree (Class 1 o r 2 Chemical Substances)

Exhibit 3

- 14 shows a screen capture of the Bona Fide navigation tree (polymer):

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 21Exhibit 3

- 14 : Bona Fide Navigation Tree (Polymer)

3.8 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 Not ices and Supports Validation’ pop

- up window generates
when you click the ‘Validate’ icon ( ) if you disable the pop

- up blocker within your
internet browser . The ‘Section 5 Notices and Supports Validation’ pop

- up window displays a report of all warning mess ages and validation errors. On screens that display an expandable/collapsible field set, you must click the ‘Save’ button displayed within the expandable/collapsible field set to save the information entered within the field set before the
‘Validate’ funct ionality initiates. Refer to Section 8 for more information on validating a
form

. The following exhibits

, Exhibit 3

- 15

, Exhibit 3

- 16 : Action Bar

– Save

, Exhibit 3

- 17 , and Exhibit 3

- 18 sh ow a screen capture s for the action b ar:

Exhibit 3

- 15 : Action Bar

– Validate

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 22• Save: Click the ‘Save’ icon ( ) at any stage of completing a Section 5 Notices and Supports
form to save the form

. To generate and access links to other pages of the form within the navigation tree, you must click the ‘Save’ icon ( ) within the action bar. After you click the ‘Save’ icon ( ), you will receive a prompt indicating that all data entered in the form has
be en saved suc cessfully. The save function does not validate any entered data. On screens that display an expandable/collapsible field set, you must click the ‘Save’ button displayed within the expandable/collapsible field set to save the information entered before being able

to click the ‘Save’ icon ( ) located within the action bar or use th e ‘Previous’ and ‘Next’
buttons to navigate to another page

. Click the ‘Previous’ and ‘Next’ buttons on a form to save
the data entered within a form. Click the ‘X’ butt on 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 completing a Section 5 Notices and

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

- CBI version if th e 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 PD F.

Exhibit 3

- 17 : Action Bar

– Preview

• Submit: As a Secondary AO you have the ability to click the ‘ Submit ’ icon ( ) to submit

Letters of Support, Joint Forms, and/or amendments to Joint Forms or after yo u or the Support have completed all sections of the Section 5 Notices and Supports submission

process. After you click the ‘Submit’ icon ( ) a pop

- up message displays to confirm the submission process. The form validates during the submission process and displays any applicable warning or error messages. Refer to Section Error! Reference source not found. for further instructions on validation errors. You can continue the submission process only after clearing all validation errors. Validation warnings will not prevent you from submitting
a form. Upon s uccessful submission of a form, the application generates and sends an email indicating the successful submission of the form to the submitter’s email address. Refer to
Section Error! Reference source not found. for more information on submitting a Section 5 Notices and Supports form.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 23Exhibit 3

- 18 : Action Bar

– Submit

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

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

of completing a Section 5 Notices and Supports form.

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

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

screen.

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

− If you clic k 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 action bar ‘ Help’ links:

Exhibit 3

- 19 : Action Bar

– Help Links

3.9 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’ checkbox, 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 applica tion will delete the previously attached file.

After you upload a document to be attached, the ‘Attach Documents’ pop

- up window will close and the document’s information will display in a table format on the screen. Depending on the screen, the attachme nt table may display the section of the page the file is associated with, the

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 24file name and file extension of the document, a description of the document, the number of pages in the document, and if the document was claimed CBI. The system allows you to de lete unwanted documents by clicking the ‘Delete’ icon ( ) located under the ‘Actions’ column. To view, open, or edit previously attached documents, click the appropriate file name of the
document within the ‘File Name’ column of the document table to view previously entered
document information.

Please note that in IE 7, the ‘Cancel’ button within the ‘Attach Documents’ pop

- up window disappears and reappears when checking the ‘CBI’ checkbox.

• Type: Select the document type of the document that you upload. This drop

- down menu

contains the following values: ‘Aquatic Ecotoxicity,’ ‘Chemical Structure Diagram,’ ‘Fate,’

‘ gel

- permeation chromatography ( GPC ) ,’ ‘Genetic Toxicity,’ ‘Health Toxicity,’ ‘IES Report,’ ‘Safety Datasheet,’ and ‘Terrestrial Ecotoxicity’ f or PMN and Biotechnology forms. This drop

- down menu contains ‘Spectrum of Substance,’ ‘Statement of Commercialization,’ ‘Statement of Research and Development,’ and ‘Other’ for Bona Fide forms. This is a required field.

• Subtype: Select the document type of the document that you upload. This drop

- down menu

contains the following values, which are grouped under specific document types: ‘Partitioning (e.g., Koc, Kd, Kow, Koa, Henry’s law constant),’ ‘Hydrolysis,’ ‘Fugacity,’ ‘Photolysis,’ ‘Monitoring data (e.g . air, water, soil, biota, human),’ ‘Biodegradation,’ ‘Bioconcentration Factors/Bioaccumulation Factors (BCF/BAF),’ ‘Material Safety Data Sheet/Safety Data Sheet (MSDS/SDS),’ ‘Technical Datasheet,’ ‘Eye Irritation,’ ‘Combined Repeated

- Dose/Developmental/Re productive Toxicity,’ ‘Sensitization,’ ‘Carcinogenicity,’ ‘Repeated

- Dose Toxicity,’ ‘Neurotoxicity,’ ‘Acute Toxicity,’ ‘Developmental Toxicity,’ ‘Pharmacokinetics/Metabolism,’ ‘Dermal Irritation,’ ‘Reproductive Toxicity,’ ‘Fish Chronic Toxicity,’ ‘Inverteb rate Acute Toxicity,’ ‘Invertebrate Chronic Toxicity,’ ‘Algae Toxicity,’ ‘Fish Acute Toxicity,’ ‘Chromosomal Aberrations Assay,’ ‘Unscheduled DNA Synthesis,’ ‘Genetic Mutation Assay,’ ‘Plant Toxicity,’ ‘Invertebrate Toxicity,’ ‘Avian Toxicity,’ and
‘Other. ’ Document subtypes are not applicable to a Bona Fide form. This is a required field when displayed.

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

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

.

• Description: Enter a description associated with the attached document. Submitters should

not include any CBI information in the document description. This is a required field.

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

PMN or Biotechnology form. This field is not applica ble to a Bona Fide form.

• 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 wil l delete the sanitized file. This checkbox is not applicable to a Bona Fide form.

• Sanitized 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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 25file types: .pdf, .ppt, .pptx, .xls, .xlsx, .doc, .docx, .rtf, .txt, .gif, .jpg, .png, .bpm, .fas, .gbk, or .embl . For any attached document claimed as CBI, you will be required to attach a sanitized version of the document. This field is not app licable to a Bona Fide form.

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

• OK: Click the ‘OK’ button to attach and link the document uploaded on the ‘Attach

Documents’ window to the form. If a field is missing, a warning messag e will display notifying you that all attachments must be re

- attached and the missing field must be populated.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 26Exhibit 3

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

- up window that displays within the majority of forms :

Exhibit 3

- 20 : Attach Documents Pop

- Up Window

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

- hand corner to cancel the document attachment process. Click the ‘OK’ button to attach the document to the form and navigate back to the original screen from which the document attachment process was initiated.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 273.10 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’ pop

- up window. You can search for the reported chemical(s) by either the ‘Chemical Abstracts Service Registry Number (CASRN)’ or ‘CA Index Name or Other Synonym.’ The application also offers the option of entering user

- specified chemical information by clicking the ‘Create New Chemical’ button. Click the ‘Create New Chemical’ button to generate the ‘Chemical Not Found In Substance Registry Services’ pop

- up window and enter chemical
information by filling in the ‘Chemical Name’ and ‘CASRN’ (if desired) field under the manual entry field set.

The system allows you to enter each chemical by clicking the ‘OK’ button located at the bottom of the ‘Search SRS’ window. Once you enter all known chemic al information and click the ‘OK’ button, the chemical information saves and populates into the chemical description table. The ‘Actions’ column of the chemical table allows you to delete chemicals that have been added.

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

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

• If both chemicals have CASRNs, they will be compared

.

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

• If neither chemicals have CASRNs, their chemical names will be compared

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

- component submission.

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

• CASRN: Enter the chemical abstracts service registry number of the chemical ; this field

accommodates das hes . 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: ‘M atches Exactly,’ ‘Contains,’ and ‘Begins With.’ Either the ‘CASRN’ or ‘CA Index Name or Other Synonym’ field is required when searching SRS.

• Search SRS : Click the ‘Search SRS’ button to initiate the database search for the ‘ CASRN ’

or ‘ CA Index Name or Oth er Synonym ’ for the desired chemical.

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

Not Found In Substance Registry Services’ pop

- up window.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 28Exhibit 3

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

- up window:

Exhibit 3

- 21 : Search Substance Registry Services Pop

- Up Wind ow

Navigation: Click the ‘Search SRS ’ button on the ‘Sear ch Substance Registry Services’ window to initiate the database search for the ‘CASRN’ or ‘CA Index Name or Other Synonym.’ After SRS returns results, select the radio button associated to a chemical, click the ‘OK’ button on the ‘Search SRS’ window, close the ‘Search Substance Registry Services’ window, and navigate
back to the screen from which the SRS search was initiated where the chemical information will be populated.

If the chemical is not found in the ‘Search Substance Registry Services’ window, click the ‘Create New Chemical’ button to generate the ‘Chemical Not Found In Substance Registry Services’ pop

- up window.

• CBI: Check the ‘CBI’ checkbox to claim the entered chemical as confidential

.

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

• CASRN: Enter the CASRN , if available

.

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

only in the ‘Chemical Not Found In Substance Regist ry Services’ window on the ‘Additional
Chemical Information’ screen.

• Cancel: Click the ‘Cancel’ button to navigate back to the ‘ Search Substance Registry

Services’ pop

- up window.

• OK: Click the ‘OK’ button to enter the manually entered chemical informati on into the fields

on the screen from which the SRS search was initiated.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 29Exhibit 3

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

pop

- up window:

Exhibit 3

- 22 : Chemical Not Found In Substance Registry Services Pop

- Up Window

Navigation: Click the ‘OK’ button to save the sp ecified chemical information and navigate back
to the screen from which the SRS search was initiated where the chemical information will be populated. Click the ‘Cancel’ button to navigate back to the ‘Search SRS’ pop

- up window. Click
the ‘X’ located in th e upper right corner to close the pop

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

3.11 Add Facility

The ‘ Add Facility ’ button displays on the ‘Submitter Operation Information’ screen and the ‘Industrial Sites Controlled By Others’ screen within a Joint 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 whi ch you will be reporting. The ‘Add Facility’ drop

- down menu contains the sites that all AO users within the same organization are registered for within CDX registration; additional facilities can be added within CDX to further populate this drop

- down menu.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 30If you are not registered to any facilities within CDX registration, or you have finished identifying all possible sites, a message displays within a pop

- up window notifying you to add additional sites within your CDX registration profile to add addition al sites to a form.

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

- up window which displays the following fields: ‘Select a site from the drop

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

• Select a site from the drop

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

from the drop

- down menu

.

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

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

pending for the form.

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

- down

menu.

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

- down menu.

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

- down menu

.

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

- down menu

.

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

- down menu.

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

- down menu.

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

initiating the search.

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 31Exhibit 3

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

- up window:

Exhibit 3

- 23 : Add Facility Pop

- Up Window

Navigation: Click the ‘Add Facility ’ button to add the selected site to the screen from which you
init i ated the site identification process

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 32

### 4 PMN Secondary User

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 submission. A PMN must be submitted at least ninety ( 90 ) days prior to the manufacture or import of the chemical.

The PMN j oint process is a multi

- step process with coordinatio n needed on the parts of Primary
and Secondary users (including AOs and Agents/Consultants) . The Primary user will first identify that a Joint S ubmission and/ or Letter of Support (s) will supplement a form

. Based on the selection, the ‘Joint Submission’ fol der and/or ‘Letter of Support’ folder will generate in the navigation tree . Each folder will contain a section for the Primary user to enter contact
information and instruction information with the Joint and/or Letter of Support unique
identification numbe r (ID)

.
When the Primary user enters the relevant ‘Joint’ or ‘Letter of Support’ folder, the user will enter
the Secondary AO or Secondary Agent/Consultant’s contact information on the first screen. The Primary user will use the email address entered on this screen to send the Secondary user the unique identification number

. The next screen in the ‘Joint’ or ‘Letter of Support’ folder will display the unique identification number that will be sent to the Secondary AO or Secondary Agent/Consultant

, and a t ext box for the Primary user to provide instructions or information to
the Secondary user about what is to be filed.

The Secondary user will register in CDX as a Secondary AO and access the Section 5 Notices and Supports application. Once you arrive at th e ‘ Section 5 Notices and Supports Forms’ screen, click the ‘Start New Form’ button and navigate to the ‘Create Passphrase’ screen. For ‘Joint PMN’ and ‘Letter of Support’ forms

, the process will work the same ; other than being able to enter a foreign addre ss for ‘Letter of Support.’ Once the Secondary AO has created a new form and assigned a passphrase, the Secondary AO may enter the required information on the form

. On the ‘ Create Passphrase’ screen, the Secondary AO will enter the unique identification number
sent via email from the Primary AO’s form . Once the Secondary AO has entered the unique
identification number , the form will display.

4.1 Create Joint Submission

As a Secondary AO, you can start a new L etter of S upport or J oint S ubmission and assign y our Supports to complete the form

.
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 AO and creating a passphrase on the ‘Create Passphrase’ screen

. The
‘General Form Information’ screen allows you to identify information that is specific to the form type selected from the ‘ Section 5 Notices and Supports Forms ’ screen.

The ‘General Form Information’ screen provides fields to input identifying information for a specific form. You will have the option to assign a ‘Form Alias’ to identify the form. A unique form alias is helpful when a user or company has multiple forms and /or when you must differentiate between forms to the help desk. Upon navigating to the ‘General Form Information’ screen, the system auto

- generates a default alias comprised of a form type, date stamp

, and time stamp in the following format: <Form Type

- YYY YMMDD

- HH:MM:SS Time Zone>.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 33The ‘PMN Identification’ section provides fields for you to enter information regarding other communications with EPA by entering a ‘TS Number’ and ‘Payment ID.’ The TS number is determined by a company and is used to identify th e form for both payment and to connect related submissions when additional communications (Letters of Support, Joint Submissions, and corrections) are sent before a PMN/LVE case number has been assigned. The TS number can be any six (6) character alphanume ric combination. The TS number should include two (2), three (3), or four (4) letters. Company names, r ecognizable words, and numeric series are not recommended. A unique identification number for the form will generate later if a Letter of Support or Join t Submission is being filed.

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

- down menu. The following values will display as checkboxes: ‘ Environmental fate data ,’ ‘ Health effects data ,’

‘ Environmental effects data ,’ ‘ Physical/Chemical properties ,’ ‘ Risk assessments ,’

‘ Structure/Activity relationships ,’ ‘ Test data not in the possession or control of the submitter ,’
and ‘Other data.’ I f you check ‘Other Data

, ’ the system will not to allow you to enter in the specific other information. More often than not

, the remaining options under ‘Test Data’ 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, process ing, distribution in commerce, use, or disposal of the new chemical substance. Standard literature citations may be submitted for data in the open scientific literature. Complete test data (written in English), not summaries of data, must be submitted if t hey 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

req uirements of §720.50 of the Premanufacture Notification Rule (40 Code of Federal Regulations ( CFR ) Part 720).

• Form Alias: Enter the form alia s. Upon navigating to the screen, the screen will auto

generate an editable form alias in the following format: < F orm Type

- YYYYMMDD

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

.

• TS Number : Enter the TS number related to the PMN form; this field accepts any six (6)

character alphanumeric combination. It is used by the financial institution that receives
payment for E PA when it notifies the Agency that the fee has been received. The TS number should include two (2), three (3), or four (4) letters. Company names, r ecognizable words,
and numeric series are not recommended. TS numbers should be unique to th e submission

an d should not be reused in subsequent submission s

.

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

form contains environmental fate data.

• Health effects data: Check the ‘Health effects data’ checkbox to indicate that the form

contains health effects data.

• Environmental effects data: Check the ‘Environmental effects data’ checkbox to indicate

that the form contains environmental effects data.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 34• Physical/Chemical properties: Check the ‘Physical/Chemical properties’ checkbox to indicate that the form contains physical/chemical properties data.

• Test data not in the possession or control of the submitter: Check the ‘Test data not in the

possession or control of the submitter’ checkbox to indicate that the form contains test data not in the possession or control of the submitter.

• Risk assessments: Check the ‘Risk assessments’ checkbox to indicate that the f orm contains
risk assessments data.

• Structure/Activity relationships: Check the ‘Structure/Activity relationships’ checkbox to

indicate that the form contains structure

- activity relationships (SAR) data.

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

of data.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 35Exhibit 4

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

Exhibit 4

- 1 : General Form Information Screen (Joint Submis sion)

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 clicking the ‘Next’ button from the ‘General
Form Information’ screen

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 36The ‘Agent Information’ screen provides fields for you to enter info rmation regarding all parties involved in representing the PMN form . The agent should be a person who can answer questions about the form. The ‘Agent Information’ screen displays an ‘Add Agent’ button that generates the ‘Add Agent’ pop

- up window for you to input the contact information on behalf of whom the submission is being made. You will be able to enter multiple agents; if the agent is the same individual who is filling out the form, click the ‘Copy CDX Registration’ button to retrieve user
information entered during CDX registration. The system provides a checkbox for you to claim entered contact information as confidential by checking the ‘Check here to claim this information as CBI’ checkbox. Each agent will have an individual CBI claim. You will be able to enter contact information for each agent, and click the ‘OK’ button, which will populate the agent table located on the ‘Agent Information’ screen. Click the ‘Delete’ icon ( ) located under the ‘Actions’ column to delete agents. To edit agent infor mation, click the agent name link within the ‘Last Name’ column, which will generate the ‘Add Agent’ pop

- up window with the previously entered agent information.

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

- up window to

enter inf ormation 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.

• Addres s: Displays the mailing address of the reported agent.

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

• Actions: Click the ‘Delete’ icon ( ) to delete specific agents; a warning message displays to

confirm deletion of the agent information.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 37Exhibit 4

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

Exhibit 4

- 2 : Agent Information Screen (Joint Submission)

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

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

4.1.2.1 Add Agent

Click the ‘Add Agent’ button to gener ate 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 in formation on the main ‘Agent Information’ screen.

The identification of an agent is optional.

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

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

• Check here to claim this information as CBI: Check the ‘Check here to claim this

information as CBI’ checkbo x to claim agent information as confidential. If the ‘CBI’ checkbox is checked before clicking the ‘Copy CDX Registration’ button, the ‘CBI’ checkbox will become unchecked upon navigating back to the pop

- up window after copying

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 38CDX registration information. Check the ‘CBI’ checkbox after importing CD X registration
information to claim agent information as confidential

.

• First Name: Enter the agent’s first name. Click the ‘Copy CDX Registration’ button to

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

.

• Last Name: Enter the agent’s last name. Click the ‘Copy CDX Registration’ button to

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

.

• Position: Enter the agent’s job title.

• Company Name: Enter the agent’s company name. Click the ‘Copy CDX Registration’

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

.

• Phone Number: Enter the agent’s daytime phone number: U.S. or international. This field

does not allow dashes. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field only if agent information will be added
to the form

.

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

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

• Email Address: Enter the agent’s email addres s. 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: Ente r the second line of the agent’s mailing address. Click the ‘Copy

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

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

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

.

• State: Select the state of the agent’s mailing address from the drop

- down menu. Click the

‘Copy CDX Registration’ button to popu late the fields with CDX registration information. This is a required field only if agent information will be added to the form and if the ‘Country’ field is set to ‘United States.’ This field is disabled if a non

- US country is selected from the ‘Country’ drop

- down menu.

• Postal Code: Enter the postal code of the agent’s mailing address. Click the ‘Copy CDX

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

. ’
Country: Select the country of the agent’s mailing address from the drop

- down menu. Click the ‘Copy CDX Registration’ button to populate the fields with CDX registration information. This field is automatically set to ‘United States’ if a value is selected from th e

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 39‘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 the ‘X’ icon in the upper right

- hand corner to stop populating agent information and navigate back to the ‘Agent In formation’ screen. Click the ‘OK’ button to populate the entered agent information and navigate back to the ‘Agent
Information’ screen.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 404.1.3 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 tree.

The technical contact should be able to answer, or obtain answers to, questions related to the
chemical su bmitted to EPA within the joint PMN form or Letter of Support . The technical contact does not have to physically work at the site reported on the form, but must be readily available by phone or email. It is required to identify at least one technical conta ct.

The system provides functionality to enter multiple technical contacts. If the contact is the same person who is filling out the form, the system presents a ‘Copy CDX Registration’ button for you to retrieve your user information from CDX. You will en ter the contact information for each
technical contact within the ‘Add Technical Contact’ window and click the ‘OK’ button at the bottom of the window, which will populate the technical contacts table located on the ‘Technical

Contact Information’ screen. Click the ‘Delete’ icon ( ) located under the ‘Actions’ column to
delete a technical contact. Click the technical contact name within the ‘Last Name’ column to
edit technical contact information.

• Add Technical Contact: Click the ‘Add Technical Contact’ bu tton 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 Technica l Contact’ pop

- up window that contains previously
identified technical contact information to edit the technical contact information.

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

• Address: Displays the address of the reported tec hnical contact.

• CBI: Indicates the CBI status of the technical contact information by displaying either a ‘Y’

or an ‘N.’

• Actions: Click the ‘Delete’ icon ( ) to delete specific technical contacts. A pop

- up

generates to confirm the deletion of the techni cal contact information.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 41Exhibit 4

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

Exhibit 4

- 4 : Technical Contact Information Screen (Jo int Submission)

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 also 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 ‘A dd Technical Contact’ pop

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

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

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

• Check here to claim this inform ation as CBI: Check the ‘Check here to claim this

information as CBI’ checkbox to claim the technical contact information as confidential. If

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 42the ‘CBI’ checkbox is checked before clicking the ‘Copy CDX Registration’ button, the
‘CBI’ checkbox will become u nchecked upon navigating back to the pop

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

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

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

button to populate the fields wit h CDX registration information. This is a required field.

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

• Company Name: Enter the technical contact’s company name. Click the ‘Copy CDX

Registration’ button to populate the fields with CDX registration i nformation. This is a required field.

• Phone Number: Enter the technical contact’s daytime phone number. Click the ‘Copy CDX

Registration’ button to populate the fields with CDX registration information. This is a required field.

• Phone Extension: Enter the technical contact’s phone number extension. Click the ‘Copy

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

• Email Address: Enter the technical contact’s email address. The email address must follow

the standard email address format: John.Doe@abc.com

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

• Mailing Address 1: Enter the first line of the technical contact’s mailing address. Click the

‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field.

• Mailing Address 2: Enter the secon d line of the technical contact’s mailing address. Click

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

• City: Enter the technical contact’s U.S. city of the mailing address. Click the ‘Copy CDX

Registration’ bu tton to populate the fields with CDX registration information. This is a required field.

• State: Select the state of the technical contact’s mailing address from the drop

- down menu.

Click the ‘Copy CDX Registration’ button to populate the fields with CDX r egistration
information. This is a required field.

• Postal Code: Enter the postal code of the technical contact’s mailing address. Click the

‘Copy CDX Registration’ button to populate the fields with CDX registration information. This is a required field.
Country: Displays ‘United States.’

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 43Exhibit 4

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

- up window:

Exhibit 4

- 5 : Add Technical Contact Pop

- Up Window

Navigation: Click the ‘Cancel’ button or ‘X’ icon at the top right 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’ or
‘Chemical Identification’ link s within the navigation tree access the ‘Chemical Identification’

screen.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 44The ‘Chemical Identification’ screen identifies the type of chemical the submitter will be entering into the application. You will be able to file a Joint PMN form for a class 1 or 2 chemical substance or a polymer. Based on your selection, the appropriate screens for the respective chemical will appear. If you select the ‘Class 1 or 2 Chemical Substance’ radio button, click the ‘Save’ icon ( ) within the bottom action bar, or click the ‘Next’ button to generate the
‘Class 1 or 2 Chemical Substances’ screen within the navigation tree. If you identify the chemical as a polymer by selecting the ‘Polymer’ radio button, click the ‘Save’ icon ( ) within the bottom action bar, or click the ‘Next’ button to generate the ‘Polymer Identification
Information’ screen a nd the ‘Monomers and Other Reactants’ screen within the navigation tree.

This screen provides a field to identify an alias for the chemical substance , and allows you to identify chemicals in a consolidated chemical submission . The chemical alias is requir ed if a Joint Submission or Letter of Support is being filed and rename s the chemical folder within the navigation tree.

• Class 1 or 2 Chemical Substance: Select the ‘Class 1 or 2 Chemical Substance’ radio button

to indicate that the chemical is a class 1 or 2 substance. If you select the ‘Polymer’ radio button after initially selecting the ‘Class 1 or 2 Chemical Substance’ radio butto n, the application generates a confirmation message warning you that you will lose all data for this
chemical if the chemic al type changes. Selecting either the ‘Class 1 or 2 Chemical Substance’ or ‘Polymer’ radio button is required.

• Polymer: Select the ‘Polymer’ radio button to indicate that the chemical is a polymer. If you

select the ‘Class 1 or 2 Chemical Substance’ radio button after initially selecting the ‘Polymer’ radio button, the application generates a confirmation message warning y ou that you will lose all data for this chemical if the chemical type changes. Selecting either the ‘Class 1 or 2 Chemical Substance’ or ‘Polymer’ radio button is required.

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

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

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 45Exhibit 4

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

Exhibit 4

- 6 : Chemical Identification Screen (Joint Submissi on)

Navigation: If you selected the ‘Class 1 or 2 Chemical Substance’ radio button, click the ‘Next’ button to navigate to the ‘Class 1 or 2 Chemical Substances’ screen. You can also access this screen by clicking the ‘Class 1 or 2 Chemical Substances’ link within the navigation tree.

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

4.1.5 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’ button. You can also access this screen by clicking the ‘Class 1 or 2 Chemical Substances’ link within the navigation tree.

The ‘Class 1 or 2 Chemical Substances’ scr een provides fields for you to enter information describing the chemical for which the PMN is to be filed. This screen will outline the unique chemical properties that show the name, composition, and structure of the chemical. The system provides fields fo r you to identify several key aspects concerning a chemical’s identity.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 4 6For a single component submission, create the field set by clicking the ‘Add New Chemical’ button. Upon clicking the ‘Add New Chemical’ button, the application generates an expandable/collapsible field set containing numerous fields for you to enter inform ation pertaining to that particular chemical.

For a multi

- component submission, create another field set by clicking the ‘Add New Chemical’
button. Multi

- component chemical submissions occur when two or more chemicals are always generated together in a si ngle 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

w ith unique identifying information, by clicking the ‘Add New Chemical’ button for each additional chemical that is part of the multi

- component mixture. All multi

- component chemicals will reside in one chemical folder in the navigation tree. Duplicate chemi cals 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’ ra dio button on the ‘Class 1 or 2 Chemical Substances’ screen, click the ‘Next’ button to navigate to the ‘Additional Chemical Information’ screen. If you select the ‘Class 2’ radio button on the ‘Class 1 or 2 Chemical Substances’ screen, click the ‘Next’ bu tton to navigate to the ‘Class 2 Substances’ screen.

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

For a class 2 substance chemical structure diagram:

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

2) Describe the nature of the reaction or process.

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

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

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

• Add New Chemical : Click the button to generate the class 1 or 2 chemical substances

expanda ble/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 fi eld set is open for editing. A confirmation message di splays to confirm the action.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 47• 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 confirma tion message displays to
confirm the deletion.

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

- right of the

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

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

- right of the

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

• 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 will appear within the navigation tree after clicking the ‘Next’ button for you to enter information concerning how the chemical was created. If multiple ‘Class 2’ chemical components are added, only one ‘Class 2 Substances’ screen will generate that applies to all the component s. Check the ‘CBI’ checkbox to claim
the chemical substance class as confidential. Either the ‘Class 1’ or ‘Class 2’ radio button
must be selected.

• Class 1: Select the ‘Class 1’ radio button to identify the chemical as a ‘Class 1’ substance. A

‘Class 1’ substance is a single molecular entity that can be represented by a single, definite structural diagram. Either the ‘Class 1’ or the ‘Class 2’ radio button in the ‘B.1.a. Class of Substance’ section is required.

• Class 2: Select the ‘Class 2’ radio button to identify the chemical as a ‘Class 2’ substance. A

‘Class 2’ substance is a substance whose composition cannot be represented by a single, definite chemical structural diagram. Class 2 substances include substances of unknown, variable, or uncertain comp osition, 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’ checkbox to claim the ‘ Class of Substance’ as confidential.

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

Services’ pop

- up window. Refer to Section Error! Reference source not found. for additional details regarding the search SRS functionality.

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

Services’ pop

- up window, if applicable.

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

Substance Registry Services’ pop

- up window. For class 1 substances, a ‘Chemical Abstracts (CA) Index Name’ must be provided. For class 2 substances either a ‘CA Index Name’ or
‘CA Preferred Name’ mus t be provided, whichever is appropriate based on current CA nomenclature rules and conventions. This is a required field.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 48• CBI: Check the ‘CBI’ checkbox to claim the ‘Chemical Name’ field as confidential and generate the ‘Generic Chemical Name’ text field.

• B.6. Generic Chemical Name: Enter the generic name to associate with a chemical. This

field only displays when ‘CASRN’ and ‘Chemical Name’ are marked as ‘CBI.’ This is a required field if there is no pending Letter of Support or Joint Submission for the form

.

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

Service)’ radio button to identify the ID method as the CAS Inventory Expert Service (IES)
meth od and generate the ‘IES Order #’ field. A copy of the identification report obtained from the CAS Inventory Expert Services must be submitted as an attachment to this notice; an IES report is required. For a consolidated submission, each chemical must be ‘Method 1’ except when the submission is pending a Letter of Support for that chemical . In the case of an LVE/LOREX modification form type, this ‘Method 1’ requirement is not applicable. A single response option in the ‘B.1.c

. ID Method’ section is require d 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
Scien tific and Technical Information Network (STN) database report or a CAS Client Services report, qualifies as ‘Method 2.’ The chemical can be ‘Method 2’ if the consolidated submission is pending a Letter of Support. A single response option in the ‘B.1.c

. ID Method’ section is required if there is no pending Letter of Support or Joint Submission for
the form

.

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

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

• B.1.d. Molecular Formula: Enter the molecular formula associated with a chemical. The

molecular formula must g ive the correct identity and number of atoms of each element contained in the PMN molecule or a description if the substance is a class 2 material. The system will not allow subscrip ts 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 drop

- down menu. This drop

- down menu contains the following values: ‘Chemical Structure Diagram’ and ‘ID M ethod.’ 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 Error! Reference source not found. 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 t hat 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.’

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 49• Actions: Click the ‘Delete’ icon ( ) to delete the entire document ro w permanently from the
system; a warning message displays to confirm the deletion of the document.

• Save: Click the button to save the information entered within the expandable/c ollapsible 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’ a nd ‘Next’ buttons. Refer to Section
3.8 for more information regarding the save functionality in an expandable/collapsible field

set.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 50TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 51Exhibit 4

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

Exhibit 4

- 7 : Class 1 or 2 Chemical Substances Scre en (Joint Submission)

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’

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 52radio 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.

4.1.6 Class 2 Substances

You can access the ‘Class 2 Substances’ screen by clicking the ‘Next’ button from the ‘Class 1 or 2 Chemical Substances’ screen when you select the ‘Class 2’ radio button for the ‘Class of Substance’ field. You can also access this screen by clicking the ‘Class 2 Substa nces’ link within the navigation tree.

The ‘Class 2 Substances’ screen captures information regarding a class 2 chemical substance. A class 2 chemical substance is a substance that may not have a defined chemical structure that has
been identified. This screen provides fields to identify specific elements in the creation of the chemical using the following fields: ‘Precursor Substances,’ ‘Nature of Reaction,’ and ‘Range of Composition.’

Enter precursor substances by searching SRS or using manual entry whe n the substance is not in SRS. The selected substances will display in a table listing the ‘Chemical Name’ and ‘CASRN.’

The system provides fields to capture ‘Nature of Reaction’ and ‘Range of Composition’ in text boxes. The ‘Nature of Reaction’ and ‘Rang e of Composition’ text boxes can be claimed as CBI.

• B.1.e.1. Precursor Substances: This table captures the chemicals identified as immediate

precursor substances, along with the respective CASRNs, if applicable.

• CBI : Check the ‘CBI’ checkbox to claim the precursor substances information as

confidential.

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

Services’ pop

- up window. Refer to Section Error! Reference source not found. 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 t he ‘CBI’ checkbox to claim the range of composition information as

confidential.

• Attachments : Select the section of the page the document you intend to attach is associated

with from the drop

- down menu. This drop

- down menu contains the following values:

‘ B.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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 53• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documents’

pop

- up window and initiate the document up load process. Refer to Section Error! Reference
source not found. for further details regarding the attach document functionality.

• Section: Displ ays the section associated with a document.

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

Documents’ window.

• Description: Displays the description associated with a document.

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

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

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

system; a warning message di splays to confirm the deletion.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 54Exhibit 4

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

Exhibit 4

- 8 : Class 2 Substances Screen (Joint Submiss ion) (Scroll 1)

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 55Exhibit 4

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

Exhibit 4

- 9 : Class 2 Substances Screen (Joint Submiss ion) (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 I nformation

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 56the ‘Monomers and Other Reactants’ screen. You can also access this screen by clicking the ‘Additional Chemical Information’ link within the navigation tree. The ‘Additional Chemical Information’ screen captures information regarding the chemicals produced as byproducts and impurities when a chemical is manufactured. This screen also captures other names for the chemical at hand in the ‘Synonyms’ and ‘Trade Identification’
tables.
An ‘Impurities’ table displays i nformation regarding the impurities that may be reasonably anticipated to be in the respective chemical or polymer as manufactured for commercial purpose.
Click the ‘Search SRS’ button to access the ‘Search SRS’ pop

- up window and populate the ‘Impurities’ table . You will also be able to enter a chemical using the ‘Chemical Name’ and ‘CASRN’ field (if applicable) on the ‘Chemical Not Found In Substance Registry Services’ pop

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

A ‘Bypr oducts’ table 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 ‘Byproduc ts’ table. You may associate a CASRN with a byproduct (if applicable) and check the ‘CBI’ checkbox to claim a byproduct as confidential. Documents may be attach ed for the ‘Byproducts’ section if necessary.

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

necessary

. A ‘Trade Identification’ table provides fields to capture information about the trade names by which the respective chemical or polymer may be referred in documentation. There is no limit to
the number of trade names that may be added. You may attach document s associated with the
‘Trade Identification’ section t o provide additional information if necessary

.
The ‘Attach Documents ’ pop

- up window provides fields to upload documents r elated to the ‘Impurities,’ ‘Byproducts,’ ‘Synonyms,’ and/or ‘Trade Identification’ section(s). Select the section of the page the document is associated with from the ‘Section’ drop

- down menu, and
click the ‘Attach Document’ button to generate the ‘Attach Documents’ pop

- up window and
attach a document . The system provides a ‘CBI’ checkbox to claim the uploaded document as confidential. If you claim a document as CBI, the system requires you to upload the sanitized
version of the attached document.

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

The attachments table displays the section of the page the document is associated with, the file name and file extension of the document, the document description, the number of pages in the

d ocument, 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’

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 57column to generate the ‘Attach Documents’ pop

- up window to view and/or edit an attached
document.

• B.3. Impurities

– Search SRS: Click the ‘Search SRS’ button to display the ‘Search

Substance Registry Services’ pop

- up window. Refer to Section Error! Reference source not
found. for further details regarding the search SRS functionality.

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

did not intend to be pre sent with your PM N substance. List all known impurities that are present, regardless of their weight percent. List the expected maximum percentage of each impurity and indicate its confidentiality status. An impurity may be suggestive of chemical precursors or chemical pro cesses. Click the ‘Impurity’ link to navigate to the ‘Search Substance Registry Services’ pop

- up window to edit chemical information for an impurity.

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

applicable).

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

accepted

.

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

• Action: Click the ‘Delete’ icon ( ) to delete the entire impurity entry permanently f rom 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 Error! Reference source not
found. for further details regarding the search SRS functionality.

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

from t he 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 t he ‘Byproduct
Name’ link to generate the ‘Search Substance Registry Services’ pop

- up window to view and/or edit byproduct information. Provide the specific chemical name, CAS numbers if they can be determined, and the confidential status of the byproducts formed. If no byproducts are formed, enter “None” or leave the section blank.

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

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

• Action: Click the ‘Delete’ ico n ( ) 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 the chemical; there is a maximum of five chemical

synonyms that can be added in the ‘Synonyms’ table. Additional synonyms can be provided in an attachment. Synonyms include common chemical names used in scientific or technical literature, and code numbers or c ode names referenced in the PMN and its attachments. Indicate which synonyms may be proprietary and require CBI protection. Chemical name synonyms must be consistent with the chemical structure and thus not misleading. If you add a blank, editable line in this table and click the ‘Next’ button, no error will display indicating

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 58that the blank line should be saved or deleted. If text is entered in a blank field and you click the ‘Next’ button, the application will save the entered value. If you click the ‘For m’ icon

( ), 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 chemi cal 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 n ot 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 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 enter ed value. If you click the ‘Form ’ icon ( ) , change the entered value(s) an d 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 identifi cation name . Click the ‘Form’ icon ( ) to edit a trade identification name . Click the ‘Delete’ icon ( ) to delete a previously added trade identification name.

• Attachments : Select the section of the page with which the document is associated from the

drop

- down menu. This drop

- down menu contains the following values: ‘Byproducts
Section ,’ ‘Impurities Section ,’ ‘Synonyms Section ,’ and ‘Trade Identification Section.’

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

pop

- up window. Refer to Section Error! Reference source not found. for further details regarding the attach document functionality.

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

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

‘Attach Documents’ pop

- up window.

• Description: Displays the description associated with a do cument.

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

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

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

from the syste m; a warning message displays to confirm deletion of the document.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 59Exhibit 4

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

Exhibit 4

- 10 : Additional Chemical Information Screen (Joint Submission) (Scroll 1)

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 60Exhibit 4

- 11 shows a screen capture of the ‘Additional Chemical Information’ screen (Joint Submission) (Scro ll 2):

Exhibit 4

- 11 : Additional Chemical Information Screen (Joint Submission) (Scroll 2)

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

4.1.8 Polymer Identification Information

You can access the ‘Polymer Identification Information’ screen by clicking the ‘Next’ button
from the ‘Chemical Identification’ screen if you select the ‘Polymer’ radio button. You can also

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 61access this screen by clicking the ‘Polymer Identification Information’ link within the navigation tree after selecting the ‘Polymer’ radio button on t he ‘Che mical Identification’ screen.

The ‘Polymer Identification Information’ screen captures information describing the polymer(s)
for which the PMN will be filed. This screen outline s the unique chemical properties that show the name, composition, and structure of the polymer. The system will provide fields for you to identify several key aspects concerning a polymer’s identity.

Click the ‘ Add New Chemical ’ button to create a chemical field set . Upon clicking the ‘ Add
New Chemical ’ button, an expandable/collapsible field set generates that contains numerous fields that pertain to the particular polymer. You are able to enter multiple chemical substances, each with unique information, by clicking the ‘ Add New Chemical ’ button for ea ch chemical you wish to identify.

For a single component submission, create the field set by clicking the ‘ Add New Chemical ’ button. Upon clicking the ‘ Add New Chemical ’ button, the application generates a field set containing numerous fields that captures information pertaining to that particular chemical.

For a multi

- component submission, click the ‘ Add New Chemical ’ button to create a field set.
Multi

- component chemical submissions occur when two or more chemicals always generate together in a single pot and are never isolated. Upon clicking the ‘ Add New Chemical ’ button, the application generates a field set that provides numerous fields to enter information pertaining to that particular chemical. Enter additional chemical substances , each with unique id entifying
informati on, by clicking the ‘Add New Chemical ’ button for each additional chemical that is part
of the multi

- component mixture. All multi

- component chemicals will reside in one chemical folder in the navigation tree.

For a consolidated submissio n, 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 e ntered 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 s et to delete the field set; a confirmation message displays to
confirm the deletion.

• Expand All: Click the link located at the upper

- right of the expandable/collapsible field sets

to expand a series of field sets.

• Collapse All: Click the link located at the upper

- right of the expandable/collapsible field sets

to collapse a series of field sets.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 62• Search SRS: Click the button to generate the ‘Search SRS’ pop

- up window. Refer to Section
Error! Reference source not found. for additional details regarding the search SRS functionality.

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

- up

window, if applicable.

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

SRS’ pop

- up window.

• CBI: Check the ‘CBI’ checkbox to identif y the chemical as confidential.

• B.6 Generic chemical name: Enter the generic name to associate with a chemical. This fi eld

displays when ‘Chemical Name’ and ‘CASRN’ are CBI. This is a required field.

• 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’

m ethod. Submit a copy of the identification report obtained from the CAS Inventory Expert Services as an attachment to this notice. For a consolidated submission, each chemical must be ‘Method 1’ except when the submission is pending a Letter of Support for that chemical.
Select the ‘Method 1 (CAS Inventory Expert Service)’ radio button to generate the ‘IES Order #’ field. A single response option in the ‘ID Method’ section is required if there is no pending Letter of Support or Joint Submission for the form

.

• IES Order # : Select the ‘Method 1 (CAS Inventory Expert Service)’ radio button to generate

this field. Enter the IES order number. This is a required field if there is no pending Letter of Support or Joint Submission for the form

.

• Method 2 (Other Me thod): Select the ‘Method 2 (Other Method)’ radio button to identify

the ID method as ‘Other Method.’ An alternative method of providing a name, such as a STN database report or a CAS Client Services report, qualifies as ‘Method 2.’ If the chemical is pend ing a Letter of Support, the method can only be ‘Method 2.’ A single response option in the ‘ID Method’ section is required if there is no pending Letter of Support or Joint
Submission for the form

.

• Attachments : Select the section of the page with which t he document is associated from the

drop

- down menu. This drop

- down menu contains the following values: ‘Chemical Structure Diagram’ and ‘ID Method.’ It is required that a document be attached for the ID Method if there is no pending Letter of Support or Joi nt Submission for the form

.

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

- up window.

Refer to Section Error! Reference source not found. 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 docume nt by displaying either a ‘Y’ or an ‘N.’

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 63• 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 enter ed 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 scr een using the ‘Previous’ and ‘Next’ buttons. Refer to Section
3.8 for more information regarding the save functionality in an expandable/collapsible field

set.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 64Exhibit 4

- 12 shows a screen capture of the ‘ Polymer Identification Information ’ screen (Joint Submission) (Scroll 1) :

Exhibit 4

- 12 : Polymer Identification Information Screen (Joint Submission) (Scroll 1)

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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 654.1.9 Monome rs 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 wit hin 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 Wei ght Information’ and ‘Monomers and Other

Reactants.’

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

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

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

• CBI: Check the ‘CBI’ checkbox to claim the ‘Polymer Weight Information’ section as

confidential.

• Method of Measurement: Only a single response option can be selected for ‘Method of

Measurement;’ valid values include ‘GPC’ and ‘Other (Specify).’ Gel

- permeation chromatography ( GPC ) is a well

- established method for establishing the number average molecular weight (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. This is a required field if there is no pending Letter of Support or Joint Sub mission for the form

.

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

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

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

weight; the entered value must be a po sitive numerical value and can contain decimal values. This is a required field if there is no pending Letter of Support or Joint Submissi on

.

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

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

• (iii) max. weig ht % 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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 66v alues. This value must be greater than or equal to the value specified in the ‘(ii) max. weight % below 500 molecular weight’ field. This is a required field if there are no pending Joint Submissions or Letters of Support.

• Add Monomer: Click the ‘Add Mono mer’ 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 d isplays 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 inform ation 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 of the

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

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

- right of the

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

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

Services’ pop

- up window. Refer to S ection Error! Reference source not found. 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 th e ‘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 t hat are less than or equal to 2% since the monomer is not considered to be included in the identity unless this checkbox is checked. This checkbox appears when a value of ‘2’ or less is entered into the ‘Typical Composition’ text field.

• CBI: Check the ‘CB I’ checkbox to claim the monomer or other reactant name and CASRN

as confidential.

• CAS Registry Number: Displays the CASRN for the specified monomer; this field

populates based on information entered on t he ‘Search SRS’ pop

- up window.

• Chemical Name: Displ ays the name of the chemical identified on the ‘Search SRS’ pop

- up

window.

• Typical Composition: Enter the typical composition value that a monomer contributes to a

polymer; the value entered must be a positive numerical value greater than zero (0) and les s than or equal to one hundred (100) and can contain decimal values. If the value entered is less than or equal to ‘2’ a warning will be displayed in the global ‘Validate’ function or during the submission process indicating that the typical composition is a value that is less

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 67than or equal to 2 percent and asking you whether it should be included in the chemical identity. This is a required field , and the value must be greater than zero (0)

.

• CBI: Check the ‘CBI’ checkbox to claim the ‘Typical Composition ’ and ‘Include In Identity’

fields as confidential.

• Maximum Residual: Enter the maximum residual value. Indicate the maximum weight

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

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

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

set. You must click this button instead of the ‘Save’ icon ( ) located wit hin 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
3.8 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 Error! Reference source not found. for additional details regarding the attach document functionality.

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

‘Attach Documents’ pop

- up window. Click the file name link to navigate to the ‘Attach Documents’ pop

- up window to make any edits.

• Description: Displays the description associated with a document.

• P ages: 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 war ning message displays to confirm the deletion of the document.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 68Exhibit 4

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

Exhibit 4

- 12 : Monomers and Other Reactants Screen (Joint Submission) (Scroll 1)

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 69Exhibit 4

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

Exhibit 4

- 13 : Monomers and Other Reactants Screen (Joint Submission) (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 Volume and Hazard /Safety Information

You can navigate to the ‘ Production Volume and Hazard /Safety Information’ screen by clicki ng the ‘Next’ button from the ‘Additional Chemical Information’ screen

. You can also access this

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 70screen by clicking the ‘ Production Volume and Hazard /Safety Information ’ link within the navigation tree

. The ‘Production Volume and Hazard/Safety Information’ screen collects different information regarding a chemical’s production and hazard elements.

Production Volume: The ‘Production Volume’ section captures information about production for the respective chemical or polymer for the ‘Maximum first 12

- month production’ and the
‘Maximum 12

- month production.’ The ‘Maximum first 12

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

- month production’ value. The maximum volume may not
exceed 100,000,000,000,000 kg/year for either field. The entered values will automatically display decimal points upon navigating away from the page . Decimals are allowed up to the milligram (.000001). Estimates should be on a 100% new chemical substance basis. Y our 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 productio n and the maximum production volume for any consecutive 12

- month period during the first three (3) years of commercial manufacture. You may upload an attachment to enter additional production information.

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

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

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

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

Close

- fitting goggles or a full

- face piece facemask are preferred for vapor, mist, or fume exposures, or wherever workplace contaminants can readily bypass loose

- fitting equipment.

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

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

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 71• 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 milligra m and is a required field if you do not 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 period during the first three (3) years of commercial manufacture. The entered value must be
a numerical value and must be greater than zero but less than 100,000,000,000,000 kg/year. This value must be greater than or equal to the ‘Maximum first 12

- month production’ value. This field accepts decimals to the milligram and is a required field if you do not have a pending Joint Submission and/or Letter of Support

.

• Binding: Check the ‘Binding’ checkbox to claim the hazard information as binding.

• Att achments : 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’ butt on to generate the ‘Attach Documents’

pop

- up window. Refer to Section Error! Reference source not found. for additional details regarding the attach document functionality.

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

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

‘Attach Documents’ pop

- up wi ndow. 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 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 72Exhibit 4

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

Exhibit 4

- 14 : Production Volume and Hazard /Safety Information Screen (Joint Submission)

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

4.1.11 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 navigatio n tree.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 73The ‘Use Information’ screen captures 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 screen contains instructional text and an ‘Add Use’ button. When you click the ‘Add Use’ button, an expandable/collapsible field set open s and display s the ‘Use Information’ fields. Upon saving the entry, the expandable/collapsible field set collapse s 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

s hould 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 poly mer making film?). LVE notices limit you to your stated category of use(s), so make sure your description fully encompasses all intended uses for any LVE. When you claim the ‘Category of Use’ as CBI, you are required to enter a ‘Generic Use Description.’ T he generic 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 perc ent in that use. Each use must capture the percent of the production and percent in formulation for each category of use. The ‘Production %’ must equal up to 100% for all uses if there is no pending Letter of Support or Joint Submission for the form, and t he field can be declared CBI. The ‘% in Formulation’ value can equal up to 100 %, and the field can be declared

CBI.

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

• Add Use: Click the ‘Add Use’ but ton to add a new use information expandable/collapsible

field set.

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

- hand corner of the

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

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

- hand corner of the

expandable/collapsible field set to modify the infor mation 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 74• Expand All: Click the ‘Expand All’ link located at the upper

- right of the expandable/collapsible field sets to expand a series of field sets.

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

- right of the

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

• Category of Use: Enter the category of use for the specific chemical substance by function

and application. This is a required field.

• CBI: Check the ‘CBI’ checkbox to claim the category of use information as confidential and

generate the ‘Generic Use Description’ field. Claiming the ‘Category of Use’ field as CBI
and then un

- checking the ‘CBI’ checkbox generates a confirmation me ssage that all attached
documents will be deleted.

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

• C.2.b. Generic Use Description: Enter the generic use description of the chemical. This

field displays when the ‘ Category of Use’ field is claimed CBI. If you claim any category of use description as confidential, enter a generic description of that category. This field is required when the ‘Category of Use’ field is claimed CBI.

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

the first three years devoted to each category of use for the specific chemical. The entered value must be a value greater than zero (0) but less than or equal to one hundred (100). The
‘Production %’ m ust equal up to 100% for all uses if there is no pending Letter of Support or
Joint Submission for the form. This field allows for decimal values. This is a required field.

• CBI: Check the ‘CBI’ checkbox to claim the ‘ Total Production for this Use ’ informa tion as

confidential.

• In Formulation % : Estimate the percent of the new substance as formulated in mixture,

suspensions, emulsions, solutions, or gels as manufactured for commercial purposes at sites under your control associated with each category of use . The entered value must be a value greater than zero (0) but less than or equal to one hundred (100) and can include decimal
values . This is a required field.

• CBI: Check the ‘CBI’ checkbox to claim the ‘Percentage in Formulation’ information as

confidential.

• CBI: Check the ‘CBI’ checkbox to claim the percentage of substance expected per use

information as confidential.

• Binding: Check the ‘Binding’ checkbox to claim the percentage of substance expected per

use information as binding.

• Site Limited %: Enter the site limited percentage of substance expected per use for the

submitted substance. Blank fields are recognized as 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

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 cat egories. Consumer

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 75use means that private individuals will use the chemical substance or products containing the substance for personal use or enjoyment.

• Industrial %: Enter the industrial percentage of substance expected per use for the

submitted substanc e. 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.

• Commercial % : Enter the commercial 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. Indicate percentage of product volume expected for the listed “use” sectors. Commercial use refers to the chemical substance or product cont aining the chemical substance being used by a company to provide a consumer service.

• If you have provided a “consumer” use, provide details: Enter consumer use details.

Provide a detailed description of the use(s) of this chemical substance in consumer pr oducts. 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 t he ‘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 provided a ‘consumer’ use,

provide details’ information as confidential.

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

pop

- up window. Refer to Section Error! Reference source not found. for additional de tails regarding the attach document functionality.

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

Documents’ pop

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

- up window to make any edits.

• Description: Displays the description associated with a document.

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

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

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

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

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

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

set.

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 76Exhibit 4

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

Exhibit 4

- 15 : Use Information Screen (Joint Submission ) (Scroll 1)

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 77Exhibit 4

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

Exhibit 4

- 16 : Use Information Screen (Joint Submission) (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 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 clicking the ‘Physical and Chemical Properties Wor ksheet’ link within the navigation tree.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 78The ‘Physical and Chemical Properties Worksheet’ screen is used to capture optional information about a chemical’s properties. EPA uses the chemical properties to determine additional safety data about a chemical; 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 substan ce,’ ‘Vapor Pressure @ temperature,’ ‘Density/relative density,’ ‘Solubility @ temperature ___ solvent ___,’ ‘Solubility in water @ temperature ___,’ ‘Melting temperature,’ ‘Boiling/sublimation temperature @ ____,’ ‘Spectra,’ ‘Dissociation constant,’ ‘Part icle 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

- down 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 to accept ‘<’ or ‘>’ symbols. When all infor mation 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 capt ure 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 che mical 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 th e most useful parameters of a new substance to EPA are the boiling point, the melting point, vapor pressure, the octanol/water partition coefficient, water solubility, Henry’s Law Constant, hydrolysis, spectral data , mass

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 physiochemical data to aid in their risk
evaluations.

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

You are no t required to generate the listed test data if you do not have it.

Physical/chemical properties data may be so unique that they could in the future link the PMN substance to a commercial product or may tend to identify unique classes of chemical substance

, and therefore some data elements may represent confidential business information. Review the CBI status of each entry carefully, and avoid making unsupportable claims.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 79Please note that in IE 7, all physical/chemical properties you wish to add must be ide ntified before navigating away from this page; otherwise, the properties are removed from the ‘Add Property’ drop

- down menu. In addition, you will be able to add the ‘Henry’s Law constant’ property more than once, and the chemical property fields located w ithin the expandable/collapsible fields sets on this page will be disorganized. After clicking the ‘Next’ button, you will navigate to the ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’ screen. After clicking the ‘Previous’ button, the physical/chemical properties have been removed from the ‘Add Property’ drop

- down menu.

• Add Property: Click the ‘Add Property’ button to add and open a new ‘Property’

expandable/collapsible field set for a selected property.

• Cancel: Click the ‘Cancel’ li nk 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 display s to confirm the action.

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

- hand corner of an expandable/collapsible

field set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has be en saved and the data is not currently editable.

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

- hand corner of an

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

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

- right of the

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

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

- right of the

expandable/collapsible field sets to colla pse a series of field sets.

• Adsorption/Coefficient

- Value: Enter the adsorption/coefficient value of the chemical

substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Adsorption/coefficient’ property is selected.

• Adsorption/Coe fficient

- Measured or Estimate : Indicate whether the property v alue is

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

- down menu. This is a required field if the ‘Adsorption/coefficient’ property is selected.

• Adsorption/Coefficient

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

adsorption/coefficient property as confidentia l.

• Boiling/sublimation temperature @

– Value : Enter the boiling/sublimation temperature in

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

@ ’ property is selected.

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

for which the boiling/sublimation of the chemical substance was determined. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Boiling/sublimation temperature @ ’ property is se lected.

• 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 80from 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

- Value: Enter the density/relative density value of the chemical

substance in g/cm3. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Density/relative density’ property is selected.

• Density/relative density

- Measured or Estimate : Indicate whether the property value i s

‘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 ens ity/relative

density ’ property as confidential.

• Dissociation constant

- Value: Enter the dissociation constant value of the chemical

substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Dissociation constant’ prop erty is selected.

• Dissociation constant

- Measured or Estimate : Indicate whether the property value is

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

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

• Dissociation constant

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

property as confidential.

• Explodability

- Value: Enter the explodability value of the chemical substance. This field

allows text or numbers to be entered and is also able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Explodability’ property is selected.

• Explodability

- Measured o r Estimate : Indicate whether the property value is ‘Measured’

or based on an ‘Estimate ’ by selecti ng 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

confidential.

• Flammability

- Value: Enter the fl ammability 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 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 ‘F lammability ’ property is selected.

• Flammability

- CBI: Check the ‘CBI’ checkbox to cl aim 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 required field if the ‘Henry’s Law c onstant’ property is selected.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 81• Henry’s Law constant

- Measured or Estimate : Indicate whether the property value is
‘Measured’ or based on an ‘Estimate ’ by selecting the appropriate value from the drop

- down menu. This is a required field if the ‘Henry’s La w 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 se lected.

• Octanol/water partition coefficient

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

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

• Particle size distribution

- Value: Enter the particle size distribution value of the chemical

substa nce. 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

- 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 ‘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 i s 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 appropriate 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 confidential.

• pH @ concentration [concentration]: Enter the concentration at which the pH w as

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 82• pH @ concentration [concentration]

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

• pH @ concentration [conc entration]

- Measured or Estimate : Indicate whether the

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

- down menu. This is a required field if the ‘ pH @ concentration [concentration] ’ property is selected.

• pH @ concentration [concentration]

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

concentration [concentration]’ property as confidential.

• Solubil ity @ temperature solvent: Enter the t emperature 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 @ temperature solvent

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

g/L.

• Solubi lity @ t emperature solvent

- Measured or Estimate : Indicate whether the property

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

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

• Solubility @ temperature solvent

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

@ temperature solvent ’ property as confidential.

• Solubility in Water @ temperature: Enter the temperature value in °C of the chemical for

which the solubility in water was measured. This is a required field if the ‘S olubility in W ater @ temperature ’ property is selected.

• Solubility in Water @ temperature

- Value: Enter the solubility in water of the chemical

subst ance 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

- Measured or 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 ‘S olubility in W ater @ temperature ’ property is selected.

• Solubility in Water @ t emperature

- CBI: Check t he ‘CBI’ checkbox to cla im 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.

• Spec tra

- 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 ‘CB I’ checkbox to claim the ‘S pectra ’ property as confidential.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 83• Vapor Pressure @ temperature : Enter the t emperature value in °C of the chemical for which the vapor pressure was measured. This is a required field if the property is selected.

• Vapor Pressure @ t emperature

- 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 @ te mperature

- Measured or Estimate : Indicate whether the property

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

- down menu. This is a required field if the ‘Vapor Pressure @ temperature’ property is
selected.

• Vapor Pressure @ temperature

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

Pressure @ temperature’ property as confidential.

• Volatilization from water

- Value : Enter the volatilization from water value of the chemical

substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Volatilization from water’ property is selected.

• Volatilization from water

- Measured or Estimate : Indicate whether the property value is

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

- down menu. This is a required field if the ‘Volatilization from water’ property is selected.

• Volatilization from water

- CBI : Chec k 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 84Exhibit 4

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

Exhibit 4

- 17 : Physical and Chemical Properties Worksheet Screen (Joint Submission) (Scroll 1)

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 85Exhibit 4

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

Exhibit 4

- 18 : Physical and Chemical Properties Worksheet Screen (Joint Submission) (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 navi gation

tree.

4.1.13 Physical and Chemical Properties Worksheet

– Continued (Optional)

You can navigate to the ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’ screen by clicking the ‘Next’ button from the ‘Physical and Chemical Properties Work sheet’

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 86screen. 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

c apture all the studies and attachments that refer to the chemical properties captured on the ‘Physical and Chemical Properties Worksheet’ screen . When you first access the ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’ screen , instruct ional text, an ‘Attach Document’ button, and an attachments table display.

When you attach a document, the properties that were selected on the ‘Physical and Chemical Properties Worksheet’ screen will be listed with checkboxes in the ‘Attach Documents’ wi ndow for you to select with which properties an attachment is associated. Check the properties that are relevant to the document, and then select a type and subtype value for the document. You will be able to attach a document, enter a description of the d ocument, and list the number of pages.

The system provides functionality to claim an uploaded document as CBI. If a document is claimed as CBI, the system requires you to upload the sanitized version of the attached document. To view, open, or edit previou sly 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 ‘Del ete’ icon ( ) located under the ‘Actions’ column to delete
unwanted documents.

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

pop

- up window. Refer to Section Error! Reference source not found

. 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’ p op

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

- up window to make any edits.

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

• Description: Displays the description associated with a document.

• Pa ges: 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 87Exhibit 4

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

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

Exhibit 4

- 19 : Physical and Chemical Properties Worksheet

– Continued (Optional) Screen (Joint Submission)

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’ l ink 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 Workshe et

– Continued (Optional)’ screen.

When attaching a document, the properties selected on the ‘Physical and Chemical Properties
Worksheet’ screen will display with checkboxes to allow the properties to which the attachment
refers to be selected. Select the type and subtype for the attachment and the properties relevant to the document, attach the document, and enter the number of pages.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 88The system allows the uploaded document to be claimed as CBI. If a document is claimed as CBI, the system requires the sa nitized 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

- do wn 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 do cument. Check the appropriate chemical properties that are associated with a document that is being attached. These checkboxes are enabled only if ‘Physical Chemical Property’ is selected from the ‘Type’ drop

- down menu.

• Attachment: Displays the ‘Browse’ bu tton to search for and identify documents on your

local hard drive to be attached that can be associated with the physical/chemical properties identified on the ‘Physical and Chemical Properties Worksheet’ screen.

• Description: Enter the description associ ated with a document.

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

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

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

search for a particular file on your hard drive. For any attached document claimed as CBI, you are required to attach a sanitized version of the document.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 89Exhibit 4

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

– Continued (Optional) Attach Documents ’ pop

- up window (Scroll 1) :

Exhibit 4

- 20 : Physical and Chemical Properties Worksheet

– Continued (Optional) Attach
Documents Pop

- Up Window (Joint Submission) (Scroll 1)

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 90Exhibit 4

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

– Continued (Optional) Attach Documents’ pop

- up window (Joint Submission) (Scroll 2) :

Exhibit 4

- 21 : Physical and Chemical Properties Worksheet

– Continued (Optional) Attach
Documents Pop

- Up Window (Joint Submission) (Scroll 2)

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

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 91information and 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 automatical ly generated within the ‘Submitter Controlled Operations’ folder within the navigation tree. If a user indicates there are sites controlled by others, the ‘Industrial Sites Controlled By Others,’ ‘Exposures/Releases,’ and ‘Byproduct Information’

screens au tomatically 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 others?: Select the ‘Yes’ radio button to indicate that you

have sites controlled by others to identify; this response automatically generates the screens within the ‘Operations Controlled by Others’ folder in the navigation tree upon clicking the ‘Next’ button. Select the ‘No’ radio button if you do not have any sites controlled by others to identify. An error message displays if a site controlled by others displays within the navigation tree and the ‘No’ radio button is sel ected.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 92Exhibit 4

- 22 shows a screen capture of the ‘Site Information’ screen (Joint Submission):

Exhibit 4

- 22 : Site Information Screen (Joint Submission)

Navig ation: 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 934.1.16 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 contr olled by the submitter. Importers do not have to complete this section for operations outside the U.S.; however, you must report any processing or use activities after import. Complete a separate ‘Operations Controlled By Others’ section for each type of

p rocessing, 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 wheth er site

- specific data for the chemical is known for ‘Sites Controlled By Others.’ If you indicate that there is site

- specific data by selecting the ‘Yes’ radio button, the screen will generate a text field to enter the ‘# of unknown sites ’ and a ‘CBI’ chec kbox 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 select ‘Yes’ the screen will display the question ‘Do you have site

- specific information?’ If you select ‘No’ only the listed navigation options will display. If an operation controlled by others displays within the navigation tree, the ‘Yes’ radi o 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 ha ve will be deleted

.

• # of unknown sites: Enter the number of unknown sites ; zero (0) is an acceptable value . This

is a required field.

• CBI: Check the ‘CBI’ checkbox to claim the number of unknown sites as confidential.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 94Exhibit 4

- 23 shows a screen capture of the ‘ Sites Controlled By Others ’ screen (Joint Submission):

Exhibit 4

- 23 : Sites Controlled By Others Screen (Joint Submission)

Navigation: Click the ‘Next’ button to navigate to the ‘ Submitter Operation Information ’ screen. You can also access this screen by clicking the ‘Submitter Operation Information’ link within the
navi gation tree.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 954.1.17 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 navigation tree under the ‘Submitter Controlled Operations’ folder.

The ‘Submitte r 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 gui ded approach is designed to eliminate errors and ensure the completion of all relevant sections for a site. You will be able to enter an operation alias to identify the operation. Importers are not required to complete this section for operations outside t he U.S.; however, any industrial processing or use operation that takes place after import must be described. It should be noted that Toll manufacturing sites are considered to be 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 operation type, you will be asked whether the
chemical is manuf actured or processed as a ‘batch’ or ‘continuous’ process. Based on the property selected, fill in the relevant information. If you select the ‘Use’ operation type, then there will be no further options on this screen. The follow

- up screens are used to cap ture 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 info rmation: (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 kilo grams (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 n ot used daily or per batch). (3) Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. If releasing to two media at the same step, assign a second release number
for the second medium.

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

The document table displays the file name and file extension of the document, the document description, the number of pages in the document, and whether a sanitized copy of the doc ument 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 96• Add Facility: Click the button to generate the ‘Add Facility’ pop

- up window and select a site from the drop

- down menu to add to the ‘Submitter Operation Information’ screen.

• Site Name: Displays the site name.

• Address: Displays the site address.

• City: Displays the si te city.

• State: Displays the site state.

• Postal Code: Displays the site postal code.

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

• Actions: Click the ‘Delete’ icon ( ) to delete a site from the table. A warning message

di splays 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 confi dential.

• Manufacturing: Check the ‘Manufacturing’ checkbox to indicate that manufacturing is

taking place at the site. Checking the ‘Manufacturing’ checkbox generates the ‘Is it batch or
continuous’ radio buttons.

• Processing: Check the ‘Processing’ checkb ox to indicate that processing is taking place at

the site. Checking the ‘Processing’ checkbox generates the ‘Is it batch or continuous’ radio
buttons.

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

• CBI: Check the ‘CBI’ checkbox to claim the amount and duration information as

confidential.

• Is it batch or continuous? : Select the ‘Batch’ radio button to indicate that the chemical is

produced in a batch process. Select the ‘Continuous’ radio button to indicate that th e chemical is produced on a continuous basis. Either the ‘Batch’ or ‘Continuous’ radio button is required to be selected.

• Max kg/batch: Enter the maximum number of kilograms produced per batch. This field only

displays when you select the ‘Batch’ radio but ton and is a required field. This field accepts
decimal values.

• Hours/batch: Enter the hours of manufacturing or processing time needed per batch. This

field only displays when you select the ‘Batch’ radio button and is a required field. This field
accepts decimal values.

• Batches/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 chem ical produced per day. This field

only displays when you select the ‘Continuous’ radio button and is a required field. This field accepts decimal values.

• Hours/d ay: Enter the number of hours per day that the chemical is processed or

manufactured; this valu e cannot exceed 24. This field only displays when you select the ‘Continuous’ radio button and is a required field. This field accepts decimal values.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 97• Days/y ear: Enter the number of days per year that the chemical is processed or manufactured; this value c annot exceed 365. This field only displays when you select the ‘Continuous’ radio button, and is a required field. This field accepts decimal values.

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

• Process Description: Enter the process description. In the ‘Process Description’ text box, or

an attachment, address the following items: (1) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specify

– e.g., 5

- gallon pails, 55

- gallon drum, rail car, tank truck, etc.). (2) Provide the identity, the approximate weight (by kg/day or kg/batch on a 100% new chemical substance basis), and entry point of all starting materials and feedstocks (including reactants, 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 Error! Reference source not found. for additional details regarding the attach document functionality.

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

‘Attach Documents’ pop

- up window.

• Description: Displays the description associated with a document.

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

• CBI: Indicat es 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 98Exhibit 4

- 24 shows a screen capture of the ‘ Submitter Operation Information ’ screen (Joint Submission) (Scroll 1) :

Exhibit 4

- 24 : Submitter Operation Information Screen (Joint Submission) (Scroll 1)

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 99Exhibit 4

- 25 shows a screen capture of the ‘Submitter Operation Information’ screen (Joint Submission) (Scroll 2) :

Exhibit 4

- 25 : Submitter Operation Inform ation Screen (Joint Submission) (Scroll 2)

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

tree.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 1004.1.18 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.

C lick 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/Engineeri ng Controls (3),’ ‘Physical Form(s) (5),’ ‘% New Substance (5),’ ‘# Workers Exposed (8),’ ‘Maximum Duration Hours/Day (10),’ and ‘Maximum Duration Days/Year (11).’ EPA is attempting to estimate exposure levels, the number of workers potentially exposed, an d 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.

Information entered into the ‘ Maximum Duration Hours/Day (10) ’ and ‘Maximum Duration

D ays/Y ear (11) ’ fields must be a positive whole number or decimal. The system does not allow special characters to be saved in these fields. If further explanation is required regarding duration of exposure, please provide this in an attachment.

• Add: Click the ‘Add’ button to generate the ‘Occupational Exposure

– Submitter Controlled

Sites’ 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 in the fields. The ‘Edit’

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

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

- hand corner of the

expandable/collapsible field set to delete the field set. A confirmation message displays to confirm the deletion. The ‘Delete’ icon ( ) displays when the user has clicked the ‘Add’
button.

• Expand All: Click the ‘Expand All’ link l ocated at the upper

- right of the

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

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

- right of the

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

• Worker Category (1): Select the category of work from the drop

- down menu in which a

worker may be exposed to a chemical substance. This is a required field.

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

• Worker Activity (1) : Select the worker activity (e.g. bag dumping, tote filling, unloading

drums, sampling, cleaning, etc.) in which workers may be exposed to a chemical substance. Please note that if you are populating this field via an XML file created from the ePMN thick

c lient, this drop

- down menu will not populate. This is a required field.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 101• User Defined Worker Activity: Enter the worker activity in which workers may be exposed to a chemical substance. This field displays only for certain worker activity values.

• Protective Equipment/Engineering Controls (3): Enter the protective

equipment/engineering controls used to protect workers. This is a required field.

• CBI: Check the ‘CBI’ checkbox to claim the protective equipment/engineering controls

information as confi dential.

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

• Binding: Check the ‘Binding’ checkbox to claim the physical form(s) information as

binding.

• % New Substance (5): Enter the percentage of new chemical substance (if part of a mixture)

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

.

• Binding: Check t he ‘Binding’ checkbox to claim the percentage new substance information

as binding.

• # Workers Exposed (8): Enter the number of workers exposed. Estimate the maximum

number of all workers involved in each activity for all sites combined. This is a required
field.

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

• Hours/Day (10): Enter the maximum duration occupational exposure occurs for the activity

for any worker in hours per day; this field allows decimal values. A va lue of zero (0) entered in this field will display an error. This is a required field.

• Days/Year (11): Enter the maximum duration occupational exposure occurs for the activity

for any worker in days per year; this field allows decimal values. A value of zero (0) entered in this field will display an error. This is a required field.

• CBI: Check the ‘CBI’ ch eckbox to claim the maximum duration values as confidential.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 102• 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
3.8 for more information regarding the save functionality in an expandable/collapsible field

set.

Exhibit 4

- 26 shows a screen capture of the ‘ Occupational Exposures ’ screen (Joint Submission):

Exhibit 4

- 26 : Occupational Exposures Screen (Joint Submission)

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 103Navigation: 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 al so access this screen by clicking the ‘Environmental Releases’ link within the navigation tree.
The ‘Environmental Releases’ screen captures information about the environmental release and disposal status of a particular site. The information on exposure and environmental release is related to the flow diagram/process description on the ‘Submitter Operation Information’ screen. This page is duplicated and populated for each f low diagram supplied in the PMN (manufacturing, each processing description, and a ny 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 substance s. In the absence of this information, EPA will make its own estimates of worker exposure and environmental release, which are usually conservative. You should present data that is accurate and as complete as possible.
The page displays an ‘Add’ button to add an expandable/collapsible field set to enter ‘Environmental Release and Disposal

– Submitter Controlled Sites’ information. The page displays fields to enter information for ‘Release Number,’ the amount of the new substance
released ‘to environment’ a nd 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 Owne d Treatment Works (POTW), navigable waterways, and others.

• Add: Click the ‘Add’ button to generate the ‘ Environmental Release and Disposal

–

Submitter 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
confi rmation 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/collaps ible 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 of the

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

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

- right of the

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

• Release Number (1): Enter the number of each release point identified in the process

description on the ‘Submitter Operation Information’ scr een. This is a required field.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 104• CBI: Check the ‘CBI’ checkbox to claim the release number information as confidential.

• Amount of new substance r eleased to E nvironment (2a): Select the applicable radio

button and e nter the amount of new substance released t o environment. Release estimates should be consistent with the release levels shown on the preceding flow diagram on the ‘Submitter Operation Information’ screen . Include intermittent release estimates from cleaning of equipment and transportation containe rs, 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.

• 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

substance released to control technolog y. 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 echnology kg/day: Select the radio butt on

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 amount of new substance released to control technology is measured in kilograms per batch.

• Media of Release (4): Identify the media of release (i.e., stack air, fugitive air, surface water,

on

- site or off

- site land or incineration, POTW, or other (please specify)) to which the new
substance will be released from that release point from the drop

- down menu. This is a required field.

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

• If Other, specify: Enter the other media of release when you select ‘Other’ from the ‘Media

of Release’ drop

- down menu.

• Control Technology Description (5a): Enter the control technology description. Describe

control technology, if any, and control efficiency used to limit the release of the new
substance to the environment. For releases d isposed 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 w aste is subject to secondary or tertiary on

- site treatment. Indicate if you want this information to bind. Check the ‘CBI’ checkbox if the information is confidential. This is a required field.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 105• Binding: Check the ‘Binding’ checkbox to claim the control te chnology description as binding.

• Release after Control Technology (5b): Enter the release after control technology. Estimate

the amount released to the environment after control technology (in kilograms per day). This is a required field.

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

set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before bein g able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section
Error! Reference source not found. for more information regarding the save functionality in an expandable/collapsible field set.

• POTW Name: Enter the POTW (publicly owned treatment works) name.

• POTW NPDES #: Enter the POTW National Pollutant Discharge Elimination System

(NPDES) number.

• POTW CBI: Check the ‘CBI’ checkbo x to claim the POTW as confidential.

• Navigable Waterway Name: Enter the navigable waterway name.

• Navigable Waterway NPDES #: Enter the navigable waterway NPDES number.

• Navigable Waterway CBI: Check the ‘CBI’ checkbox to claim the navigable waterway as

confidential.

• Other (Specify) Name: Enter the name of the other destination of release to water.

• Other (Specify) CBI: Check the ‘CBI’ checkbox to claim the other destination of release to

water as confidential.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 106Exhibit 4

- 27 shows a screen capture of the ‘ Environmental Releases ’ screen (Joint Submission) :

Exhibit 4

- 27 : Environmental Releases Screen (Joint Submission)

N avigation: Click the ‘Next’ button to navigate to the ‘Industrial Sites Controlled By Others’

screen. You can also access this screen by clicking the ‘Industrial Sites Controlled By Others’ link within the navigation tree. Click the ‘Add Operation’ link under the ‘Operations Controlled

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 107By Others’ folder within the navigation tree to generate the screens f or an operation controlled by others.

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 ‘Environmenta l Releases’ screen. You can also access this screen by clicking the ‘Industrial Sites Controlled By Others’ link within the navigation tree under the ‘Operations Controlled by Others’ folder.

The ‘Industrial Sites Controlled By Others’ screen captures inf ormation about activities occurring at a particular site or group of sites. You will be able to enter an operation alias to identify the operation. Importers are not required to complete this section for operations outside the U.S.; however, any industrial processing or use operation that takes place after import must
be described.

You will first be asked to select the site(s) and chemical(s) for the operation. You will then proceed to the next screen to enter resources concerning the operation. The system provides a field to add an operation process description.

The site(s) and chemical(s) for the operation must be identified. The system then navigates to the next screen to enter resources concerning the operation. The ‘Industrial Sites Controlled By
Others ’ screen also displays a field to add an operation process description. In the operation description, include the following information: (1) Diagram the major unit operation steps and chemical conversions, including interim storage and specify transport co ntainers (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 k g/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 ba tch). (3) Either in the diagram or in the text field, identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance.

• Operation Alias: Enter the operation alias. This is a required field if the form is pending a

Joint Submission or a Letter of Support.

• Add Facility : Click the button to generate the ‘Add Facility’ pop

- up window and s elect a site

from the drop

- down menu to add to the ‘Industrial Sites Controlled By Others’ screen

. Refer

to Section Error! Reference source not found. for additional details regarding the add facility functionality.

• Site Name: Displays the site name.

• Address: Displays the site address.

• City: Displays the site city.

• State: Displays the site state.

• Postal Code: Displays the site postal code.

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 108• Actions: Click the ‘Delete’ i con ( ) 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 pr ocess description. Cover the following items:

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

– e.g., 5

- gallon pails, 55

- gallon drums, rail cars, tank trucks, etc.). On the di agram, identify by letter and briefly describe each worker activity. (2) Either in the diagram or in the text field, provide the identity, the approximate weight (by kg/day or kg/batch, on a 100% new chemical substance basis), entry point of all feedstocks (including reactants, solvents and catalysts, etc.), all products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) Either in the diagram or in the text field, identify by number the points of re lease, including small or intermittent releases, to the environment of the new chemical substance. Either this field is required or a document must be attached.

• CBI: Check the ‘CBI’ checkbox to claim the operation description as confidential.

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

pop

- up window. Refer to Section Error! Reference source not found. for additional detail s 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: Displa ys 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 109Exhibit 4

- 28 shows a screen capture of the ‘ Industrial Sites Controlled By Others ’ screen (Joint Submission):

Exhibit 4

- 28 : Industrial Sites Controlled By Others Screen (Joint Submission)

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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 1104.1.21 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/Releases’ link within the navigation tree under the ‘Opera tions Controlled By
Others’ folder.

The screen provides buttons to add expandable/collapsible field sets for worker exposure release information and environmental disposal information. The screen displays fields in the worker exposure expandable/collapsib le 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 Exposure Days/Year (4b)’ fields must be a positive whole num ber or decimal. The system does not allow special characters to be saved in these fields. If further explanation is required regarding duration of exposure, please provide this in an attachment.

• Add: Click the ‘Add’ button to generate the ‘Worker Exposure ’ expandable/collapsible field

set.

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

- hand corner of the

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

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

- hand corner of the

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

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

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

- hand corner of the

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

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

- right 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 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’ checkb ox to claim the number of workers exposed as confidential.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 111• Duration of Exposure Hours/Day (4a): Enter an estimate of the typical duration of exposure per worker in hours/day. This field allows decimal values.

• Duration of Exposure Days/Year (4b): Enter an estimate of the typical duration of

exposure per worker in days/year. This field allows decimal values.

• CBI: Check the ‘CBI’ checkbox to claim the duration of exposure hours/day and days/year

as confidential.

• Protective Equipment/Engineering Controls (6): Enter a description of any protective

equipment and engineering controls, if any, used to protect workers. Please pay particular attention to the information within if this field is populated via XML file. The information
contained within the ‘Protective Equipment/Engineering Controls/Physical Forms’ field in the thick client separates into two (2) separate fields, the ‘Protective Equipment/Engineering Controls’ and ‘Physical Forms’ field when these fields are populated via an XML file generated from the e PMN thick client.

• CBI: Check the ‘CBI’ checkbox to claim the protective equipment/engineering controls

information as confidential.

• Physical Form (6): Enter a description of physical forms of exposure. Please pay particular

attention to the information populated in this field if this field is populated via XML file. The information contained within the ‘Protective Equipment/Engineering Controls/Physical forms’ field in the thick client separates into two (2) separate fields, the ‘Protective Equipment/Eng ineering Controls’ and ‘Physical Forms’ field when these fields are populated via an XML file generated from the ePMN thick client.

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

• % in Formulation (7): Estimate the per cent of the new substance as formulated when

packaged or used as a final product.

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

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

Error! Reference source not found. for more information regarding the save functionality in an expandable/collapsible field set.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 112Exhibit 4

- 29 shows a screen capture of the ‘ Exposures / Releases ’ screen (Joint Submission) (Scroll 1) :

Exhibit 4

- 29 : Exposures / Releases Screen (Joint Submission) (Scroll 1)

• Add: Click the ‘Add’ button to generate the ‘Environmental Disposal’

expandable/collapsible field set.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 113• 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 dir ectly to the environment in Kg/day or Kg/batch

.

• Amt New Substa nce Rele ased Directly into Environment Kg/D ay: Select the ‘Kg/D ay’

radio button to indicate that the amount of substance released into environment measures in kilograms per day.

• Amt New Substance Rele ased Directly into Environment Kg/B atch: Select the

‘Kg /B atch’ radio button to indicate that the amount of substance released into environment measures in kilograms per batch.

• Amt New Substance Released Directly into Control Technology (10b): Estimate the

amount of the new substance relea sed into control technology in Kg/Day or Kg/B atch.

• Amt New Substance Released Di rectly into Control Technology Kg/D ay: Select the

‘Kg/D ay’ radio button to indicate that the amount of substance released into control technology measures in kilograms per day.

• Amt New Substan ce Released Di rectly into Control Technology Kg/B atch: Select the

‘Kg/B atch’ radio button to indicate that the amount of substance released into control technology measures in kilograms per batch.

• Media of Release (12): Select a value from the drop

- dow n menu to capture the media of

release. The ‘Media of Release’ drop

- down menu contains the following values: ‘Fugitive Air,’ ‘Off

- Site Incineration,’ ‘On

- site Incineration,’ ‘On

- site WWT,’ ‘POTW,’ ‘Stack Air,’ ‘Surface Water,’ and ‘Other,’ that will be use d to limit the release of the new substance to the
environment. Please pay particular attention to the information within if this field is populated via XML file. The information contained within the ‘Media of Release & Control Technology’ field in the thi ck client separates into two (2) separate fields, the ‘Media of Release’ drop

- down menu and ‘Control Technology’ field when these fields are populated via an XML file generated from the ePMN thick client.

• If Other, s pecify: Enter the other media of relea se.

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

• Control Technology (12): Enter the control te chnology, if any, which will be used to limit

the release of the new substance to the environment. Please pay particular attenti on to the information within if this field is populated via XML file. The information contained within the ‘Media of Release & Control Technology’ field in the thick client separates into two (2) separate fields, the ‘Media of Release’ drop

- down menu and ‘ Control Technology’ field when these fields are populated via an XML file generated from the ePMN thick client.

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

set. You must click this button instead of the ‘S ave’ 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

Error ! Reference source not found. for more information regarding the save functionality in an expandable/collapsible field set.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 114Exhibit 4

- 30 shows a screen capture of the ‘Exposures/Releases ’ screen (Joint Submission) (Scroll 2) :

Exhibit 4

- 30 : Exposures / Releases Screen (Joint Submis sion) (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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 1154.1.22 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 under the ‘Operations Controlled By Others’ folder withi n the navigation tree.
The ‘Byproduct Information’ screen captures byproducts resulting from a particular site. The system displays fields to enter byproducts.
Note that in IE 7, the right side of the ‘Byproduct’ text box may be cut off.

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

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

• Actions: Click the ‘Save’ icon ( ) to save an entered byproduct. Click the ‘Delete’ icon ( )

to delete a byproduct. Click the ‘Add’ ico n ( ) to add a byproduct. Click the ‘Form’ icon ( ) to edit a saved byproduct.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 116Exhibit 4

- 31 shows a screen capture of the ‘ Byproduct Information ’ screen (Joint Submission):

Exhibit 4

- 31 : Byproduct Information Screen (Joint Submission)

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 1174.1.23 Optional Pollution Prevention

You can nav igate 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 Pollu tion Prevention’ screen provides fields for companies to enter data about their pollution prevention efforts. The company has the option of entering information as a free text field or as an attachment. The company can claim the information as confidential by checking the ‘CBI’ checkbox

. The system allows an uploaded document to be claimed as CBI. If a document is claimed as CBI, the system requires the sanitized version of the attached document to be uploaded. To access or edit previously attached documen ts, click the appropriate file name of the document
within the ‘File Name’ column of the document table.
The attachment table displays the file name and file extension of the document, the document description, the number of pages the document contains, an d the CBI status of the document. Click the ‘Delete’ icon ( ) located within the ‘Actions’ column to delete unwanted documents.
You may provide information not reported elsewhere in this form regarding your efforts to reduce or minimize potential risks as sociated with activities surrounding manufacturing, processing, use, and disposal of the PMN substance on the ‘Optional Pollution Prevention’

screen . Include new information pertinent to pollution prevention, including source reduction, recycling activitie s and safer processes or products available due to the new chemical substance. Source reduction includes the reduction in the amount or toxicity of chemical wastes by technological modification, process and procedure modification, product reformulation, an d/or raw materials substitution. Recycling refers to the reclamation of useful chemical components from wastes that would otherwise be treated or released as air emissions or water discharges, or land disposal. Quantitative or qualitative descriptions of p ollution prevention, source reduction and recycling should emphasize potential risk reduction in addition to compliance with existing regulatory requirements. EPA is interested in the information to assess overall net reductions in toxicity or environmenta l 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 relati ve risk determination. In addition, information on the relative cost or performance characteristics of the PMN substance to potential alternatives may be provided.
Describe the expected net benefits, such as:

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

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

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

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

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 118EPA strongly encourages submitters to provide pollution pre vention data in their notices, as this information assists the Agency in balancing the benefits of a PMN substance against its unique
risks.
While Agency staffers frequently receive information on the benefits of the PMN substance with respect to its use(s ), data on pollution prevention effects are rarely included. This section should be utilized to indicate to EPA benefits in terms of the raw materials incorporated, the manufacturing process, emission reductions, less toxic waste byproducts, or lower risks upon end use and disposal. You should consider the entire life cycle of the PMN substance in your
evaluation.
Also consider opportunities for product stewardship or other risk management controls that could significantly reduce risk characteristics of the new substance (e.g., disposal techniques that can be easily implemented and substantially reduce waste toxicity).
Initiatives in the New Chemicals Program such as Environmental Technology Initiative (ETI) for Chemicals, and the Pollution Prevention Recog nition 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 benef its.
Describe any pollution prevention benefits here, and indicate if this information is confidential business information. Attempt to quantify the expected benefits to the extent possible and avoid exaggeration and highly speculative statements. The fol lowing questions can be used to assess pollution prevention benefits:

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

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

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

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

(5) Does your manufacturing process eliminate or reduce the use/release of hazardous
substances?

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

Click the link to display additional information regarding the pollution information.

• Check here to claim this information as CBI: Check the ‘Check here to claim this

information as CB I’ checkbox to claim the pollution prevention information as confidential.

• Optional Pollution Prevention text box: Enter information about pollution prevention in

this field.

• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Doc uments’

pop

- up window. Refer to Section Error! Reference source not found. for additional details regarding the attach document functionality.

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

‘Attach Documents’ pop

- up window. Click the file name link to navigate to the ‘Attach Documents’ pop

- up window to make any edits to an attached document

.

• Description: Displays the des cription associated with a document.

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 119• CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’

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

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

Exhibit 4

- 32 shows a screen capture of the ‘ Optional Pollution Prevention ’ screen (Joint Submission):

Exhibit 4

- 32 : Optional Pollution Prevention Screen (J oint Submission)

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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 120The ‘Additiona l Attachments’ screen provides a table for you to add additional attachments that have not been incorporated into the form. This screen allows documents that did not have a suitable place in the application to be uploaded.

• Please click here to view a list of commonly attached documents and where they should

be attached: Clicking the link displays a list of documents and where they should be
attached.

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

pop

- up window. Refer to Section 3.9 for further information regarding the attach document functionality

.

• File Name: Displays the file name and file extension of the f ile that is uploaded on the ‘Attach Documents’ pop

- up window.

• Description: Displays the description associated with a document.

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

• Date: Displays the date a document was uploaded.

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

. ’

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

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 1 21Exhibit 4

- 33 shows a screen capture of the ‘ Additional Attachments ’ screen (Joint Submission):

Exhibit 4

- 33 : Additional Attachments Screen (Joint Submission)

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’ screen by clicking the ‘Next’ button from the ‘Additional Attachments’ screen. You can also access this screen by clicking the ‘Attachment Summary’ link within the navigation tree.

The ‘Attachment Summ ary’ 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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 122name and file extension of a document, the document description, number of pages in a
docume nt, date attached, and whether the document is CBI.

• Section: Displays the section of the PMN form that t he attached document is associated.

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

‘Attach Documents’ pop

- up window.

• Description: Displays the description of a document that was uploaded on the ‘Attach

Documents’ pop

- up window.

• Pages: Displays the number of pages a document contains

.

• Date: Displays the upload date of a document that was uploaded on the ‘Attac h Documents’

pop

- up window.

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

Exhibit 4

- 34 shows a screen capture of the ‘ Attachment Summary ’ screen (Joint Submission):

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 123Exhibit 4

- 34 : Attachment Summary Screen (Joint Submission)

N avigation: 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 124• 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.

Exhibit 4

- 35 shows a screen capture of the ‘Optional Cover Letter’ screen (Joint Submission):

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 125Exhibit 4

- 35 : Optional Cover Letter Screen (Joint Submission)

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. Click

the ‘Submit’ ( ) icon located in the bottom action bar to begin the submission process.

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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 126The ‘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 joint
PMN form for joint PMN forms with numerous chemicals. You also have the option to export a

current joint PMN form into an XML file using the ‘Export XML’ link. The upload XML functionality is only available for a PMN form.

If you upload an XML file into a pre

- populated form , the XML file overwrites the contents of the

pre

- populated form. In addition, uploading any file removes the attached documents within a form, which must be re

- attached. You must also add any sites identified within the form to your CDX registration profi le.

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 th e ‘Letter of Activity (1),’ ‘Protective Equipment/Engineering Controls,’ ‘Physical Form,’ ‘Media of Release,’ ‘Control Technology,’ and ‘% New Substance’ fields of entry have been populated correctly.

Please note that in IE 7, if an upload fails, the actio n 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 record archive file populated with PMN information. The cop y 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 cu rrent PMN form that a user

can download.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 127Exhibit 4

- 36 shows a screen capture of the ‘Upload XML’ screen:

Exhibit 4

- 36 : Upload XML Screen

Navigation: Click the ‘Validate’ icon ( ) located in the bottom action bar to validate the form. Click the ‘Save’ icon ( ) located in the bottom action bar to perform a global save on the form. Click the ‘Preview’ icon ( ) located in the bottom action bar to view a PDF preview of the

form. Click the ‘Submit’ icon ( ) located in the bottom action bar to begin the submission

process.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 128

### 5 Biotech nology Secondary User

5.1 Joint and Letter of Support Process

The Biotechnology form is used to collect information about “ intergeneric ” microorganisms that
will be manufactured or imported into the United States. EPA collects the information provided
in a Biotechnology form through a free text box and attachments. The Biotechnology form does not have a structured data format, but there are several types of Biotechnology notices that can be filed. The different types are as follows: Microbial Commercial Activity Notice ( MCAN )

, TSCA Experimental Release Application ( TERA ) , Tier I Exemption, Tier II Exemption, and Biotechnology Test Market Exemption (TME) forms. All the forms have the same upload requirements and EPA will retain responsibility for verifying the correct information is received.

The Biotech nology Joint and/or Letter of Support process will be a multi

- step process with
coordination required between the Primary

, Joint , and/or Letter of Support submitters . The

P rimary user would first state that a J oint Submission and/or Letter of Support would supplement the application on the ‘G eneral Form Information’ screen. Based on the selection, the ‘Joint
Submission’ and/or ‘Letter of Support’ folder will populate. Each folder will contain a section
for you to enter contact information, field information, and instruction information with th e secondary user’s unique identification number . The Primary submitter may identify up to two
Joint Submissions and an unlimited number of Letter s of Support.

When the Primary user enters the relevant Joint Submission and/or Letter of Support folder

, the Primary user will be asked to enter contact information for the Joint and/or Letter of Support
submitter on the first screen. The Primary user will use the email address entered on this screen
will be used to send the Joint and/or Letter of Support Submitter the unique identifier . The
second screen in the Joint and/or Letter of Support folder will display the unique ID that will be
sent to the Secondary use at and a text box for the Primary user to provide the Secondary user instructions or informati on about what is to be filed. The Secondary user will not be sent the information that the Primary user captured or be able to access the Joint and/or Letter of Support form until the Primary AO has submitted the original Biotech nology form.

The secondary submitter will register in CDX as a Secondary AO 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 identifier on the ‘ Enter Passphrase’ screen sent via email by the Primary user which will generate the appropriate form
that the secondary submitter will be populating. The unique ID will link the primary and joint forms on the backend. The joint form will contain the same s creens listed for the primary
Biotech nology form, except the Joint submitter will not be supplied the ‘Joint Folder.’ All screens will be identical with regards to requirements and view with the exception of the

‘ Section 5 Notices and Supports Forms ’ scree n and the ‘General Form Information’ screen, which are listed below. The secondary submission process will also be identical to the primary
submission.

5.1.1 General Form Information

You can access the ‘General Form Information’ screen by creating a passphrase i n the ‘Create Passphrase’ screen or by entering a passphrase in the ‘Enter Passphrase’ screen.

The ‘General Form Information’ screen presents a list of text fields and drop

- down menus for you to input identifying information for the specific form. You will have the option to assign a

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 129‘Form Alias’ to help you identify the form. A form alias is helpfu l when a user or company has multiple forms and/or when you must differentiate between forms to the help desk. Upon navigating to the ‘General Form Information’ screen, the system auto

- generate s a default alias in the following format: < Form T ype

- YYYYMMDD

- HH:MM:SS Time Zone>.

The TS number must be a six (6) character alphanumeric combination and should include two (2), three (3), or four (4) letters. Company names, recognizable words, and numerical series are
not recommended.

The ‘Text/Comments’ text box captures information regarding the submission/attachment. A
‘CBI’ checkbox displays above the ‘Text/Comments’ text box to claim the information as
confidential.

The ‘General Form Information’ screen displays the option to attach a document by clicking the ‘Attach Document’ button. For more information regarding the attach document functionality, please refer to Section Error! Reference sou rce not found.

.

• Form Alias: Enter a custom form alia s, if applicable . Upon navigating to the screen, the
system auto

- generate s an editable alias comprised of <Form Type

- YYYYMMDD

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

• Type of Submission: Select the submission type from the drop

- down menu. This drop

down menu contains the following values: ‘MCAN (Microbial Commercial Activity Notice),’ ‘TERA (TSCA Experimental Release Application),’ ‘ Tier I Exemption,’ ‘Tier II Exemption,’ and ‘Biotechnology TME (Test Market Exemption).’

• TS Number: Enter the TS number. The TS number can be any six (6) character alphanumeric combination and should include two (2), three (3), or four (4) letters. Compan y names, recognizable words , and numeric series are not recommended. This field is required if ‘MCAN’ is selected from the ‘Type of Submission’ drop

- down menu, but is also required regardless of the submission type if a Letter of Support is pending,
and/or if a joint Bio technology form is being filed.

• Text/Comments: Enter a description of the form and/or attachment.

• CBI: Check the ‘CBI’ checkbox to claim the ‘Text/Comments’ information as
confidential.

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

- up window. Upload attachments including published literature, regulations and certifications, ID data, construct data, effects data, MSD S , manufacturing details, use details, inactivation data, and/or other types of d ocuments. At least one document is required even if a Letter of Support or Joint Submission is claimed. Please
refer to Section Error! Reference source not found. for additional details regarding the attach document process.

• File Name: Displays the file name and file extension of a document that is uploaded on the ‘Attach Documents’ pop

- up window.

• Description: Displays the description of a document.

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

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 130• Actions: Click the ‘Delete’ icon ( ) to delete the entire attached document row permanently from the system. A w arning message displays to confirm the deletio n.

Exhibit 5

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

Exhibit 5

- 1 General Form Information Screen (Joint Biotechnology )

Navigation: Click the ‘Next’ button to navigate to the ‘Technical Contact Information’ screen. You can also access this screen by clicking the ‘T echnical Contact Information’ link within the navigation tree.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 1315.1.2 Technical Contact Information

You can access the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from
the ‘General Form Information’ screen

. You can also navigate to the ‘Technical Contact Information’ screen by clicking the ‘Technical Contact Information’ link within the navigation

tree.

The ‘Technical Contact Information’ screen displays an ‘Add Technical Contact’ button. Click the ‘Add Technical Contact’ button to gen erate an ‘Add Technical Contact’ pop

- up window to
enter information into the text fields. Click the ‘Copy CDX Registration’ button to populate the text fields using your CDX registration information. Check the ‘Check here to claim this
information as CBI’ checkbox to indicate that the information is confidential and will not be released to the public.

• Add Technical Contact: Click the ‘Add Technical Contact’ button to generate the ‘Add

Technical Contact’ pop

- up window.

• Last Name: Displays the technical contact ’s last name

.

• First Name: Displays the technical contact ’s first name.

• Address: Displays the technical contact ’s address.

• CBI: Indicates the CBI status of the reported technical contact information by displaying

either a ‘Y’ or an ‘N.’

• Actions: Click the ‘Delete’ icon ( ) to delete the technical contact information from the

table. A warning message displays to confirm the deletion.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 132Exhibit 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 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 b y clicking the ‘Add Technical
Contact’ button on the ‘Technical Contact Information’ screen

.

• Copy CDX Registration: Click the ‘Copy CDX Registration’ button to copy your

information from CDX registration; a message displays confirming the import of CDX registration information.

• Check here to claim this information as CBI: Check the ‘Check here to claim this

informatio n as CBI’ checkbox to claim the technical contact information as confidential.

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

button to populate the fields with information entered during CDX registration. This is a required field.

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

button to populate the fields with information entered during CDX registration. This is a required field.

• Position: Enter the technical contact’s jo b title.

• Company Name: Enter the technical contact’s company name. Click the ‘Copy CDX

Registration’ button to populate the fields with information entered during CDX registration. This is a required field.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 133• Phone Number: Enter the technical contact ’s day time U.S. phone number; this must be at least 10 characters long and does not accept dashes. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field.

• Phone Extension : Enter the technical contact’s phone nu mber 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 ‘Co py CDX Registration’ button to populate the fields with information entered during CDX registration.

• Mailing Address 1: Enter the first line of the technical contact ’s mailing address. Click the

‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field.

• Mailing Address 2: Enter the second line of the technical contact ’s mailing address. Click

the ‘Copy CDX Registrati on’ button to populate the fields with information entered during CDX registration.

• City: Enter the city of the technical contact ’s mailing address. Click the ‘Copy CDX

Registration’ button to populate the fields with information entered during CDX regist ration. This is a required field.

• State: Select the state of the technical contact ’s mailing address from the drop

- down menu

.

Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a re quired field.

• Postal Code: Enter the postal code of the technical contact ’s mailing address. Click the

‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a required field.

• Country: Displays ‘Uni ted States.’

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 134Exhibit 5

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

- up window:

Exhibit 5

- 3 : Add Technical Contact Pop

- Up Window

Navigation: Click the ‘Cancel’ button to stop populating technical contact information and navigate back to the ‘Technical Contact Information’ screen. Click the ‘OK’ button to save and populate the entered technical contact information and navigate back to the ‘Techn ical 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’ link within the navigation tree

. The ‘Optional Cover Letter’ screen is used to communicate information to EPA not collected elsewhere in the form. The cover letter is used to give OPPT resources and special instructions

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 135regarding the application. The cover letter should be either fully CBI or non

- CBI to eliminate user error to promote transparency between the company and EPA.

• Check here to claim this information as CBI: Check the ‘Check here to claim this

inf ormation 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 perform a global save of the form.

Click the ‘Preview’ icon ( ) located in the bottom action bar to view a P DF preview of the

form. Click the ‘Submit’ ( ) icon located in the bottom action bar to begin the submission

process.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 136

### 6 Bona Fide Form Secondary User

T he purpose of the Bona Fide module is to receive an official determination from EPA as to
whether a substa nce 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 edit a Joint Bona Fide form, navigate to the ‘Section 5 Notices and Supports Forms’ screen and select ‘Bona Fide’ from the ‘Form Type’ drop

- down menu. Refer to Section 3.4 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen.

Refer to Section 3.5 for additional details regard ing 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 ‘Ge neral Document Information’ screen presents text fields and checkboxes for you to input identifying information for the specific form. You will have the option to assign a ‘Form Alias’ by which the form can be identified. The form alias is helpful when you or the company has multiple forms and/or when a user must differentiate between forms to the help desk. If a form alias is not entered, the system will provide a default alias comprised of a form type and date and time stamp in the following format: < Form Type

- YYYYMMDD

- HH:MM:SS Time Zone>.

You can claim the entirety of the form as CBI. The entire form will be claimed as CBI if you check the ‘I claim the entirety of the submission as CBI’ checkbox. The entire form will be
considered non

- CBI if you leave the ‘I claim the entirety of the submission as CBI’ checkbox
unchecked

.
You can indicate that a technical contact will be identified by checking the ‘Technical Contact’ checkbox. The technical contact must possess sufficient knowledge to answer any questi ons EPA may have about the chemical reported with in the form . The application will generate a
‘Technical Contact Information’ screen when you check the ‘Technical Contact’ checkbox.

• Form Alias: Enter the form alias. Upon navigating to the screen, the scre en auto

- generate s

an editable form alias comprised of <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 con tained within the form as confidential
business information

.

• Technical Contact: Check the ‘Technical Contact’ checkbox to generate a ‘Technical

Contact Information’ screen for you to enter contact information about the technical contact
associated with the reported chemical.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 137Exhibit 6

- 1 shows a screen capture of the ‘General Document Information’ screen (Letter of Support):

Exhibit 6

- 1 : General Document Information Screen (Letter 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 138The data fields on the ‘Primary Contact Information’ screen are pre

- populated based on information entered during CDX registration. All fields are editable allowing for necessary updates. The ‘ Job Title’ field on this screen is not pre

- populated from CDX registrat ion and is a required field.

If you checked the ‘I claim the entirety of the submission as CBI’ checkbox on the ‘General Document Information’ screen, all entered primary contact information is flagged as CBI.

The following fields are captured and display ed from the logged in user’s CDX registration
information:

• Prefix: Select the primary contact’s prefix from the drop

- down menu.

• First Name: Enter the primary contact’s first name. This is a required field.

• Middle Initial: Enter the primary contact’s middl e initial.

• Last Name: Enter the primary contact’s last name. This is a required field.

• Suffix: Select the primary contact’s suffix from the drop

- down menu.

• Title: Enter the primary contact’s job title. This is a required field.

• Company Name: Enter the pri mary contact’s company name. This is a required field.

• Phone Number: Enter the primary contact’s daytime phone number; dashes are not allowed. This is a required field.

• Phone Extension: Enter the extension to the primary contact’s daytime phone number.

• Email Address: Enter the primary contact’s email address. The email address must
follow the standard email address format: John.Doe@ABC.com . This is a required field.

• Mailing Address 1: Enter the first line of the pr imary contact’s mailing address. This is a required field.

• Mailing Address 2: Enter the second line of the primary contact’s mailing address.

• City: Enter the city of the primary contact’s mailing address. This is a required field.

• State: Select the stat e of the primary contact’s mailing address from the drop

- down menu. The state field is required if the user selects ‘United States’ from the ‘Country’ drop

- down menu.

• Postal Code: Enter the postal code of the primary contact’s mailing address. This is a

re quired field.

• Country: Select the country of the primary contact’s mailing address. This is a required
field.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 139Exhibit 6

- 2 shows a screen capture of the ‘Primar y 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 1406.1.3 Technical Contact Information

If you indicated on the ‘General Document Information’ screen that technical contact information will be provided, then you can navigate to the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from the ‘Primary Cont act Information’ screen. You can
also access this screen by clicking the ‘Technical Contact Information’ link within the navigation

tree

. The technical contact is a subject matter expert (SME) who is capable of answering questions
related to the chemical submitted to EPA within the Bona Fide form. The technical contact does not have to work at the port or site reported on the form but must p ossess sufficient knowledge to answer EPA’s questions pertaining to the chemical reported in the form.

The text fields on the ‘Technical Contact Information’ screen will be blank upon accessing the screen. To add information, you will enter data into the blank text boxes for the listed text fields. If you checked the ‘I claim the entirety of the submission as CBI’ checkbox on the ‘General Document Information’ screen, all entered technical contact information will be flagged as CBI

. Please note that if yo u 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 require d 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 conta ct’s job title.

• Company Name: Enter the technical contact’s company name.

• Phone Number: Enter the technical contact’s daytime U.S. phone number; dashes are not allowed. This is a required field.

• Phone Extension: Enter the technical contact’s phone number extension.

• Email Address: Enter the technical contact’s email address. The email address must
follow the standard email address format: John.Doe@ABC.com . This is a require d 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: Se lect the state of the technical contact’s mailing address from the drop

- down

menu.

• Postal Code: Enter the postal code of the technical contact’s mailing address.

• Country: Displays ‘United States.’

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 141Exhibit 6

- 3 shows a screen capture of the ‘Technical Contact Information’ screen:

Exhibit 6

- 3 : Technical Contact Information Screen

Navigation: Click the ‘ 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 navigate to the ‘C hemical Identification Information’ screen by clicking the ‘Next’
button from the ‘Chemical Identification Information’ screen. You can also access this screen by clicking the ‘Chemical Identification Information’ link within the navigation tree.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 142The ‘Che mical Identification Information’ screen identifies the type of chemical the submitter will enter into the application. You will be able to file a Bona Fide form for a class 1 or

2 /Biotechnology chemical substance or a polymer. Based on your selection, the appropriate screens for the respective chemical will appear.

This screen also provides a text field for you to identify an alias for the chemical substance.

• Class 1 or 2 /Biotechnology Chemical Substance: Select the ‘Class 1 or 2 /Biotechnology

Chemical Substance’ radio button to indicate that the chemical is a class 1 or 2 /biotechnology substance. If you select the ‘Polymer’ radio button after initially selecting the ‘Class 1 or

2 /Biotechnology Chemical Substance’ radio button, the application generates an error message warning you that you will lose all data for this chemical if the chemical type changes. The user is required to select one of the two radio button options displayed in the ‘Chemical Type’ section.

• Polymer: Select the ‘Polymer’ ra dio button to indicate that the chemical is a polymer. If you

select the ‘Class 1 or 2 /Biotechnology Chemical Substance’ radio button after initially selecting the ‘Polymer’ radio button, the application generates an error message warning you that you will lose all data for this chemical if the chemical type changes. The user is required to select one of the two radio button options displayed in the ‘Chemical Type’ section.

• Chemical Alias: Enter the chemical alias to associate with a chemical.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 143Exhibit 6

- 4 shows a screen capture of the ‘Chemical Identification Information’ screen :

Exhibit 6

- 4 : Chemical Identification Information Screen

Navigation: If you selected the ‘Class 1 or 2 Chemical Substance’ radio button, click the ‘Next’ button to navigate to the ‘Class 1 or 2 Chemical Substances’ screen. If you selected the ‘Polymer’ radio button, click the ‘Next’ button to navigate to the ‘Polymer Identification
Information’ screen.

6.1.5 Class 1 or 2/Biotechnology Chemical Substance

If you selected the ‘Class 1 or 2 /Biotechnology Chemical Substance’ radio button, click the ‘Next’ button to navigate to the ‘Cl ass 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 w ill 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 ‘At tach 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 des cription of the document.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 144Click 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 attach ed documents

. Please note that if you are using IE 7, part of the content on this screen displays behind the Bona Fide navigation tree and certain fields on this screen may display twice.

• Add New Chemical: Click the button to generate the class 1 or 2 /B iotechnology 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 e ntered 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 s et to delete the field set. A confirmation message displays to
confirm the deletion.

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

- right of the

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

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

- right of the

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

• Class of Substance: In the section, ‘Class of Substance,’ you identify whether a ‘Class 1’ or

‘Class 2 /Biotechnology ’ chemical subs tance is being reported. When you select the ‘Class

2 /Biotechnology ’ chemical substance radio button, you are indicating that some portions of the structure may not be known and an additional screen will appear within the navigation tree that provides fiel ds 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 Chemi cal ID’ pop

- up window by clicking the

‘Add Chemical ID’ button within the ‘Chemical Identification Information’ field set. You can search for the reported chemical(s) either by the ‘CASRN’ or ‘CA Index Name or Other Synonym.’ If you retrieve zero results, the system provides fields for you to enter the chemical information by filling in the ‘Chemical Name’ and the ‘Chemical Abstract Services Registry Number’ under the manual entry field set. The system provides functionality to enter the
selected chemical b y clicking the ‘OK’ button located at the bottom of the ‘Add Chemical ID’
window. Refer to Section Error! Reference source not found. for additional details regard ing the search SRS functionality.

• Chemical Name: The system provides fields for you to identify the ‘Chemical Name’ and the

‘CASRN’ (if available). The system provides functionality for you to search for the chemical substance using the ‘Add Chemical ID’ search or manually enter the chemical information in the ‘Add Chemical ID’ pop up.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 145• 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 I ES report. You can also select ‘Method 2 (Other Method).’

• Attach IES Report: To access the ‘Attach IES Report’ pop

- up window, click the ‘Attach IES

Report’ button that displays within the ‘Chemical Identification Information’ field set. After you attach the document(s), and click the ‘OK’ button, the ‘Attach IES Report’ pop

- up window
close s and the document information displays in a table format on the ‘Class 1 or

2 /Biotechnolog y Chemical Substances’ screen. The document attachment table displays the file name of the document(s) and the user

- provided description of the document(s). Click the ‘Delete’ icon ( ) located under the ‘Actions’ column to delete unwanted documents

. Click the
file name link under the ‘File Name’ column to access or edit previously attached documents

.

• Molecular Formula: Enter a molecular formula in a text field using a free text format. This

field is optional.

• Chemical Structure Diagram: The system allows yo u 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 . Yo u 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 descr iption of the chemical structure

.

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

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

.

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

set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navig ate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section
Error! Reference source not found. for more information regarding the save functionality in an expandable/collapsible field set.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 146Exhibit 6

- 5 shows a screen capture of the ‘Class 1 or 2 /Biotech nology Chemical Substances’ screen (Joint Bona Fide):

Exhibit 6

- 5 : Class 1 or 2/Biotechnology Chemical Substances Screen (Joint Bona F ide)

Navigation: If you selected the ‘Class 1’ radio 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 also access this screen by clicking the ‘Use Information’ link within the navigation tree. If you selected the ‘Class 2 /Biotechnology ’ radio button and clicked the ‘Save’ button within the expandable/collapsible field set, then 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 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 bar and clicking the ‘Class 2 /Biotechnology Substances’ link within the

na vigation tree.

The ‘Class 2 /Biotechnology Substances’ screen provides fields for you to enter information regarding a class 2 /biotechnology chemical substance. A class 2 /biotechnology chemical substance is a substance that may not have a defined chemical structure that has been identified. This screen provides fields for you to identify specific elements in the creation of the chemical using the following fields: ‘Precursor Substances,’ ‘Nature of Reaction,’ and ‘Range of Composition (Optional).’

You will be able to enter precursor substances by searching SRS or by the manual entry fields when the substance is not in SRS. The substances will display in a table listing the ‘Chemical
Name’ and CASRN.

The system provides fields for you to capture ‘Nature of R eaction’ 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 Su bstance Registry

Services’ pop

- up window. Refer to Section Error! Reference source not found. for additional details regarding the search SRS functionality.

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

the ‘Chemical Name’ link to navigate to the ‘Search SRS’ pop

- up window for edits.

• CASRN: Displays the CASRN associated with a precursor substance.

• Action : Click the ‘D elete’ icon ( ) to delete the entire chemical row permanently from the

system. A warning message will display to confirm the deletion of the chemical.

• Nature of Reaction: Enter the ‘Nature of Reaction’ description. This is a required field.

• Range of Co mposition: Enter the ‘Range of Composition’ description.

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

pop

- up window and upload a document. Refer to Section Error! Reference source not
foun d. for further details regarding the attach document functionality.

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

‘Attach Documents’ window.

• Description: Displays the description associated with a document.

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

system. A warning message displays to confirm the deletion.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 148Exhibit 6

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

Exhibit 6

- 6 : Class 2 Substances Screen

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 149Exhibit 6

- 7 shows a screen capture of the ‘Class 2 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 Identification Inf ormation’ screen by clicking the ‘Next’ button from the ‘Chemical Identification Information’ screen when you select the ‘Polymer’ radio button. You can also access this screen by clicking the ‘Polymer Identification Information’ link within the navigation tree after clicking the ‘Save’ icon within the bottom
action bar

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 150Click the ‘Add New Chemical ’ button to create a chemical substance . Upon clicking the ‘Add
New Chemical ’ button, an expandable/collapsible field set generates that contains numerous
field s that pertain to the particular polymer. The system provides numerous fields for you to enter multiple chemical substances , each with unique information, by clicking the ‘Add New
Chemical ’ button for each chemical you wish to identify.

For a single compo nent 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 chemic al.

For a multi

- component submission, create individual field sets by clicking the ‘Add New
Chemical ’ button. Multi

- component chemical submissions occur when two or more chemicals always generate together in a single pot and are never isolated. Upon clicki ng 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 click ing the ‘Add New Chemical’ button for each additional chemical that is part of the multi

- component mixture. All multi

- component chemicals will reside in one chemical folder in the navigation tree.

• Add New Chemical: Click the button to generate the ‘Polymer Identification Information’

field set.

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

- hand corner of the

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

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

- hand corner of the

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

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

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

- hand corner of the

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

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

- right of the

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

• Collapse All: Click the Collapse All’ link locate d at the upper

- right 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 ‘Chemical A bstract 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. Refer to Section 3.10 for further details regarding the search SRS functionality.

• Chemical Name: The system provides fields for you to identify the ‘Chemical Name’ a nd

the CASRN (if available). The system provides functionality for you to search for the

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 151chemical substance using the ‘Add Chemical ID’ search or manually enter the chemical information in the ‘Add Chemical ID’ pop up.

• ID Method: The system shall require that you identify which ID method was used to

determine the chemical identity. When you select ‘Method 1 (CAS Inventory Expert Service),’ the system generates an ‘Attach IES Report’ button for you to attach an IES report. If you select ‘Method 1,’ you are required to attach an IES report. You can also select ‘Method 2 (Other Method).’

• Attach IES Report: Click the ‘Attach IES Report’ button within the ‘Polymer Identification

I nformation ’ field set after selecting the ‘Method 1 (CAS Inventory Expert Service) ’ radio
button to access the ‘Attach IES Report’ pop

- up window. After you attach the document(s), and click the ‘OK’ button, the ‘Attach IES Report’ pop

- up window closes and the document
information displays in a table format on the ‘Polymer Identification Information’ screen. The attachment table displays the file name of the document and the user

- provided description of the document. Click the ‘Delete’ icon ( ) located under the ‘Actions’ column
to delete unwanted documents. Click the file name link under the ‘File Name’ column to access or edit previously attached documents

.

• Chemical Structure Diagram: The system allows you to attach a chemical structure

diagram.

• Attach Chemical Structure: Click the ‘Attach Chemical Structure’ button within the

‘Polymer Identification 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 ch emical structure row

permanently from the system. A warning message displays to confirm the deletion.

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

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

Error! Reference source not found. for more information regarding the save functionality in an expandable/collapsible field set.
After the document is attached and you click the ‘OK’ button, the ‘ Attach Chemical Structure’

pop

- up window closes and the document information will be displayed in a table format on the ‘Polymer Identification Information’ screen. The attachment table displays the file name of the document and provided description of the document. The system provides functionality for you to delete unwanted documents by clicking the ‘Delete’ icon ( ) located under the ‘Actions’
column. Click the appropriate file name of the document within the ‘File Name’ column of the
attachment table to access or edit previously attached documents

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 152Exhibit 6

- 5 shows a screen capture of the ‘Polymer Identification Information’ screen:

Exhibit 6

- 5 : 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 ‘Monomer s and Other Reactants’ screen by clicking the ‘Next’ button from the ‘Polymer Identification Information’ screen. You can also access this screen by clicking the ‘Monomers and Other Reactants’ link within the navigation tree.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 153The ‘Monomers and Other React ants’ screen is used to identify the chemical measurements and monomers that make up a polymer. The ‘Monomers and Other Reactants’ screen has an ‘Add Monomer’ button that allows you to identify the monomer(s) that make up the polymer composition.

• Add Monom er: 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 mod ify 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

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

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

- right of the

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

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

- right of the

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

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

Services’ pop

- up window. Refe r to Section Error! Reference source not found. 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.

• Monomer or Other Reactant: Displays the monomer or other reactant name; t his field

populates based on information entered on the ‘Search Substance Registry Services’ pop

- up window. This is a required field.

• Include in Identity: Check the ‘Include in Identity’ checkbox to claim the value for

‘Monomer or Other Reactant’ as part of the monomer identification.

• Typical Composition: Enter the ‘Typical Composition’ value that a monomer contributes to

a polymer; the value entered must be a positive numerical value greater than zero (0) and less than or equal to 100 with up to three de cimal points . If the value entered is less than or equal to ‘2’ a warning will be displayed in the global ‘Validate’ function or during the submission process indicating that the ‘Typical Composition’ is a value that is less than or equal to 2% and asking the user whether it should be included in the ‘Chemical Identity.’ This is a required field.

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

set. You must click this button instead of the ‘Save’ icon ( ) loca ted within the bottom action bar to successfully save the entered information within the field set before being able

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 154to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section
Error! Reference source not found. for more information regarding the save functionality in an expandable/collapsible field set.

• Attach Document: Click the ‘Attach Document’ button to generate the ‘Attach Documen ts’

pop

- up window. Refer to Section Error! Reference source not found. for additional details regarding the attach document functionality.

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

‘Attach Documents’ pop

- up window. Click the file name link to navigate to the ‘Attach Documents’ pop

- up window to make any edits.

• Description: Displays the description associated with a do cument.

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

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

Exhibit 6

- 6 shows a screen capture of the ‘Monomers and Other Reactants’ screen:

Exhibit 6

- 6 : Monomers and Other Reactants Screen

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 155Navigation: 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’ butto n from the ‘Class 1 or 2 Chemical Substances’ screen, from the ‘Class 2 Substances’ screen, or from the ‘Monomers and Other Reactants’ screen, depending on the choice made on the ‘Chemical Identification
Information’ screen. You can also access this screen by clicking the ‘Use Information’ link within the navigation tree.

The ‘Use Information’ screen capture s data about the chemical substance’s intended use. When you navigate to the screen, the screen contains a text box with instructional text that reads, ‘How will the substance be used?’ Enter specific data for the chemical substance and then advance to
the next screen.

• How will the substance be used ? : Enter data regarding how the chemical substance is

intended to be used. This is a required field.

Exhibit 6

- 7 shows a screen capture of the ‘Use Information’ screen:

Exhibit 6

- 7 : 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.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 1566.1.10 Document Management

You can navigate to the ‘Document Management’ s creen by clicking 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 elec tronic form. The user must attach three required documents: ‘Spectrum of Substance,’ ‘Statement of Commercialization,’ and ‘Statement of Research and Development.’ The application also allows
the user to attach ‘Other’ documents.

Please note that in IE 7, you must attach the three required documents before clicking the ‘Next’ button and navigating to the next screen. If you click the ‘Next’ button with only one or two documents attached, you will be taken to an error screen. Navigate away from this screen u sing the back button on your browser and check that the correct documents have been attached.

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

pop

- up window to upload documents. Refer to Section Error! Reference source not found. for additional details regarding the attach document functionality.

• Document Name: Displays the document name and file extension of the document uploaded

on the ‘Attach Documents’ pop

- up window.

• Document Type: Displays the document type associated with the uploaded document.

• Action: Click the ‘Delete’ icon ( ) to delete the entire document row permanently from t he

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

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 157Exhibit 6

- 8 shows a screen capture of the ‘Document Management’ screen:

Exhibit 6

- 8 : 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.

6.1.11 Optional Cover Letter

You can navigate to the ‘Optional Cover Letter’ scree n by clicking the ‘Next’ button from the

‘ Document Management ’ screen. You can also access this screen by clicking the ‘Optional
Cover Letter’ link within the navigation tree

. The ‘Optional Cover Letter’ screen is used to communicate information with EPA that is not collected elsewhere in the form. The cover letter is used to give EPA resources and special instructions regarding the application.

• Optional Cover Letter: Enter any additional special instructions regarding the form.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 158Exhibit 6

- 9 shows a screen capture of the ‘Optional Cover Letter’ screen:

Exhibit 6

- 9 : 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 ( ) to view a PDF preview of the form. Click the ‘Submit’ icon ( ) located in the bottom action bar to begin the submission process and navigate to the ‘Submitting Official
Information’ screen.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 159

### 7 Preview

The system provides the option to preview a form at any point during the submission process.

Click the ‘Preview’ icon ( ), located within the b ottom action bar, to see a PDF version of the form. A screen will display for you to view either the ‘Full’ or the ‘Sanitized’ version of the PDF differentiated by buttons. After you choose either the ‘Full’ or ‘Sanitized’ PDF, the application generates a draft

, watermarked PDF version of the form.

Please note in IE 7, the ‘Preview EPMN FORM’ screen text might be misaligned.

The watermark reads ‘Not for Submission’ and displays across each page in the background . The form preview displays the entire form in a printable format. The preview functionality provides the flexibility to track the status of the form and see the entire form in a single viewpoint.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 160Exhibit 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 161Exhibit 7

- 2 shows a screen capture for the ‘Preview’ of the Biotech nology form:

Exhibit 7

- 2 : Preview Biotech nology For m PDF

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 162

### 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 ( ). Disable t he pop

- up blocker within your internet browser so that the ‘Section 5 Notices and Supports Validation’ pop

- up window displays correctly . The ‘Section 5 Notices and Supports Validation’ pop

- up window displays a report of all validation errors and warning messages. Du ring the validation process, the application validates each screen of the Section 5 Notices and Supports form to find missing and invalid data.

Please note in IE 7, the ‘Help’ button aligns to the right side of the ‘Section 5 Notices and Supports Validatio n’ pop

- up window.

Validation Errors: Errors are denoted by an ‘Error’ icon ( ) and can be fixed by clicking the error link. The links will display the Screen Title Name (e.g., Chemical Identification) and the
associated error. After you click a link, the m ain application screen will display the section where the error occurred so you can easily fix the error. Once you have fixed the error(s), click
the ‘Validate’ icon ( ) again to refresh the ‘Section 5 Notices and Supports Validation’ pop

- up window. If the information you fixed passes validation, the error will be removed from the ‘Section 5 Notices and Supports Validation’ pop

- up window. You must fix all validation errors to submit the form to CDX successfully.

Warning Messages : Warnings are denoted by a ‘ Warning’ icon ( ) and can be fixed by clicking the warning link. The links will display the Screen Title and the associated warning

. After you click a link, the main application screen will display the section where the warning occurred so you can easily f ix the warning. Once you have fixed the warning(s), click the
‘Validate’ icon ( ) again to refresh the ‘Section 5 Notices and Supports Validation’ pop

- up window. If the information you fixed passes validation, the warning will be removed from the
‘Section 5 Notices and Supports Validation’ pop

- up window. You can pass validation and continue to submit a form to CDX with active warning messages.

You can close the ‘Section 5 Notices and Supports Validation’ pop

- up window by clicking the
‘X’ button located at t he top right corner of the window

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 163Exhibit 8

- 1 show s a screen capture s for the ‘ Section 5 Notices and Supports Validation’ pop

- up window:

Exhibit 8

- 1 : Section 5 Notices and Supports Validat ion Pop

- Up W indow

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 164

### 9 Submit to EPA via CDX

As the Secondary AO, you have the ability to sign and submit a Joint or Letter of Support form
for a Section 5 Notices and Supports form to EPA. You may also submit amendments for Joint
forms. You can save your form at any point during the data entry process. Any assigned Supports for your form cannot submit the Section 5 Notices and Supports form . The save functionality
allow s you to return to a form at any point in the future.

Once you comple te all required information and pass validation, the system will allow a Section 5 Notices and Supports form to be successfully submitted.

9.1 Submitting Official Information

Click the ‘Submit’ icon ( ) located in the bottom action bar of the Section 5 Notice s and Supports application to access the ‘Submitting Official Information’ screen. This screen displays

to a Secondary AO upon submission.

After clicking the ‘Submit’ icon ( ), the system requires you to review your contact information provided during CDX registration. The system also requires you to identify your job title. Click the ‘Home’ button to navigate to the Section 5 Notices and Supports ‘Home’ screen.

The following statement

, which displays to the Primary AO and Secondary AO

, must be
confirmed before the system will allow you to move forward: “Please confirm that you are the legally responsible party from the submitting company.” If you check the checkbox associated
with this statement, the application navigates to either the appropriate certifi cation screen or the

‘Cross

- Media Electronic Reporting Regulation (CROMERR)’ screen. The checkbox must be
checked in order to continue with the submission.

A ‘Submitting On Behalf Of’ checkbox will be displayed on the screen if you are submitting an
amend ment. 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

a mendments/revisions/updates to the original submission.

Please note in IE 7, the ‘Cancel’ and ‘Next’ buttons will be misaligned in the center of the ‘Submitting Official Information’ screen.

• Submitting On Behalf Of: This checkbox only displays for amendments/revisions/updates

to an original submission.

• CBI: Check the ‘CBI’ checkbox to claim the submitting official’s information as

confidential.

• Please confirm that you are the legally responsible party from the submitting company:

Check the checkbox to confirm that the individual submitting the form has perm ission to do

so.

• First Name: Displays the first name of the submitting official, which has been pre

- populated

from CDX registration information.

• Middle Initial: Displays the middle initial of the submitting official, which has been pre

populated from CDX registration information.

• Last Name: Displays the last name of the submitting official, which has been pre

- populated

from CDX registration information.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 165• Job Title: Enter the job title of the submitting official. This is a required field.

• Company Name: Di splays the company name of the submitting official, which has been

pre

- populated from CDX registration information.

• Phone Number: Displays the phone number of the submitting official, which has been pre

populated from CDX registration information.

• Email Ad dress: Displays the email address of the submitting official, which has been pre

populated from CDX registration information.

• Mailing Address 1: Displays the first line of the mailing address from CDX registration

information.

• Mailing Address 2: Displays the second line of the submitting official’s mailing address,

which has been pre

- populated from CDX registration information.

• City: Displays the city of the submitting official’s mailing address, which has been pre

populated from CDX registration informa tion.

• State: Displays the state of the submitting official’s mailing address, which has been pre

populated from CDX registration information.

• Postal Code: Displays the postal code of the submitting official’s mailing address, which has

been pre

- populated from CDX registration information.

• Country: Displays the country of the submitting official’s mailing address, which has been

pre

- populated from CDX regist ration information.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 166Exhibit 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

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 amendments/revisions/updates/etc. to an original submission.

After c hecking the ‘Submitting On Behalf Of’ checkbox on the ‘Submitting Official Information’ screen (which is only displayed for amendments/revisions/updates/etc. to an

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 167original submission), you will be taken to the ‘Submitting On Behalf Of’ screen to enter in the
information about the company on which you are submitting the form. Click the ‘Home’ button to navigate to the Section 5 Notices and Supports ‘Home’ screen.

• CBI : Check the ‘CBI’ checkbox to claim the ‘Submitting On Behalf Of’ information as

confident ial.

• First Name: Enter the first name of the ‘Submitting On Behalf Of’ individual on whose

behalf you are submitting this form.

• Middle Initial: Enter the middle initial of the ‘Submitting On Behalf Of’ individual on

whose behalf you are submitting this fo rm.

• Last Name: Enter the last name of the ‘Submitting On Behalf Of’ individual on whose

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.

• Phone Number: Enter the phone number of the ‘Submitting On Behalf Of’ individual on

whose behalf you are submitting this form.

• Email A ddress: Enter the email address of the ‘Submitting On Behalf Of’ individual on

whose behalf you are submitting this form. The email address must follow the standard email
address format: John.Doe@abc.com

.

• Mailing Ad dress 1: Enter the first line of the mailing address of the ‘Submitting On Behalf

Of’ individual on whose behalf you are submitting this form.

• Mailing Address 2: Enter the second line of the mailing address of the ‘Submitting On

Behalf Of’ individual on w hose behalf you are submitting this form.

• City: Enter the city of the mailing address of the ‘Submitting On Behalf Of’ individual on

whose behalf you are submitting you are submitting this form.

• State: Enter the state of the mailing address of the ‘Submi tting On Behalf Of’ individual on

whose behalf you are submitting this form.

• Postal Code: Enter the postal code of the ‘Submitting On Behalf Of’ individual on whose

behalf you are submitting this form.

• Country: Enter the country of the ‘Submitting On Beha lf Of’ individual on whose behalf

you are submitting this form.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 168Exhibit 9

- 2 shows a screen capture of the ‘Submitting On Behalf Of’ screen:

Exhibit 9

- 2 : Submitting On Behalf Of Screen

Navigation: Click the ‘Next’ button to continue with submitting the form and proceed to the
‘Submission Process: Validation’ screen

. Click the ‘Home’ button to navigate back to the Section 5 Notices and Supports ‘Home’ screen.

9.3 Submission Process: Validation

Click the ‘Submit’ icon ( ) that is located in the bottom action bar of the Section 5 Notices and Supports form to begin the subm ission process and access the ‘Submission Process: Validation’

screen.
The first step in the submission process will validate the information entered within the Section 5 Notices and Supports form. After a form is validated, the system will generate a PDF.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 169Exhibit 9

- 3 shows a screen capture of the ‘Submission Process: Validation’ screen:

Exhibit 9

- 3 : Submission Process: Validation Screen

Exhibit 9

- 4 shows a screen capture of the ‘Submission Process: PDF Generation’ screen:

Exhibit 9

- 4 : Submission Process: PDF Generation Screen

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 170Navigat ion: Click the ‘View PDF’ button to generate and view a PDF of the form. Click the
‘Continue’ button to continue with submitting the form and proceed to the ‘Cross

- Media Electronic Reporting Regulation (CROMERR) Certification’ screen

. 9.4 Cross

- Media Electroni c Reporting Regulation ( CROMERR ) Certification

Click the ‘Continue’ button on the ‘Submission Process: PDF Generation’ screen to access the

‘Cross

- Media Electronic Reporting Regulation (CROMERR) Certification’ screen.

CROMERR provides the legal framework f or electronic reporting under all of EPA’s environmental regulations.

After clicking the ‘Continue’ button, the system requires you to certify that the form is CROMERR compliant. By clicking the ‘I Certify’ button on the ‘Cross

- Media Electronic Reporting R egulation (CROMERR) Certification’ screen, you authenticate all of the information entered in the form. Click the ‘Cancel’ button to navigate back to the Section 5 Notices and Supports application.

Exhibit 9

- 5 shows a screen capture for the ‘Cross

- Media Electronic Reporting Regulation (CROMERR) Certification’ screen:

Exhibit 9

- 5 : Cross

- Media Electron ic Reporting Regulation (CROMERR) Certification
Screen

Navigation: Click the ‘I Certify’ button to continue with submitting the form and proceed to the ‘CROMERR Login’ screen

.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 1719.5 Cross

- Media Electronic Reporting Regulation ( CROMERR ) Login

You can access the ‘Cross

- Media Electronic Reporting Regulation (CROMERR) Login’ screen by clicking the ‘I Certify’ button on the ‘Cross

- Media Electronic Reporting Regulation (CROMERR) Certification’ screen.

To proceed with the submission, log into CDX us ing the credentials you provided during CDX registration:

• Please login with your CDX password: Enter your CDX registration password.

Exhibit 9

- 6 shows a screen capture of the ‘Cross

- Media Electronic Reporting Regulation (CROMERR) Login’ screen.

Exhibit 9

- 6 : Cross

- Media Electronic Report ing 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 Reporting Reg ulation ( 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 a nd clicking the ‘Next’ button.

The ‘Cross

- Media Electronic Reporting Regulation (CROMERR) Security Question’ screen randomly selects and displays one of the five CROMERR eSIG

- PIN questions you answered on
the ‘20

- 5

- 1 Question’ screen during the initial lo gin to CDX.

eSIG

- PIN Authorization Code: Provide one of the five secret answers to the questions that were pulled from the list of 20 CDX security questions.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 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 clicking the ‘Next’ button.

On the ‘Submit to CDX’ screen, you will see a certification message. Read the message and acknowledge by clicking the ‘Confirm’ button. Once you have clicked the ‘Confirm’ button, your form will be submitted to CDX.

This screen is only applicable to the original forms (PMN, Biotechnology

, and Bona Fide ). This screen will display during the submission process for joint submissions and Letters of Support.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 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 acknowledgi ng 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 submitted to EPA via C DX.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 174Exhibit 9

- 9 shows a screen capture of the ‘Cross

- Media Electronic Reporting Regulation (CROMERR) Submission ’ screen:

Exhibit 9

- 9 : Cross

- Media Electronic R eporting Regulation (CROMERR) Submission
Screen

Navigation: Click the ‘Finish’ button to navigate back to the Section 5 Notices and Supports
‘Home’ screen. Click the ‘Forms’ link or tab to find your locked processed submission. The
‘Section 5 Notices a nd 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 175

### 10 Download Copy of Record

To download a Copy of Record, navigate to the ‘Section 5 Notices and Supports Forms’ s creen and locate a form alias for which you have successfully completed a submission and which has a
status of ‘Submitted.’

Click the ‘Copy of Record’ icon ( ) from the ‘Section 5 Notices and Supports Forms’ screen to navigate to the ‘Enter Passphrase’ screen to login into CDX. The ‘Enter Passphrase’ screen requires you to enter the passphrase originally associated with the form. If your passphrase is entered correctly, you will access the ‘Cross

- Media Electronic Reporting Regul ation (CROMERR) Login’ screen where you are required to enter your credentials you provided during CDX registration. Once you have provided the correct CDX password, click the ‘Next’ button to navigate to the ‘Cross

- Media Electronic Reporting Regulation (C ROMERR) 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 regi stration. 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 during the submission process, PDF version of the submission or the XML version of the Section 5 Notices and Supports form. When you click the ‘Copy of Record’ icon ( ), the system will

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 176allow you to view or download the individual files that were uploaded during the submission

process.
After you click the ‘Copy of Record’ icon ( ), enter the passphrase associated with the case number, and click the ‘Next’ butto n. If the passphrase was correctly entered, the application will take you to the ‘CROMERR Login’ screen to enter the CDX password. If your login was successful, you will access to the ‘CROMERR Security Question’ screen. The ‘CROMERR Security Question’ scre en randomly selects and displays one of the five CROMERR eSIG

- PIN questions that you answered on the 20

- 5

- 1 Question screen during the initial login to CDX. Answer the CROMERR security question and click the ‘OK’ button. If your answer was successful, you will navigate to the ‘Download Copy of Record’ screen.

Exhibit 10

- 2 shows a screen capture of the download prompt 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 177

### 11 Create an Amendment

To amend a submitted Joint PMN

, Joint Biotechnology

, or Bona Fide Letter of Support
submission , navigate to the ‘ Section 5 Notices and Supports Forms’ screen and locate a previously submitted form with a status of ‘ Submitted. ’ In addition to displaying a status of

‘ Submitted ’ under the ‘ Status ’ column, the ‘ Lock ’ icon ( ) will be displayed under the ‘ Action ’

column. Click the ‘ Lock ’ icon ( ) under the ‘ Action ’ column to start an amendment

.
Exhibit 11

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

Exhibit 11

- 1 : Section 5 Notices and Supports Form

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 178Navigation: After clicking the ‘Lock’ icon ( ), you will receive a prompt to confirm the unlock process. If you do not want to continue with the amendment

, click the ‘ Cancel ’ button to cancel
the amendment process and return to the ‘ Section 5 Notices and Supports Forms’ screen. Click
the ‘ OK ’ button to close the prompt and continue with the amendment

.
Exhibit 11

- 2 shows a screen capture of the ‘Unlock Prompt’ message:

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 revised notice process. After you enter the passphrase and click the ‘ Next ’ button you will be taken to the ‘ General
Form Information ’ screen. Refer to Section 3.6 for further instructions on the ‘ Enter Passphrase ’

screen.

After a submission has been unlocked , the ‘ Section 5 Notices and Supports Forms’ scre en will
display a status of ‘ In Progress ’ under the ‘ Status ’ column, and an ‘ U nlocked ’ icon ( ) will display under the ‘ Action ’ column ; however

, you will not see these changes until you navigate
back to the ‘ Section 5 Notices and Supports Forms’ screen . Refer to Section 1 through Section
4.1.26 for instructions on editing a revised PMN form

. Refer to Section 5.1.1 through Section
5.1.3 for instructions on editing a revised Biotechnology form.

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

use r guides as well as additional helpful links. Click the ‘User Guide’ link to access the Section 5 Notices and Supports user guide document.

• Regulatory Impact Analysis for the Regulation of Microbial Products of Biotechnology:

Government Costs: If you click this link, a new internet browser window will generate displaying the ‘Regulatory Impact Analysis for the Regulation of Microbial Products of Biotechnology: Government Costs’ screen.

• Microbial Products of Biotechnology: Final Rule (62 FR 17910): If you c lick this link, a

new internet browser window will generate displaying the ‘Microbial Products of Biotechnology: Final Rule (62 FR 17910)’ screen.

• Points to Consider in the Preparation of TSCA Biotechnology Submissions for

Microorganisms: If you click thi s link, a new internet browser window will generate displaying the ‘Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms’ PDF.

• CDX Homepage: If you click this link, a new internet browser window will generate

displaying the CDX Homepage.

• TSCA Chemical Substances Inventory: If you click this link, a new internet browser

window will generate displaying the ‘TSCA Chemical Substances Inventory’ screen.

• Substance Registry Services (SRS): If you click this link, a ne w internet browser window

will generate displaying the ‘Substance Registry Services (SRS)’ screen.

• Facility Registry System (FRS): If you click this link, a new internet browser window will

generate displaying the ‘Facility Registry System (FRS)’ screen.

The FRS generally includes such core data elements as name, address, affiliated organizations and contacts, and industrial classifications. When using this query to search for facilities, use any combination of facility name, geographic location, facility industrial classification, affiliated organization and contact, program category, and national systems information. Enter in as many fields as possible, otherwise the system will return a results list too big to display.
To search for a specific facility, search by Facility Name, Registry ID, Zip Code, and State for an accurate list of results. Search by City Name, Zip Code, and State to return a truncated list of results within a geographic region.

• CAS Inventory Expert Services: If you click this link, a new internet browser window will

generate displaying the ‘CAS Inventory Expert Services (IES)’ screen.

• National Pollutant Discharge Elimination System (NPDES): If you click this link, a new

internet browser window will generate displaying the ‘National Pol lutant Discharge Elimination System (NPDES)’ screen.

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 180• New Chemicals Program Homepage: If you click this link, a new internet browser window will generate displaying the ‘New Chemicals Program’ screen.

• Status of Section 5 Notices: If you click this link, a n ew internet browser window will

generate displaying the ‘Status of Section 5 Notices’ screen.

Exhibit 12

- 1 shows a screen capture of the ‘ Resources ’ screen (Scroll 1) :

Exhibit 12

- 1 : Resources Screen (Scroll 1)

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 181Exhibit 12

- 2 shows a screen capture of the ‘Resources’ screen (Scroll 2):

Exhibit 12

- 2 : Resources Screen (Scroll 2)

TDD 9.21 OPPT MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 182

### Appendix A

The following table displays all the definitions, acronyms, and abbreviations used in this
document and their full name.

Definitions, Acronyms, and Abbreviations

Acronym Full Name

ACM Alternative Control Measures

AO Authorized Official

BCF/BAF Bioconcentration Factors/Bioaccumulation Factors

CBI Confidential Business Information

CA Chemical Abstracts

CAS Chemical Abstracts Service

CASRN Chemical 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized Official 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 MTS Section 5 Notices and Supports User Guide December 17 , 2014 Secondary Authorized
Official 184