## Section 5 Notices and Supports
User Guide

– Secondary Support

Environmental Protection Agency

Office of Pollution Prevention and Toxics

Delivery Order # GS00Q09BGD0022

Task Order # EP

- G11H

- 00154

Project # TDD 9.21

Version 1.0

December 19, 2014

### T able of Contents

Table of Contents

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

List of Exhibits

................................ ................................ ................................ ......................... iii

1 Introduction

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

2 System Requirements

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

2.1 Supported Browsers

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

2.2 Screen Resolution

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

3 Secondary Support Functions

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

3.1 Log into Section 5 Notices and Supports Application

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

3.2 Home Screen Navigation

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

3.3 Section 5 Notices and Supports Forms

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

3.4 Enter Passphrase Screen

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

3.5 Navigation Tree

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

3.6 Action Bar

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

3.7 Attach Documents

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

3.8 Search Substance Registry Services (SRS)

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

3.9 Add Facility

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

4 Edit Joint Premanufacture Notice (PMN) Form

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

4.1 Edit Joint/Letter of Support PMN

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

4.1.1 General Form Information

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

4.1.2 Agent Information

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

4.1.3 Technical Contact Information

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

4.1.4 Chemical Identification

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

4.1.5 Class 1 or 2 Chemical Substances

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

4.1.6 Class 2 Substances

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

4.1.7 Additional Chemical Information

................................ ................................ ........... 48

4.1.8 Polymer Identification Information

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

4.1.9 Monomers and Other Reactants

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

4.1.10 Production Volume an d Hazard/Safety Information

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

4.1.11 Use Information

................................ ................................ ................................ .... 65

4.1.12 Physical and Chemical Properties Worksheet

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

4.1.13 Physical and Chemical Properties Worksheet

– Continued (Optional)

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

4.1.14 Physical and Chemical Properties Worksheet

– Continued (Optional) Attach
Documents

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

4.1.15 Site Information

................................ ................................ ................................ ..... 84

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support i4.1.16 Sites Controlled By Others

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

4.1.17 Submitter Operation Information

................................ ................................ ........... 87

4.1.18 Occupational Exposures

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

4.1.19 Environmental Releases

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

4.1.20 Industrial Sites Controlled By Others

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

4.1.21 Exposures/Releases

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

4.1.22 Byproduct Information

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

4.1.23 Optional Pollution Prevention

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

4.1.24 Additional Attachments

................................ ................................ ....................... 112

4.1.25 Attachment Summary

................................ ................................ ......................... 114

4.1.26 Optional Cover Letter

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

4.1.27 Upload XML

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

5 Edit Joint Biotechnology Form

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

5.1 Edit Joint/Letter of Support Biotechnology Form

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

5.1.1 General Form Information

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

5.1.2 Technical Contact Information

................................ ................................ ............ 121

5.1.3 Optional Cover Letter

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

6 Edit Letter of Support Bona Fide Form

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

6.1 Edit Letter of Support Bona Fide Form

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

6.1.1 General Document Information

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

6.1.2 Primary Contact Information

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

6.1.3 Technical Contact Information

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

6.1.4 Chemical Identification Information

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

6.1.5 Class 1 or 2/Biotechnology Chemical Substance

................................ ................ 134

6.1.6 Class 2/Biotechnology Substances

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

6.1.7 Polymer Identification Information

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

6.1.8 Monomers and Other Reactants

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

6.1.9 Use Information

................................ ................................ ................................ .. 146

6.1.10 Document Management

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

6.1 .11 Optional Cover Letter

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

7 Preview

................................ ................................ ................................ .......................... 151

8 Validate

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

9 Resources

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

10 Appendix A.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support ii

### List of Exhibit s

Exhibit 3

- 1 Section 5 Notices and Supports User Roles Matrix

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

Exhibit 3

- 2 Chemical Information Submission System Screen

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

Exhibit 3

- 3: Section 5 Notices and Supports Home Screen

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

Exhibit 3

- 4: Section 5 Notices and Supp orts Forms Screen

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

Exhibit 3

- 5: Enter Passphrase Screen

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

Exhibit 3

- 6: Navigation Prompt

................................ ................................ ................................ .. 11

Exhibit 3

- 7: Premanufacture Notice Navigation Tree (Scroll 1)

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

Exhibit 3

- 8: Premanufacture Notice Navigation Tree (Scroll 2)

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

Exhibit 3

- 9: Premanufacture Notice Navigation Tree (Scroll 3)

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

Exhibit 3

- 10: Biotechnology Navigation Tree

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

Exhibit 3

- 11: Bona Fide Navigation Tree (Polymer)

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

Exhibit 3

- 12: Bona Fide Navigation Tree (Clas s 1 or 2 Chemical)

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

Exhibit 3

- 13: Action Bar

– Validate

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

Exhibit 3

- 14: Action Bar

– Save

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

Exhibit 3

- 15: Action Bar

– Preview

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

Exhibit 3

- 16: Action Bar

– Help Links

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

Exhibit 3

- 17: Attach Documents Pop

- Up Window

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

Exhibit 3

- 18: Search Substance Registry Services Pop

- Up Window

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

Exhibit 3

- 19: Chemical Not Found In Substance Registry Services Pop

- Up Window

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

Exhibit 3

- 20: Add Facility Pop

- Up Window

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

Exhibit 4

- 1: General Form Information Screen (Scroll 1)

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

Exhibit 4

- 2: Agent Information Screen

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

Exhibit 4

- 3: Add Agent Pop

- Up Window

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

Exhibit 4

- 4: Technical Contact Information Screen

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

Exhibit 4

- 5: Add Technical Contact Pop

- Up Window

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

Exhibit 4

- 6: Chemical Identification Screen

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

Exhibit 4

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

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

Exhibit 4

- 8: Class 1 or 2 Chemi cal Substances Screen (Scroll 2)

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

Exhibit 4

- 9: Class 2 Substances Screen (Scroll 1)

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

Exhibit 4

- 10: Class 2 Substances Screen (Scroll 2)

................................ ................................ .. 48

Exhibit 4

- 11: Additional Chemical Information Screen (Scroll 1)

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

Exhibit 4

- 12: Additional Chemical Information Screen (Scroll 2)

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

Exhibit 4

- 13: Polymer Ide ntification Information Screen (Scroll 1)

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

Exhibit 4

- 14: Polymer Identification Information Screen (Scroll 2)

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

Exhibit 4

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

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

Exhibit 4

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

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

Exhibit 4

- 17: Production Volume and Hazard/Safety Information Screen

................................ .. 65

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support iiiExhibit 4

- 18: Use Information Screen (Scroll 1)

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

Exhibit 4

- 19: Use Information Screen (Scroll 2)

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

Exhibit 4

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

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

Exhibit 4

- 21: Phy sical and Chemical Properties Worksheet Screen (Scroll 2)

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

Exhibit 4

- 22: Physical and Chemical Properties Worksheet

– Continued (Optional) Screen

...... 80

Exhibit 4

- 23: Physical and Chemical Properties Worksheet

– Continued (Optional) Attach Documents Pop

- Up Window (Scroll 1)

................................ ................................ ...................... 82

Exhibit 4

- 24: Physical and Chemical Properties Worksheet

– Continued (Optional) Attach Documents Pop

- Up Window (Scroll 2)

................................ ................................ ...................... 83

Exhibit 4

- 25: Site Information Screen

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

Exhibit 4

- 26: Sites Controlled By Others Screen

................................ ................................ ....... 87

Exhibit 4

- 27: Submitter Operation Information Screen (Scroll 1)

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

Exhibit 4

- 28: Submitter Operation Information Screen (Scroll 2)

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

Exhibit 4

- 29: Occupational Exposures Screen

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

Exhibit 4

- 30: Environmental Releases Screen (Scroll 1)

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

Exhibit 4

- 31: Environmental Releases Screen (Scroll 2)

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

Exhibit 4

- 32: Industrial Sites Controll ed By Others Screen

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

Exhibit 4

- 33: Exposures/Releases Screen (Scroll 1)

................................ ............................... 106

Exhibit 4

- 34: Exposures/Releases Screen (Scroll 2)

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

Exhibit 4

- 35: Byproduct Information Screen

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

Exhibit 4

- 36: Optional Pollution Prevention Screen

................................ ................................ . 112

Exhibit 4

- 37: Additional Attachments Screen

................................ ................................ ........... 114

Exhibit 4

- 38: Attachment Summary Screen

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

Exhibit 4

- 39: Optional Cover Letter Screen

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

Exhibit 4

- 40: Upload XML Screen

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

Exhibit 5

- 1: General Form Information Screen (Joint Biotechnology)

................................ ...... 121

Exhibit 5

- 2: Technical Contact Information Screen (Joint Biotechnology)

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

Exhibit 5

- 3: Add Technical Contact Pop

- Up Window (Joint Biotechnology)

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

Exhibit 5

- 4 : Optional Cover Letter Screen (Joint Biotechnology)

................................ ............. 125

Exhibit 6

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

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

Exhibit 6

- 2: Primary Contact Information Screen

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

Exhibit 6

- 3: Technical Contact Information Screen

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

Exhibit 6

- 4: Chemical Identification Information Screen

................................ ........................... 134

Exhibit 6

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

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

Exhibit 6

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

................................ ........... 139

Exhibit 6

- 7: Class 2/Biotechnology Substances Screen (Scroll 2)

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

Exhibit 6

- 8: Polymer Identification Information Screen

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

Exhibit 6

- 9: Monomers and Other Reactants Screen

................................ .............................. 146

Exhibit 6

- 10: Use Information Screen

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support ivExhibit 6

- 11: Document Management Screen

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

Exhibit 6

- 12: Optional Cover Letter Screen

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

Exhibit 7

- 1 : Preview Biotechnology Form Screen

................................ ................................ .... 151

Exhibit 7

- 2 Preview Biotechnology Form PDF

................................ ................................ ......... 152

Exhibit 8

- 1: Section 5 Notices and Supports Validation Pop

- Up Window

................................ 154

Exhibit 9

- 1 Resources Screen (Scroll 1)

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

Exhibit 9

- 2 Resources Screen (Scroll 2)

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support v

### Revision Log

Date Version
No. Description Author Reviewer Review
Date

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

J. DeRosa P. Saari 09/20 /13

12 / 19 /14 1.0 Final Section 5 Notices and Supports Secondary AO User Guide

Incorporated OPPT comments given
on 11/07/2013

Incorporated Release 1.00 enhancements, other OPPT

comments C. Yeh J. Bronick 12 / 19 /14

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support vi

### 1 Introduction

This document presents the user guide 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 Support user of the Section 5 Notices and Supports application

.
The Section 5 Notices and Supports Forms 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 Support, you can modify a Letter of Suppo rt or Joint Submission for a Premanufacture Notice (PMN)

, Biotechnology , or a Letter of Support for a Bona Fide form that a Secondary Authorized Official (AO) has assigned to you

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

- 888

- 890

- 1995 between the hours of 8 am

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

- Hotl ine@epamail.epa.gov or call 202

- 554

- 1404 between the hours of 8:30 am

– 5:00 pm EST.

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

- pr oduction and known issues within IE 7 are identified within the appropriate sections of this guide)

− Go to the following link to download:

− http://windows.microsoft.com/en

- US/internet

- explorer/downloads/ie

• Mozilla Firefox 3. 0 or above

− Go to the following link to download:

− http://www.mozilla.com/en

- US/firefox/all

- older.html

• S afari 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 CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 2

### 3 Secondary Support Functions

This section describes how to:

• Access the application

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

• Edit the Section 5 Notices and Supports Letters of Support and Joint Submission for a PMN

,

Biotechnology , or a Letter of Support for a Bona Fide form

• Upload an Extensible Markup Language ( XML ) file
The Secondary Support is designated by a Secondary Authorized Official ( AO ) to provide supporting information on behalf of a company. A Secondary Support may either work on behalf of a United States (U.S.)

- ba sed company or non

- U.S. based company. Examples of a Secondary Support may include, but are not limited to, a corporate on

- site contact, a technical contact, a paid employee of the company, an outside consultant for the company, or an authorized
representa tive agent for the company. Secondary Supports do not have the ability to sign the certification statement required for a form , but they may enter or modify data for the form for which they have access. The Secondary Support does not have access rights to create or submit a joint PMN , Biotechnology, or Letter of Support for a Bona Fide form

. Once the Secondary AO creates a new form

, the Secondary AO will provide the Secondary Support with the passphrase to access the form and complete all sections of form

. The Secondary Support can edit a Joint Submission and/or Letter of Support created by the Secondary AO. The Secondary Support is only allowed to access forms to which the Secondary AO has granted

access.
The system will allow the Secondary Support to save a form at any point during the data entry process. The save functionality allows you to return to a form at any point in the future. After the Secondary Support completes a form, the Secondary AO will access, review, and submit the

form to EPA via CDX.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 3Exhibit 3

- 1 displays a table of the capabilities of user roles within the Section 5 Notices and Supports application.

Exhibit 3

- 1 Section 5 Notices and Supports User Roles Matrix

3.1 Log into Section 5 Notices and Supports A pplication

After you create an account in CDX and click the ‘ Secondary Support ’ link for the Chemical Safety and Pesticide Programs (CSPP) data flow, you will be taken to the ‘Chemical Information Submission System’ screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 4Exhibit 3

- 2 shows a screen capture of the ‘Chemical Information Sub mission System’ screen:

Exhibit 3

- 2 Chemical Information Submission System Screen

Navigation: To access the Section 5 Notices and Supports ‘Home’ screen, s elect the submission
type of ‘ TSCA Section 5 Notices and Supports

– ePMN ’ from the drop

- down menu and click the

‘ OK ’ button.

3.2 Home Screen Navigation

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

– ePMN’ from the submission type drop

- down menu on the ‘ Chemical

Information Submission System ’ screen and clicking the ‘ OK ’ button.

The Section 5 Notices and Supports ‘ Home ’ screen is the first screen within the Section 5 Notices and Supports application. It provides you with links and tabs to access the ‘Section 5

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 5Notices and Supports Form s’ and ‘Resources’ screens. To navigate to either of these screens,

click the screen lin k ( highlighted in blue text ), or click the screen tab (located within the application header ). The links and tabs provide the same functionality

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

.

• Forms: Click the ‘ Forms ’ link or t ab to navigate to the ‘ Section 5 Notices and Supports Forms’

screen. You can access a Section 5 Notices and Supports form using the ‘ Section 5 Notices and Supports Forms ’ screen. For additional details about the ‘ Section 5 Notices and Supports

Forms ’ scree n, please refer to Section 3.3

.

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

find the Section 5 Notices and Supports user guide , as well as useful links for guidance

documents on the ‘ Resources ’ screen. For additional details about the ‘ Resources ’ screen, please refer to Section 9

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 6Exhibit 3

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

Exhibit 3

- 3 : Section 5 Notices and Supports Home Screen

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

screen.

3.3 Section 5 Notices and Supports Form s

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 7Only one Section 5 Notices and Supports form is created per form alias . The form alias is created by the AO to identify and diffe rentiate forms. Each column within the table of the ‘Section 5 Notices and Supports Forms’ screen can be sorted by clicking the individual column headers

.
Edit a n ‘In Progress’ Form : To modify an existing Section 5 Notices and Supports form

, click

the alias link for a form that has a status of ‘ In Progress. ’ You are required to enter the passphrase created by the AO and associated with that particular form to access and edit the

form. Refer to Section 4.1 for further instructions on viewing and modifying a form that is ‘In Progress.’

The ‘Section 5 Notices and Supports Forms’ screen displays the following columns of

information:

• Alias : Displays the form alias p r ovided on the ‘General Information’ screen of a Section 5

Notices and Supports form

. The ‘Alias’ column will display a default alias comprised of a form type, date stamp, and time stamp in the following format: <Form Type

- YYYYMMDD

HH:MM:SS Time Zone> if yo u 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.

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

column can contain the following values: ‘ Joint PMN

, ’ ‘ Joint Biotech nology

, ’ or ‘ Joint Bona

Fide

. ’

• Subtype: This value will not be populated

.

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

or mixture after EPA receives the submission. In all cases, the ‘XX’ represents the fiscal year in which the form was submitted, and the ‘XXXX’ represents the order in which the f orm was received. A consolidated submission will generate sequential case numbers for each chemical

identified within the form and will display all case numbers associated with that specific form. If the form has not been submitted and received, the ‘Case Number’ field remains blank.

• Status: Displays the status of the Section 5 Notices and Supports form. The values will display

as ‘In Progress’ or ‘Submitted.’

• Modify Date: Displays the date the submission was last modified.

• Submission Date: Displays the da te when the form was submitted to EPA via CDX. This date

populates only after the form has been submitted

.

• Export Options: Displays ‘CSV,’ ‘Excel,’ ‘XML,’ and ‘PDF’ links for you to export the

‘Section 5 Notices and Supports Forms’ screen in one of the sp ecified formats as an Excel spreadsheet, Comma

- Separated Values (CSV), Extensible Markup Language, or Portable Document Format (PDF). The export options section will not display until a form is created.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 8Exhibit 3

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

Exhibit 3

- 4 : Section 5 Notices and Supports Forms Screen

Navi gation: Click the alias link in the ‘Alias’ column of an ‘In Progress’ form to navigate to the ‘Enter Passphrase’ screen

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 93.4 Enter Passphrase Screen

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 give to you by the Secondary AO that is associated

with the form

.

Exhibit 3

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

Exhibit 3

- 5 : Enter Passphrase Screen

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

‘Joint Bona Fide ’ form.

3.5 Navigation Tree

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 10• Collapse and E xpand folders: Each section of the form falls under a collapsible folder within

t he navigation tree which allows you to save space or easily view items in the navigation tree. When a folder is expanded, you can click the minus sign (

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

red.

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

screens within the application and the different sections of the form. Each section of the form is denoted with a ‘Form’ icon ( ). You can click a ‘Form’ icon ( ) or a section title link to navigate between screens. You are required to save all information entered on a particular screen before navigating to the next screen or all entered information will be lost. A prompt will appear after you click a link in the navigation tree indicating, ‘Are you sure you want to leave the current page? Any unsaved changes will be lost.’ If you click the ‘OK’ button, you will be taken to the requested screen without saving any of the data in the previous screen. If you click the ‘Cancel’ button, the prompt will close and you will not be taken to the requested

screen.

Exhibit 3

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

Exhibit 3

- 6 : Navigation Prompt

• Delete c hemical folders: To delete specific c hemical 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 del eted, all information entered within the deleted chemical folder is lost and

cannot be retrieved. You can add a new chemical folder by clicking the ‘Add Consolidated Chemical’ link, and filling in all corresponding data. This delete functionality is not ap plicable to the Biotechnology or Bona Fide module within the Section 5 Notices and Supports application.

• Copy c hemical folders: To copy a specific chemical folder, click the ‘Copy’ icon ( ) that

displays at the bottom of each chemical folder within the navigation tree of a PMN form

. When a chemical folder is copied, the chemical name, Chemical Abstracts Service Registry Number (CASRN), and attached documents are removed from the copied chemical. This copy functionality is not applicabl e to the Biotechnology or Bona Fide module within the Section 5 Notices and Supports application.

• Delete ‘Submit ter Controlled Operations’ or ‘Operations Controlled By Others’ folders :

Click the ‘Delete’ icon ( ) that displays a t the bottom of each ‘Submit ter Controlled

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 11Operations’ 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 enter ed within the deleted operation is lost and cannot be retrieved. You can add a new ‘Submitter Controlled Operations’ or ‘Operation Controlled By Others’ folder by clicking the ‘Add Operation’ link under the appropriate folder and filling in all correspondi ng data. 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 Notice s and Supports application.

• 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 j oint PMN form, or to export an existing joint PMN form

into an XML file format. A user may also upload eTSCA thick client files into a joint PMN form. If an XML file is uploaded into an existing form, the contents of that XML file overwrite

the contents within the PMN form. For more information about the upload XML functionality,

refe r to Section Error! Reference source not found.

.

• Please note that in IE 7, the scroll bar within the navigation bar may freeze or portions of the

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 fo rm

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 12Exhibit 3

- 7 show s a screen capture s of the ‘ Premanufacture Notice ’ navigation tree (Scroll 1) :

Exhibit 3

- 7 : Premanufacture Notice Navigation Tree (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 13Exhibit 3

- 7 shows a screen capture s of the ‘Premanufacture Notice’ navigation tree (Scroll 2):

Exhibit 3

- 8 : Premanufacture Notice Navigation Tree (Scroll 2)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 14Exhibit 3

- 7 shows a screen capture s of the ‘Premanufacture Notice’ navigation tree (Scroll 3):

Exhibit 3

- 9 : Premanufacture Notice Navigation Tree (Scroll 3)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 15Exhibit 3

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

Exhibit 3

- 10 : Biotech nology Navigation Tree

Exhibit 3

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

Exhibit 3

- 11 : Bona Fide Navigation Tree (Polymer)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 16Exhibit 3

- 12 shows a screen capture of the ‘ Bona Fide ’ navigation tree ( Class 1 or 2 Chemical ):

Exhibit 3

- 12 : Bona Fi de Navigation Tree (Class 1 or 2 Chemical)

3.6 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: You can click the ‘Validate’ icon ( ) at any stage of completing a Section 5

Notices and Supports form. A ‘Section 5 Notices and Supports Validation’ pop

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

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

- up window displays a report of all warning messages and validation errors. On screens that display an expandable/collapsible field set, you must click the ‘Save’ button displayed within the expandable/collapsible field set to sa ve the information entered within the field set before the ‘Validate’ functionality initiates

. Refer to Section 8 for more information on validatin g a form

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 17The following exhibits

, Exhibit 3

- 13

, Exhibit 3

- 14

, and Exhibit 3

- 15 sh ow a screen capture s for

the action b ar:

Exhibit 3

- 13 : Action Bar

– Validate

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

form to save the form

. To generate and access a 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 enter ed in the form has been
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 th e 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 for m. Click the ‘X’ button in the upper right

- hand corner of the form in your

browser to close the form without saving

. Exhibit 3

- 14 : Action Bar

– Save

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

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

version of the form or the non

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

Exhibit 3

- 15 : Action Bar

– Preview

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

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

of completing a Section 5 Notices and Supports form.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 18− If you click the ‘CDX Homepage’ link, the application takes you to the CDX Homepage.

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

screen.

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

− If you click the ‘Terms and Conditions’ link, the application takes you to the CDX Terms

and Conditions screen.

− If you click the ‘Privacy Notice’ link, the application takes you to the CDX Privacy and

Security Notice screen.

Exhibit 3

- 16 shows a screen capture of the action bar ‘Help’ links:

Exhibit 3

- 16 : Action Bar

– Help Links

3.7 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. You can access the ‘Attach Documents’ pop

- up window by clicking the ‘Attach Document’

button displayed on a screen. You can attach a file and enter a description, number of pages, and

indicate CBI status. There is no limit on the size of the file that can be attached; however, the application prevents a user from uploading an empty document

. The system allows you to claim an uploaded document as CBI. If you claim a document as CBI, the system requires you to uploa d 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

po pulate a required field and click the ‘OK’ button, an error message will display to indicate the missing field and the application will delete the previously attached file

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

- up window w ill close and the document’s information will display in a table format on the screen. Depending on the screen, the attachment table may display the section of the page the file is associated with, the file name and file extension of the document, a descri ption of the document, the number of pages in the document, and if the document was claimed CBI. The system allows you to delete unwanted documents by clicking the ‘Delete’ icon ( ) located under the ‘Actions’ column. To view, open, or edit previously atta ched 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,’ ‘GPC,’ ‘Genetic Toxi city,’ ‘Health Toxicity,’ ‘IES Report,’ ‘Safety Datasheet,’ and ‘Terrestrial Ecotoxicity.’ This is a required field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 19• Subtype: Select the subtype of the document that you upload. This drop

- down menu contains the following values, which are grouped under sp ecific 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/Reproductive Toxicity,’ ‘Sensitization,’ ‘Carcinogenicity,’ ‘Repeated

Dose Toxicity,’ ‘Neurotoxicity,’ ‘Acute Toxicity,’ ‘Developmental Toxicity,’ ‘Pharmacokinetics/Metabolism,’ ‘Dermal Irritation,’ ‘Reproductive Toxicity,’ ‘Fish Chronic Toxicity,’ ‘Invertebrate 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.’ This is a required field when displayed.

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

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

• Description: Enter a description associated with the attached document. Submitters should not

include any CBI information in the document description. This is a required field.

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

• Check to claim the attachment as CBI: Check the ‘CBI’ checkbox to claim the attached

document as confidential. Un

- checking the ‘CBI’ checkbox for a CBI document generates a

warnin g notifying you that un

- checking the CBI claim will delete the sanitized file.

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

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

version of the document.

• Cancel: Click the ‘Cancel’ but ton to canc el the attach document process.

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

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

- attached and the missing field must be populated.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 20Exhibit 3

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

- up window:

Exhibit 3

- 17 : Attach Documents Pop

- Up Window

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 213.8 Search Substance Registry Services (SRS)

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

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

a lso 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’ window and enter chemical informa tion 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 che mical 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 Suppor ts application contains functionality to prevent a user from adding duplicate chemicals within a multi

- component submission. Chemicals are checked in the following order:

• If both chemicals have CASRNs, they will be compared

.

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

.

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

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

- component submission

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

Services’ window.

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

accommodates dashes . Eithe r the ‘CASRN’ or ‘CA Index Name or Other Synonym’ field is required when searching SRS.

• CA Index Name or Other Synonym: Enter the chemical abstract ‘(CA) Index Name or Other

Synonym’ of the chemical. This field displays the following options: ‘Matches Exa ctly,’ ‘Contains,’ and ‘Begins With.’ Either the ‘CASRN’ or ‘CA Index Name or Other Synonym’ field is required when searching SRS.

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

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

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

Not Found In Substance Registry Services’ pop

- up window.

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

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

- up window:

Exhibit 3

- 18 : Search Substance Registry Services Pop

- Up Wind ow

Navigation: Click the ‘Search’ button on the ‘Search Substance Registry Services’ window to initiate the database search for the CASRN or CA Index Name or Other Synonym. After SRS returns results, select the chemical, click the ‘OK’ button on the ‘Search SRS’ window, close the

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 23‘Search Substance Registry Services’ window, and navigate back to the screen from which the SRS search was initiated where the chemical information will be populated.
If the chemical is not found in the ‘Search Substance Registry Services’ window , click the ‘Create New Chemical’ button to generate the ‘Chemical Not Found In Substance Registry Services’ pop

- up window.

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

checkbox will not be displayed on the ‘Chemic al Not Found In Substance Registry Services’ window for the ‘Class 1 or 2 Chemical Substances,’ ‘Polymer Identification Information,’ or

the ‘Monomers and Other Reactants’ screen.

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

• CASRN: E nter the manually entered CASRN, if available.

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

only in the ‘Chemical Not Found In Substance Registry Services’ window on the ‘Additional

Chemical Information’ screen

.

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

window.

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

on the screen from which the SRS search was initiated.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 24Exhibit 3

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

pop

- up window:

Exhibit 3

- 19 : Chemical Not Found In Substance Registry Services Pop

- Up Window

Navigation: Click the ‘OK’ button to save the manually entered chemical information and navigate back to the screen from which the SRS search was initi ated where the chemical information will be populated. Click the ‘Cancel’ button to navigate back to the ‘Search SRS’

pop

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

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

3.9 Add Facility

The ‘ Add Facility ’ button displays on the ‘Submitter Operation Information’ screen and the ‘Industrial Sites Controlled By Others’ screen within a PMN form. This button also displays on the ‘Site Information’ screen wi thin a NOC form and the ‘Submitter Site Identification’ screen

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 25within a Bona Fide form. The ‘ Add Facility ’ button is used to generate the ‘Add Facility’ pop

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

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

- down menu.

If you are not registered to any facilities with in CDX registration, or you have finished identifying all possible sites, a message displays within a pop

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

Click the ‘ Add Facility ’ butt on to generate the ‘ Add Facility ’ pop

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

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

• Select a site from the drop

- down menu below : Select a single or multiple sites from the

drop

- down menu that you will be reporting on

.

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

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

pending for the form.

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

- down menu.

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

- down menu.

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

- down menu

.

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

- down menu

.

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

- down menu

.

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

- down menu

.

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

initiating the search

.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 26Exhibit 3

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

- up window:

Exhibit 3

- 20 : 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 CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 27

### 4 Edit Joint Premanufacture Notice (PMN) Form

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

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

4.1 Edit Joint/Letter of Support PMN

To edit a Joint PMN or Letter of Support , navigate to the ‘Section 5 Notices and Supports

Forms’ screen and click the alias link in the ‘Alias’ column of a form with a status of ‘In Progress

. ’ Refer to Section 3.3 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen.

Refer to Section 0 for ad ditional details regarding the enter passphrase process.

4.1.1 General Form Information

You can navigate to the ‘General Form Information’ screen by accessing a Section 5 Notices and Supports form that is ‘In Progress’ and entering the passphrase associat ed with the selected form

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

- generates a default alias comprised of a form type, date stamp and time stamp in the following form at: <Form Type

- YYYYMMDD

- HH:MM:SS Time Zone>

. The ‘PMN Identification’ section provides fields for you to enter information regarding other communications with EPA by entering a ‘TS Number’ and ‘Payment ID.’ The TS number is determined by a company and is used to identify the form for both payment and 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 alphanumeric combination. The TS number should include two (2), three (3), or four (4) letters. Company names, recognizable words, and numeric series are not recommended. A unique identification number for the form will generate later if a Letter of Support or Joint Submission is being filed

. The ‘Test Data’ section provides checkboxes to identify data that is included in the type of notice you selected from the ‘Type of Notice’ drop

- down menu. The following values will display as

checkboxes: ‘En vironmental fate data,’ ‘Health effects data,’ ‘Environmental effects data,’ ‘Physical/Chemical properties,’ ‘Risk assessments,’ ‘Structure/Activity relationships,’ ‘Test data not in the possession or control of the submitter,’ and ‘Other data.’

You are r equired to submit all test data in your possession or control and to provide a description

of all other data known to or reasonably ascertainable by you if the data is related to the health and environmental effects on the manufacture, processing, distribu tion in commerce, use, or disposal of the new chemical substance. Standard literature citations may be submitted for data in the open scientific literature. Complete test data (written in English), not summaries of data, must be submitted if they do not ap pear 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 28requirements of §720.50 of the Premanufacture Notification Rule (40 Code of Federal Regulations (CFR) Part 720).

• Form Alias: E dit the form alias. U pon navigating to the screen, the screen will have auto

generate d an editable form alias for the AO in the following format: < Form Type

YYYYMMDD

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

.

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

character alphanumeric combination. It is used by the financial institution that receives

pay ment for EPA when it notifies the Agency that the fee has been received. The TS number should include two (2), three (3), or four (4) letters. Company names, recognizable words, and numeric series are not recommended. TS numbers should be unique to the sub mission and should not be reused in subsequent submission s . This field is required if ‘Premanufacture (PMN)’ or ‘Significant New Use Notice (SNUN)’ is selected from the ‘Type of Notice’ drop

down menu

.

• Environmental fate data: Check the ‘Environmental fat e 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 effect s data’ checkbox to indicate that

the form contains environmental effects data.

• Physical/Chemical properties: Check the ‘Physical/Chemical properties’ checkbox to

indicate that the form contains physical/chemical properties data.

• Test data not in the pos session 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 assessm ents’ checkbox to indicate that the form contains

risk assessments data.

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

indicate that the form contains structure

- activity relationships (SAR) data.

• Other data: C heck the ‘Other data’ checkbox to indicate that the form contains other types of

data.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 29Exhibit 4

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

Exhibit 4

- 1 : General Form Information Screen (Scroll 1)

Naviga tion: 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 CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 30The ‘Agent Information’ screen provides fields for you to enter information regarding a ll 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 conta ct information for each agent, and click the ‘OK’ button, which will populate the agent table located on the ‘Agent Information’ screen. Click the ‘Delete’ icon ( ) located under the ‘Actions’ column to delete agents. To edit agent information, click the a gent name link within the ‘Last Name’ column, which will generate the ‘Add Agent’ pop

- up window with the previously entered agent information.

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

- up window to

enter information for mul tip le agents

.

• Last Name: Displays the last name of the reported agent. Click the ‘Last Name’ link to

generate the ‘Add Agent’ pop

- up window and edit the agent information.

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

• Address: Displays the mai ling address of the reported agent.

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

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

confirm deletion of the agent information.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 31Exhibit 4

- 2 shows a screen capture of the ‘ Agent Information ’ screen:

Exhibit 4

- 2 : Agent Information Screen

Navigation: Click the ‘Add Agent’ button to begin the process of adding agent information. Click the ‘Next’ button to navigate to the ‘Technical Contact Information’ screen. You can also access this screen by clicking the ‘Technical Contact Information’ link within t he navigation

tree.

4.1.2.1 Add Agent

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

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

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

The identification of an agent is optional.

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 32• Check here to claim this information as CBI: Check the ‘Check here to claim this
info rmation 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 CDX

r egistration information. Check the ‘CBI’ checkbox after importing CDX registration

information to claim agent information as confidential

.

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

populate the fields with CDX re gistration information. This is a required field only if agent

information will be added to the form

.

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

populate the fields with CDX registration information. This is a requ ired 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 i s a required field only if agent

information will be added to the form

.

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

does not allow dashes. Click the ‘Copy CDX Registration’ button to populate the fields with

CDX registration information. This is a required field only if agent information will be added

to the form

.

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

Registration’ button to populate the fields with CDX registration information

.

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

email address format: John.Doe@abc.com

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

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

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

.

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

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

.

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

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

information will be added to the form

.

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

- down menu. Click the

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

is set to ‘United States.’ This field is disabled if a non

- US country is selected from the ‘Country’ drop

- down menu

.

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

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

set to ‘United States

. ’

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 33• Country: Select the country of the agent’s mailing address from the drop

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

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

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 th e ‘X’ icon in the upper right

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

Information’ screen

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 344.1.3 Techni cal Contact Information

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

The technical contact should be able to answer, or obtain answers to, questions related to the

chemical submitted to EPA within the joint PMN form or Letter of Support . The technical contact does not have to physically work at the site reported on th e form, but must be readily available by phone or email. It is required to identify at least one technical contact.

The system provides functionality to enter multiple technical contacts. If the contact is the same person who is filling out the form, the system presents a ‘Copy CDX Registration’ button for you to retrieve your user information from CDX. You will enter the contact information for each

technical contact within the ‘Add Technical Contact’ window and click the ‘OK’ button at the

bottom of the window, which will populate the technical contacts table located on the ‘Technical

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

edit technical contact information.

• Add Technical Contact: Click the ‘Add Technical Contact’ button to generate the ‘Add

Technical Contact’ pop

- up window, which provides fields for you to enter technical contact

information.

• Last Name: Di splays the last name of the reported technical contact. Click the ‘Last Name’

link to generate the ‘Add Technical Contact’ pop

- up window that contains previously

identified technical contact information to edit the technical contact information.

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

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

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

an ‘N.’

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

- up generates

to confirm the deletion of the technical contact information.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 35Exhibit 4

- 4 shows a screen capture of the ‘ Technical Contact Information ’ screen:

Exhibit 4

- 4 : Technical Contact Information Screen

Navigation: Click the ‘Add Technical Contact’ button to begin the process of adding technical
contact information. Click the ‘Next’ button to navigate to the ‘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 ‘Add Technical Contact’ pop

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

‘Technical Contact Information’ screen.

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 36• Check here to claim this information as CBI: Check the ‘Check here to claim this

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

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

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

button t o populate the fields with CDX registration information. This is a required field.

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

to populate the fields with CDX registration information. This is a required fi eld.

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

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

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

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

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

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

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

.

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

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

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

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

‘Copy CDX Registration’ button to populate t he fields with CDX registration information. This is a required field.

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

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

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

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

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

- down menu.

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

information. This is a required field.

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

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

• Country: Displays ‘United States.’

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 37Exhibit 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 upper right

- hand corner of the window

to return to the ‘ Technical Contact Information ’ screen without saving the technical contact information. Click the ‘OK’ button to save and populate the entered technical co ntact information 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 cli ck the ‘Add Consolidated Chemical’ or ‘Chemical Identification’ link s within the navigation tree access the ‘Chemical Identification’

screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 38The ‘Chemical Identification’ screen identifies the type of chemical the submitter will be entering into the appli cation. 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, cl ick the ‘Save’ icon ( ) within the bottom action bar, or click the ‘Next’ button to generate the ‘Polymer Identification Information’ screen and the ‘Monomers and Other Reactants’ screen within the navigation tree.

This screen provides a field to identify an alias for the chemical substance , and allows you to identify chemicals in a consolidated chemical submission . The chemical alias is required if a Joint Submission or Letter of Support is being filed and 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 Subs tance’ radio butto n, the application generates a confirmation message warning you that you will lose all data for this chemical if the chemical type changes. Selecting either the ‘Class 1 or 2 Chemical Substance’ or ‘Polymer’ radio button is required.

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

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

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

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

blank. This field is required.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 39Exhibit 4

- 6 shows a screen capture of the ‘Chemical Identification’ screen :

Exhibit 4

- 6 : Chemical Identification Screen

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

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

Identification Information’ link within the nav igation 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 a lso access this screen by clicking the ‘Class 1 or 2 Chemical Substances’ link within the navigation tree

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 40chemical properties that show the name, composition, and structure of the chemical. The system provides fields for you to identify several key aspects concerning a chemical’s identity. For a single component submission , create the field set by clicking the ‘Add New Chemical’ button. Upon clicking the ‘Add New Chemical’ button, the application generates an expandable/collapsible field set containing numerous fields for you to enter information pertaining to that particul ar chemical.

For a multi

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

- component chemical submissions occur when two or more chemicals are always generated together in a single pot and are never isolated. Upon clicking the ‘Add New Chemical’ button, the application generates a field set containing numerous fields for you to enter information pertaining to that particular chemical. Enter additional chemical components, each with unique identifying informatio n, by clicking the ‘Add New Chemical’ button for each additional chemical that is part of the multi

- component mixture. All multi

- component chemicals will reside in one chemical folder in the navigation tree. Duplicate chemicals are not allowed

within a mul ti

- component submission.

For a consolidated submission, create and identify chemicals in separate chemical folders by clicking the ‘Add Consolidated Chemical’ link within the navigation tree. If you select the ‘Class 1’ radio button on the ‘Class 1 or 2 C hemical Substances’ screen, click the ‘Next’ button to navigate to the ‘Additional Chemical Information’ screen. If you select the ‘Class 2’ radio button on the ‘Class 1 or 2 Chemical Substances’ screen, click the ‘Next’ button to navigate to the ‘Class 2 Substances’ screen.

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

For a class 2 substance chemical structure diagram:

• List the immediate precursor substances with their respective CASRN.

• Describe the nature of the reaction or process.

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

• Provide a correct representative or partial chemical structure diagram, as complete as can be

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

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

expandable/collapsible field set.

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

- hand corner of the

expandable/collapsible field set to prevent edits from saving and to remove a field set. The

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 41• Edit: Click the ‘Edit’ link located in the upper right

- hand corner of the expandable/collapsible

f ield set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has been saved and the data is not currently editable.

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

- hand corner o f the

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

confirm the deletion.

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

- right of the

expandable/collapsible field sets to expand a series of fiel d 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

id entify 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 na vigation tree after clicking the ‘Next’ button for you to enter information concerning how the chemical was created. If multiple ‘Class 2’ chemical components are added, only one ‘Class 2 Substances’ screen will generate that applies to all the components. Check the ‘CBI’ checkbox to claim the

chemical substance class as confidential. Either the ‘Class 1’ or ‘Class 2’ radio button must be

selected

.

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

‘Class 1’ sub stance 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 composi tion, 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 ‘Cla ss 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

Prefer red Name’ must be provided, whichever is appropriate based on current CA nomenclature rules and conventions. This is a required field.

• CBI: Check the ‘CBI’ checkbox to claim the ‘Chemical Name’ field as confidential and

generate the ‘Generic Chemical Name ’ text field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 42• 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.’

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

Service)’ radio button to identify the ID method as the CAS Inventory Expert Service (IES) method and generate the ‘IES Order #’ field. A copy of the identification report obtained from the CAS Inventory Expert Services must be submitted as an attachme nt 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’ r equirement is not applicable.

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

ID method as ‘Other Method.’ An alternative method of providing a name, such as a Scientific and Technical Information Network (STN) d atabase 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.

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

‘Method 1 (CAS Inventory Expert Service)’ radio button is selected. This is a required field if the ‘Method 1 (CAS Inventory Expert Service)’ radio button is selected

.

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

molecular formula must give the correct identity and number of atoms of each element contained in the PMN molecule or a description if the substance is a class 2 material. The system will not allow subscripts and superscripts to be used

.

• CBI: Check the ‘C BI’ 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

Str ucture Diagram’ and ‘ID Method.’ This is a required field to upload an attachment.

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

pop

- up window. Refer to Section 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 that is uploaded on the ‘Attach

Documents’ pop

- up window.

• Description: Displays the description associated with a document.

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

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

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

system; a warning message displays to confir m the deletion of the document.

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

set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.6

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 43for more information regarding the save functionality in an expandable/collapsible field set.

Exhibit 4

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

Exhibit 4

- 7 : Class 1 or 2 Chemical Substances Screen (Scr oll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 44Exhibit 4

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

Exhibit 4

- 8 : Class 1 or 2 Chemical Substances Screen (Scr oll 2)

Navigation: If you select the ‘Class 1’ radio button, click the ‘Next’ button to navigate to the ‘Additional Chemical Information’ screen. You can also access this screen by clicking the

‘Additional Chemical Information’ link within the navigation tree. If you select the ‘Class 2’ radio button, click the ‘Next’ button to navigate to the ‘Class 2 Substances’ screen. You can also access this screen by clicking the ‘Class 2 Substances’ link within the navigation tree.

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 Substances’ link within the navigation tree.

The ‘Class 2 Substances’ screen captures information regarding a class 2 chemical substance. A class 2 chemical substance is a substance that may not have a defined chemical structure that has

been iden tified. 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.’

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 45Enter precursor substances by searching SRS or using man ual entry when the substance is not in SRS. The selected substances will display in a table listing the ‘Chemical Name’ and ‘CASRN.’

The system provides fields to capture ‘Nature of Reaction’ and ‘Range of Composition’ in text

boxes. The ‘Nature of Reacti on’ and ‘Range of Composition’ text fields can be claimed as CBI.

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

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

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

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

Services’ pop

- up window. Refer to Section 3.8 for further details regarding the search SRS functionality.

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

chemical name link to generate the ‘Search SRS’ pop

- up window to make edits.

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

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

system; a warning message displays to confirm the deletion of the chemical

.

• B.1.e.2. Nature of Reaction: Enter the nature of the reaction or process description.

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

• B.1.e.3

. Range of Composition: Enter the range of composition and the typical composition

description. Provide the range of composition in weight percent for each specific component or class of components that you intend to manufacture for commercial purposes.

• CBI : Check the ‘CBI’ chec kbox 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.

Prec ursor Substances, ’ ‘B.1.e.2. Nature of Reaction,’ and ‘ B.1.e.3. Range of Composition .’ This is a required field.

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

pop

- up window and initiate the document upload process. Refer to Section 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 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 docume nt 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 ro w permanently from the

system; a warning message displays to confirm the deletion.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 46Exhibit 4

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

Exhibit 4

- 9 : Class 2 Substances Scr een (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 47Exhibit 4

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

Exhibit 4

- 10 : Class 2 Substances Screen (Scroll 2)

Navigation: Click the ‘Next’ button to navigate to the ‘Additional Chemical Information’

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

.
4.1.7 Additional Chemical Information

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

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

tables.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 48An ‘Impurities’ table displays information regarding the impurities that may be reasonably anticipated to be in the respective chemical or polymer as manufactured for commercial purpose.

Click the ‘Search SRS’ button to access the ‘Se arch 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 uniden tified 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 ‘Byproducts’ 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 ‘Byproducts’ table. You may associate a CASRN with a byproduct (if applicable) and check the ‘CBI’ checkbox to claim a byproduct as confidential. Documents may be attach ed for the ‘Byproducts’ section if necessa ry.
A ‘Synonyms’ table provides fields to capture the synonyms that the respective chemical or polymer may be referred to in the documentation. A maximum of five synonyms can be entered

in the table. The search SRS functionality cannot be used to populate the ‘Synonyms’ table. You may attach documents associated with the ‘Synonyms’ section to provide additional synonyms if

necessary

. A ‘Trade Identification’ table provides fields to capture information about the trade names by which the respective chemical or polymer may be referred in documentation. There is no limit to

the number of trade names that may be added. You may attach document s associated with the

‘Trade Identification’ section t o provide additional information if necessary

.
The ‘Attach Document s ’ pop

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

- down menu, and

clic k 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 th e 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 attach ed documents, click the appropriate file name of the document within the ‘File

Name’ column of the attachments table.

The attachments table displays the section of the page the document is associated with, the file name and file extension of the document, the document description, the number of pages in the document, and if the document was claimed CBI. Click the ‘Delete’ icon ( ) located under the
‘Actions’ column to delete unwanted documents. Click a file name link in the ‘File Name’ column to generate th e ‘Attach Documents’ pop

- up window to view and/or edit an attached

document.

• B.3. Impurities

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

Substance Registry Services’ pop

- up window. Refer to Section 3.8 for further details regarding the search SRS functionality.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 49• 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 fr om 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 the manufacture, processing, use, or disposal of the new chemical substance. List any byproducts that you reasonably anticipate will result from the manufacture, processing, use an d disposal of the new chemical substance at si tes under your control. Click the ‘Byproduct

Name’ link to generate the ‘Search Substance Registry Services’ pop

- up window to view and/or edit byproduct information. Provide the specific chemical name, CAS numb ers 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 b yproduct by displaying either a ‘Y’ or an ‘N.’

• Action: Click the ‘Delete’ icon ( ) 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 che mical names used in scientific or technical literature, and code numbers or code names referenced in the PMN and its attachments. Indicate which synonyms may be proprietary and require CBI protection. Chemical name synonyms must be consistent with the chem ical structure and thus not misleading. If you add a blank, editable line in this table and click the ‘Next’ button, no error will display indicating that the blank line should be saved or deleted. If text is entered in a blank field and you click the

‘Nex t’ button, the application will save the entered value. If you click the ‘Form’ icon ( ), edit the entered values and click the ‘Next’ button without saving the changed value, an error will generate

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 50• Action s : Click the ‘Add’ icon ( ) to add a new text fie ld to enter additional synonyms. Click the ‘Save’ icon ( ) to save a chemical synonym. Click the ‘Form’ icon ( ) that appears after saving to edit a chemical synonym. Click the ‘Delete’ icon ( ) to delete a previously added chemical synonym. To cancel chan ges 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 u sed or will be

used for the neat chemical substance, whether or not they are registered brands/trademarks.

There is no limit to the number of trade names that can be added. Check the ‘CBI’ checkbox to

i ndicate the CBI status of trade names. If you add a bl ank, 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) and click the ‘Next’ button without saving the changed value(s), an error message will generate

.

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

identification names. Click the ‘Save’ icon ( ) to save a trade identification name . Click the ‘Form’ icon ( ) to edit a trade identification name . Click the ‘Delete’ icon ( ) to delete a previously added trade identification name.

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

drop

- down menu. This drop

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

• Attach Doc ument: 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 document.

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

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 51Exhibit 4

- 11 sho ws a screen capture of the ‘ Additional Chemical Information ’ screen (Scroll 1) :

Exhibit 4

- 11 : Additional Chemical Information Screen (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 52Exhibit 4

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

Exhibit 4

- 12 : Additional Chemical Information Screen (Scroll 2)

Navigation: Click the ‘ Next ’ button to navigate to the ‘Production Volume and Hazard /Safety

Information’ screen. You can also access this screen by clicking the ‘Production Volume and Hazard/Safety Information’ link within the navigation tr ee.

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 access this screen by clicking the ‘Polymer Identification Information’ link within the navigation tree after selecting the ‘Polymer’ radio button on the ‘Che mical Identification’ screen

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 53The ‘Polymer Id entification 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 fiel ds 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 numero us fields that pertain to the particular polymer. You are able to enter multiple chemical substances, each with unique information, by clicking the ‘ Add New Chemical ’ button for each chemical you wish to identify.

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

For a multi

- component s ubmission, 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 ap plication generates a field set that provides numerous fields to enter information pertaining to that particular chemical. Enter additional chemical substances , each with unique identifying

informati on, by clicking the ‘Add New Chemical ’ button for each ad ditional chemical that is part

of the multi

- component mixture. All multi

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

For a consolidated submission, create separate chemical folders by clicking the ‘Add

Consolidated Chemic al’ 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

confirmatio n message displays to confirm the action

.

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

- hand corner of the expandable/collapsible

field set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has been saved and the data is not currently editable.

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

- hand corner of the

expandable/collapsible fiel d set to delete the field set; a confirmation message displays to

confirm the dele tion.

• 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.

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

- up window. Refer to Section

Error! Reference sour ce not found. for additional details regarding the search SRS functionality.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 54• 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. Th is field

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 ’ method. Submit a copy of the identification report obtained from the CAS Inventory Expert Services as an attachment to this notice. For a consolidated submission, each chemical must be ‘Method 1’ except when the submission is pending a Letter of Support for that chemical. Select the ‘Method 1 (CAS Inventory Expert Service)’ radio button to generate the ‘IES Order #’

field

.

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

this field. Enter the IES order number

.

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

ID method as ‘Other Method.’ An alternative method of providing a name, such as a STN database report or a CAS Client Services report, qualifies as ‘Method 2.’ If th e chemical is pending a Letter of Support, the method can only be ‘Method 2.’

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

drop

- down menu. This drop

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

• 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 document by displaying either a ‘Y’ or an ‘N.’

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

from the system. A warning message di splays to confirm the deletion.

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

set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.6 for more information regarding the save functionality in an expandable/collapsible field set

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 55Exhibit 4

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

Exhibit 4

- 13 : Polymer Identification Information Screen (Scroll 1 )

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 56Exhibit 4

- 14 shows a screen capture of the ‘Polymer Identification Information’ screen (Scroll 2) :

Exhibit 4

- 14 : Polymer Identification Information Screen (Scroll 2)

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

.
4.1.9 Monomers and Other Reactants

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

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 57The ‘Monomers and Other Reactants’ screen is used to identify the chemical measurements and monomers that make up a polymer. The screen is divided into two sections to identify different elements describing a polymer: ‘Polymer Weight Information’ and ‘M onomers 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 res idual 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 calibration standards
can le ad to questionable GPC data. Correction estimates can be documented and presented in cases where only a soluble fraction of the polymer can be analyzed

.

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

the ‘Other (Speci fy)’ 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 n umerical value and can contain decimal values

.

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

below 500 molecular weight; the value entered must be a positive numerical value greater than or 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.

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

below 1,000 molecular weight; the value entered must be a positive numeri cal value greater than or equal to zero (0) but less than or equal to one hundred (100) and can contain decimal values. This value must be greater than or equal to the value specified in the ‘(ii) max. weight % below 500 molecular weight’ field.

• Add Monom er: Click the ‘Add Monomer’ button to generate the monomer

expandable/collapsible field set.

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

- hand corner of the

expandable/collapsible field set to prevent edits from saving and to remove a field s et. The

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 58‘Cancel’ link displays when the expandable/collapsible field set is open for editing. A confirmation message displays to confirm the action

.

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

- hand corner of the expandable/collapsible

field se t to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has been saved and the data is not currently editable.

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

- hand corner of the

e xpandable/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 win dow. Refer to Section 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 the ‘Search SRS’ pop

- up window. This is a required

field.

• Include in Identity: Check the ‘Include in Identity’ checkbox to claim the value for ‘Monomer

or Ot her Reactant’ as part of the monomer identification. This checkbox is most applicable for monomers that are less than or equal to 2% since the monomer is not considered to be included in the identity unless this checkbox is checked. This checkbox appears w hen a value of ‘2’ or less is entered into the ‘Typical Composition’ text field.

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

confidential.

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

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

- up window.

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

- up

window.

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

polymer; the value entered must be a positive numerical value greater than zero (0) and less than or equal to one hundred (100) and can contain decimal values. If the value entered is less

than or equal to ‘2’ a warning will be displayed in the global ‘Validate’ function or during the submission process indicating that the typical composition is a value that is less than or equal to 2 percent and asking you whether it should be included in the ch emical identity. This is a required field , and the value must be greater than zero (0)

.

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

fields as confidential.

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 59positive 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 a s confidential.

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

set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section 3.6 for more information regarding the save functionality in an expandable/collapsible field set.

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

pop

- up window. Refer to Section 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.

• Pages: Displays the number of pages a document contains

.

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 60Exhibit 4

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

Exhibit 4

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 61Exhibit 4

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

Exhibit 4

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

Navig ation: Click the ‘Add Monomer’ button to generate the expandable/collapsible field set. 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 clicking

the ‘Next’ button from the ‘Additional Chemical Information’ screen

. You can also access this screen by clicking the ‘ Production Volume and Hazard/Safety Information ’ link within the navigation tree

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 62The ‘Production Volume and Hazard/Safety Information’ screen collects different information regarding a chemical’s producti on 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 1 2

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

- month production’ value. The maximum volume may not
exceed 100,000,000,000,000 kg/year for either field. The entered values will automatically display decimal points upon navigating away from the page . Decimals are allowed up to the milligram (.000001). Estimates should be on a 100% new chemical substance basis. Your production volumes should be estimated as accurately as possible, but you are not bound to your estimates unless you ch eck the ‘Binding’ checkbox. Include amounts you intend to produce for export. Provide an estimate of the first 12 months of production and the maximum production volume for any consecutive 12

- month period during the first three (3) years of commercial

manu facture. 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 substance must specify a respirator that is appropriate for the types of anticipated exposures. For the same reason, all respirators must be certified by the Nati onal Institute for Occupational Safety and Health (NIOSH), and be referenced in the MSDS as “NIOSH certified” respirators.

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

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

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

well as suitable for the type of tasks.

Close

- fitting goggles or a full

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

- fitting equipment.

The information is collected in a file attachment. The sy stem 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 l abels, if relevant. The personal protection requirements of the MSDS become integral requirements of an LVE notice.

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

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

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

.

• Maximum first 12

- month p roduction: Provide an estimate of the first 12 months of

production. The entered value must be a numerical value and must be greater than zero but less than 100,000,000,000,000 kg/year. This field accepts decimals to the milligram and is a required field if you do not have a pending Joint Submission and/or Letter of Support

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 63• Maximum 12

- month p roduction: Enter the data associat ed 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 bu t 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 Le tter of Support

.

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

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

This drop

- down menu contains the following value: ‘Production In formation Section ’ and

‘Hazard Information 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 additional details regarding the attach document functionality.

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

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

Documents’ pop

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

pop

- up window to make any edits.

• Description: Displays the description associated with a document.

• Pages: Displays the numbe r of pages a document contains.

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 64Exhibi t 4

- 17 shows a screen capture of the ‘Production Volume and Hazard /Safety Information’

screen:

Exhibi t 4

- 17 : Production Volume and Hazard /Safety Information Screen

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

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

The ‘Use Information’ screen captures data about how the new chemical substance is intended to

be use d by function and application. Function refers t o the chemical purpose for which the

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 65substance 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 applic ation 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 collapses and displays the ‘Category of Use’ and ‘Production %’ values.

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

– is it photographic dye, a reactive dye for nylon fibers, or a dye to be incorporated in a polymer making film?). LVE notices limit you to your stated category of use(s), so make sure your description fully encompasses all intended uses for any LVE. Whe n you claim the ‘Category of Use’ as CBI, you are required to enter a ‘Generic Use Description.’ The generic use description will be available publicly.

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

CBI.

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

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

field set.

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

- hand corner of the

expandable/collapsible field set to prevent edits from saving and to remove a field set. The

‘Cancel’ link displays when the expandable/collapsible field set is open for editing. A

conf irmation message displays to confirm the action

.

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

- hand corner of the expandable/collapsible

field set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/colla psible 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 t he 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/collapsibl e field sets to collapse a series of field sets.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 66• 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 a s confidential and

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

then un

- checking the ‘CBI’ checkbox generates a confirmation message that all attached

documents will be deleted.

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

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

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

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

first three years devo ted to each category of use for the specific chemical. The entered value must be a value greater than zero (0) but less than or equal to one hundred (100). The ‘Production %’ must equal up to 100% for all uses if there is no pending Letter of Support or

Jo int Submission for the form. This field allows for decimal values. This is a required field.

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

confidential.

• In Formulation % : Estimate the percent of the new substan ce 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 sub stance. 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 categories. Consumer use means that private individuals will use the chemical substance or products containing the substance for personal use or enjoyme nt.

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

substance. Blank fields are recognized as zero e s. This field allows for decimal values. Break

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 67down the use(s) by percentage for the indicated end user catego ries. 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 su bstance. 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 ref ers to the chemical substance or product containing the chemical substance being used by a company to provide a consumer service.

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

Provide a detailed description of the use (s) of this chemical substance in consumer products. In addition, include estimates of the concentration of the new chemical substance as expected in consumer products and describe the chemical reactions by which this substance loses its identity in the co nsumer product. This is a required field if the ‘Consumer % of substance expected per use’ field is populated and is a value greater than zero (0).

• CBI: Check t he ‘CBI’ checkbox to claim the ‘ If you have provided a ‘consumer’ use, provide

details’ informa tion 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 details regarding the attach document functionality.

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

Documents’ pop

- up window. Click the ‘File Name’ link to navigate to th e ‘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 a n ‘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 expandab le/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 ‘Previou s’ and ‘Next’ buttons. Refer to Section 3.6 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 CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 68Exhibit 4

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

Exhibit 4

- 18 : Use Information Screen (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 69Exhibit 4

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

Exhibit 4

- 19 : Use Information Screen (Scroll 2)

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

The ‘Physical and Chemical Properties Worksheet’ screen is used to capture optional information about a chemical’s properties. EPA uses the chemical properties to determine

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 70additional 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 substa nce,’ ‘Vapor Pressure @ temperature,’ ‘Density/relative density,’ ‘Solubility @ temperature ___ solvent ___,’ ‘Solubility in water @ temperature ___,’ ‘Melting temperature,’ ‘Boiling/sublimation temperature @ ____,’ ‘Spectra,’ ‘Dissociation constant,’ ‘Par ticle 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 th e 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’ butto n. 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 info rmation 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 cap ture 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 ch emical 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 t he 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.

In dicate 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 n ot 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 substanc e, and therefore some data elements may represent confidential business information. Review the CBI status of each entry carefully, and avoid making unsupportable claims.

Please note that in IE 7, all physical/chemical properties you wish to add must be id entified 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’

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 71property more than once, and the chemical property fields located within the expandable/collapsible fields sets on this page will be disorganized. After clicking the ‘Next’ button, you will navigate to the ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’ screen. After clicking the ‘Previous’ button, th e physical/chemical properties have been removed from the ‘Add Property’ drop

- down menu.

• Add Property: Click the ‘Add Property’ button to add and open a new ‘Property’

expandable/collapsible field set for a selected property.

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

- hand corner of an

expandable/collapsible field set to prevent edits from saving and to remove a field set. The

‘Cancel’ link displays when an expandable/collapsible field set is open for editing. A

confir mation message displays to confirm the action

.

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

- hand corner of an expandable/collapsible

field set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsib le field set has been saved and the data is not currently editable.

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

- hand corner of an

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

confirm the de letion.

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

- hand corner of the

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

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

- hand corner of the

ex pandable/collapsible field sets to collapse a series of field sets.

• Adsorption/Coefficient

- Value: Enter the adsorption/coefficient value of the chemical

substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the

‘Adsor ption/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 confidential.

• Boiling/sublimation temperature @

– Value : Enter the boiling/sublimation temperature in °C

of the chemical substance. This is a required field if the ‘Boiling/sublimation temperature @ ’ property is selected.

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

for which the boiling/sublimation of the chemical substance was determined. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Boiling/sublimation temperature @ ’ property is selecte d.

• Boiling/sublimation temperature @

- Measured or Estimate : Indicate whether the property

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

down menu. This is a required field if the ‘Boiling/sublimation tempe rature @ ’ property is

selected.

• Boi ling/sublimation temperature @

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 72• 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 Estim ate : Indicate whether the property value is

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

- down menu. This is a required field if the ‘Density/relative density’ property is selected.

• Density/relative density

- CBI: C heck the ‘CBI’ checkbox to claim the ‘D ensity/relative

density ’ property as confidential.

• Dissociation constant

- Value: Enter the dissociation constant value of the chemical

substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Dissociation constant’ property is selected.

• Dissociation constant

- Measured or Estimate : Indicate whether the property value is

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

- down menu. This is a req uired 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 sub stance. 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 ‘Meas ured’ or

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

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

• Explodability

- CBI: Check the ‘CBI’ checkbox to claim the ‘E xplodability ’ property as

confid ential.

• Flammability

- Value: Enter the flammability value of the chemical substance. This field

allows text and is also able to accept ‘<’ or ‘>’ symbols. This is a required field if the

‘F lammability ’ property is selected.

• Flam mability

- Measured or Est imate : Indicate whether the property value is ‘Measured’ or

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

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

• Flammability

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

confidential.

• Henry’s Law constant

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

substance in atm

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

• Henry’s Law constant

- Measured or Estimate : Indicate whether the property value is

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

- down menu. This is a required field if the ‘Henr y’s Law constant’ property is selected.

• Henry’s Law

- CBI: Check the ‘CBI’ checkbox to claim the ‘ Henry’s Law constant ’ property

as confidential.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 73• Melting Temperature

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

• Melting Tem perature

- Measured or Estimate : Indicate whether the property value is

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

- down

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

• Melting Temperature

- CBI: Check the ‘CBI’ checkbox to claim the ‘M elting T emperature ’

property as confidential.

• Octanol/water partition coefficient

- Value: Enter the octanol/water partition coefficient

value of the chemical substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘O ctanol/water partition coefficient ’ property is selected.

• Octanol/water partition coe fficient

- Measured or Estimate : Indicate whether the property

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

down menu. This is a required field if the ‘O ctanol/water partition coefficient ’ property is

selected.

• Octanol/water partition coefficient

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

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

• Particle size di stribution

- Value: Enter the particle size distribution value of the chemical

substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the

‘P article size distribution ’ property is selected.

• Particle size dist ribution

- Me asured or Estimate : Indicate whether the property value is

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

- down menu. This is a required field if the ‘P article size distribution ’ property is selected.

• Particle size di stribution

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

distribution ’ property as confidential.

• Physical state of neat substance

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

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

‘ Physical state of neat substance ’ property is selected.

• Physical state of neat s ubstance

- Measured or Estimate : Indicate whether the property

value is ‘Measured’ or based on an ‘Estimate ’ by selecting the appropri ate 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 was measured.

This field allows for text. This is a required field if the ‘pH @ concentration [concentration]’ property is selected

.

• pH @ concentration [concentration]

- Value: Enter the pH value. This field allows text and

is also able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘pH @ concentration [concentration]’ property is selected.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 74• pH @ concentration [conc entrat ion]

- 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 temperature value in °C for which the solubility

was measured. This field allows text and is also able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Solubility @ temperature solvent’ property is selected

.

• Solubility @ temperature solvent

- S olvent: Enter the solvent that will be used for the

chemical subs tance. 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.

• Solubility @ t emperature solvent

- Measured or Estimate : Indicate whether the property

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

down menu. This is a required field i f the ‘Solubility @ temperature solvent’ proper ty 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 s olubility in water was measured. This is a required field if the ‘S olubility in W ater @ temperature ’ property is selected.

• Solubility in Water @ temperature

- Value: Enter the solubility in water of the chemical

substance in g/L. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Solubility in Water @ temperature’ property is selected.

• Solubility in Water @ t emperature

- Measured or Estimate : Indicate whether the property

value is ‘Measured’ or based on an ‘Estimate ’ by s electing the appropriate value from the drop

down menu. This is a required field if the ‘S olubility in W ater @ temperature ’ property is

selected.

• Solubility in Water @ t emperature

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

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

• Spectra

- Value: Enter the spectra value of the chemical substance. Value fields are able to

accept ‘<’ or ‘>’ symbols. This is a required field if the spectra property is selected.

• Spectra

- Measured or Estimate : In dicate whether the property value is ‘Measured’ or based

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

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

• Spectra

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

• 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 ‘Vapor Pressure @ temperature’ property is selected.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 75• Vapor Pressure @ temperature

- Value : Enter the value of the Vapor Pressure in torr units of the chemical substance. Value fields are able to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Vapor Pressure @ temperature’ property is selected.

• Vapor Pressure @ t emperature

- 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 ab le 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 t he appropriate value from the drop

- down menu. This is a required field if the ‘Volatilization from water’ property is selected.

• Volatilization from water

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

water ’ property as confidential.

• V olatilization from soil

- Value : Enter the volatilization from soil value. Value fields are able

to accept ‘<’ or ‘>’ symbols. This is a required field if the ‘Volatilization from soil’ property is

selected.

• Volatilization from soil

- Measured or Estimate : Indicate whether the property value is

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

- down menu. This is a required field if the ‘Volatilization from soil’ property is selected.

• Volatilization from soil

- CBI : Chec k the ‘CBI’ checkbox to claim the ‘V olatilization from

soil ’ property as confidential.

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

• Other

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

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

• Other

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

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

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

• Other

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 76Exhibit 4

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

Exhibit 4

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 77Exhibit 4

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

Exhi bit 4

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

Navigation: Click the ‘Next’ button to navigate to the ‘ Physical and Chemical Properties

Worksheet

– Continued (Optional) ’ screen. You can also access this screen by clicking the ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’ link within the navigation

tree.

4.1.13 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 Worksheet’ screen. You can also access this screen by clicking the ‘Physical and Che mical Properties

Worksheet

– Continued (Optional)’ link within the navigation tree.

The ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’ screen is used to capture all the studies and attachments that refer to the chemical properties cap tured on the ‘Physical and Chemical Properties Worksheet’ screen . When you first access the ‘Physical and

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 78Chemical Properties Worksheet

– Continued (Optional)’ screen , instructional 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’ window for you to select with which properties an attachment is associated. Check the properties that are relevant to the document, and then select a type and subtype value for the document. You will be able to attach a document, enter a description of the document, and list the number of pages.

The system provides functionality to clai m an uploaded document as CBI. If a document is claimed as CBI, the system requires you to upload the sanitized version of the attached document. To view, open, or edit previously attached documents, click the appropriate file name

of the document within t he ‘File Name’ column of the attachment table.

The attachment table displays the ‘File Name,’ ‘Properties,’ ‘Description,’ ‘Pages,’ ‘CBI,’ and ‘Actions’ columns. Click the ‘Delete’ icon ( ) located under the ‘Actions’ column to delete

unwanted documents.

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

pop

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

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

‘Attach Documents’ pop

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

- up window to make any edits.

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

• Description: Displays the description associated with a document.

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

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

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

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

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 79Exhibit 4

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

– Continued (Optional)’ screen:

Exhibit 4

- 22 : Physical and Chemical Properties Worksheet

– Continued (Optional) Screen

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

Consolidated Chemical’ l ink within the navigation tree.

4.1.14 Physical and Chemical Properties Worksheet

– Con tinued (Optional) Attach
Documents

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

– Continued (Optional)’ screen.

When attaching a document, the properties sele cted on the ‘Physical and Chemical Properties

Worksheet’ screen will display with checkboxes to allow the properties to which the attachment refers to be selected. Select the type and subtype for the attachment and the properties relevant to the document, attach the document, and enter the number of pages.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 80The system allows the uploaded document to be claimed as CBI. If a document is claimed as CBI, the system requires the sanitized version of the attached document to be uploaded. To access or edit previou sly attached documents, click the appropriate file name of the document

within the ‘File Name’ column of the attachment table.

• Type: Select the document type from the drop

- down menu.

• Subtype: Select the document subtype from the drop

- down menu.

• Chemical P roperties: Displays the physical and/or chemical properties identified on the

‘Physical and Chemical Properties Worksheet’ screen that can be potentially associated with a document. Check the appropriate chemical properties that are associated with a docum ent that is being attached. These checkboxes are enabled only if ‘Physical Chemical Property’ is selected from the ‘Type’ drop

- down menu.

• Attachment: Displays the ‘Browse’ button to search for and identify documents on your local

hard drive to be attached that can be associated with the physical/chemical properties identified on the ‘Physical and Chemical Properties Worksheet’ screen.

• Description: Enter the description associated with a document.

• Pages: Enter the number of pages a document contains

.

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

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

search for a particular file on your hard drive. For any attached document cla imed as CBI, you are required to attach a sanitized version of the document.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 81Exhibit 4

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

– Continued (Optional) Attach Documents ’ pop

- up window (Scroll 1) :

Exhibit 4

- 23 : Physical and Chemical Properties Worksheet

– Continued (Optional) Attach
Documents Pop

- Up Window (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 82Exhibit 4

- 24 shows a s creen capture of the ‘Physical and Chemical Properties Worksheet

– Continued (Optional) Attach Documents’ pop

- up window (Scroll 2):

Exhibit 4

- 24 : Physical and Chemical Properties Worksheet

– Continued (Optional) Attach
Documents Pop

- Up Window (Scroll 2)

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

- hand corner to stop the process of adding document information. C lick the ‘OK’ button to save the entered information and navigate back to the ‘Physical and Chemical Properties Worksheet

– Continued (Optional)’ screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 834.1.15 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 identificatio n of submitter

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

- controlled sites, the ‘Submitter Operation Information,’ ‘Occupational Exposures,’ and ‘Environmental Releases’ screens are automatically generated with in the ‘Submitter Controlled Operations’ folder within the navigation tree. If a user indicates there are sites controlled by others, the ‘Industrial Sites Controlled By Others,’ ‘Exposures/Releases,’ and ‘Byproduct Information’ screens automatically gener ate within the ‘Operations Controlled By Others’ folder within the navigation tree upon clicking the ‘Next’ button. Toll manufacturing sites are considered sites controlled by the submitter.

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

you have submitter controlled sites to identify; this response automatically generates the screens within the ‘Submitter Controlled Operations’ folder in the navigation tree upon clicking the ‘Next’ button. Select the ‘No’ rad io 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 th e ‘Yes’ radio button to indicate that you

have sites controlled by others to identify; this response automatically generates the screens within the ‘Operations Controlled by Others’ folder in the navigation tree upon clicking the

‘Next’ button. Select the ‘No’ radio button if you do not have any sites controlled by others to identify. An error message displays if a site controlled by others displays within the navigation

tree and the ‘No’ radio button is selected.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 84Exhibit 4

- 25 shows a screen capture of the ‘ Site Information ’ screen:

Exhibit 4

- 25 : Site Information Screen

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

.
4.1.16 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 Controll ed 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 chemica l substance at sites not controlled by the submitter. Importers do not have to complete this section for operations outside the U.S.; however, you must report any processing or use activities after import. Complete a separate ‘Operations Controlled By Othe rs’ section for each type of processing, or use operation involving the new chemical substance. If the same operation is performed at more than one site, describe the typical operation common to these sites. The

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 85screen first captures whether there is any d ata for other controlled sites. If there is no data for sites controlled by others, the screen will not update and the option of selecting the ‘Next’ button is available. If there is data for sites controlled by others, an additional question will appear. The screen then captures whether site

- specific data for the chemical is known for ‘Sites Controlled By Others.’ If you indicate that there is site

- specific data by selecting the ‘Yes’ radio button, the screen will generate a text field to enter the ‘# of u nknown sites ’ and a ‘CBI’ checkbox to claim

the number of unknown sites as confidential. If there is no site

- specific data, the screen display s a text box to capture the number of unknown sites.

Please note that in IE 7, after adding a site, the ‘# of unk nown 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 si te

- specific information?’ If you select ‘No’ only the listed navigation options will display. If an operation controlled by others displays within the navigation tree, the ‘Yes’ radio button must be selected for this question.

• Do you have site

- specific information?: If you select ‘Yes’ the screen generates fields to

capture specific site information. If you select ‘No

, ’ an error message displays indicating that any other sites you have will be deleted

.

• # of unknown sites: Enter the number of unknown s ites ; zero (0) is an acceptable value. This

is a required field.

• CBI: Check the ‘CBI’ checkbox to claim the number of unknown sites as confidential.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 86Exhibit 4

- 26 shows a screen capture of the ‘ Sites Controlled By Others ’ screen:

Exhibit 4

- 26 : Sites Controlled By Others Screen

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 navigation tree.

4.1.17 Submitter Operation Information

You can navigate to the ‘Submitter Operation Information’ screen by clicking the ‘Next’ button from the ‘Sites Controlled By Others’ screen. You can also access this screen by clicking the ‘Submitter Operation Information’ link under the ‘Submitter Control led Operations’ folder within the navigation tree. You can add additional sites by clicking the ‘Add Operation’ link within the navigation tree under the ‘Submitter Controlled Operations’ folder.

The ‘Submitter Operation Information’ screen captures infor mation about an operation that occurs at a particular site or group of sites. You are asked a series of questions and

, based on the

responses , a series of fields displays regarding a specific operation. The guided approach is designed to eliminate errors a nd ensure the completion of all relevant sections for a site. You will be able to enter an operation alias to identify the operation. Importers are not required to complete this section for operations outside the U.S.; however, any industrial processing or use

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 87operation 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 wil l then select the applicable operation type checkboxes.

If you select an option other than ‘Use’ for the operation type, you will be asked whether the chemical is manufactured or processed as a ‘batch’ or ‘continuous’ process. Based on the property select ed, fill in the relevant information. If you select the ‘Use’ operation type, then there will be no further options on this screen. The follow

- up screens are used to capture specific information about the operation type process.

The system provides a text box for describing the process description. Additional process information may also be included in an attachment. In the process description, include the following information: (1) Diagram the major unit operation steps and chemical conversions.

Include i nterim storage and specify transport containers (e.g., 5

- gallon pails, 55

- gallon drum, rail car, tank truck, etc.). (2) Provide the identity, approximate weight (by kilograms (kg) kg/day or kg/batch on a new chemical substance basis), and entry point of all starting materials, feedstocks (including reactants, solvents, catalysts, etc.), products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used dai ly 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.

Y ou may claim the process description or attachment as CBI. If an attached document is claimed as CBI, the system requires a sanitized version of the attached document to be uploaded. To access or edit previously attached documents, click the file name of t he document within the

‘File Name’ column of the document table.

The document table displays the file name and file extension of the document, the document description, the number of pages in the document, and whether a sanitized copy of the document

was a ttached. 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 operat ion. This is a required field

if the form is pending a Joint Submission or a Letter of Support.

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

- up window and select a site

from the drop

- down menu to add to the ‘Submitter Operation Inform ation’ screen.

• 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 eithe r a ‘Y’ or an ‘N.’

• Actions: Click the ‘Delete’ icon ( ) to delete a site from the table. A warning message

displays to confirm the deletion of the site.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 88• Select the chemical(s) that this submission pertains to : Displays all consolidated chemicals

in a PMN submission with associated checkbox(es)

.

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

• Manufacturing: Check the ‘Manufacturing’ checkbox to indicate that manufacturing is taking

place at the site. Checking the ‘Manufacturing’ checkbox generates the ‘Is it batch or

continuous’ radio buttons.

• Processing: Check the ‘Processing’ checkbox to indicate that processing is taking place at the

site. Checking the ‘Processing’ checkbox generates the ‘Is it batch or continuous’ radio

butto ns.

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

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

• Is it batch or continuous? : Select the ‘Batch’ radio button to indicate that the chemical is

produced in a batch process. Select the ‘Continuous’ radio button to indicate that the chemical is produced on a continuous basis. Either the ‘Batch’ or ‘Continuous’ radio button is required

to be selected.

• Max kg/batch: Enter the maximum number of kilograms produced per batch. This field only

displays when you select the ‘Batch’ radio button and is a required field. This field accepts

decimal values.

• Hours/batch: Enter the hours of manufacturing or processing time needed per b atch. 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 butt on and is a required field. This field accepts decimal values.

• Max kg/ d ay: Enter the maximum number of kg of a chemical produced per day. This field

only displays when you select the ‘Continuous’ radio button and is a required field. This field accepts dec imal values.

• Hours/d ay: Enter the number of hours per day that the chemical is processed or manufactured;

this value cannot exceed 24. This field only displays when you select the ‘Continuous’ radio button and is a required field. This field accepts decimal values.

• Days/y ear: En ter the number of days per year that the chemical is processed or manufactured;

this value cannot exceed 365. This field only displays when you select the ‘Continuous’ radio button, and is a required field. This field accepts decimal values.

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

• Process Description: Enter the process description. In the ‘Process Description’ text box, or

an attachment, address the following items: (1) Diagram the major unit operation steps and

chem ical conversions. Include interim storage and transport containers (specify

– e.g., 5

- gallon pails, 55

- gallon drum, rail car, tank truck, etc.). (2) Provide the identity, the approximate weight (by kg/day or kg/batch on a 100% new chemical substance basis ), and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc.), and of all products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) Identify by numb er the points of release, including small or intermittent

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 89releases, 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 docum ent 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 wi th 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 t he system. A warning message displays to confirm the deletion.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 90Exhibit 4

- 27 shows a screen capture of the ‘ Submitter Operation Information ’ screen (Scroll 1) :

Exhibit 4

- 27 : Submitter Operation Information Screen (Scro ll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 91Exhibit 4

- 28 shows a screen capture of the ‘Submitter Operation Information’ screen (Scroll 2) :

Exhibit 4

- 28 : Submitter Operation Information Screen (Scro ll 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

.
4.1.18 Occupational Exposures

You can navigate to the ‘Occupational Exposures’ screen by clicking the ‘Next’ button from the ‘Submitter Operation Information’ screen. You can also access this screen by clicking the ‘Occupational Exposures’ link within the navigation tree.

Click the ‘A dd’ button to generate an expandable/collapsible field set to enter occupational exposure information. The application displays fields for you to enter information for ‘Worker

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 92Category (1),’ ‘Worker Activity (1),’ ‘Protective Equipment/Engineering Controls (3),’ ‘Physical Form(s) (5),’ ‘% New Substance (5),’ ‘# Workers Exposed (8),’ ‘Maximum Duration Hours/Day (10),’ and ‘Maximum Duration Days/Year (11).’ EPA is attempting to estimate exposure levels, the number of workers potentially exposed, and possible routes and duration of exposure to the PMN substance. Work with your plant 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/Year (11) ’ f ields 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’ butto n 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 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.

• 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 wo rker activity (e.g. bag dumping, tote filling, unloading

drums, sampling, cleaning, etc.) in which workers may be exposed to a chemical substance. Please note that if you are populating this field via an XML file created from the ePMN thick client, this dr op

- down menu will not populate. This is a required field.

• User Defined Worker Activity: Enter the worker activity in which workers may be exposed

to a chemical substance. This field displays only for certain worker activity values.

• Protective Equipment/E ngineering Controls (3): Enter the protective equipment/engineering

controls used to protect workers. This is a required field.

• CBI: Check the ‘CBI’ checkbox to claim the protective equipment/engineering controls

information as confidential.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 93• Binding: Che ck 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 exposur e. Be as specific as possible on the physical form (e.g., is the PMN substance isolated as a crystalline or amorphous powder, wet cake, flake solid, granular solid, or a fused solid?). If data on particle size of solids are available, it should be included as an attachment. For wet cakes, a percent moisture estimate may prevent EPA from making an estimate that is too conservative. Please pay particular attention to the information within if this field is populated via XML file. The information

contained wit hin 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. Th is 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) en tered in this field will display an error. Please pay particular attention to the information if this field is populated via XML file. The information contained within the ‘Physical Forms and % New Substance’ field in the thick client separates into two (2 ) separate fields, the ‘Physical Form(s)’ field and ‘% New Substance’ field when these fields are populated via an XML file generated from the ePMN

thick client. This is a required field that accepts decimal values

.

• Binding: Check the ‘Binding’ checkbox to claim the percentage new substance information as

binding.

• # Workers Exposed (8): Enter the number of workers exposed. Estimate the maximum

number of all workers involved in each activity for all sites combined. This is a required field.

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

• Hours/Day (10): Enter the maximum duration occupational exposure occurs for the activity

for any worker in hours per day; this field allows decimal values. A value of zero (0) entered in this field will display an error. This is a required field.

• Days/Year (11): Enter the maximum duration occupational exposure occurs for the activity for

any worker in days per year; this field allows decimal values. A value of zero (0) entered in

this field will display an error. This is a required field.

• CBI: Check the ‘CBI’ checkbox to claim the maximum duration values as confidential.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 94Exhibit 4

- 29 shows a screen capture of the ‘ Occupational Exposures ’ screen :

Exhibit 4

- 29 : Occupational Exposures Screen

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

4.1.19 Environmental Releases

You can navigate to the ‘Environmental Releases’ screen by clicking the ‘Next’ button from the ‘Occupational Exposures’ screen. You can also access this screen by clicking the ‘Environmental Releases’ link within the navigation tree.
The ‘Environmental Releases’ screen captures information about the en vironmental release and disposal status of a particular site. The information on exposure and environmental release is related to the flow diagram/process description on the ‘Submitter Operation Information’ screen. This page is duplicated and populated fo r each f low diagram supplied in the PMN

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 95(manufacturing, each processing description, and any use diagrams). The information provided

should focus on the PMN substan ce. EPA reviewers pay particular attention to human exposure

and environmental release date under their TSCA mandate to protect against unreasonable risks from new chemical substances. In the absence of this information, EPA will make its own estimates of worker exposure and environmental release, which are usually conservative. You should presen t data that is accurate and as complete as possible.
The page displays an ‘Add’ button to add an expandable/collapsible field set to enter ‘Environmental Release and Disposal

– Submitter Controlled Sites’ information. The page displays fields to enter inf ormation for ‘Release Number,’ the amount of the new substance released ‘to environment’ and the amount of new substance released ‘to control technology,’ ‘Media of Release,’ ‘Control Technology Description,’ and ‘Release after Control Technology.’

You will be asked to enter information concerning the release to water, such as Publicly Owned Treatment Works (POTW), navigable waterways, and others.

• Add: Click the ‘Add’ button to generate the ‘ Environmental Release and Disposal

– Submitter

Controlled Site s’ e xpandable/collapsible field set.

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

- hand corner of the

expandable/collapsible field set to prevent edits from saving and remove the field set. The

‘Cancel’ link displays when the expandable/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 ente red in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has been saved and the data is not currently editable.

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

- hand corner of the

expandable/collapsible field set to delete the field set. A confirmation message displays to confirm the deletion. The ‘Delete’ icon ( ) displays when the user clicks the ‘Add’ button.

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

- right of the

expandable/collapsible field s ets 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’ screen. This is a required field.

• 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 a pplicable radio button

and e nter the amount of new substance released to environment. Release estimates should be consistent with the release levels shown on the preceding flow diagram on the ‘Submitter Operation Information’ screen . Include intermittent r elease estimates from cleaning of equipment and transportation containers, even if cleaned off

- site. Either the ‘Amoun t of new

substance released to E nvironment’ or the ‘Amount of new substance released to Control Technology’ field should be populated.

• Am oun 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

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 96• 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 con trol 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): Ente r the control technology description. Describe

control technology, if any, and control efficiency used to limit the release of the new substance to the environment. For releases disposed of on land, characterize the disposal method and state

whether it is approved for disposal of Resource Conservation and Recovery Act (RCRA) hazardous waste. For each site, describe any additional disposal methods that will be used and whether the waste is subject to secondary or tertiary on

- site treatment. Indicate if you w ant this

information to bind. Check the ‘CBI’ checkbox if the information is confidential. This is a required field.

• Binding: Check the ‘Binding’ checkbox to claim the control technology description as

binding.

• Release after Control Technology (5b): Ente r 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 fiel d

set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before being able to navigate away from the screen using the ‘Previous’ and ‘Next’ butto ns. 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 CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 97• POTW Name: Enter the POTW (publicly owned treatment works) name.

• POTW NPDES #: Enter the POTW National Pollutant Discharge Elimination System

(NPDES) number.

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

• Navigable Waterway Name: Enter the navigable waterway name.

• Navigable Waterway NPDES #: Enter the navigable waterway NPDES number.

• Navigable Waterway CBI: Check the ‘CBI’ checkbox to claim the navigable waterway as

confidential.

• Other (Specify) Name: Enter the name of the other destinati on of release to water.

• Other (Specify) CBI: Check the ‘CBI’ checkbox to claim the other destination of release to

water as confidential.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 98Exhibit 4

- 30 shows a screen capture of the ‘ Environmental Rel e ases ’ screen (Scroll 1):

Exhibit 4

- 30 : Environmental Releases Screen (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 99Exhibit 4

- 31 shows a screen capture of the ‘ Environmental Releases ’ screen (Scroll 2) :

Exhibit 4

- 31 : Environmental Releases Screen (Scroll 2)

Navigation: Click the ‘Next’ button to navigate to the ‘ Industrial Sites Controlled By Others ’

screen. You can also access this screen by clicking the ‘Industrial Sites Controlled By Others’ link within the navigation tree. Click the ‘Add Operation’ link under the ‘Operations Controlled By Others’ folder within the navigation tree to generate the screens fo r 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 100this screen by clicking the ‘Next’ button from the ‘Environmental Releases’ screen. You can also access this screen by clicking the ‘Industrial Sites Controlled By Others’ link within the navigation tree under the ‘Operations Controlled by Othe rs’ folder.

The ‘Industrial Sites Controlled By Others’ screen captures information about activities occurring at a particular site or group of sites. You will be able to enter an operation alias to identify the operation. Importers are not required to co mplete 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 re sources concerning the operation. The ‘Industrial Sites Controlled By

Others’ screen also displays a field to add an operation process description. In the operation description, include the following information: (1) Diagram the major unit operation steps and chemical conversions, including interim storage and specify transport containers (e.g., 5

- gallon pails, 55

- gallon drums, rail cars, tank trucks, etc.). On the diagram, identify by letter and briefly describe each worker activity. (2) Either in the diag ram or in the text field, provide the identity, the approximate weight (by kg/day or kg/batch, on a 100% new chemical substance basis), and entry point of all feedstocks (including reactants, solvents and catalysts, etc.), products, recycle streams, and wa stes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) Either in the diagram or in the text field, identify by number the points of release, including small or intermittent releases, to the environment of the new chemical sub stance.

• 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 rega rding the add facility functionality.

• Site Name: Displays the site name.

• Address: Displays the site address.

• City: Displays the site city.

• State: Displays the site state.

• Postal Code: Displays the site postal code.

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

• Actions: Click the ‘Delete’ icon ( ) to delete a site from the table. A warning message

confirming deletion of the site displays.

• Select the chemical(s) that this submission pertains to : Displays all consolidat ed chemicals

in a PMN form.

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 101and transport containers (specify

– e.g., 5

- gallon pails, 55

- gallon drums, rail cars, tank trucks, etc.). On the diagram, identify by letter and briefly describe each worker activity. (2) Either in the diagram or in the text field, provide the identity, the approximate weight (by kg/day or kg/bat ch, 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) Eithe r in the diagram or in the text field, identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. Either this field is required or a

document must be attached.

• CBI: Check the ‘CBI’ checkbox to claim the operation description as confidential.

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

pop

- up window. Refer to Section 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 was uploaded on the

‘Attach Documents’ pop

- up window.

• Description: Displays the description associated with a document.

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

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 102Exhibit 4

- 32 shows a screen capture of the ‘ Industrial Sites Controlled By Others ’ screen :

Exhibit 4

- 32 : Industrial Sites Controlled By Others Screen

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

4.1.21 Exposures / Releases

You can navigate to the ‘Exposures/Releases’ screen by clicking the ‘Next’ button from the ‘Industrial Sites Controlled By Others’ screen. You can also access this screen by clicking the ‘Exposures/Releases’ link within the navigation tree under the ‘Opera tions Controlled By

Others’ folder.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 103The 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 ‘E dit’ 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.

• 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 ac tivity as confidential.

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

combined.

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

• Duration of Exposure Hours/Day (4a): Enter an estimate of the typical duration of exposure

per worker in hours/day. This field allows decimal values.

• Duration of Exposure Days/Year (4b): Enter an estimate of the typical duration of exposure

per worker in days/year. This field allows decimal values.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 104• 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 prote ct 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 ePMN thick client

.

• CBI: Check the ‘CBI’ checkbox to claim the protective equipment/engineering co ntrols

information as confidential.

• Physical Form (6): Enter a description of physical forms of exposure. Please pay particular

attention to the information populated in this field if this field is populated via XML file. The

information contained within the ‘Protective Equipment/Engineering Controls/Physical forms’ field in the thick client separates into two (2) separate fields, the ‘Protective Equipment/Engineering Controls’ and ‘Physical Forms’ field when these fields are populated via an XML file gene rated from the ePMN thick client.

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

• % in Formulation (7): Estimate the percent of the new substance as formulated when

packaged or used as a final product.

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

set. You must click this button instead of the ‘Save’ icon ( ) located within the bottom action bar to successfully save the entered information within the field set before bei ng able to navigate away from the screen using the ‘Previous’ and ‘Next’ buttons. Refer to Section Error!
Reference source not found. for more info rmation regarding the save functionality in an expandable/collapsible field set.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 105Exhibit 4

- 33 shows a screen capture of the ‘ Exposures / Releases ’ screen (Scroll 1):

Exhibit 4

- 33 : Exposures / Releases Screen (Scroll 1)

• Add: Click the ‘Add’ button to generate the ‘Environmental Disposal’ expandable/collapsible

field set.

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

previously entered.

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 106• 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 Substance Rele ased Directly into Envir onment 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 Substance 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

- down menu to capture the media of

relea se. The ‘Media of Release’ drop

- down menu contains the following values: ‘Fugitive Air,’

‘Off

- Site Incineration,’ ‘On

- site Incineration,’ ‘On

- site WWT,’ ‘POTW,’ ‘Stack Air,’ ‘Surface Water,’ and ‘Other,’ that will be used to limit the release of the new su bstance to the

environment. Please pay particular attention to the information within if this field is populated via XML file. The information contained within the ‘Media of Release & Control Technology’ field in the thick client separates into two (2) sep arate 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 release.

• 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 attention to the
information within if this f ield 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 f ields are populated via an XML file generated from the ePMN thick client.

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

set. You must click this button instead of the ‘Save’ icon ( ) located within the botto m 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 CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 107Exhibit 4

- 34 shows a screen capture of the ‘ Exposures / Releases ’ screen (Scroll 2 ):

Exhibit 4

- 34 : Exposures / Releases Screen (Scroll 2)

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

4.1.22 Byproduct Information

• You can navigate to the ‘Byproduct Information’ screen by clicking the ‘Next’ button from t he

‘Exposures/Releases’ screen. You can also access this screen by clicking the ‘Byproduct

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 108Information’ link under the ‘Operations Controlled By Others’ folder within the navigation

tree.

• The ‘Byproduct Information’ screen captures byproducts resulting fr om 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 ma y result from the operation.

• Actions: Click the ‘Save’ icon ( ) to save an entered byproduct. Click the ‘Delete’ icon ( )

to delete a byproduct. Click the ‘Add’ icon ( ) to add a byproduct. Click the ‘Form’ icon ( )

to edit a saved byproduct.

Exhibit 4

- 35 shows a screen capture of the ‘ Byproduct Inf o rmation ’ screen:

Exhibit 4

- 35 : Byproduct I nformation Screen

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 109Navigation: Click the ‘Next’ button to navigate to the ‘ Optional Pollution Prevention ’ screen. You can also access this screen by clicking the ‘Optional Pollution Prevention’ link within the navigation tree

.
4.1.23 Optional Pollution Prevention

You can navigate to the ‘ Optional Pollution Prevention ’ screen by clicking the ‘Next’ button

from the ‘ Byproduct Information ’ screen. You can also access this screen by clicking the

‘ Optional Pollution Prevention ’ link within the navigation tree

. The ‘Optional Pollution Prevention’ screen provides fields for companies to enter data about their pollution prevention efforts. The company has the option of entering information as a free text field or as an attachment. The company can claim the infor mation 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 previ ously attached documents, click the appropriate file name of the document

within the ‘File Name’ column of the document table.
The attachment table displays the file name and file extension of the document, the document description, the number of pages the document contains, and the CBI status of the document. Click the ‘Delete’ icon ( ) located within the ‘Actions’ column to delete unwanted documents.
You may provide information not reported elsewhere in this form regarding your efforts to

reduce or minim ize potential risks associated with activities surrounding manufacturing, processing, use, and disposal of the PMN substance on the ‘Optional Pollution Prevention’

screen . Include new information pertinent to pollution prevention, including source reductio n, recycling activities and safer processes or products available due to the new chemical substance. Source reduction includes the reduction in the amount or toxicity of chemical wastes by technological modification, process and procedure modification, pro duct reformulation, and/or raw materials substitution. Recycling refers to the reclamation of useful chemical components from wastes that would otherwise be treated or released as air emissions or water discharges, or land disposal. Quantitative or qualita tive descriptions of pollution prevention, source reduction and recycling should emphasize potential risk reduction in addition to compliance with existing regulatory requirements. EPA is interested in the information to assess overall net reductions in

to xicity or environmental releases and exposures, not the shifting of risks to other media (e.g., air to water) or non

- environmental areas (e.g., occupational or consumer exposure). To the extent known, information about the technology being replaced will as sist EPA in its relative risk determination. In addition, information on the relative cost or performance characteristics of the PMN substance to potential alternatives may be provided.

Describe the expected net benefits, such as:

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

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

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 110(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

. EPA strongly encourages submitters to pr ovide pollution prevention data in their notices, as this information assists the Agency in balancing the benefits of a PMN substance against its unique

risks.
While Agency staffers frequently receive information on the benefits of the PMN substance with

r espect 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 byprodu cts, 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 cha racteristics 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 Polluti on Prevention Recognition Project, are geared towards incorporating this type of information into the Agency’s risk management decision making and recognizing innovative chemical design or technological innovation that shows potential for environmental

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

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

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

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

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

Does your manufacturing process eliminate or reduce the use/release of hazardous substances?

• Please click h ere to review additional information that should be included on this page:

Click the link to display additional information regarding the pollution information.

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

information as CBI’ checkbox to claim the pollution prevention information as confidential.

• Optional Pollution Prevention text box: Enter information about pollution prevention in this

field

.

• 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

re garding 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 an y edits to an attached document

.

• Description: Displays the description associated with a document.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 111• 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: Cli ck the ‘Delete’ icon ( ) to delete the entire attached document row permanently

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

.

Exhibit 4

- 36 shows a screen capture of the ‘ Optional Pollution Prevention’ screen :

Exhibit 4

- 36 : Optional Pollution Prevention Screen

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

4.1.24 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 CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 112• The ‘Additional Attachments’ screen provides a table for you to add additional attachments
that have not been incorporated into the form. This screen allows documents that did not have a suitable place in the application to be uploaded.

• Please click here to view a list of commonly attached documents and where they should

be attached : Click the link to display a list of documents and where they should be attached

.

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

pop

- up window. Refer to Section 3.7 for additional details regarding the attach document functionality

.

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

‘Attach Documents’ pop

- up window. Click the file na me link in the ‘File Name’ column to

view and/or edit an attached document.

• Description: Displays the description associated with a document.

• Pages: Displays the number of pages a document contains

.

• Date: Displays the date a document was uploaded.

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

. ’

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 113Exhibit 4

- 37 shows a screen capture of the ‘ Additional Attachments ’ screen:

Exhibit 4

- 37 : Additional Attachments Screen

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

4.1.25 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 Summary’ scre en displays a summary of the documents attached to the PMN form. The attachment table displays the section of the form a document is associated with, file name and file extension of a document, the document description, number of pages in a document, date attached, and whether the document is CBI.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 114• 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 ‘Attach Documen ts’

pop

- up window.

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

Exhibit 4

- 38 shows a screen capture of the ‘ Attachment Summary ’ screen:

Exhibit 4

- 38 : Attachment Summary Screen

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 1154.1.26 Optional Cover Letter

You can navigate to the ‘Optional Cover Letter’ screen by clicking the ‘Next’ button from the

‘ Attachment Summary ’ screen. You c an also access this screen by clicking the ‘Optional Cover

Letter’ link within the navigation tree

. The ‘Optional Cover Letter’ screen is used to communicate information with EPA that is not collected elsewhere in the form. The cover letter is used to give OPPT resources and special instructions regarding the application.

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

as CBI’ checkbox to claim the information as confidential.

• Optional Cover Letter: Enter the description and any additional special instructions regarding

the form.

Exhibit 4

- 39 shows a screen capture of the ‘Op t ional Cover Letter’ screen:

Exhibit 4

- 39 : Optional Cover Letter Screen

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 116Navigation: 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 preview of the PMN PDF.

4.1.27 Upload XML

You can access the ‘Upload XML’ screen by clicking the ‘Upload XML’ button within the lowe r left

- hand side of the bottom action bar.

The ‘Upload XML’ screen is used to upload a PMN XML file (created from the PMN thick client with a file type of .pmn_tsca or the ZIP file generated from a CoR) into a current joint

PMN form for joint PMN forms wit h 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 fil e overwrites the contents of the

pre

- populated form. In addition, uploading any file removes the attached documents within a form, which must be re

- attached. You must also add any sites identified within the form to your CDX registration profile.

After up loading a file, click the ‘Preview’ icon ( ) located in the bottom action bar to view a PDF preview of the form ensuring that all the data has populated correctly and any other information is displayed accurately. In particular, ensure that the ‘Letter of Activity (1),’ ‘Protective Equipment/Engineering Controls,’ ‘Physical Form,’ ‘Media of Release,’ ‘Control Technology,’ and ‘% New Substance’ fields of entry have been populated correctly.

Please note that in IE 7, if an upload fails, the action bar at the bottom of the screen might be misaligned when the ‘Upload XML’ screen reloads.

• Upload archive 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 copy of record a rchive file must contain the XML form in a file labeled ‘formdata.xml.’ The application processes the ZIP copy of record archive file and displays any applicable error messages

.

• Export XML: Click the button to generate the XML file of the current PMN form that a user

can download.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 117Exhibit 4

- 40 shows a screen capture of the ‘ Upload XML ’ screen:

Exhibit 4

- 40 : Upload XML Screen

Navigation: Click the ‘Validate’ icon ( ) located in the bottom action bar to validate the form. Click the ‘Save’ icon ( ) located in the bottom action bar to perform a global save on the form. Click the ‘Preview’ icon ( ) located in the bottom action bar to view a PDF preview of the
form.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 118

### 5 Edit Joint Biotech nology Form

The Biotechnology form is used to collect information about “ intergeneric ” microorganisms that will be manufactured or imported into the United States. EPA collects the information provided in a Biotechnology form through a free text box and at tachments. 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 App lication (TERA), Tier I Exemption, Tier II Exemption, and Biotechnology Test Market Exemption (TME) forms. All the forms have the same upload requirements and EPA will retain responsibility for verifying the correct information is received.

5.1 Edit Joint/Lett er of Support Biotech nology Form

To edit a Joint Biotech nology form, navigate to the ‘Section 5 Notices and Supports Forms’

screen , and click the alias link in the ‘Alias’ column of a Joint Biotechnology form with a status of ‘In Progress

. ’ Refer to Section 3.3 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen.

Refer to Section 0 for additional details regarding the enter passphrase process.

5.1.1 General Form Information

You can access the ‘General Form Information’ screen by entering a passphrase o n the ‘Enter Passphrase’ screen for the selected Joint Biotechnology form with a status of ‘In Progress

. ’

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 opt ion to assign a

‘Form Alias’ to help you identify the form. A form alias is helpful when a user or company has multiple forms and/or when you must differentiate between forms to the help desk. Upon navigating to the ‘General Form Information’ screen, the s ystem auto

- generate s a default alias in the following format: < Form T ype

- YYYYMMDD

- HH:MM:SS Time Zone>.

The system will provide a ‘ TS number ’ field for you to enter a TS number to tie support forms or J oint S ubmissions to the original Biotech nology form. The TS number can be a six (6) character alphanumeric combination

. The TS number should include two ( 2 )

, three ( 3 ) , or four ( 4 ) letters. Company names, recognizable words

, and numerical series are not recommended

.
The ‘Text/Comments’ text box is re quired when an attachment is not provided. A ‘CBI’ checkbox is displayed next to the ‘Text/Comments’ text box to claim the information as

confidential

.
The ‘General Form Information’ screen also enables you to attach a document by clicking the

‘Attach Docu ment’ button. For more information regarding the attach document functionality

, please refer to Section 3.7

.

• 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 Time Zone>. This is a required field.

• Type of Submission: Select the submission type from the drop

- down menu. This drop

- d own

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).’

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 119• TS Number: Enter the TS number . The TS number can be any six (6) character alphanumeric combination and should include two (2), three (3), or four (4) letters. Company names, recognizable words

, and numeric series are not recommended. This field is required if

‘MCAN’ is selected from t he ‘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

cer tifications, ID data, construct data, effects data, MSD S , manufacturing details, use details, inactivation data, and/or other types of documents. At least one document is required even if a Letter of Support or Joint Submission is claimed. Please refer to Section 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 ei ther 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 deletio n.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 120Exhibit 5

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

Exhibit 5

- 1 : General Form Information Screen ( Joint Bi otechnology)

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

5.1.2 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 Informat ion’ link within the navigation

tree.

The ‘Technical Contact Information’ screen displays an ‘Add Technical Contact’ button. Click the ‘Add Technical Contact’ button to generate an ‘Add Technical Contact’ pop

- up window to

enter information into the text f ields. Click the ‘Copy CDX Registration’ button to populate the text fields using your CDX registration information. Check the ‘Check here to claim this

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 121information 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.

Exhibit 5

- 2 shows a screen capture of the ‘ Technical Contact I n formation ’ screen (Joint
Biotechnolo gy) :

Exhibit 5

- 2 : Technical 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 by clicking the ‘Add Technical

Contact’ button on the ‘Technical Contact Information’ screen

.

• Copy CDX Re gistration: Click the ‘Copy CDX Registration’ button to copy your information

from CDX registration; a message displays confirming the import of CDX registration

information.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 122• Check here to claim this information as CBI: Check the ‘Check here to claim this

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

.

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

button to populate the fields with information entered during CDX registrati on. This is a required field

.

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

to populate the fields with information entered during CDX registration. This is a required

field.

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

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

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

• Phone Number: E nter the technical contact ’s daytime U.S. phone number; this must be at

least 10 characters long and does not accept dashes. Click the ‘Copy CDX Registration’ button to populate the fields with information entered during CDX registration. This is a require d

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

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

‘Copy CDX Registration’ butt on to populate the fields with information entered during CDX registration. This is a required field.

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

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

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

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

.

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

- down menu

.

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

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

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

• Country: Displays ‘United States.’

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 123Exhibit 5

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

- up window (Joint Biotechnology) :

Exhibit 5

- 3 : Add Technical Contact Pop

- Up Window (Joint Biotechnology)

Navigation: Click the ‘Cancel’ button to stop populating technical contact information and navigate back to the ‘Technical Contact Information’ screen. Click th e ‘OK’ button to save and populate the entered technical contact information and navigate back to the ‘Technical Contact

Information’ screen.

5.1.3 Optional Cover Letter

You can access the ‘Optional Cover Letter’ screen by clicking the ‘Next’ button from the

‘ T echnical Contact Information’ screen. You can also access this screen by clicking the ‘Optional Cover Letter’ link within the navigation tree

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 124The ‘Optional Cover Letter’ screen is used to communicate information to EPA not collected

elsewhere in the form. The cover letter is used to give OPPT resources and special instructions regarding the application. The cover letter should be either fully CBI or non

- CBI to eliminate user error to promote transparency between the company and EPA.

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

information as CBI’ checkbox to claim the cover letter information as confidential.

• Optional Cover Letter: Enter the description and any additional special instructions regarding

the form.

Exhibit 5

- 4 shows a screen capture of the ‘ Optional Cover Letter ’ screen (Joint Biotechnology) :

Exhibit 5

- 4 : Optional Cover Letter Screen (Joint Biotechnology)

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 PDF preview of the
form.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 125

### 6 Edit Letter of Support Bona Fide Form

T he purpose of the Bona Fide module is to receive an official determination from EPA as to

whether a substance is on the TSCA inventory. Submitters may attempt to avoid submitting a PMN by completing a Bona Fide form to establish that the chemical already exists on the inventory. The Bona Fide process is cove red in a thirty (30) day period.

6.1 Edit Letter of Support Bona Fide Form

To edit a Letter of Support Bona Fide form, navigate to the ‘Section 5 Notices and Supports

Forms’ screen and click the alias link in the ‘Alias’ column of a Letter of Support Bona Fide form with a status of ‘In Progress

. ’ Refer to Section 3.3 for additional details regarding the ‘Section 5 Notices and Supports Forms’ screen.

Refer to Section 0 for additional details regarding the enter passphrase process.

6.1.1 General Document Information

You can access the ‘ General Document Information ’ screen by entering the passphrase on the

‘Enter Passphrase’ screen for a selected Letter of Support Bona Fide form with a status of ‘In Progress.’ The ‘General Document Information’ screen allows you to identify information that is specific to the form type selected from the ‘ Section 5 Notices and Suppo rts Forms ’ screen.

The ‘General Document Information’ screen presents text fields and checkboxes that allow you to input identifying info rmation for the specific form. You will have the option to edit a ‘Form Alias’ by which you will identify the form. A form alias is helpful when you or your company has multiple forms and/or when you must differentiate between forms to the help desk. Upon navigating to the ‘General Document Information’ screen, the system will have already auto

generated an editable default alias comprised of a form type, date stamp and time stamp for the AO 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 yo u 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 identifi ed by checking the ‘Technical Contact’ checkbox. The technical contact must possess sufficient knowledge to answer any questions EPA may have about the chemical reported in the submission. The application will generate a ‘Technical Contact Information’ scr een when you check the ‘Technical Contact’ checkbox.

• Form Alias: Edit the form alias if necessary . Upon navigating to the screen, the screen will

auto

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

- YYYYMMDD

HH:MM:SS Time Zone >

.

• I cla im the entirety of the submission as CBI: By checking the ‘I claim the entirety of the

submission as CBI’ checkbox, all data contained within the submission is flagged as CBI

.

• Technical Contact: Check the ‘Technical Contact’ checkbox to display a ‘Technical Contact

Information’ screen for you to enter contact information about the technical contact associated with the reported chemical.

• Submitting on Behalf of Company: Check the ‘Submitting on Behalf of Company’ checkbox

to indicate that you will be submitting a Bona Fide form on behalf of another company. A

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 126‘Submitting on Behalf of Company’ screen will display during the submission process for you to enter information pertaining to the company that will manufacture or import the chemical

substanc e , on whose behalf you are submitting a Bona Fide form

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 127Exhibit 6

- 1 shows a screen capture of the ‘General Document Information’ screen (Letter of Support Submissi on):

Exhibit 6

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 128The data fields on the ‘Primary Contact Information’ screen are pre

- populated based on information entered during CDX registr ation. All fields are editable allowing for necessary updates. The ‘ Job Title’ field on this screen is not pre

- populated from CDX registration and is a required field.

If you checked the ‘I claim the entirety of the submission as CBI’ checkbox on the ‘Gen eral Document Information’ screen, all entered primary contact information is flagged as CBI.

The following fields are displayed for the primary contact :

• Prefix: Select the primary contact’s prefix from the drop

- down menu.

• First Name: Enter the primary c ontact’s first name. This is a required field.

• Middle Initial: Enter the primary contact’s middle initial.

• Last Name: Enter the primary contact’s last name. This is a required field.

• Suffix: Select the primary contact’s suffix from the drop

- down menu.

• Title: Enter the primary contact’s job title. This is a required field.

• Company Name: Enter the primary contact’s company name. This is a required field.

• Phone Number: Enter the primary contact’s daytime phone number; dashes are not allowed.

This is a req uired field.

• Phone Extension: Enter the extension to the primary contact’s daytime phone number.

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

standard email address format: John.Doe@ABC.com . This is a required field.

• Mailing Address 1: Enter the first line of the primary contact’s mailing address. This is a

required field.

• Mailing Address 2: Enter the second line of the primary contact’s mailing address.

• City: Enter th e city of the primary contact’s mailing address. This is a required field.

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

- down menu. The

state field is required if the user selects ‘United States’ from the ‘Country’ drop

- down menu.

• Postal Code: Enter the postal code of the primary contact’s mailing address. This is a required

field.

• Country: Select the country of the primary contact’s mailing address. This is a required field.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 129Exhibit 6

- 2 shows a screen capture of the ‘Primary Contact Information’ screen :

Exhibit 6

- 2 : Primary Contact Information Screen

Navigation: Click the ‘ Next ’ button to navigate to the ‘Technical Contact Information’ screen if you checked the ‘Technical Contact’ checkbox on the ‘General Document Information’ screen. You can also access this screen by clicking the ‘Technical Contact Information’ link within the navigation tree.

6.1.3 Technical Contact Information

If you indicated on the ‘General Document Information’ screen that technical contact information would be provided, then you can navigate to the ‘Technical Contact Information’ screen by clicking the ‘Ne xt’ button from the ‘Primary Contact Information’ screen. You can

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 130also 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 q uestions

related to the chemical submitted to EPA within the Bona Fide form. The technical contact does not have to work at the port or site reported on the form but must possess sufficient knowledge to answer EPA’s questions pertaining to the chemical rep orted in the form.

The text fields on the ‘Technical Contact Information’ screen will be blank upon accessing the screen. To add information, you will enter data into the blank text boxes for the listed text fields. If you checked the ‘I claim the entirety of the submission as CBI’ checkbox on the ‘General Document Information’ screen, all entered technical contact information will be flagged as CBI

. Please note that if you are using IE 7, there will be a spacing issue between the ‘Suffix’ drop

dow n menu and the ‘Title’ text field.

• Prefix: Select the technical contact’s prefix from the drop

- down menu.

• First Name: Enter the technical contact’s first name. This is a required field.

• Middle Initial: Enter the technical contact’s middle initial.

• Last Name: Enter the technical contact’s last name. This is a required field

.

• Suffix: Select the technical contact’s suffix from the drop

- down menu.

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

• Company Name: Enter the technical contact’s company name.

• P hone Number: Enter the technical contact’s daytime U.S. phone number; dashes are not

allowed. This is a required field

.

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

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

standard email address format: John.Doe@ABC.com . This is a required field

.

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

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

• City: Enter the city of the technical contact’s mailing address.

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

- down menu.

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

• Country: Displays ‘United States.’

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 131Exhibit 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 by clicking the ‘Chemical Identification Information’ link within the navigation tree

.
6.1.4 Chemical Identification Information

You can navigate to the ‘Chemical 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.

The ‘Chemical 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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 1322 /Biotechnology chemical substance or a polymer. Based on your selection, the appropriate screens for the respective chemical will appear.

This scre en 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 /b iotechnology 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 chemica l if the chemical type changes. The user is required to select one of the two radio button options displayed in the ‘Chemical Type’

section.

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

select the ‘Class 1 o r 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 CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 133Exhibit 6

- 4 shows a screen capture of the ‘Chemical Identification Information’ screen:

Exhibit 6

- 4 : Chemical Identification Information Screen

Navig ation: If you select ed the ‘Class 1 or 2 Chemical S ubstance’ radio button, click the ‘Next’
button to navigate to the ‘Class 1 or 2 Chemical Sub stances’ screen. You can also access this screen if you click the ‘Class 1 or 2 Chemical Substances’ link within the navigation tree. If you

select ed the ‘Polymer’ radio button, click the ‘Next’ button to navigate to the ‘Polymer

Identification Information’ screen. You can also access this screen by clicking the ‘Polymer

Identification Information’ link within the n avigation tree.

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 ‘Class 1 or 2 /Biotechnology Chemical Substances’ screen.

The ‘Class 1 or 2 /Biotechnology Chemical Substances’ screen provides fields for you to enter information describing the chemical for the Bona Fide which is to be filed, including its name, composition, and structure.

You can add a chemical component by clicking the ‘Add New Chemical ’ button. Upon clicking

the ‘Add New Chemical ’ button, an expandable/collapsible field set generates that contains numerous fields to identify the chemical in question. You will be able to enter multiple chemical

substances , each with uniq ue information, by clicking the ‘Add New Chemical ’ button for each

chemical substance you wish to identify.

After the document(s) is/are attached and you have clicked the ‘OK’ button, the ‘Attach Chemical Structure’ pop

- up window closes and the document in formation will be displayed in a

table format on the ‘Class 1 or 2 /Biotechnology Chemical Substances’ screen. The attachment table displays the file name of the document and user

- provided description of the document.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 134Click the ‘Delete’ icon ( ) located und er the ‘Actions’ column to delete unwanted documents

. Click the appropriate file name of the document within the ‘File Name’ column of the

attachment table to access or edit previously attached documents

. Please note that if you are using IE 7, part of th e content on this screen displays behind the Bona Fide navigation tree and certain fields on this screen may display twice

.

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

substances field set.

• Cancel: Click the ‘Ca ncel’ 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 ent ered 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 ‘Coll apse 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 substance is being reported. When you select the ‘Class

2 /Biotechnology ’ chemical substance radio button, you are indicating that some portions of the structure may not be known and an additional screen will appear within the navigation tree that provides fields fo r you to enter information concerning how the chemical was created. If multiple class 2 chemical substances are added, one ‘Class 2 /Biotechnology Substances’ screen will apply to all chemical substances

.

• Add Chemical ID: You can access the ‘Add Chemical I D’ 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 s ystem provides fields for you to enter the chemical information by filling in the ‘Chemical Name’ and the ‘Chemical Abstract Services Registry Number’ under the manual entry field set. The system provides functionality to enter the selected chemical by cli cking the ‘OK’ button located at the bottom of the ‘Add Chemical ID’

window. Refer to Section 3.8 for further details regarding the search SRS func tionality.

• 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 ente r the chemical information in the ‘Add Chemical ID’ pop up.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 135• ID Method: The system shall require that you identify which ID method was used to determine the chemical identity. If you select ‘Method 1,’ you are required to attach an IES report. You can also select ‘Method 2 (Other Method).’

• Attach IES Report: To access the ‘Attach IES Report’ pop

- up window, click the ‘Attach IES

Report’ button that displays within the ‘Chemical Identification Information’ field set. After you attach the document(s), and cli ck the ‘OK’ button, the ‘Attach IES Report’ pop

- up window

close s and the document information displays in a table format on the ‘Class 1 or

2 /Biotechnology Chemical Substances’ screen. The document attachment table displays the file name of the document(s) and the user

- provided description of the document(s). Click the ‘Delete’ icon ( ) located under the ‘Actions’ column to delete unwanted documents

. Click t he

file name link under the ‘File Name’ column to access or edit previously attached documents

.

• Molecular Formula: Enter a molecular formula in a text field using a free text format. This

field is optional.

• Chemical Structure Diagram: The system allows you to attach a chemical structure diagram.

This field is optional.

• Attach Chemical Structure: Click the ‘Attach Chemical Structure’ button within the

‘Chemical Identification Information’ field set to access the ‘Attach Chemical Structure’ pop

up window . You can attach the file(s) and enter a description of the document regarding the

chemical structure.

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

Chemical Structure’ window.

• Description: Displays the descri ption 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 t he 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 naviga te 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 CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 136Exhibit 6

- 5 shows a screen capture of the ‘Class 1 or 2 /Biote chnology Chemical Substances’

screen :

Exhibit 6

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

Navigation: If you selected the ‘Class 1’ radio button, click the ‘Save’ button within the expanda ble/collapsible field, then click the ‘Next’ button to navigate to the ‘Use Information’ screen. If you selected the ‘Class 2’ radio button, click the ‘Save’ button within the expandable/collapsible field set, then click the ‘Next’ button to navigate to th e ‘Class 2
Substances’ screen.

6.1.6 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 selected the ‘Class

2 /Biotechnology ’ radio button. You can also access this screen by clicking the ‘Save’ icon ( )

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 137within the action bar and clicking the ‘Class 2 /Biotechnology Substances’ link within the navigation tree.

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

You will be able to enter precursor substances by searching SRS or by the ma nual entry fields when the substance is not in SRS. The substances will display in a table listing the ‘Chemical

Name’ and CASRN.

The system provides fields for you to capture ‘Nature of Reaction’ and ‘Range of Composition’

in text boxes. The text boxes for both ‘Nature of Reaction’ and ‘Range of Composition’ can be

claimed as CBI.

• Precursor Substances: This table captures the chemicals identified as immediate precursor

substances, alo ng with the respective CASRNs.

• Search SRS: Click the ‘Search SRS’ butt on to display the ‘Search Substance Registry

Services’ pop

- up window. Refer to Section 3.8 for further details regarding the search SRS

functionalit y.

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

‘Chemical Name’ link to navigate to the ‘Search SRS’ pop

- up window for edits.

• CASRN: Displays the CASRN associated with a precursor substance.

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

system. A warning message will display to confirm the deletion of the chemical

.

• Nature of Reaction: Enter the ‘Nature of Reaction’ description. This is a required field.

• Range of C omposition: Enter the ‘Range of Composition’ description. This field is optional

.

• 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 found. 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 ‘Atta ch

Documents’ window.

• Description: Displays the descripti on associated with a document.

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

system. A warning message displays to confirm the deletion.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 138Exhibit 6

- 6 shows a screen capture of the ‘Class 2 /Biotechnology Substances’ screen (Scroll 1) :

Exhibit 6

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 139Exhibit 6

- 7 shows a screen capture of the ‘Class 2 /Biotechnology Substances’ screen (Scroll 2) :

Exhibit 6

- 7 : Class 2 /Biotechnology Substances Screen (Scroll 2)

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

.
6.1.7 Polymer Identification Information

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

Information ’ link within the navigation tree.

Click the ‘Add New Chemical ’ button to create a chemical substance . Upon clicking the ‘Add

New Chemical ’ button, an expandable/collapsible field set generates that contains numerous

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 140fields that pertain to the particular polymer. The system provides numerous fields for you to enter multiple chemical substances , each with unique information, by clicking the ‘Add New
Chemical ’ button for each chemical you wish to identify.

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

For a multi

- component submissi on, create individual field sets by clicking the ‘Add New
Chemical ’ button. Multi

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

- component mixture. All multi

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

• Add New Chemical: Click the button to generate the ‘Polymer Identification Information’

field set.

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

- hand corner of the

expandable/collapsible field set to prevent edits from saving and to remove a field set. The

‘C ancel’ 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/c ollapsible 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.

• Add Chemical ID: Click the ‘Add Chemical ID’ button within the ‘Polymer Identification

I nformation ’ field set to gener ate the ‘Add Chemical ID’ pop

- up window. You can search for the reported chemical(s) either by the ‘CASRN’ or ‘CA Index Name or Other Synonym.’ If you retrieve zero results, the system provides fields for you to enter the chemical information by filling in the ‘Chemical Name’ and the ‘Chemical Abstract Services Registry Number’ (CASRN) under the manual entry field set. The system provides functionality for you to enter the selected chemical by clicking the ‘OK’ button located at the bottom of the ‘Add Chemi cal

ID’ window. Refer to Section 3.8 for further details regarding the search SRS functionality.

• Chemical Name: The system provides fields for you t o identify the ‘Chemical Name’ and the

CASRN (if available). The system provides functionality for you to search for the chemical substance using the ‘Add Chemical ID’ search or manually enter the chemical information in the ‘Add Chemical ID’ pop up.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 141• ID M ethod: 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: To access the ‘Attach IES Report’ pop

- up window, click the ‘Attach IES

Report’ button within the ‘Polymer Identification I n formation ’ field set after selecting the ‘Method 1 (CAS Inventory Expert Service)’ radio button. After you attach the document(s), and click the ‘OK’ button, the ‘Attach IES Report’ pop

- up window will close and the document information will be displayed in a table format on the ‘Polymer Identification Information’ screen. The attachment table displays the file name of the document and the user

provided description of the document. Click the ‘Delete’ icon ( ) located under the ‘Actions’
column to delete unwa nted documents. Click the file name link under the ‘File Name’ column to access or edit previously attached documents

.

• Chemical Structure Diagram: The system allows you to attach a chemical structure diagram.

This field is optional.

• Attach Chemical Structure: Click the ‘Attach Chemical Structure’ button within the

‘Polymer Identification I nformation ’ field set to access the ‘Attach Chemical Structure’ pop

- up window . You can attach the file(s) and enter a description of the document.

• F ile 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 atta ched chemical structure row

permanently from the system. A warning message displays to confirm the deletion.

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

set. You must click this button instead of the ‘Sav e’ 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. 6 for more information regardi ng 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

‘Po lymer 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 CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 142Exhibit 6

- 8 shows a screen capture of the ‘Polymer Identification Information’ screen:

Exhibit 6

- 8 : Polymer Identification Information Screen

Navigat ion: 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 ‘Mo nomers and Other Reactants’ screen by clicking the ‘Next’ button from the ‘Polymer Identification Information’ screen. You can also access this screen by clicking the ‘Monomers and Other Reactants’ link within the navigation tree.

The ‘Monomers and Other Reactants’ screen is used to identify the chemical measurements and monomers that make up a polymer. The ‘Monomers and Other Reactants’ screen has an ‘Add

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 143Monomer’ button that allows you to identify the monomer(s) that make up the polymer composition.

• Add Monomer: Click the ‘Add Monomer’ button to generate an expandable/collapsible field

set.

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

- hand corner of the

expandable/collapsible field set to prevent edits from saving and to remove a field set. The

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

.

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

- hand corner of the expandable/collapsible

field set to modify the information entered in the fields. The ‘Edit’ link displays when the expandable/collapsible field set has been saved and the data is not cur rently editable.

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

- hand corner of the

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

confirm the deletion.

• Expand All: Click the ‘Expand All’ link l ocated at the upper

- right of the

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

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

- right of the

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

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

Services’ pop

- up window. Refer to Section Error! Reference source not found. for

add itional 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 fiel d.

• Monomer or Other Reactant: Displays the monomer or other reactant name; this field

populates based on information entered on the ‘Search Substance Registry Services’ pop

- up window. This is a required field.

• Include in Identity: Check the ‘Include in I dentity’ checkbox to claim the value for ‘Monomer

or Other Reactant’ as part of the monomer identification.

• Typical Composition: Enter the ‘Typical Composition’ value that a monomer contributes to a

polymer; the value entered must be a positive numerical value greater than zero (0) and less than or equal to 100 with up to three decimal points . If the value entered is less than or equal to ‘2’ a warning will be displayed in the global ‘Validate’ function or during the submission process indicating that the ‘Typical Composition’ is a value that is less than or equal to 2% and asking the user whether it should be included in the ‘Chemical Identity.’ This is a required

field.

• Save: Click the button to save the information entered within the expandable/collapsi ble 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 ‘Nex t’ buttons. Refer to Section 3. 6 for more information regarding the save functionality in an expandable/collapsible field set.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 144• 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. Click the file name link to navigate to the ‘Attach Documents’

pop

- up window to make any edits

.

• Description: Displays the description associated with a document.

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

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

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 145Exhibit 6

- 9 shows a screen capture of the ‘Monomers and Other Reactants’ screen:

Exhibit 6

- 9 : Monomers and Other Reactants Screen

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

6.1.9 Use Information

You can navigate to the ‘Use Information’ screen by clicking the ‘Next ’ button from the ‘Class 1 or 2 Chemical Substances’ screen, on the ‘Class 2 /Biotechnology Substances’ screen, or on the ‘Monomers and Other Reactants’ screen, depending on the choice made on the ‘Class 1 or 2

Chemical Substances’ screen. You can also acce ss this screen by clicking the ‘Use Information’ link within the navigation tree.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 146The ‘Use Information’ screen is used to capture data about the chemical substance’s intended use. When the user navigates to the screen, the screen contains a text box with i nstructional 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. Th is is a required field.

Exhibit 6

- 10 shows a screen capture of the ‘Use Information’ screen:

Exhibit 6

- 10 : Use Information Screen

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

.
6.1.10 Document Management

You can navigate to the ‘Document Management’ screen by clicking the ‘Next’ button fr om 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 electronic form.

The user must attach thre e 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 doc uments before clicking the ‘Next’ button and navigating to the next screen. If you click the ‘Next’ button with only one or two

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 147documents attached, you will be taken to an error screen. Navigate away from this screen using the back button on your browser a nd ensure 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 Do cuments’ pop

- up window.

• Document Type: Displays the document type associat ed with the uploaded document.

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

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

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 148Exhibit 6

- 11 shows a screen capture of the ‘Document Management’ screen:

Exhibit 6

- 11 : Document Management Screen

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

6.1.11 Optional Cover Letter

You can navigate to the ‘Optional Cover Letter’ screen by clicking the ‘Next’ button from the

‘ Document Management ’ screen. You can also access this screen by clicking the ‘Optional

Cover Letter’ link within the navigation tree

. The ‘Optional Cover Letter’ s creen 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.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 149• Optional Cover Letter: Enter any additional special instructions regarding the form.

Exhibit 6

- 12 shows a screen capture of the ‘Optional Cover Letter’ screen:

Exhibit 6

- 12 : Optional Cover Letter Screen

Navigation: Click the ‘Validate’ icon ( ) located in the bottom action bar to validate the form

. Click the ‘Save’ icon ( ) located in the bottom action bar to perform a global save on the form.

Click the ‘Preview’ icon ( ) located in the bottom action bar to preview the Bona Fide PDF.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 150

### 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 en tire form in a single viewpoint.

Exhibit 7

- 1 shows a screen capture for the ‘Preview’ of the Biotech nology form:

Exhibit 7

- 1 : Preview Biotech nology Form Screen

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 151Exhibit 7

- 2 shows a screen capture for the ‘Preview’ of the Biotech nology form:

Exhibit 7

- 2 Preview Biotechnology Form PDF

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 152

### 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 ( ). T he pop

- up blocker within your internet browser must be
dis abled to ensure that the window displays correctly . The ‘Section 5 Notices and Supports Validation’ pop

- up window displays a report of all validation errors and warning messages. During the validation process, the application validates each screen of the S ection 5 Notices and Supports form to find missing and invalid data.

Please note in IE 7, the ‘Help’ button is aligned to the right side of the ‘Section 5 Notices and Supports Validation’ pop

- up window.

Validation Errors: Errors are denoted by an ‘Error’ i con ( ) and can be fixed by clicking the error link. The links will display the Screen Title Name (e.g., Chemical Identification) and the

associated error. After you click a link, the main application screen will display the section

where the error occurre d 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 fro m the ‘Section 5 Notices and Supports Validation’ pop

- up window.

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 cli ck a link, the main application screen will display the section where the warning occurred so you can easily fix the warning. Once you have fixed the warning(s), click the
‘Validate’ icon ( ) again to refresh the ‘Section 5 Notices and Supports Validation’ pop

- up window. If the information you fixed passes validation, the warning will be removed from the ‘Section 5 Notices and Supports Validation’ pop

- up window.

You can close the ‘Section 5 Notices and Supports Validation’ pop

- up window by clicking the

‘X’ button located at the upper right

- hand corner of the window

.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 153Exhibit 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 Validation Pop

- Up W indow

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 154

### 9 Resources

You can access the ‘Resources’ screen by clicking the ‘Resources’ tab located at the top of the screen at any time durin g 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

us er 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 179 10): If you click 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 this 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 l ink, a new 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.

• 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 Pollutant Discharge Elimination System (NPDES)’ screen.

• New Chemicals Program Homepage: If you click this link, a new internet browser window

will generate displaying the ‘New Chemicals Progra m’ screen.

• Status of Section 5 Notices: If you click this link, a new internet browser window will

generate displaying the ‘Status of Section 5 Notices’ screen.

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 155Exhibit 9

- 1 shows a screen capture of the ‘ Resources ’ screen (Scroll 1) :

Exhibit 9

- 1 Resources Screen (Scroll 1)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 156Exhibit 9

- 2 shows a screen capture of the ‘Resources’ screen (Scroll 2):

Exhibit 9

- 2 Resources Screen (Scroll 2)

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 157

### 10 Appendix A.

The following table di splays all the definitions, acronyms, and abbreviations used in this

document and their full name.

Definitions, Acronyms, and Abbreviations

Acronym Full Name

ACM Alternative Control Measures

AO Authorized Official

BCF/BAF Bioconcentration Factors/Bioaccumulation Factors

CBI Confidential Business Information

CA Chemical Abstracts

CAS Chemical Abstracts Service

CASRN Chemical Abstract s Service Registry Number

CDX Central Data Exchange

CFR Code of Federal Regulations

CoR Copy of Record

CROMERR Cross

- Media Electronic Reporting Regulation

CSPP Chemical Safety and Pesticide Programs

CSV Comma

- Separated Values

DNA Deoxyribonucleic Acid

EPA Environmental Protection Agency

EST Eastern Standard Time

ETI Environmental Technology Initiative

FR Federal Regulation

FRS Facility Registry System

GPC Gel

- permeation Chromatography

ID Identification

IE Internet Explorer

IES Inventory Expert Service

IH Industrial Hygienist

IR Infrared

KG Kilogram

LOREX Low Release/Low Exposure Exemption

LOS Letter of Support

LVE Low Volume Exemption

MCAN Microbial Commercial Activity Notice

MS Mass Spectrometry

MSDS Material Safety Data Sheet

NIOSH National Institute for Occupational Safety and Health

NMR Nuclear Magnetic Resonance

NOC Notice of Commencement

NPDES National Pollutant Discharge Elimination System

OPPT Office of Pollution Prevention and Toxics

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19, 2014 Secondary Support 158PDF Portable Document Format

PMN Premanufacture Notice

POTW Publicly Owned Treatment Works

PPE Personal Protective Equipment

PPM Parts Per Million

RCRA Resource Conservation and Recovery Act

SAR Structure

- Activity Relationship

SDS Safety Data Sheet

SME Subject Matter Expert

SNUN Significant New Use Notice

SNUR Significant New Use Rule

SRS Substance Registry Services

STN Scientific and Technical Information Network

TERA TSCA Experimental Release Application

TME Test Market Exemption

TMEA Test Marketing Exemption Application

TS Toxic Substances

TSCA Toxic Substances Control Act

UV Ultraviolet

XML Extensible Markup Language

TDD 9.21 OPPT CIS Section 5 Notices and Supports User Guide December 19 , 2014 Secondary Support 159