Chemical Manufacturer Chemical Substance Risk Evaluation Submission Request

Procedures for Requesting a Chemical Risk Evaluation under TSCA

Risk Evaluation Rule User Guide - Primary Authorized Official v2.0

Chemical Manufacturer Chemical Substance Risk Evaluation Submission Request

OMB: 2070-0202

Document [pdf]

Download: pdf | pdf

Risk Evaluation Rule User Guide –
Primary Authorized Official
Environmental Protection Agency
Office of Pollution Prevention and Toxics

Contract # GS00Q09BGD0022
Task Order # 47QFCA-18-F-0009
Project Title: EPA CDX
Version 2.0
January 16, 2020
New Chemical Data Collection:
OMB Control No. 2070-0012 and EPA ICR No. 0574
Existing Chemical Data Collection:
OMB Control No. 2070-0038 and EPA ICR No. 1188
TSCA Fees Payment:
OMB Control No. 2070-0208; EPA ICR No. 2569

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

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

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

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

2.2

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

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

Log into Risk Evaluation Application ............................................................................. 4

3.2

Risk Evaluation Home Screen Navigation..................................................................... 7

3.3

Submission History ....................................................................................................... 8

3.4

User Management ...................................................................................................... 10

3.5

Create Passphrase ..................................................................................................... 12

3.6

Enter Passphrase ....................................................................................................... 14

3.7

Action Bar ................................................................................................................... 15

Chemical Substance Risk Evaluation Request ................................................................. 18
4.1

Create a Manufacturer Requested Risk Evaluation .................................................... 18

4.2

Contact ....................................................................................................................... 18

4.3

Submitting on Behalf of Consortium............................................................................ 23

4.4

United States Agent .................................................................................................... 32

4.5

Chemical Substance or Category ............................................................................... 34

4.6

Document Upload ....................................................................................................... 45

4.7

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

4.8

Submitting Official Information .................................................................................... 50

4.9

Submission of Referenced Information ....................................................................... 53

4.10

Instructions for Substantiating Confidential Business Information (CBI) Claims .......... 54

4.11

Attach Documents for CBI Substantiation ................................................................... 58

Withdrawal Request ......................................................................................................... 60
5.1

Create a Withdrawal Request ..................................................................................... 60

5.2

Contact Information .................................................................................................... 60

5.3

Original Submitter Information .................................................................................... 63

5.4

Submitting Official Information .................................................................................... 65

5.5

Instructions for Substantiating Confidential Business Information (CBI) Claims .......... 67
Initial Response ................................................................................................................ 68

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
i

6.1

Create an Initial Response ......................................................................................... 68

6.2

Contact ....................................................................................................................... 68

6.3

United States Agent .................................................................................................... 71

6.4

Company .................................................................................................................... 73

6.5

Response Information................................................................................................. 76

6.6

Submitting Official Information .................................................................................... 79

6.7

Submission of Referenced Information ....................................................................... 82

6.8

Instructions for Substantiating Confidential Business Information (CBI) Claims .......... 83

6.9

Attach Documents for CBI Substantiation ................................................................... 87

EPA Initiated Risk Evaluation Request ............................................................................. 89
7.1

Create a EPA Initiated Risk Evaluation ....................................................................... 89

7.2

Contact ....................................................................................................................... 89

7.3 Submitting on Behalf of Consortium ................................................................................. 93
7.3

United States Agent .................................................................................................. 103

7.4

Chemical Substance or Category ............................................................................. 105

7.5

Document Upload (Optional) .................................................................................... 108

7.6

Fees Certification...................................................................................................... 112

7.7

Submitting Official Information .................................................................................. 113

7.8

Submission of Referenced Information ..................................................................... 116

7.9

Instructions for Substantiating Confidential Business Information (CBI) Claims ........ 117

7.10

Attach Documents for CBI Substantiation ................................................................. 121

Preview .......................................................................................................................... 123

Validate .......................................................................................................................... 125

Submit to EPA via CDX .................................................................................................. 126

10.1

TSCA Certification .................................................................................................... 126

10.2

Risk Evaluation Certification ..................................................................................... 127

10.3

Validation.................................................................................................................. 127

10.4

Risk Evaluation PDF Generation .............................................................................. 128

10.5

CROMERR Certification ........................................................................................... 129

10.6

eSignature Widget .................................................................................................... 130

10.7

Submission Finished ................................................................................................ 131

Download Copy of Record .............................................................................................. 132

EPA Communications .................................................................................................... 134

12.1

CSPP Payment Processor ........................................................................................ 140

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
ii

12.2

Invoice Communications........................................................................................... 144

Create An Amendment ................................................................................................... 149

Appendix A. Document Types and Subtypes.................................................................. 150

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
iii

List of Exhibits
Exhibit 3-1 Risk Evaluation User Roles Matrix............................................................................. 4
Exhibit 3-2 Chemical Information Submission System Screen (Scroll 1) ..................................... 5
Exhibit 3-3 Chemical Information Submission System Screen (Scroll 2) ..................................... 6
Exhibit 3-4 Risk Evaluation Home Screen ................................................................................... 8
Exhibit 3-5 Risk Evaluation Submission History Section ............................................................ 10
Exhibit 3-6 User Management Screen....................................................................................... 12
Exhibit 3-7 Create Passphrase Screen ..................................................................................... 13
Exhibit 3-8 Enter Passphrase Screen........................................................................................ 14
Exhibit 3-9 Action Bar – Save .................................................................................................... 15
Exhibit 3-10 Action Bar – Preview ............................................................................................. 15
Exhibit 3-11 Action Bar – Validate ............................................................................................. 16
Exhibit 3-12 Action Bar – Submit ............................................................................................... 16
Exhibit 3-13 CDX Links ............................................................................................................. 17
Exhibit 4-1 Contact Screen (Scroll 1) ........................................................................................ 20
Exhibit 4-2 Contact Screen (Scroll 2) ........................................................................................ 21
Exhibit 4-3 Contact Screen (Scroll 3) ........................................................................................ 22
Exhibit 4-4 Submitting on Behalf of Consortium Screen (Scroll 1) ............................................. 24
Exhibit 4-5 Submitting on Behalf of Consortium Screen (Scroll 2) ............................................. 25
Exhibit 4-6 Submitting on Behalf of Consortium Screen (Scroll 3) ............................................. 26
Exhibit 4-7 Small Business Concern Definition Window (Scroll 1) ............................................. 28
Exhibit 4-8 Small Business Concern Definition Window (Scroll 2) ............................................. 29
Exhibit 4-9 Small Business Concern Definition Window (Scroll 3) ............................................. 30
Exhibit 4-10 Small Business Concern Definition Window (Scroll 4) ........................................... 31
Exhibit 4-11 United States Agent Screen (Scroll 1) ................................................................... 33
Exhibit 4-12 United States Agent Screen (Scroll 2) ................................................................... 34
Exhibit 4-13 Chemical Substance or Category Screen (Scroll 1) ............................................... 37
Exhibit 4-14 Chemical Substance or Category Screen (Scroll 2) ............................................... 38
Exhibit 4-15 Chemical Substance or Category Screen (Scroll 3) ............................................... 39
Exhibit 4-16 Attach Document Pop-Up Window (Chemical Substance or Category Screen) ..... 41
Exhibit 4-17 Search Substance Registry Services (SRS) Window ............................................ 43
Exhibit 4-18 Create New Chemical Window .............................................................................. 44
Exhibit 4-19 Document Upload Screen (Scroll 1) ...................................................................... 46
Exhibit 4-20 Document Upload Screen (Scroll 2) ...................................................................... 47
Exhibit 4-21 Attach Document Window ..................................................................................... 48
Exhibit 4-22 Risk Evaluation Request Fee Structure ................................................................. 49
Exhibit 4-23 Fees Certification Screen ...................................................................................... 50
Exhibit 4-24 Submitting Official Information Screen (Scroll 1).................................................... 52
Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
iv

Exhibit 4-25 Submitting Official Information Screen (Scroll 2).................................................... 53
Exhibit 4-26 Submission of Referenced Information Screen ...................................................... 54
Exhibit 4-27 Instructions for Substantiating Confidential Business Information (CBI) Claims
Screen (Scroll 1) ....................................................................................................................... 56
Exhibit 4-28 Instructions for Substantiating Confidential Business Information (CBI) Claims
Screen (Scroll 2) ....................................................................................................................... 57
Exhibit 4-29 Instructions for Substantiating Confidential Business Information (CBI) Claims
Screen (Scroll 3) ....................................................................................................................... 58
Exhibit 4-30 Attach Documents for CBI Substantiation Window ................................................ 59
Exhibit 5-1 Withdrawal Request - Contact Information Screen (Scroll 1) ................................... 61
Exhibit 5-2 Withdrawal Request - Contact Information Screen (Scroll 2) ................................... 62
Exhibit 5-3 Withdrawal Request - Contact Information Screen (Scroll 3) ................................... 62
Exhibit 5-4 Withdrawal Request – Original Submitter Information Screen (Scroll 1) .................. 64
Exhibit 5-5 Withdrawal Request – Original Submitter Information Screen (Scroll 2) .................. 64
Exhibit 5-6 Withdrawal Request – Original Submitter Information Screen (Scroll 3) .................. 65
Exhibit 5-7 Withdrawal Request – Submitting Official Information Screen (Scroll 1) .................. 66
Exhibit 5-8 Withdrawal Request – Submitting Official Information Screen (Scroll 2) .................. 67
Exhibit 6-1 Initial Response – Contact Screen (Scroll 1) ........................................................... 69
Exhibit 6-2 Initial Response – Contact Screen (Scroll 2) ........................................................... 70
Exhibit 6-3: Initial Response – United States Agent Screen (Scroll 1) ....................................... 72
Exhibit 6-4 Initial Response – United States Agent Screen (Scroll 2) ........................................ 73
Exhibit 6-5 Initial Response – Company Screen (Scroll 1) ........................................................ 75
Exhibit 6-6 Initial Response – Company Screen (Scroll 2) ........................................................ 76
Exhibit 6-7 Response Information – Screen (Scroll 1) ............................................................... 78
Exhibit 6-8 Initial Response – Response Information Screen (Scroll 2) ..................................... 79
Exhibit 6-9 Initial Response – Submitting Official Information Screen (Scroll 1)......................... 81
Exhibit 6-10 Initial Response – Submitting Official Information Screen (Scroll 2)....................... 82
Exhibit 6-11 Initial Response – Submission of Referenced Information Screen ......................... 83
Exhibit 6-12 Initial Response – Instructions for Substantiating Confidential Business Information
(CBI) Claims Screen (Scroll 1) .................................................................................................. 85
Exhibit 6-13 Initial Response – Instructions for Substantiating Confidential Business Information
(CBI) Claims Screen (Scroll 2) .................................................................................................. 86
Exhibit 6-14 Initial Response – Instructions for Substantiating Confidential Business Information
(CBI) Claims Screen (Scroll 3) .................................................................................................. 87
Exhibit 6-15 Attach Documents for CBI Substantiation Window ................................................ 88
Exhibit 7-1 EPA Initiated Risk Evaluation – Contact Screen (Scroll 1) ....................................... 91
Exhibit 7-2 EPA Initiated Risk Evaluation – Contact Screen (Scroll 2) ....................................... 91
Exhibit 7-3 EPA Initiated Risk Evaluation – Contact Screen (Scroll 3) ....................................... 93
Exhibit 7-4 EPA Initiated Risk Evaluation – Consortium Member Pop Up Window (Scroll 1) ..... 95
Exhibit 7-5 EPA Initiated Risk Evaluation – Consortium Member Pop Up Window (Scroll 2) ..... 96
Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
v

Exhibit 7-6 EPA Initiated Risk Evaluation – Consortium Member Screen (Scroll 3) ................... 97
Exhibit 7-7 EPA Initiated Risk Evaluation – Small Business Concern Definition Window (Scroll 1)99
Exhibit 7-8 EPA Initiated Risk Evaluation – Small Business Concern Definition Window (Scroll 2)100
Exhibit 7-9 EPA Initiated Risk Evaluation – Small Business Concern Definition Window (Scroll 3)101
Exhibit 7-10 EPA Initiated Risk Evaluation – Small Business Concern Definition Window (Scroll
4) ............................................................................................................................................ 102
Exhibit 7-11 EPA Initiated Risk Evaluation – United States Agent Screen (Scroll 1) ................ 104
Exhibit 7-12 EPA Initiated Risk Evaluation – United States Agent Screen (Scroll 2) ................ 105
Exhibit 7-13 EPA Initiated Risk Evaluation – Chemical Substance or Category Screen (Scroll 1)107
Exhibit 7-14 EPA Initiated Risk Evaluation – Document Upload Screen (Scroll 1) ................... 109
Exhibit 7-15 EPA Initiated Risk Evaluation – Document Upload Screen (Scroll 2) ................... 110
Exhibit 7-16 EPA Initiated Risk Evaluation – Attach Document Window .................................. 111
Exhibit 7-17 EPA Initiated Risk Evaluation – Risk Evaluation Request Fee Structure ............. 112
Exhibit 7-18 EPA Initiated Risk Evaluation – Fees Certification Screen ................................... 113
Exhibit 7-19 EPA Initiated Risk Evaluation – Submitting Official Information Screen (Scroll 1) 115
Exhibit 7-20 EPA Initiated Risk Evaluation – Submitting Official Information Screen (Scroll 2) 116
Exhibit 7-21 EPA Initiated Risk Evaluation – Submission of Referenced Information Screen .. 117
Exhibit 7-22 EPA Initiated Risk Evaluation – Instructions for Substantiating Confidential
Business Information (CBI) Claims Screen (Scroll 1) .............................................................. 119
Exhibit 7-23 EPA Initiated Risk Evaluation – Instructions for Substantiating Confidential
Business Information (CBI) Claims Screen (Scroll 2) .............................................................. 120
Exhibit 7-24 EPA Initiated Risk Evaluation – Instructions for Substantiating Confidential
Business Information (CBI) Claims Screen (Scroll 3) .............................................................. 121
Exhibit 7-25 EPA Initiated Risk Evaluation – Attach Documents for CBI Substantiation Window122
Exhibit 8-1 Preview Risk Evaluation PDF ................................................................................ 124
Exhibit 9-1 TSCA Risk Evaluation Validation Window ............................................................. 125
Exhibit 10-1 TSCA Certification Screen ................................................................................... 126
Exhibit 10-2 Risk Evaluation Certification Screen .................................................................... 127
Exhibit 10-3 Validation Screen ................................................................................................ 128
Exhibit 10-4 PDF Generation Screen ...................................................................................... 129
Exhibit10-5 CROMERR Certification Window ......................................................................... 130
Exhibit 10-6 eSignature Widget Window ................................................................................. 130
Exhibit 10-7 Submission Finished Screen ............................................................................... 131
Exhibit 11-1 Download Copy of Record Screen....................................................................... 132
Exhibit 12-1 New EPA Communication Email Notification ....................................................... 134
Exhibit 12-2 New EPA Communication CDX Inbox Notification ............................................... 135
Exhibit 12-3 TSCA Risk Evaluation Home Screen ................................................................... 136
Exhibit 12-4 Enter Passphrase Screen .................................................................................... 137
Exhibit 12-5 Cross-Media Electronic Reporting Regulation (CROMERR) Certification Window137

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
vi

Exhibit 12-6 eSignature Widget ............................................................................................... 138
Exhibit 12-7 Download Copy of Record Screen....................................................................... 140
Exhibit 12-8 CSPP Payment Processor (ACH Payment) ......................................................... 142
Exhibit 12-9 CSPP Payment Processor (Credit/Debit Card) .................................................... 143
Exhibit 12-10 Successful Payment .......................................................................................... 144
Exhibit 12-11 Invoice Communication Email ........................................................................... 145
Exhibit 12-12 CDX Inbox Invoice Communication ................................................................... 146
Exhibit 12-13 Risk Evaluation Request Fee Invoice PDF ........................................................ 147
Exhibit 12-14 Risk Evaluation Request Payment Receipt ........................................................ 148

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
vii

Introduction

This document presents the user guide for the Office of Pollution Prevention and Toxics (OPPT)
Risk Evaluation Rule application submission process. This document is the user guide for the
Primary Authorized Official (AO) of the Risk Evaluation Rule application.
The Risk Evaluation Rule application is the electronic, web-based tool provided by the United
States Environmental Protection Agency (EPA) for the submission of Risk Evaluation data and
responses to FR Notices. As a Primary AO, you can create, modify, and/or submit a
Manufacturer Risk Evaluation request, EPA Initiated Risk Evaluation, and an Initial Response.
You can also pay invoices and receive EPA communications. You can also delete request and
responses, submit a Withdrawal Request, create amendments, and download the Copy of Record
(CoR).
For questions concerning the Toxic Substances Control Act (TSCA) Risk Evaluation software
requirements, please contact the Central Data Exchange (CDX) Help Desk at
[email protected] or call 1-888-890-1995 between the hours of 8 am - 6 pm Eastern
Standard Time (EST).

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
1

System Requirements

To use the Risk Evaluation Rule application to submit a Risk Evaluation request, 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

One of the following supported browsers is required to access the Risk Evaluation Rule
application:
 Vendor supported versions of Internet Explorer (IE) or Edge
Go to the following link to download:
https://support.microsoft.com/en-us/help/17621/internet-explorer-downloads
 Vendor supported versions of Mozilla Firefox
Go to the following link to download:
https://www.mozilla.org/en-US/firefox/new/
 Vendor supported versions of Safari
Go to the following link to download:
https://support.apple.com/downloads/
 Vendor supported versions of Google Chrome
Go to the following link to download:
http://www.google.com/chrome
2.2

Screen Resolution

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

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
2

Primary Authorized Official (AO) Functions

This section describes how to:
 Access the application
 Navigate the Risk Evaluation ‘Home’ screen
 Assign Supports to complete a form
 Start and complete the Risk Evaluation request
 Start and complete EPA’s Initiated Risk Evaluation
 Start and complete the Withdrawal Request
 Start and complete an Initial Response
 Download a Copy of Record
 Create an amendment
The Primary AO is responsible for the submission of Risk Evaluation requests. As a Primary
AO, you can create a new form. You are also responsible for submitting amendments, unlocking
submissions, and deleting forms. You can assign Supports (or other authorized individuals) to
edit and complete a form on your behalf.
You can save the form at any point during the data entry process. The save functionality allows
you to return to that same form at any point in the future. Additionally, a PDF version of the
form can be previewed at any point.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
3

Exhibit 3-1 displays a table of the user role capabilities within the Risk Evaluation Rule
application.
Exhibit 3-1 Risk Evaluation User Roles Matrix

3.1

Log into Risk Evaluation Application

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

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
4

Exhibit 3-2 shows a screen capture of the ‘Chemical Information Submission System’ screen
(Scroll 1):
Exhibit 3-2 Chemical Information Submission System Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
5

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

Navigation: To access the Risk Evaluation ‘Home’ screen, select ‘TSCA Risk Evaluation Rule’
from the submission type drop-down menu and click the ‘OK’ button.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
6

3.2

Risk Evaluation Home Screen Navigation

You can access the Risk Evaluation ‘Home’ screen by selecting ‘TSCA Risk Evaluation Rule’
from the submission type drop-down menu on the ‘Chemical Information Submission System’
screen and clicking the ‘OK’ button.
The Risk Evaluation ‘Home’ screen is the first screen within the Risk Evaluation application. It
displays the ‘Create New Request or Response,’ ‘Useful Resources,’ and ‘Submission History’
sections and displays a link to the ‘User Management’ page.
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.
 Create New Request or Response: Click the ‘Create’ button to navigate to the ‘Create
Passphrase’ screen to create the form selected from the ‘Form Type’ drop-down menu.
 Useful Resources: Click the links within the ‘Useful Resources’ section.
 Submission History: Modify or delete a Risk Evaluation request using the ‘Submission
History’ section. For additional details about the ‘Submission History’ section, please refer to
Section 3.3.
 User Management: Click the ‘User Management’ link to navigate to the ‘User
Management’ screen. You can manage the access rights of Supports per form alias using the
‘User Management’ screen. For additional details about the ‘User Management’ screen, refer
to Section 3.4.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
7

Exhibit 3-4 shows a screen capture of the Risk Evaluation ‘Home’ screen:
Exhibit 3-4 Risk Evaluation Home Screen

3.3

Submission History

Only one Risk Evaluation request is created per form alias, which helps differentiate between
forms. Each column within the table of the ‘Submission History’ section can be sorted by
clicking the individual column headers.
Start New Form: To create a new EPA Initiated Risk Evaluation, Initial Response,
Manufacturer Requested Evaluation, or Withdrawal Request select the form type from the ‘Form
Type’ drop-down menu and click the ‘Create’ button. You are required to create a passphrase
that will be associated with that particular form. Make sure to create a passphrase that you will
remember, as it cannot be retrieved or reset. Refer to Section 3.5 for further instructions on
creating a passphrase.
Edit an ‘In Progress’ Form: To modify an existing Risk Evaluation request, click the ‘Form
Alias’ link for a form with a status of ‘In Progress.’ You are required to enter the passphrase

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
8

associated with that particular form to access and edit the form. It is possible for more than one
user to modify a form simultaneously; the user that clicks the ‘Save’ button first will have his/her
changes saved.
Amend a submitted form: To edit an already submitted Risk Evaluation request (i.e., to create
an amendment), you must first unlock the particular submission by clicking the ‘Lock’ icon ( )
under the ‘Action’ column. You will be required to enter the passphrase associated with that
particular submission to gain access and continue amending the submission. All further changes
that are made will be submitted as an amendment. Refer to Section 13 for further instructions on
creating an amendment.
Pay an invoice: To pay an invoice for a Risk Evaluation request, click the ‘Unpaid Invoice’ icon
( ) to begin the process of accessing the ‘Copy of Record’ screen to pay an invoice.
The ‘Submission History’ table displays the following fields and columns of information:
 Show Entries: Select a value from the ‘Entries’ drop-down menu to specify the number of
entries that display on the current page.
 Search: Enter search criteria to filter the submissions within the ‘Submission History’ table.
 Form Alias: Displays the form alias of a Risk Evaluation request. Click the form alias link to
navigate to the ‘Enter Passphrase’ page and complete/edit a request.
 Form Type: Displays ‘EPA Initiated Risk Evaluation’, ‘Initial Response’, ‘Manufacturer
Requested Evaluation’, and ‘Withdrawal Request.’
 Case Number: Displays the case number of a completed submission in the following format:
, , and . The ‘YY’ represents the
calendar year in which the request was submitted, and the ‘XXXX’ represents the order in
which the request was received. Each submitted request generates a single case number.
 Submission Date: Displays the date that a form was successfully submitted to EPA via
CDX. This date populates only after the request has been submitted.
 Status: Displays the status of a Risk Evaluation request (e.g., ‘In Progress,’ ‘Submitted,’
‘Completed,’ ‘Completed – Awaiting Payment,’ or ‘Completed – Payment Received’).
 Action: Click the ‘Copy of Record’ icon ( ) to navigate to the ‘Enter Passphrase’ screen to
continue to the ‘Copy of Record’ screen. The ‘Copy of Record’ icon displays only after the
request has been completed. Click the ‘Delete’ icon ( ) to delete an in-progress request.
Click the ‘Lock’ icon ( ) to unlock a request for an amendment. The request remains
unlocked and will display the ‘Unlocked’ icon ( ) until the request is resubmitted by the
AO. Click the red ‘Unpaid Invoice’ icon ( ) to access the ‘Copy of Record’ screen to pay a
fee, when applicable. The ‘Unpaid Invoices’ icon displays only after personnel sends an
invoice. After a user pays the invoice, the icon disappears.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
9

 Export Options: Click the ‘XML,’ ‘CSV,’ ‘PDF,’ or ‘Excel’ button to download the
‘Submission History’ table as an .xml, .csv, .pdf, or .xlsx file, respectively.
 Previous: Click the ‘Previous’ button to navigate to the previous set of submissions currently
displayed (if applicable).
 Next: Click the ‘Next’ button to navigate to the subsequent set of submissions (if applicable).
Exhibit 3-5 shows a screen capture of the Risk Evaluation ‘Submission History’ section:
Exhibit 3-5 Risk Evaluation Submission History Section

Navigation: Click the ‘User Management’ link to access the ‘User Management’ screen to
assign Primary Supports or Primary Agents/Consultants (if applicable).
3.4

User Management

You can access the ‘User Management’ screen by clicking the ‘User Management’ link on the
application header of the Risk Evaluation ‘Home’ screen.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
10

On the ‘User Management’ screen, you have the ability to assign/un-assign one or more Primary
Supports or Primary Agents/Consultants to have access to modify any of the Risk Evaluation
requests you have created.
Form Alias: A form alias is unavailable in this drop-down menu until one has been created.
Select a form alias from the drop-down menu to begin assigning Supports or Primary
Agents/Consultants. Once a form alias has been selected, the ‘Assign Users’ group box will
update to display only the Supports or Primary Agents/Consultants who have identified you as
their AO during CDX registration, or a user you have specified that is able to submit on your
behalf.
Form Information: This field displays information pertaining to the form selected from the
‘Form Alias’ drop-down menu.
Form Alias: Displays the form alias that a Risk Evaluation request is given.
Assign Supports: This box shows all the Supports or Primary Agents/Consultants you can
assign/un-assign to complete a Risk Evaluation request for the form alias selected. To move
support persons from the ‘Unassigned’ group box to the ‘Assigned’ group box, highlight an
individual or multiple Support(s) or Primary Agent(s)/Consultant(s) and click the ‘Add >>’
button.
 Unassigned: This box/field contains the registered Support(s) and/or Primary
Agent(s)/Consultant(s) associated with the AO who can potentially be assigned to access and
edit the selected request. To move support persons from the ‘Unassigned’ group box to the
‘Assigned’ group box, highlight an individual or multiple support persons and click the ‘Add
>>’ button. To highlight multiple support persons hold down the key on your
keyboard while clicking each Support and/or Primary Agent/Consultant. To highlight
multiple consecutive support persons, hold down the key on your keyboard while
clicking the first and last Support and/or Primary Agent/Consultant in the list.
 Assigned: This box/field contains the registered Support(s) and/or Primary
Agent(s)/Consultant(s) given permission, by the AO, to access and edit the selected request.
This group box shows all support persons assigned to complete the Risk Evaluation request
for a single form alias. To move Supports and/or Primary Agents/Consultants from the
‘Assigned’ group box to the ‘Unassigned’ group box highlight individual or multiple support
persons and click the ‘<< Remove’ button. To highlight multiple support persons hold down
the key on your keyboard while clicking each Support and/or Primary
Agent/Consultant. To highlight multiple consecutive support persons, hold down the
key on your keyboard while clicking the first and last Support and/or Primary
Agent/Consultant in the list.
 Add >>: Click the button to move selected Supports and/or Primary Agents/Consultants
from the ‘Unassigned’ box to the ‘Assigned’ box.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
11

 << Remove: Click the button to move selected Supports and/or Primary Agents/Consultants
from the ‘Assigned’ box to the ‘Unassigned’ box.
 Save: Click the button to save the selection.
Exhibit 3-6 shows a screen capture of the ‘User Management’ screen:
Exhibit 3-6 User Management Screen

Navigation: Click the ‘Home’ link located within the application header to navigate to the Risk
Evaluation ‘Home’ screen.
3.5

Create Passphrase

To start a new Request or Response, select ‘EPA Initiated Risk Evaluation,’ ‘Initial Response,’
‘Manufacturer Requested Evaluation,’ or ‘Withdrawal Request’ from the ‘Form Type’ dropdown menu, and click the ‘Create’ button on the Risk Evaluation ‘Home’ screen to navigate to
the ‘Create Passphrase’ screen, which allows you to create a passphrase and associate that
passphrase with your newly created request.
The application uses the passphrase as an encryption key to protect the contents of the request.
You are responsible for remembering the passphrase and distributing it to the appropriate
individuals.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
12

If you lose or forget your passphrase, you will not be able to access your Risk Evaluation Form
to print, submit, or make changes. You will need to complete a new Risk Evaluation Form and
create a new passphrase for the form. For security reasons, the system administrator will not
have access to your passphrase and will not be able to retrieve it or reset it.
 New Passphrase: Enter a passphrase that is between 8 to 20 characters. For maximum
security, your passphrase should contain a combination of letters and numbers. Your
passphrase should not contain special characters (for example, +, ?, and *). As a Primary
user, you are responsible for remembering your passphrase and distributing it to only
authorized individuals. The passphrase is used as an encryption key to protect the contents of
the form data.
 Confirm Passphrase: Enter the same passphrase that was entered into the ‘New Passphrase’
field. The same passphrase may be associated with multiple forms. The user can choose to
have the same passphrase for all forms. Supports do not have the ability to start a new form
or create a passphrase for a form.
Exhibit 3-7 shows a screen capture of the ‘Create Passphrase’ screen:
Exhibit 3-7 Create Passphrase Screen

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
13

Navigation: For a new EPA Initiated Risk Evaluation, Initial Response, Manufacturer Requested
Evaluation, or Withdrawal Request, create a passphrase and click the ‘Continue’ button to
navigate to the ‘Contact’ screen.
3.6

Enter Passphrase

To edit a form, click the ‘Form Alias’ link for a Risk Evaluation request with a status of ‘In
Progress.’ The ‘Enter Passphrase’ screen requires you to enter the passphrase that is associated
with the request.
 Form Alias: Displays the form alias that is used to identify the request.
 Enter Passphrase: Enter the same passphrase that was used to originally create the request.
For security reasons, the system administrator does not have access to the passphrase and
cannot retrieve it or reset it to a new one. If a user has forgotten the passphrase, a new request
will need to be created with a new passphrase.
Exhibit 3-8 shows a screen capture of the ‘Enter Passphrase’ screen:
Exhibit 3-8 Enter Passphrase Screen

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
14

Navigation: Enter the passphrase that you originally created and associated with the request and
click the ‘Continue’ button to navigate to the ‘Contact’ screen in a Manufacturer Requested Risk
Evaluation form.
3.7

Action Bar

The action bar is located at the top and bottom of the form on each screen. You can perform the
following functions using the action bar:
 Home: Click the ‘Home’ link to navigate to the Risk Evaluation ‘Home’ screen.
 User ID: Click the user ID link in the top right-hand corner to log out of the application.
The following exhibits, Exhibit 3-9, Exhibit 3-10, Exhibit 3-11, and Exhibit 3-12 show screen
captures for the action bar:
 Save: Click the ‘Save’ link at any stage of completing a Risk Evaluation request to save the
form. To generate and access links to other pages of the request within the navigation header,
you must click the ‘Save’ link within the action bar. After you click the ‘Save’ link, you will
receive a message indicating that all data entered in the request has been saved successfully.
The save function does not validate any entered data. Click the ‘Previous’ and ‘Next’ buttons
on a form to save the data entered within a request. Click the ‘X’ button in the upper righthand corner of the form in your browser to close the request without saving.
Exhibit 3-9 Action Bar – Save

 Preview: Click the ‘Preview’ link to preview the request. After you click the ‘Preview’ link,
you will be given the option to view a regular version of the PDF(s) or a sanitized version of
the PDF(s). Choosing either option will generate a watermarked PDF containing each
chemical substance identified within the request. Refer to Section 5 for more information on
previewing a request.
Exhibit 3-10 Action Bar – Preview

 Validate: Click the ‘Validate’ link at any stage of completing a Risk Evaluation request. A
‘TSCA Risk Evaluation’ window generates when you click the ‘Validate’ link if you disable
the pop-up blocker within your internet browser. The ‘TSCA Risk Evaluation’ pop-up
window displays a report of all warning messages. Refer to Section 9 for more information
on validating a request.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
15

Exhibit 3-11 Action Bar – Validate

 Submit: Click the ‘Submit’ link to submit a Risk Evaluation request after completing all
sections of a Risk Evaluation request. After you click the ‘Submit’ link a pop-up message
displays to confirm the submission process. The request validates during the submission
process and displays any applicable warning or error messages. Refer to Section 9 for further
instructions on validation errors. You can continue with the submission process only after
clearing all validation errors. Upon successful submission of the request, the application
generates and sends an email indicating the successful submission of the request to the
submitter’s email address. Refer to Section 10 for more information on submitting a Risk
Evaluation request.
Exhibit 3-12 Action Bar – Submit

 CDX Links: Click any of the ‘CDX Links,’ located at the bottom of each screen within the
‘CDX Links’ drop-down menu, at any stage of completing a Risk Evaluation request.
o Click the ‘CDX Homepage’ link to navigate to the ‘CDX’ homepage.
o Click the ‘MyCDX Homepage’ link to navigate to the ‘MyCDX’ page.
o Click the ‘EPA Homepage’ link to navigate to EPA’s Homepage.
o Click the ‘Terms and Conditions’ link to navigate to the ‘CDX Terms and
Conditions’ screen.
o Click the ‘Privacy Notice’ link to navigate to the ‘CDX Privacy and Security
Notice’ screen.
Exhibit 3-13 shows a screen capture of the action bar ‘CDX Links’:

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
16

Exhibit 3-13 CDX Links

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
17

Chemical Substance Risk Evaluation Request

The purpose of the Risk Evaluation request is to determine whether a chemical substance
presents an unreasonable risk to health or the environment, under the conditions of use, including
an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. Users can
complete the request to solicit a Risk Evaluation for their manufactured chemical(s).
Each risk evaluation request must include a list of all the existing information that is relevant to
whether the chemical substance, under the conditions of use identified by the manufacturer,
presents an unreasonable risk of injury to health or the environment. The request does not need
to include copies of the information; citations are sufficient, if the information is publicly
available. The request must include or reference all available information on health and
environmental hazard(s) of the chemical substance, human and environmental exposure(s), and
exposed population(s), as relevant to the conditions of use identified in the request.
At a minimum this information must include: hazard and exposure potential, persistence and
bioaccumulation, potentially exposed or susceptible subpopulations the requestor believes to be
relevant, whether there is any storage of the chemical substance near significant sources of
drinking water (this could include a storage facility), production volume or significant changes to
production volume, and any other information relevant to the potential risks of the chemical
substance.
4.1

Create a Manufacturer Requested Risk Evaluation

To create a new Risk Evaluation request, navigate to the Risk Evaluation ‘Home’ screen and
select ‘Manufacturer Requested Evaluation’ from the ‘Form Type’ drop-down menu. Refer to
Section 3.2 for additional details regarding the Risk Evaluation ‘Home’ screen.
Refer to Section 3.5 for additional details regarding the passphrase creation process.
4.2

Contact

You can navigate to the ‘Contact’ screen by clicking the ‘Create’ button and creating a new
passphrase, or by accessing a Risk Evaluation request that is ‘In Progress’ and entering the
passphrase associated with the selected request.
The ‘Contact’ screen provides fields to input identifying information for a technical contact. You
will have the option to assign a ‘Submission Alias’ to identify the request. A unique submission
alias is helpful when a user or company has multiple requests and/or when you must differentiate
between requests to the help desk. Upon navigating to the ‘Contact’ screen, the system autogenerates a default alias comprised of a form type, date stamp, and time stamp in the following
format: .
 Submission Alias: Enter the submission alias. Upon navigating to the screen, the application
displays an auto-generated editable submission alias in the following format: . This is a required field.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
18

 N/A: Select the ‘N/A’ radio button to indicate that the form will be submitted on behalf of
the reporting organization. Selecting this radio button generates the ‘Fees Certification’ page.
 This is a submission on behalf of a consortium: Select the ‘This is a submission on behalf
of a consortium to indicate that the request is submitted on behalf of a consortium. Selecting
this radio button generates the ‘Submitting on Behalf of Consortium’ screen.
 CBI: Check the ‘CBI’ checkbox to claim the contact information as confidential.
 Copy from CDX: Click the ‘Copy from CDX’ link to copy CDX registration information.
 First Name: Enter the first name of the contact. This is a required field.
 Last Name: Enter the last name of the contact. This is a required field.
 Position: Enter the job title of the contact.
 Company Name: Enter the company name of the contact. This is a required field.
 Additional Companies: Enter an additional company in this field, if applicable.
 Add: Click the button to add the company entry into the ‘Additional Companies’ table.
 Additional Company Name: Displays the additional company name(s) associated with the
contact.
 Action: Click the ‘Delete’ icon (

) to remove an additional company name.

 Phone Number: Enter the phone number of the contact. This is a required field.
 Phone Number Extension: Enter the extension to the phone number, if applicable.
 Email Address: Enter the email address of the contact.
 Mailing Address 1: Enter the mailing address of the contact. This is a required field.
 Mailing Address 2: Enter the second line of the mailing address of the contact, if applicable.
 City: Enter the city of the mailing address of the contact. This is a required field.
 State: Select the state of the mailing address of the contact. This is a required field if ‘United
States’ is identified as the country.
 Postal Code: Enter the postal code of the mailing address of the contact. This is a required
field.
 Country: Select the country of the mailing address of the contact from the drop-down menu.
Selecting a non-US country generates the ‘United States Agent’ screen. This is a required
field.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
19

Exhibit 4-1 shows a screen capture of the ‘Contact’ screen (Scroll 1):
Exhibit 4-1 Contact Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
20

Exhibit 4-2 shows a screen capture of the ‘Contact’ screen (Scroll 2):
Exhibit 4-2 Contact Screen (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
21

Exhibit 4-3 shows a screen capture of the ‘Contact’ screen (Scroll 3):
Exhibit 4-3 Contact Screen (Scroll 3)

Navigation: Click the ‘Continue’ button to navigate to the ‘Chemical Substance or Category’
screen if a U.S. contact is identified and the request is submitted on behalf of the reporting
organization. Click the ‘Continue’ button to navigate to the ‘Submitting on Behalf of
Consortium’ screen if the request is submitted on behalf of a consortium. You can also access
this screen by clicking the ‘Chemical Substance or Category’ or ‘Submitting on Behalf of
Consortium’ link, respectively, within the navigation header. Click the ‘Continue’ button to
navigate to the ‘United States Agent’ screen if a non-U.S. contact is identified. You can also
access this screen by clicking the ‘U.S. Agent’ link within the navigation header.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
22

4.3

Submitting on Behalf of Consortium

You can navigate to the ‘Submitting on Behalf of Consortium’ screen by selecting the ‘This is a
submission on behalf of a consortium’ radio button and clicking the ‘Continue’ button on the
‘Contact’ screen.
The ‘Submitting on Behalf of Consortium’ screen provides fields to capture consortium
information and individual consortium members. The user populating the form is identified as a
consortium member by default upon navigating to the ‘Submitting on Behalf of Consortium’
page. A minimum of two consortium members is required.
 Consortium Name: Enter the name of the consortium. This is a required field.
 Consortium CBI: Check the ‘CBI’ checkbox to claim the consortium as confidential.
 Add Consortium Member: Click the ‘Add Consortium Member’ button to generate an
additional set of consortium input fields. At least two (2) consortium members are required to
be identified.
 First Name: Enter the first name of the consortium member. This is a required field.
 Last Name: Enter the last name of the consortium member. This is a required field.
 Position: Enter the job title of the consortium member.
 Company Name: Enter the company name of the consortium member. This is a required
field.
 Phone Number: Enter the phone number of the consortium member. This is a required field.
 Phone Number Extension: Enter the extension to the phone number, if applicable.
 Email Address: Enter the email address of the consortium member. This is a required field.
 Mailing Address 1: Enter the mailing address of the consortium member. This is a required
field.
 Mailing Address 2: Enter the second line of the mailing address of the consortium member,
if applicable.
 City: Enter the city of the mailing address of the consortium member. This is a required
field.
 State: Select the state of the mailing address of the consortium member. This is a required
field.
 Postal Code: Enter the postal code of the mailing address of the consortium member. This is
a required field.
 Country: Select the country of the mailing address of the consortium member. This is a
required field.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
23

 My company is a "small business concern" as defined under 40 CFR 700.43: Select the
radio button to indicate that the consortium is a small business concern. A fee certification
statement is required to be selected.
 My company is not a "small business concern" as defined under 40 CFR 700.43: Select
the radio button to indicate that the consortium member does not represent a small business
concern. A fee certification statement is required to be selected.
Exhibit 4-114 shows a screen capture of the ‘Submitting on Behalf of Consortium’ screen (Scroll
1):
Exhibit 4-4 Submitting on Behalf of Consortium Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
24

Exhibit 4-125 shows a screen capture of the ‘Submitting on Behalf of Consortium’ screen (Scroll
2):
Exhibit 4-5 Submitting on Behalf of Consortium Screen (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
25

Exhibit 4-6 shows a screen capture of the ‘Submitting on Behalf of Consortium’ screen (Scroll
3):
Exhibit 4-6 Submitting on Behalf of Consortium Screen (Scroll 3)

Navigation: Click the ‘Save’ button to save the consortium member information. Click the
‘Continue’ button to navigate to the ‘Chemical Substance or Category’ screen if the request is
submitted on behalf of the reporting organization. You can also access this screen by clicking the
‘Chemical Substance or Category’ link within the navigation header. Click the ‘Continue’ button
to navigate to the ‘U.S. Agent’ screen if a non-U.S. contact is identified. You can also access this
screen by clicking the ‘U.S. Agent’ link within the navigation header.
4.3.1 Small Business Concern Definition
Click the ‘View the updated definition of a small business concern’ link to generate the ‘Small
Business Concern Definition’ window. This window displays a table of the North American

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
26

Industry Classification System (NAICS) codes, NAICS descriptions, and applicable small
business concern size in number of employees.
As noted in the definition, if there are codes that are not listed within the NAICS table, a small
business definition applies to 500 or fewer employees that a company “owns or controls.”

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
27

Exhibit 4-7 shows a screen capture of the ‘Small Business Concern Definition’ window (Scroll
1):
Exhibit 4-7 Small Business Concern Definition Window (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
28

Exhibit 4-8 shows a screen capture of the ‘Small Business Concern Definition’ window (Scroll
2):
Exhibit 4-8 Small Business Concern Definition Window (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
29

Exhibit 4-9 shows a screen capture of the ‘Small Business Concern Definition’ window (Scroll
3):
Exhibit 4-9 Small Business Concern Definition Window (Scroll 3)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
30

Exhibit 4-10 shows a screen capture of the ‘Small Business Concern Definition’ window (Scroll
4):
Exhibit 4-10 Small Business Concern Definition Window (Scroll 4)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
31

Navigation: Click the ‘X’ icon in the upper right-hand corner to close the ‘Small Business
Concern Definition’ window.
4.4

United States Agent

You can navigate to the ‘United States Agent’ screen by identifying a non-U.S. contact and
clicking the ‘Continue’ button on the ‘Contact’ screen.
The ‘United States Agent’ screen provides fields to input identifying information for a U.S.
agent.
 CBI: Check the ‘CBI’ checkbox to claim the agent information as confidential.
 First Name: Enter the first name of the agent. This is a required field.
 Last Name: Enter the last name of the agent. This is a required field.
 Position: Enter the job title of the agent.
 Company Name: Enter the company name of the agent. This is a required field.
 Phone Number: Enter the phone number of the agent. This is a required field.
 Phone Number Extension: Enter the extension to the phone number, if applicable.
 Email Address: Enter the email address of the agent. This is a required field.
 Mailing Address 1: Enter the mailing address of the agent. This is a required field.
 Mailing Address 2: Enter the second line of the mailing address of the agent, if applicable.
 City: Enter the city of the mailing address of the agent. This is a required field.
 State: Select the state of the mailing address of the agent. This is a required field.
 Postal Code: Enter the postal code of the mailing address of the agent. This is a required
field.
 Country: Displays ‘United States.’
Exhibit 4-11 shows a screen capture of the ‘United States Agent’ screen (Scroll 1):

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
32

Exhibit 4-11 United States Agent Screen (Scroll 1)

Exhibit 4-12 shows a screen capture of the ‘United States Agent’ screen (Scroll 2):

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
33

Exhibit 4-12 United States Agent Screen (Scroll 2)

Navigation: Click the ‘Continue’ button to navigate to the ‘Chemical Substance or Category’
screen if the request is submitted on behalf of the reporting organization. You can also access
this screen by clicking the ‘Chemical Substance or Category’ link within the navigation header.
4.5

Chemical Substance or Category

You can access the ‘Chemical Substance or Category’ screen by clicking the ‘Continue’ button
from the ‘Contact’ screen if identifying a U.S. contact. If identifying a non-U.S. contact within
the ‘Contact’ screen, you can access this screen by clicking the ‘Continue’ button from the
‘United States Agent’ screen. You can also access this screen by clicking the ‘Chemical
Substance or Category’ link within the navigation header.
The ‘Chemical Substance or Category’ screen displays the following fields and columns of
information:

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
34

 Chemical Type: Select ‘Chemical Category’ from the ‘Chemical Type’ drop-down menu to
indicate that the chemical substances included will be classified under a single chemical
category. Select ‘Chemical Substance’ to identify one chemical substance for evaluation.
 Chemical Category Description: Enter a description of the chemical category; either
chemicals or a chemical category must be identified. ‘Chemical category’ means a group of
chemical substances the members of which are similar in molecular structure, in physical,
chemical, or biological properties, in use, or in mode of entrance into the human body or into
the environment, or the members of which are in some other way suitable for classification as
such for purposes of this Act, except that such term does not mean a group of chemical
substances which are grouped together solely on the basis of their being new chemical
substances. This is a required field (if displayed).
 Search: Enter criteria to filter the attached documents.
 Document Type: Displays the document type of the uploaded chemical category attachment.
A chemical category rationale document and either chemicals or a chemical category
substance list document is required if the user is reporting a chemical category.
 File Name: Displays the file name of the uploaded chemical category attachment. Click the
link to navigate to the ‘Attach Document’ window with uploaded document information.
 File Description: Displays the description of the uploaded chemical category attachment.
 Page Count: Displays the number of pages the uploaded chemical category attachment
contains.
 Date: Displays the date the chemical category attachment is uploaded.
 CBI: Displays a ‘Y’ or an ‘N’ to indicate the confidentiality status of the uploaded
attachment.
 Action: Click the ‘Delete’ icon (

) to remove the uploaded chemical category document.

 Attach Chemical Category Document: Click this link to navigate to the ‘Attach Document’
pop-up window and upload a new document. You are required to upload a ‘Chemical
Category Rationale’ document if you selected ‘Chemical Category’ from the ‘Chemical
Type’ drop-down menu on the ‘Chemical Substance or Category’ screen. Refer to Section
4.5.1 for further details on the ‘Attach Document’ window.
 Search: Enter criteria to filter the identified chemical substances.
 CASRN: Displays the Chemical Abstract Services Registry Number (CASRN) (if
applicable) of the identified chemical substance.
 PMN No.: Displays the Premanufacture (PMN) Number (if applicable) of an identified
chemical substance.
 Acc. No.: Displays the Accession Number (if applicable) of an identified chemical substance.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
35

 Chemical Name (TSCA Inventory): Displays the chemical name of an identified chemical
substance.
 Chemical Name (Generic): Displays the generic name of an identified chemical substance.
 Action: Click the ‘Edit’ icon ( ) to enable the chemical fields and modify the chemical
information. Click the ‘Delete’ icon ( ) to remove the identified chemical substance.
 Add Chemical: Click the ‘Add Chemical’ button to enable the chemical information fields.
 Search SRS: Click the ‘Search SRS’ button to generate the ‘Search Substance Registry
Services (SRS)’ window. See Section 4.5.2 for additional details about the ‘Search SRS’
functionality.
 CASRN: Displays the Chemical Abstract Services Registry Number (CASRN) of the
identified chemical substance.
 Chemical Name: Displays the chemical name of the identified chemical substance.
 Trade Name: Enter the trade name of the identified chemical substance. This is a required
field.
 Molecular Structure: Enter the molecular structure of the identified chemical substance.
This is a required field.
 Cancel: Click the ‘Cancel’ button to close the chemical information fields.
 Save: Click the ‘Save’ button to save the entered chemical substance information.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
36

Exhibit 4-13 shows a screen capture of the ‘Chemical Substance or Category’ screen (Scroll 1):
Exhibit 4-13 Chemical Substance or Category Screen (Scroll 1)

Exhibit 4-14 shows a screen capture of the ‘Chemical Substance or Category’ screen (Scroll 2):

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
37

Exhibit 4-14 Chemical Substance or Category Screen (Scroll 2)

Exhibit 4-15 shows a screen capture of the ‘Chemical Substance or Category’ screen (Scroll 3):

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
38

Exhibit 4-15 Chemical Substance or Category Screen (Scroll 3)

Navigation: Click the ‘Next’ button to navigate to the ‘Document Upload’ screen. You can also
access this screen by clicking the ‘Document Upload’ link within the navigation header.
4.5.1 Attach Document
The ‘Attach Document’ window displays the following fields of information:
 CBI: Check this checkbox to claim the uploaded document as confidential.
 Document Type: Select the type of document you are uploading from this drop-down menu.
Refer to Appendix A. Document Types and Subtypes for a list of all the document types
available in this drop-down menu. This is a required field.
 Document Subtype: Select the subtype of the document you are uploading from this dropdown menu, if applicable. Refer to Appendix A. Document Types and Subtypes for a list of

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
39

all the document subtypes available in this drop-down menu. This is a required field, if
shown.
 Description: Enter a description for the uploaded document. This is a required field.
 Page Count: Enter the number of pages the attached document contains.
 Attachment: Click the ‘Browse’ button to search for and select a document to attach.
 Sanitized Attachment: Click the ‘Browse’ button to search for and select a sanitized
document to attach.
 Save Document: Click the button to save and upload the selected document.
 Close: Click this button to close the ‘Attach Document’ pop-up window and return to the
‘Chemical Substance or Category’ screen without saving any information.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
40

Exhibit 4-16 shows a screen capture of the ‘Attach Document’ pop-up window within the
‘Chemical Substance or Category’ screen:
Exhibit 4-16 Attach Document Pop-Up Window (Chemical Substance or Category Screen)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
41

4.5.2 Search Substance Registry Services (SRS)
The ‘Search SRS’ button displays on the ‘Chemical Substance or Category’ screen to identify
chemicals in SRS.
Search SRS: Click the ‘Search SRS’ button to generate the ‘Search Substance Registry Services
(SRS)’ pop-up window. You can search for the reported chemical(s) by either the ‘CASRN,’
‘TSCA Inventory Name,’ ‘Accession Number,’ or ‘Generic Name.’
The system allows you to save each chemical by clicking the ‘Save’ button located at the bottom
of the ‘Search Substance Registry Services (SRS)’ pop-up window. Once you select the specified
chemical substance and click the ‘Save’ button, the chemical information saves and populates
into the chemical substance fields.
 CASRN: Select the ‘CASRN’ radio button to search by the Chemical Abstracts Service
Registry Number of the chemical; this field accommodates dashes.
 TSCA Inventory Name: Select the ‘TSCA Inventory Name’ radio button to search by the
inventory name of the chemical.
 Accession Number: Select the ‘Accession Number’ radio button to search by the accession
number of the chemical.
 Generic Name: Select the ‘Generic Name’ radio button to search by the generic chemical
name.
 Begins With/Matches Exactly/Contains: Select an option to apply a specific filter to the
entered search criteria.
 Search: Click the ‘Search’ button to search SRS using the entered search criteria.
 Create New Chemical: To identify a new chemical, click the ‘Create New Chemical’
button. Refer to Section 4.5.3 for further details on the process of creating a new chemical.
 Close: Click this button to close the ‘Search Substance Registry Services (SRS)’ window and
return to the ‘Chemical Substance or Category’ screen without saving any information.
 Save: Click the ‘Save’ button to return to the ‘Chemical Substance or Category’ screen and
populate the selected chemical into the chemical substance fields.
Exhibit 4-17 shows a screen capture of the ‘Search Substance Registry Services (SRS)’ window:

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
42

Exhibit 4-17 Search Substance Registry Services (SRS) Window

Navigation: Click the ‘Save’ button to return to the ‘Chemical Substance or Category’ screen
and populate the selected chemical into the chemical substance fields.
4.5.3

Create New Chemical

The ‘Create New Chemical’ button displays on the ‘Search Substance Registry Services (SRS)’
window to identify new chemicals.
 Create New Chemical: Click the ‘Create New Chemical’ button to generate the ‘Create
New Chemical’ window. You can enter chemical information into the ‘Chemical Name,’
‘CASRN,’ ‘PMN Number,’ ‘Generic Name,’ ‘PMN Number,’ and/or ‘Accession Number’
fields.
 Chemical Name: Enter the name of the identified chemical substance.
 CBI: Check the ‘CBI’ checkbox to claim the chemical name as confidential; this is disabled
if a CASRN is entered.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
43

 CASRN: Enter the CASRN of the entered chemical substance; either the ‘CASRN,’ ‘PMN
Number,’ or ‘Accession Number’ must be entered. The ‘CBI’ checkbox is disabled if a
CASRN is identified.
 Generic Name: Enter the generic name of the entered chemical substance.
 PMN Number: Enter the PMN Number of the entered chemical substance; either the
‘CASRN,’ ‘PMN Number,’ or ‘Accession Number’ must be entered.
 Accession Number: Enter the Accession Number of the entered chemical substance; either
the ‘CASRN,’ ‘PMN Number,’ or ‘Accession Number’ must be entered.
 OK: Click the ‘OK’ button to return to the ‘Chemical Substance or Category’ screen and
populate the entered chemical information into the chemical substance fields.
 Close: Click the ‘Close’ button to close the ‘Create New Chemical’ window and return to the
‘Search Substance Registry Services (SRS)’ window without saving the entered data.
Exhibit 4-18 shows a screen capture of the ‘Create New Chemical’ window:
Exhibit 4-18 Create New Chemical Window

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
44

4.6

Document Upload

) to remove the uploaded document.

 Attach Document: Click the ‘Attach Document’ link to generate the ‘Attach Document’
window. Refer to Section 4.5.1 for further details on the ‘Attach Document’ window.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
45

Exhibit 4-19 shows a screen capture of the ‘Document Upload’ screen (Scroll 1):
Exhibit 4-19 Document Upload Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
46

Exhibit 4-20 shows a screen capture of the ‘Document Upload’ screen (Scroll 2):
Exhibit 4-20 Document Upload Screen (Scroll 2)

Navigation: Click the ‘Next’ button to navigate to the ‘Submitting Official Information’ screen
if this form is submitted on behalf of a consortium. You can also access this screen by clicking
the ‘Submitting Official Information’ link within the navigation header. Click the ‘Next’ button
to navigate to the ‘Fees Certification’ screen if this form is submitted on behalf of the reporting
organization. You can also access this screen by clicking the ‘Fees Certification’ link within the
navigation header.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
47

Exhibit 4-21 shows a screen capture of the ‘Attach Document’ window:
Exhibit 4-21 Attach Document Window

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
48

Navigation: Click the ‘Save Document’ button to upload the selected attachment to the
‘Documents’ table.
4.7

Fees Certification

The ‘Fees Certification’ screen presents radio buttons to indicate the applicable fee certification
statement.
You can access the ‘Fees Certification’ screen by selecting the ‘N/A’ radio button within the
‘Contact’ screen and clicking the ‘Continue’ button from the ‘Chemical Substance or Category’
screen.
The purpose of the ‘Fees Certification’ screen is to inform EPA of the fee amount that a primary
submitter pays on behalf of the reporting organization based on the business size. The
certification statement selected on the ‘Fees Certification’ screen is non-editable when amending
a Risk Evaluation Request. See Section 4.3.1 for additional information regarding the definition
of a small business concern.
Exhibit 4-22 shows the fee structure implemented for Risk Evaluation Requests:
Exhibit 4-22 Risk Evaluation Request Fee Structure
Business Concern
Not a small business
concern

Small business

Fee Category

Fee Amount

EPA-initiated Risk
Evaluation

 $1,350,000

Manufacturer-requested
risk evaluation on a
chemical in the TSCA
Work Plan

 Initial $1,250,000 payment + final invoice to recover
50% of Actual Costs

Manufacturer-requested
risk evaluation on a
chemical not in the TSCA
Work Plan

 Initial $2,500,000 payment+ final invoice to total 100%
of Actual Costs

EPA-initiated Risk
Evaluation

 $270,000

Manufacturer-requested
risk evaluation on a
chemical in the TSCA
Work Plan

 Initial $1,250,000 payment + final invoice to recover
50% of Actual Costs

Manufacturer-requested
risk evaluation on a
chemical not in the TSCA
Work Plan

 Initial $2,500,000 payment+ final invoice to total 100%
of Actual Costs

The following certification statements display:

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
49

 My company is a "small business concern" as defined under 40 CFR 700.43: Select this
radio button to indicate that the reporting organization is a small business concern.
 My company is not a "small business concern" as defined under 40 CFR 700.43: Select
this radio button to indicate that the reporting organization is not a small business concern.
Exhibit 4-23 shows a screen capture of the ‘Fees Certification’ screen:
Exhibit 4-23 Fees Certification Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Submitting Official Information’ screen.
You can also access this screen by clicking the ‘Submitting Official Information’ link within the
navigation header.
4.8

Submitting Official Information

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
50

The information below has been pre-populated from CDX registration. If the information listed
is incorrect please make the appropriate edits to your user information in CDX registration.
 Submitter is CBI: Check the ‘CBI’ checkbox to claim the submitter information as
confidential.
 First Name: Displays the first name of the submitter.
 Middle Initial: Displays the middle initial of the submitter.
 Last Name: Displays the last name of the submitter.
 Company Name: Displays the company name of the submitter.
 Phone Number: Displays the phone number of the submitter.
 Email Address: Displays the email address of the submitter.
 Mailing Address 1: Displays line 1 of the mailing address of the submitter.
 City: Displays the city of the mailing address of the submitter.
 State: Displays the state of the mailing address of the submitter.
 Postal Code: Displays the postal code of the mailing address of the submitter.
 Country: Displays the country of the mailing address of the submitter.
 This confirmation is required to proceed with the submission process: Check the legal
verification checkbox to begin the submission process; this is required and gets reset when
accessing the form.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
51

Exhibit 4-24 shows a screen capture of the ‘Submitting Official Information’ screen (Scroll 1):
Exhibit 4-24 Submitting Official Information Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
52

Exhibit 4-25 shows a screen capture of the ‘Submitting Official Information’ screen (Scroll 2):
Exhibit 4-25 Submitting Official Information Screen (Scroll 2)

Navigation: Click the ‘Continue’ button to navigate to the ‘Submission of Referenced
Information’ screen. You can also access this screen by clicking the ‘Certification’ link within
the navigation header.
4.9

Submission of Referenced Information

You can access the ‘Submission of Referenced Information’ screen by clicking the ‘Continue’
button from the ‘Submitting Official Information’ screen. You can also access this screen by
clicking the ‘Certification’ link within the navigation header.
The purpose of the ‘Submission of Referenced Information’ screen is for users to commit to
providing EPA referenced information contained in this Risk Evaluation request.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
53

Exhibit 4-26 shows a screen capture of the ‘Submission of Referenced Information’ screen:
Exhibit 4-26 Submission of Referenced Information Screen

Navigation: If any CBI claims were made, check the certification checkbox and click the
‘Continue’ button to navigate to the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen. You can also access this screen by clicking the
‘Substantiating CBI Claims’ link within the navigation header. If no CBI claims were made,
check the certification checkbox and click the ‘Start Submission Process’ button to initiate the
submission process.
4.10

Instructions for Substantiating Confidential Business Information (CBI) Claims

EPA modified the electronic reporting applications for TSCA submissions to accept CBI
substantiations for CBI claims made during the creation of electronic submissions. Other than
information exempt from substantiation under TSCA Section 14(c)(2), users who wish to assert
CBI claims for data within a submission must substantiate those claims at the time of submission
as required by TSCA Section 14(c)(3).
You can access the ‘Instructions for Substantiating Confidential Business Information (CBI)
Claims’ screen by claiming information as CBI within a form and clicking the ‘Continue’ button

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
54

from the ‘Submission of Referenced Information’ screen. You can also access this screen by
clicking the ‘Substantiating CBI Claims’ link within the navigation header. This screen will not
generate until a CBI claim is made within a submission. Information claimed CBI must either be
substantiated or claimed exempt pursuant to TSCA Section 14(c)(2) at the time of submission.
To substantiate a CBI claim, upload documentation asserting your claim(s) on the ‘Instructions
for Substantiating CBI Claims’ screen within the form. You may also opt-out of substantiation
on the ‘Instructions for Substantiating CBI Claims’ screen if, for example, you believe your CBI
claim is exempt under TSCA Section 14(c)(2). Common exemption reasons can be found at
https://www.epa.gov/tsca-cbi/what-information-include-cbi-substantiations. To opt-out of
substantiation at the time of submission, all CBI claims within a submission must be exempt.
 Substantiation Opt-Out: Check this checkbox to opt out of providing CBI substantiation.
You will be required to provide reasoning if you choose to opt out.
 Substantiation Opt-Out Reason: Enter reasoning for opting out of CBI substantiation. This
is a required field.
 Attach Document for CBI Substantiation: Click the ‘Attach Document for CBI
Substantiation’ link to generate the ‘Attach Documents for CBI Substantiation’ pop-up
window.
If you are unfamiliar with substantiating CBI claims or require assistance preparing
substantiation documents, EPA offers a link to templates and other information for substantiating
CBI claims on the ‘Instructions for Substantiating Confidential Business Information (CBI)
Claims’ screen. It is suggested that you right-click the link and open in a new tab or new window
so you do not leave your submission as this may affect your saved data.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
55

Exhibit 4-27 shows a screen capture of the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen (Scroll 1):
Exhibit 4-27 Instructions for Substantiating Confidential Business Information (CBI)
Claims Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
56

Exhibit 4-28 shows a screen capture of the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen (Scroll 2).
Exhibit 4-28 Instructions for Substantiating Confidential Business Information (CBI)
Claims Screen (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
57

Exhibit 4-29 shows a screen capture of the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen (Scroll 3):
Exhibit 4-29 Instructions for Substantiating Confidential Business Information (CBI)
Claims Screen (Scroll 3)

Navigation: Click the ‘Start Submission Process’ button to begin the submission process.
4.11

Attach Documents for CBI Substantiation

You can access the ‘Attach Documents for CBI Substantiation’ window by clicking the ‘Attach
Document for CBI Substantiation’ link within the ‘Instructions for Substantiating Confidential
Business Information (CBI) Claims’ screen.
 Document Type: ‘CBI Substantiation’ is stored in the ‘Document Type’ drop-down menu.
 Page Count: Enter the number of pages in the attached document.
 Attachment: Click the ‘Browse’ button to search for and select a document to attach. This is
a required field.
 I claim the attachment as CBI: Check the ‘I claim the attachment as CBI’ checkbox to
claim the document as confidential.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
58

 Sanitized Attachment: Click the ‘Browse’ button to search for and select a sanitized
document to attach. This is a required field, if it displays.
 Save Document: Click the ‘Save Document’ button to save the uploaded CBI substantiation
document(s).
 Close: Click the ‘Close’ button to close the ‘Attach Documents for CBI Substantiation’
window without saving any uploaded attachment information.
Exhibit 4-30 shows a screen capture of the ‘Attach Documents for CBI Substantiation’ window:
Exhibit 4-30 Attach Documents for CBI Substantiation Window

Navigation: Click the ‘Save Document’ button to upload the substantiation document and
navigate back to the ‘Instructions for Substantiating Confidential Business Information (CBI)
Claims’ screen.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
59

Withdrawal Request

You can withdraw a manufacturer-requested risk evaluation at any time after the request is
submitted, and within 30 days of receiving EPA’s notification that the request is granted.
5.1

Create a Withdrawal Request

To create a new Withdrawal Request, navigate to the Risk Evaluation ‘Home’ screen and select
‘Withdrawal Request’ from the ‘Form Type’ drop-down menu. Refer to Section 3.2 for
additional details regarding the Risk Evaluation ‘Home’ screen.
Refer to Section 3.5 for additional details regarding the passphrase creation process.
5.2

Contact Information

You can navigate to the ‘Contact Information’ screen by clicking the ‘Create’ button and
creating a new passphrase, or by accessing a Withdrawal Request that is ‘In Progress’ and
entering the passphrase associated with the selected request.
The ‘Contact Information’ screen provides fields to input identifying information for a technical
contact. You will have the option to assign a ‘Submission Alias’ to identify the request. A unique
submission alias is helpful when a user or company has multiple requests and/or when you must
differentiate between requests to the help desk. Upon navigating to the ‘Contact Information’
screen, the system auto-generates a default alias comprised of a form type, date stamp, and time
stamp in the following format: .
 Case Number: Enter the case number of the Manufacturer-Requested Risk Evaluation that
you would like to withdraw from EPA review. The case number must be in the format ‘RERYY-####.’ Type-ahead suggestions will appear in a drop-down for any of your submitted
Risk Evaluation requests. This is a required field.
 Submission Alias: Enter the submission alias. Upon navigating to the screen, the application
displays an auto-generated editable submission alias in the following format: . This is a required field.
 CBI: Check the ‘CBI’ checkbox to claim the contact information as confidential.
 Copy from CDX: Click the ‘Copy from CDX’ link to copy CDX registration information.
 First Name: Enter the first name of the contact. This is a required field.
 Last Name: Enter the last name of the contact. This is a required field.
 Position: Enter the job title of the contact.
 Company Name: Enter the company name of the contact. This is a required field.
 Phone Number: Enter the phone number of the contact. This is a required field.
 Phone Number Extension: Enter the extension to the phone number, if applicable.
 Email Address: Enter the email address of the contact. This is a required field.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
60

 Mailing Address 1: Enter the mailing address of the contact. This is a required field.
 Mailing Address 2: Enter the second line of the mailing address of the contact, if applicable.
 City: Enter the city of the mailing address of the contact. This is a required field.
 State: Select the state of the mailing address of the contact. This is a required field if ‘United
States’ is identified as the country.
 Postal Code: Enter the postal code of the mailing address of the contact. This is a required
field.
 Country: Select the country of the mailing address of the contact from the drop-down menu.
This is a required field.
Exhibit 5-1 shows a screen capture of the Withdrawal Request ‘Contact Information’ screen
(Scroll 1):
Exhibit 5-1 Withdrawal Request - Contact Information Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
61

Exhibit 5-2 shows a screen capture of the Withdrawal Request ‘Contact Information’ screen
(Scroll 2):
Exhibit 5-2 Withdrawal Request - Contact Information Screen (Scroll 2)

Exhibit 5-3 shows a screen capture of the Withdrawal Request ‘Contact Information’ screen
(Scroll 3):
Exhibit 5-3 Withdrawal Request - Contact Information Screen (Scroll 3)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
62

Navigation: Click the ‘Continue’ button to navigate to the ‘Original Submitter Information’
screen.
5.3

Original Submitter Information

You can navigate to the ‘Original Submitter Information’ screen by clicking the ‘Continue’
button within the ‘Contact Information’ screen. You can also access this screen by clicking the
‘Original Submitter Information’ link within the navigation header.
The purpose of the ‘Original Submitter Information’ screen is to capture the information of the
Authorized Official who submitted the original Risk Evaluation Request for which you are filing
a Withdrawal Request.
 Copy from CDX: Click the ‘Copy from CDX’ link to copy CDX registration information.
 First Name: Enter the first name of the original submitter. This is a required field.
 Last Name: Enter the last name of the original submitter. This is a required field.
 Position: Enter the job title of the original submitter.
 Company Name: Enter the company name of the original submitter. This is a required field.
 Phone Number: Enter the phone number of the original submitter. This is a required field.
 Phone Number Extension: Enter the extension to the phone number, if applicable.
 Email Address: Enter the email address of the original submitter. This is a required field.
 Mailing Address 1: Enter the mailing address of the original submitter. This is a required
field.
 Mailing Address 2: Enter the second line of the mailing address of the original submitter, if
applicable.
 City: Enter the city of the mailing address of the original submitter. This is a required field.
 State: Select the state of the mailing address of the original submitter. This is a required field
if ‘United States’ is identified as the country.
 Postal Code: Enter the postal code of the mailing address of the original submitter. This is a
required field.
 Country: Select the country of the mailing address of the original submitter from the dropdown menu. This is a required field.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
63

Exhibit 5-4 shows a screen capture of the Withdrawal Request ‘Original Submitter
Information’ screen (Scroll 1):
Exhibit 5-4 Withdrawal Request – Original Submitter Information Screen (Scroll 1)

Exhibit 5-5 shows a screen capture of the Withdrawal Request ‘Original Submitter
Information’ screen (Scroll 2):
Exhibit 5-5 Withdrawal Request – Original Submitter Information Screen (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
64

Exhibit 5-6 shows a screen capture of the Withdrawal Request ‘Original Submitter
Information’ screen (Scroll 3):
Exhibit 5-6 Withdrawal Request – Original Submitter Information Screen (Scroll 3)

Navigation: Click the ‘Continue’ button to navigate to the ‘Submitting Official Information’
screen.
5.4

Submitting Official Information

You can access the ‘Submitting Official Information’ screen by clicking the ‘Continue’ button
from the ‘Original Submitter Information’ screen. You can also access this screen by clicking the
‘Submitting Official Information’ link within the navigation header.
The information below has been pre-populated from CDX registration. If the information listed
is incorrect, please make the appropriate edits to your user information in CDX registration.
 Submitter is CBI: Check the ‘CBI’ checkbox to claim the submitter information as
confidential.
 First Name: Displays the first name of the submitter.
 Middle Initial: Displays the middle initial of the submitter.
 Last Name: Displays the last name of the submitter.
 Company Name: Displays the company name of the submitter.
 Phone Number: Displays the phone number of the submitter.
 Email Address: Displays the email address of the submitter.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
65

 Mailing Address 1: Displays line 1 of the mailing address of the submitter.
 City: Displays the city of the mailing address of the submitter.
 State: Displays the state of the mailing address of the submitter.
 Postal Code: Displays the postal code of the mailing address of the submitter.
 Country: Displays the country of the mailing address of the submitter.
 This confirmation is required to proceed with the submission process: Check the legal
verification checkbox to begin the submission process; this is required and gets reset when
accessing the form.
Exhibit 5-7 shows a screen capture of the Withdrawal Request ‘Submitting Official
Information’ screen (Scroll 1):
Exhibit 5-7 Withdrawal Request – Submitting Official Information Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
66

Exhibit 5-8 shows a screen capture of the Withdrawal Request ‘Submitting Official Information’
screen (Scroll 2):
Exhibit 5-8 Withdrawal Request – Submitting Official Information Screen (Scroll 2)

Navigation: If any CBI claims were made, check the legal verification checkbox and click the
‘Continue’ button to navigate to the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen. You can also access this screen by clicking the
‘Substantiating CBI Claims’ link within the navigation header. If no CBI claims were made,
check the legal verification checkbox and click the ‘Start Submission Process’ button to begin
the submission process.
5.5

Instructions for Substantiating Confidential Business Information (CBI) Claims

You can access the ‘Instructions for Substantiating Confidential Business Information (CBI)
Claims’ screen by claiming information as CBI within a Withdrawal Request and clicking the
‘Continue’ button from the ‘Submitting Official Information’ screen. You can also access this
screen by clicking the ‘Substantiating CBI Claims’ link within the navigation header. This screen
will not generate until a CBI claim is made within a form. Information claimed CBI must either
be substantiated or claimed exempt pursuant to TSCA Section 14(c)(2) at the time of submission.
For more information regarding CBI substantiation, please refer to Section 4.10.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
67

Initial Response

The purpose of the Initial Response is for a manufacturer or importer to respond to a preliminary
list published by the EPA in the federal register. Consortium leaders who are not the
manufacturer or importer do not need to submit this form.
6.1

Create an Initial Response

To create a new Initial Response, navigate to the Risk Evaluation ‘Home’ screen and select
‘Initial Response’ from the ‘Form Type’ drop-down menu. Refer to Section 3.2 for additional
details regarding the Risk Evaluation ‘Home’ screen.
Refer to Section 3.5 for additional details regarding the passphrase creation process.
6.2

Contact

You can navigate to the ‘Contact’ screen by clicking the ‘Create’ button and creating a new
passphrase, or by accessing an Initial Response that is ‘In Progress’ and entering the passphrase
associated with the selected request.
The ‘Contact’ screen provides fields to input identifying information for a technical contact. You
will have the option to assign a ‘Submission Alias’ to identify the request. A unique submission
alias is helpful when a user or company has multiple requests and/or when you must differentiate
between requests to the help desk. Upon navigating to the ‘Contact’ screen, the system autogenerates a default alias comprised of a form type, date stamp, and time stamp in the following
format: .
 Submission Alias: Enter the submission alias. Upon navigating to the screen, the application
displays an auto-generated editable submission alias in the following format: . This is a required field.
 CBI: Check the ‘CBI’ checkbox to claim the contact information as confidential.
 Copy from CDX: Click the ‘Copy from CDX’ link to copy CDX registration information.
 First Name: Enter the first name of the contact. This is a required field.
 Last Name: Enter the last name of the contact. This is a required field.
 Position: Enter the job title of the contact.
 Company Name: Enter the company name of the contact. This is a required field.
 Phone Number: Enter the phone number of the contact. This is a required field.
 Phone Number Extension: Enter the extension to the phone number, if applicable.
 Email Address: Enter the email address of the contact.
 Mailing Address 1: Enter the mailing address of the contact. This is a required field.
 Mailing Address 2: Enter the second line of the mailing address of the contact, if applicable.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
68

 City: Enter the city of the mailing address of the contact. This is a required field.
 State: Select the state of the mailing address of the contact. This is a required field if ‘United
States’ is identified as the country.
 Postal Code: Enter the postal code of the mailing address of the contact. This is a required
field.
 Country: Select the country of the mailing address of the contact from the drop-down menu.
Selecting a non-US country generates the ‘United States Agent’ screen. This is a required
field.
Exhibit 6-1shows a screen capture of the Initial Response ‘Contact’ screen (Scroll 1):
Exhibit 6-1 Initial Response – Contact Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
69

Exhibit 6-2 shows a screen capture of the Initial Response ‘Contact’ screen (Scroll 2):
Exhibit 6-2 Initial Response – Contact Screen (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
70

6.3

United States Agent

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
71

Exhibit 6-3 shows a screen capture of the Initial Response ‘United States Agent’ screen (Scroll
1):
Exhibit 6-3: Initial Response – United States Agent Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
72

Exhibit 6-4shows a screen capture of the Initial Response ‘United States Agent’ screen (Scroll
2):
Exhibit 6-4 Initial Response – United States Agent Screen (Scroll 2)

Navigation: Click the ‘Continue’ button to navigate to the ‘Company’ screen. You can also
access this screen by clicking the ‘Company’ link within the navigation header.
6.4

Company

You can access the ‘Company’ screen by clicking the ‘Continue’ button from the ‘Contact’
screen if identifying a U.S. contact. If identifying a non-U.S. contact within the ‘Contact’ screen,
you can access this screen by clicking the ‘Continue’ button from the ‘United States Agent’
screen. You can also access this screen by clicking the ‘Company’ link within the navigation
header.
The ‘Company’ screen displays the following fields and columns of information:

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
73

 Company Name: Enter the name of the company of the contact. This is a required field.
 CBI: Check the ‘CBI’ checkbox to claim the company information as confidential.
 Mailing Address 1: Enter the mailing address of the company. This is a required field.
 Mailing Address 2: Enter the second line of the mailing address of the company, if
applicable.
 City: Enter the city of the mailing address of the company. This is a required field.
 State: Select the state of the mailing address of the company. This is a required field if
‘United States’ is identified as the country.
 Postal Code: Enter the postal code of the mailing address of the company. This is a required
field.
 Country: Displays ‘United States.’
 Company Size Certification: Select a radio button option for the company size certification.
See Section 4.3 for the fee structure. See Section 4.3.1for Small Business Concern
definition. This is required.
 Will you be joining a consortium?: Select a radio button option. This is required.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
74

Exhibit 6-5shows a screen capture of the Initial Response ‘Company’ screen (Scroll 1):
Exhibit 6-5 Initial Response – Company Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
75

Exhibit 6-6 shows a screen capture of the Initial Response ‘Company’ screen (Scroll 2):
Exhibit 6-6 Initial Response – Company Screen (Scroll 2)

Navigation: Click the ‘Continue’ button to navigate to the ‘Response Information’ screen. You
can also access this screen by clicking the ‘Response Information’ link within the navigation
header.
6.5

Response Information

You can access the ‘Response Information’ screen by clicking the ‘Continue’ button from the
‘Company’ screen if identifying a U.S. contact. You can also access this screen by clicking the
‘Response Information’ link within the navigation header.
The ‘Response Information’ screen displays the following fields and columns of information:

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
76

 Risk Evaluation Activity: Select the Risk Evaluation Activity you are responding to in the
drop-down. This is required.
 Response Options: Select one response option. Select ‘Self-Identification’ if you are
representing a company that is a manufacturer or importer of the chemical substance subject
to the Risk Evaluation Activity. Select ‘Certification of No Manufacture’ if you are
representing a company that was included in error on EPA’s Preliminary List of responsible
fee payers for the Risk Evaluation Activity. Select ‘Certification of Cessation’ if you are
representing a company that was manufacturer or importer of the chemical substance subject
to this Risk Evaluation Activity. A selection is required.
 Additional Information and Attachments (Only if Requested by Agency): Use this
section to submit additional information regarding your initial response.
 File Name: Displays the file name of the uploaded document.
 File Description: Displays the description of the uploaded document.
 Page Count: Displays the number of pages in the uploaded document.
 Date: Displays the date that the uploaded document was attached.
 CBI: Displays a ‘Y’ or an ‘N’ to indicate the confidentiality status of the uploaded
document. Action: Click the ‘Delete’ icon ( ) to remove the uploaded document.
 Attach Document: Click the ‘Attach Document’ link to generate the ‘Attach Document’
window.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
77

Exhibit 6-7 shows a screen capture of the ‘Response Information’ screen (Scroll 1):
Exhibit 6-7 Response Information – Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
78

Exhibit 6-8 shows a screen capture of the ‘Response Information’ screen (Scroll 2):
Exhibit 6-8 Initial Response – Response Information Screen (Scroll 2)

6.6

Submitting Official Information

You can access the ‘Submitting Official Information’ screen by clicking the ‘Continue’ button
from the ‘Response Information’ screen if the request is submitted on behalf of the reporting
organization. You can also access this screen by clicking the ‘Submitting Official Information’
link within the navigation header.
The information below has been pre-populated from CDX registration. If the information listed
is incorrect please make the appropriate edits to your user information in CDX registration.
 Submitter is CBI: Check the ‘CBI’ checkbox to claim the submitter information as
confidential.
 First Name: Displays the first name of the submitter.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
79

 Middle Initial: Displays the middle initial of the submitter.
 Last Name: Displays the last name of the submitter.
 Company Name: Displays the company name of the submitter.
 Phone Number: Displays the phone number of the submitter.
 Email Address: Displays the email address of the submitter.
 Mailing Address 1: Displays line 1 of the mailing address of the submitter.
 City: Displays the city of the mailing address of the submitter.
 State: Displays the state of the mailing address of the submitter.
 Postal Code: Displays the postal code of the mailing address of the submitter.
 Country: Displays the country of the mailing address of the submitter.
 This confirmation is required to proceed with the submission process: Check the legal
verification checkbox to begin the submission process; this is required and gets reset when
accessing the form.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
80

Exhibit 6-9 shows a screen capture of the Initial Response ‘Submitting Official Information’
screen (Scroll 1):
Exhibit 6-9 Initial Response – Submitting Official Information Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
81

Exhibit 6-10 shows a screen capture of the Initial Response ‘Submitting Official Information’
screen (Scroll 2):
Exhibit 6-10 Initial Response – Submitting Official Information Screen (Scroll 2)

Submission of Referenced Information

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
82

Exhibit 6-11 Initial Response – Submission of Referenced Information Screen

Instructions for Substantiating Confidential Business Information (CBI) Claims

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
83

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
84

Exhibit 6-12 shows a screen capture of the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen (Scroll 1):
Exhibit 6-12 Initial Response – Instructions for Substantiating Confidential Business
Information (CBI) Claims Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
85

Exhibit 6-13 shows a screen capture of the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen (Scroll 2).
Exhibit 6-13 Initial Response – Instructions for Substantiating Confidential Business
Information (CBI) Claims Screen (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
86

Exhibit 6-14 shows a screen capture of the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen (Scroll 3):
Exhibit 6-14 Initial Response – Instructions for Substantiating Confidential Business
Information (CBI) Claims Screen (Scroll 3)

Navigation: Click the ‘Start Submission Process’ button to begin the submission process.
6.9

Attach Documents for CBI Substantiation

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
87

 I claim the attachment as CBI: Check the ‘I claim the attachment as CBI’ checkbox to
claim the document as confidential.
 Sanitized Attachment: Click the ‘Browse’ button to search for and select a sanitized
document to attach. This is a required field, if it displays.
 Save Document: Click the ‘Save Document’ button to save the uploaded CBI substantiation
document(s).
 Close: Click the ‘Close’ button to close the ‘Attach Documents for CBI Substantiation’
window without saving any uploaded attachment information.
Exhibit 6-15 shows a screen capture of the ‘Attach Documents for CBI Substantiation’ window:
Exhibit 6-15 Attach Documents for CBI Substantiation Window

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
88

EPA Initiated Risk Evaluation Request

The purpose of the EPA Initiated Risk Evaluation request is to determine whether a chemical
substance presents an unreasonable risk to health or the environment, under the conditions of
use, including an unreasonable risk to a relevant potentially exposed or susceptible
subpopulation. Select this form type if you are manufacturer/importer and/or consortium leader
responding to the finalized Risk Evaluation Request published by EPA in the Federal Register.
7.1

Create a EPA Initiated Risk Evaluation

To create a new EPA Initiated Risk Evaluation, navigate to the Risk Evaluation ‘Home’ screen
and select ‘EPA Initiated Risk Evaluation’ from the ‘Form Type’ drop-down menu. Refer to
Section 3.2 for additional details regarding the Risk Evaluation ‘Home’ screen.
Refer to Section 3.5 for additional details regarding the passphrase creation process.
7.2

Contact

You can navigate to the ‘Contact’ screen by clicking the ‘Create’ button and creating a new
passphrase, or by accessing an EPA Initiated Risk Evaluation request that is ‘In Progress’ and
entering the passphrase associated with the selected request.
The ‘Contact’ screen provides fields to input identifying information for a technical contact. You
will have the option to assign a ‘Submission Alias’ to identify the request. A unique submission
alias is helpful when a user or company has multiple requests and/or when you must differentiate
between requests to the help desk. Upon navigating to the ‘Contact’ screen, the system autogenerates a default alias comprised of a form type, date stamp, and time stamp in the following
format: .
 Submission Alias: Enter the submission alias. Upon navigating to the screen, the application
displays an auto-generated editable submission alias in the following format: . This is a required field.
 N/A: Select the ‘N/A’ radio button to indicate that the form will be submitted on behalf of
the reporting organization. Selecting this radio button generates the ‘Fees Certification’ page.
 This is a submission on behalf of a consortium: Select the ‘This is a submission on behalf
of a consortium to indicate that the request is submitted on behalf of a consortium. Selecting
this radio button generates the ‘Submitting on Behalf of Consortium’ screen.
 CBI: Check the ‘CBI’ checkbox to claim the contact information as confidential.
 Copy from CDX: Click the ‘Copy from CDX’ link to copy CDX registration information.
 First Name: Enter the first name of the contact. This is a required field.
 Last Name: Enter the last name of the contact. This is a required field.
 Position: Enter the job title of the contact.
 Company Name: Enter the company name of the contact. This is a required field.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
89

 Additional Companies: Enter an additional company in this field, if applicable.
 Add: Click the button to add the company entry into the ‘Additional Companies’ table.
 Additional Company Name: Displays the additional company name(s) associated with the
contact.
 Action: Click the ‘Delete’ icon (

) to remove an additional company name.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
90

Exhibit 7-1 shows a screen capture of the ‘Contact’ screen (EPA Initiated Risk Evaluation)
(Scroll 1):
Exhibit 7-1 EPA Initiated Risk Evaluation – Contact Screen (Scroll 1)

Exhibit 7-2 shows a screen capture of the ‘Contact’ screen (EPA Initiated Risk Evaluation)
(Scroll 2):
Exhibit 7-2 EPA Initiated Risk Evaluation – Contact Screen (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
91

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
92

Exhibit 7-3 shows a screen capture of the ‘Contact’ screen (Scroll 3):
Exhibit 7-3 EPA Initiated Risk Evaluation – Contact Screen (Scroll 3)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
93

The ‘Submitting on Behalf of Consortium’ screen provides fields to capture consortium
information and individual consortium members. The user populating the form is identified as a
consortium member by default upon navigating to the ‘Submitting on Behalf of Consortium’
page. A minimum of two consortium members is required.
 Consortium Name: Enter the name of the consortium. This is a required field.
 Consortium CBI: Check the ‘CBI’ checkbox to claim the consortium as confidential.
 Add Consortium Member: Click the ‘Add Consortium Member’ button to generate a pop
up with an additional set of consortium input fields. At least two (2) consortium members are
required to be identified.
 Case Number: Enter the case number of the Initial Response form. The case number must
be in the format ‘IR-YY-####.’ Enter ‘N/A’ if the consortium member did not submit an
Initial Response. This is a required field.
 First Name: Enter the first name of the consortium member. This is a required field.
 Last Name: Enter the last name of the consortium member. This is a required field.
 Position: Enter the job title of the consortium member
 Company Name: Enter the company name of the consortium member. This is a required
field.
 Phone Number: Enter the phone number of the consortium member. This is a required field.
 Phone Number Extension: Enter the extension to the phone number, if applicable.
 Email Address: Enter the email address of the consortium member. This is a required field.
 Mailing Address 1: Enter the mailing address of the consortium member. This is a required
field.
 Mailing Address 2: Enter the second line of the mailing address of the consortium member,
if applicable.
 City: Enter the city of the mailing address of the consortium member. This is a required
field.
 State: Select the state of the mailing address of the consortium member. This is a required
field.
 Postal Code: Enter the postal code of the mailing address of the consortium member. This is
a required field.
 Country: Select the country of the mailing address of the consortium member. This is a
required field.
 My company is a "small business concern" as defined under 40 CFR 700.43: Select the
radio button to indicate that the consortium is a small business concern. A fee certification
statement is required to be selected

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
94

 My company is not a "small business concern" as defined under 40 CFR 700.43: Select
the radio button to indicate that the consortium member does not represent a small business
concern. A fee certification statement is required to be selected.
Exhibit 4-114 shows a screen capture of the ‘Consortium Member’ pop-up window (Scroll 1):
Exhibit 7-4 EPA Initiated Risk Evaluation – Consortium Member Pop Up Window (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
95

Exhibit 7-5 shows a screen capture of the ‘Consortium Member’ pop-up window (Scroll 2):
Exhibit 7-5 EPA Initiated Risk Evaluation – Consortium Member Pop Up Window (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
96

Exhibit 4-6 shows a screen capture of the ‘Consortium Member’ screen (Scroll 3):
Exhibit 7-6 EPA Initiated Risk Evaluation – Consortium Member Screen (Scroll 3)

Navigation: Click the ‘Save Changes’ button to save the consortium member information. Click
the ‘Continue’ button to navigate to the ‘Chemical Substance or Category’ screen if the request
is submitted on behalf of the reporting organization. You can also access this screen by clicking
the ‘Chemical Substance or Category’ link within the navigation header. Click the ‘Continue’
button to navigate to the ‘U.S. Agent’ screen if a non-U.S. contact is identified. You can also
access this screen by clicking the ‘U.S. Agent’ link within the navigation header.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
97

7.3.1 Small Business Concern Definition
Click the ‘View the updated definition of a small business concern’ link to generate the ‘Small
Business Concern Definition’ window. This window displays a table of the North American
Industry Classification System (NAICS) codes, NAICS descriptions, and applicable small
business concern size in number of employees.
As noted in the definition, if there are codes that are not listed within the NAICS table, a small
business definition applies to 500 or fewer employees that a company “owns or controls.”

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
98

Exhibit 7-7 shows a screen capture of the ‘Small Business Concern Definition’ window (Scroll
1):
Exhibit 7-7 EPA Initiated Risk Evaluation – Small Business Concern Definition Window
(Scroll 1)

Exhibit 7-8 shows a screen capture of the ‘Small Business Concern Definition’ window (Scroll
2):

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
99

Exhibit 7-8 EPA Initiated Risk Evaluation – Small Business Concern Definition Window
(Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
100

Exhibit 7-9 shows a screen capture of the ‘Small Business Concern Definition’ window (Scroll

3):
Exhibit 7-9 EPA Initiated Risk Evaluation – Small Business Concern Definition Window
(Scroll 3)

Exhibit 7-10 shows a screen capture of the ‘Small Business Concern Definition’ window (Scroll
4):

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
101

Exhibit 7-10 EPA Initiated Risk Evaluation – Small Business Concern Definition Window
(Scroll 4)

Navigation: Click the ‘X’ icon in the upper right-hand corner to close the ‘Small Business
Concern Definition’ window.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
102

7.3

United States Agent

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
103

Exhibit 7-11 shows a screen capture of the ‘United States Agent’ screen (Scroll 1):
Exhibit 7-11 EPA Initiated Risk Evaluation – United States Agent Screen (Scroll 1)

Exhibit 7-12 shows a screen capture of the ‘United States Agent’ screen (Scroll 2):

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
104

Exhibit 7-12 EPA Initiated Risk Evaluation – United States Agent Screen (Scroll 2)

Chemical Substance or Category

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
105

 Chemical Substance Type: Select the chemical substance type from the drop-down menu.
This drop-down is disabled until a Risk Evaluation Notice is selected. Once selection is made
from the drop-down, click ‘Add’ to add the chemical substance type to the table. At least one
chemical substance or chemical category is required.
 Chemical Categories: Select the chemical categories from the drop-down menu. This is
disabled until a Risk Evaluation Notice is selected. Once a selection is made from the dropdown, click ‘Add’ to add the chemical substance type to the table. At least one chemical
substance or chemical category is required.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
106

Exhibit 7-13 shows a screen capture of the ‘Chemical Substance or Category’ screen (Scroll 1):
Exhibit 7-13 EPA Initiated Risk Evaluation – Chemical Substance or Category Screen
(Scroll 1)

Navigation: Click the ‘Next’ button to navigate to the ‘Document Upload’ screen. You can also
access this screen by clicking the ‘Document Upload’ link within the navigation header.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
107

7.5

Document Upload (Optional)

You can access the ‘Document Upload’ screen by clicking the ‘Next’ button from the ‘Chemical
Substance or Category’ screen. You can also access this screen by clicking the ‘Document
Upload’ link within the navigation header.
A condition of use rationale document is required to be uploaded within a Risk Evaluation
request.
 Condition of Use: Enter text including a rationale for the conditions of use. The term
‘condition of use’ means the circumstances, as determined by the Administrator, under which
a chemical substance is intended, known, or reasonably foreseen to be manufactured,
processed, or distributed in commerce, used or disposed of.
 CBI: Check the box to indicate the confidentiality status of the Condition of Use.
 Hazard Studies / Information: Enter text of all existing information that is relevant to
whether the chemical substance, under the conditions of use identified by the manufacturer,
presents an unreasonable risk of injury to health or the environment. At minimum this must
include:
 hazard and exposure potential,
 persistence and bioaccumulation,
 potentially exposed or susceptible subpopulations the requester believes to be relevant,
 whether there is any storage of the chemical substance near significant sources of drinking
water (including storage facilities),
 production volume or significant changes to the production volume, and
 any other information relevant to the potential risks of the chemical substance.
 CBI: Check the box to indicate the confidentiality status of the Hazard Studies/ Information.
 Additional Information: Enter text for any additional information.
 CBI: Check the box to indicate the confidentiality status of the Additional Information.
 Search: Enter criteria to filter the uploaded document(s).
 Document Type: Displays the document type of the uploaded document.
 Document Subtype: Displays the document subtype of the uploaded document.
 File Name: Displays the file name of the uploaded document.
 File Description: Displays the description of the uploaded document.
 Page Count: Displays the number of pages in the uploaded document.
 Date: Displays the date that the uploaded document was attached.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
108

 CBI: Displays a ‘Y’ or an ‘N’ to indicate the confidentiality status of the uploaded
document.
 Action: Click the ‘Delete’ icon (

) to remove the uploaded document.

 Attach Document: Click the ‘Attach Document’ link to generate the ‘Attach Document’
window. Refer to Section 4.5.1 for further details on the ‘Attach Document’ window.
 Information Submitted: Enter text regarding the type of information that has been included
in the risk evaluation form.
 CBI: Check the box to indicate the confidentiality status of the information submitted.
Exhibit 7-14 shows a screen capture of the ‘Document Upload’ screen (Scroll 1):
Exhibit 7-14 EPA Initiated Risk Evaluation – Document Upload Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
109

Exhibit 7-15 shows a screen capture of the ‘Document Upload’ screen (Scroll 2):
Exhibit 7-15 EPA Initiated Risk Evaluation – Document Upload Screen (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
110

Exhibit 7-16 shows a screen capture of the ‘Attach Document’ window:
Exhibit 7-16 EPA Initiated Risk Evaluation – Attach Document Window

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
111

Navigation: Click the ‘Save Document’ button to upload the selected attachment to the
‘Documents’ table.
7.6

Fees Certification

The ‘Fees Certification’ screen presents radio buttons to indicate the applicable fee certification
statement.
You can access the ‘Fees Certification’ screen by selecting the ‘N/A’ radio button within the
‘Contact’ screen and clicking the ‘Continue’ button from the ‘Chemical Substance or Category’
screen.
The purpose of the ‘Fees Certification’ screen is to inform EPA of the fee amount that a primary
submitter pays on behalf of the reporting organization based on the business size. The
certification statement selected on the ‘Fees Certification’ screen is non-editable when amending
a Risk Evaluation Request. See Section 4.3.1 for additional information regarding the definition
of a small business concern.
Exhibit 7-17 shows the fee structure implemented for Risk Evaluation Requests:
Exhibit 7-17 EPA Initiated Risk Evaluation – Risk Evaluation Request Fee Structure
Business Concern
Not a small business
concern

Small business

Fee Category

Fee Amount

EPA-initiated Risk
Evaluation

 $1,350,000

Manufacturer-requested
risk evaluation on a
chemical in the TSCA
Work Plan

 Initial $1,250,000 payment + final invoice to recover
50% of Actual Costs

Manufacturer-requested
risk evaluation on a
chemical not in the TSCA
Work Plan

 Initial $2,500,000 payment+ final invoice to total 100%
of Actual Costs

EPA-initiated Risk
Evaluation

 $270,000

Manufacturer-requested
risk evaluation on a
chemical in the TSCA
Work Plan

 Initial $1,250,000 payment + final invoice to recover
50% of Actual Costs

Manufacturer-requested
risk evaluation on a
chemical not in the TSCA
Work Plan

 Initial $2,500,000 payment+ final invoice to total 100%
of Actual Costs

The following certification statements display:

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
112

 My company is a "small business concern" as defined under 40 CFR 700.43: Select this
radio button to indicate that the reporting organization is a small business concern.
 My company is not a "small business concern" as defined under 40 CFR 700.43: Select
this radio button to indicate that the reporting organization is not a small business concern.
Exhibit 7-18 shows a screen capture of the ‘Fees Certification’ screen:
Exhibit 7-18 EPA Initiated Risk Evaluation – Fees Certification Screen

Submitting Official Information

You can access the ‘Submitting Official Information’ screen by clicking the ‘Next’ button from
the ‘Fees Certification’ screen if the request is submitted on behalf of the reporting organization.
You can also access this screen by clicking the ‘Submitting Official Information’ link within the
navigation header.
The information below has been pre-populated from CDX registration. If the information listed
is incorrect please make the appropriate edits to your user information in CDX registration.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
113

 Submitter is CBI: Check the ‘CBI’ checkbox to claim the submitter information as
confidential.
 First Name: Displays the first name of the submitter.
 Middle Initial: Displays the middle initial of the submitter.
 Last Name: Displays the last name of the submitter.
 Company Name: Displays the company name of the submitter.
 Phone Number: Displays the phone number of the submitter.
 Email Address: Displays the email address of the submitter.
 Mailing Address 1: Displays line 1 of the mailing address of the submitter.
 City: Displays the city of the mailing address of the submitter.
 State: Displays the state of the mailing address of the submitter.
 Postal Code: Displays the postal code of the mailing address of the submitter.
 Country: Displays the country of the mailing address of the submitter.
 This confirmation is required to proceed with the submission process: Check the legal
verification checkbox to begin the submission process; this is required and gets reset when
accessing the form.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
114

Exhibit 7-19 shows a screen capture of the ‘Submitting Official Information’ screen (Scroll 1):
Exhibit 7-19 EPA Initiated Risk Evaluation – Submitting Official Information Screen
(Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
115

Exhibit 7-20 shows a screen capture of the ‘Submitting Official Information’ screen (Scroll 2):
Exhibit 7-20 EPA Initiated Risk Evaluation – Submitting Official Information Screen
(Scroll 2)

Submission of Referenced Information

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
116

Exhibit 7-21 shows a screen capture of the ‘Submission of Referenced Information’ screen:
Exhibit 7-21 EPA Initiated Risk Evaluation – Submission of Referenced Information
Screen

Instructions for Substantiating Confidential Business Information (CBI) Claims

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
117

clicking the ‘Substantiating CBI Claims’ link within the navigation header. This screen will not
generate until a CBI claim is made within a submission. Information claimed CBI must either be
substantiated or claimed exempt pursuant to TSCA Section 14(c)(2) at the time of submission.
To substantiate a CBI claim, upload documentation asserting your claim(s) on the ‘Instructions
for Substantiating CBI Claims’ screen within the form. You may also opt-out of substantiation
on the ‘Instructions for Substantiating CBI Claims’ screen if, for example, you believe your CBI
claim is exempt under TSCA Section 14(c)(2). Common exemption reasons can be found at
https://www.epa.gov/tsca-cbi/what-information-include-cbi-substantiations. To opt-out of
substantiation at the time of submission, all CBI claims within a submission must be exempt.
 Substantiation Opt-Out: Check this checkbox to opt out of providing CBI substantiation.
You will be required to provide reasoning if you choose to opt out.
 Substantiation Opt-Out Reason: Enter reasoning for opting out of CBI substantiation. This
is a required field.
 Attach Document for CBI Substantiation: Click the ‘Attach Document for CBI
Substantiation’ link to generate the ‘Attach Documents for CBI Substantiation’ pop-up
window.
If you are unfamiliar with substantiating CBI claims or require assistance preparing
substantiation documents, EPA offers a link to templates and other information for substantiating
CBI claims on the ‘Instructions for Substantiating Confidential Business Information (CBI)
Claims’ screen. It is suggested that you right-click the link and open in a new tab or new window
so you do not leave your submission as this may affect your saved data.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
118

Exhibit 7-22 shows a screen capture of the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen (Scroll 1):
Exhibit 7-22 EPA Initiated Risk Evaluation – Instructions for Substantiating Confidential
Business Information (CBI) Claims Screen (Scroll 1)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
119

Exhibit 7-23 shows a screen capture of the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen (Scroll 2).
Exhibit 7-23 EPA Initiated Risk Evaluation – Instructions for Substantiating Confidential
Business Information (CBI) Claims Screen (Scroll 2)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
120

Exhibit 7-24 shows a screen capture of the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen (Scroll 3):
Exhibit 7-24 EPA Initiated Risk Evaluation – Instructions for Substantiating Confidential
Business Information (CBI) Claims Screen (Scroll 3)

Navigation: Click the ‘Start Submission Process’ button to begin the submission process.
7.10

Attach Documents for CBI Substantiation

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
121

 Sanitized Attachment: Click the ‘Browse’ button to search for and select a sanitized
document to attach. This is a required field, if it displays.
 Save Document: Click the ‘Save Document’ button to save the uploaded CBI substantiation
document(s).
 Close: Click the ‘Close’ button to close the ‘Attach Documents for CBI Substantiation’
window without saving any uploaded attachment information.
Exhibit 7-25 shows a screen capture of the ‘Attach Documents for CBI Substantiation’ window:
Exhibit 7-25 EPA Initiated Risk Evaluation – Attach Documents for CBI Substantiation
Window

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
122

Preview

The system provides the option to preview a form during the submission process. Click the
‘Preview’ link, located within the bottom action bar, to preview a PDF file of the regular or
sanitized version of the form. After you choose either the ‘Regular’ or ‘Sanitized’ PDF, the
application generates a watermarked PDF draft of the form.
The watermark reads ‘Not For Submission’ and displays across each page in the background.
The form preview displays the entire form in a printable format. The preview functionality
provides the flexibility to track the status of the form and see the entire form in a single
viewpoint.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
123

Exhibit 8-1 shows a screen capture for the ‘Preview Risk Evaluation’ PDF:
Exhibit 8-1 Preview Risk Evaluation PDF

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
124

Validate

You can click the ‘Validate’ link located within the bottom action bar at any stage of completing
a Risk Evaluation request. The ‘TSCA Risk Evaluation’ window displays when you click the
‘Validate’ link. Disable the pop-up blocker within your internet browser so that the ‘TSCA Risk
Evaluation’ window displays correctly. The ‘TSCA Risk Evaluation’ window displays a report
of all validation errors. During the validation process, the application validates each screen of the
Risk Evaluation request to find missing and invalid data.
Validation Errors: Errors can be fixed by clicking the error link. The links will display the
Screen Title Name (e.g., Chemical Substance or Category) and the associated error. After you
click a link, the main application screen will display the section where the error occurred so you
can easily fix the error. Once you have fixed the error(s), click the ‘Validate’ link again to
refresh the ‘TSCA Risk Evaluation’ window. If the information you fixed passes validation, the
error will be removed from the ‘TSCA Risk Evaluation’ window. You must fix all validation
errors to submit the form to CDX successfully.
Click the ‘X’ button, located at the upper right-hand corner of the window, to close the ‘TSCA
Risk Evaluation’ window.
Exhibit 9-1 shows a screen capture for the ‘TSCA Risk Evaluation Validation’ window:
Exhibit 9-1 TSCA Risk Evaluation Validation Window

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
125

Submit to EPA via CDX

As a Primary AO, you have the ability to sign and submit a Risk Evaluation request to EPA via
CDX. You can save your form at any point during the data entry process. Any assigned Supports
for your form cannot submit the Risk Evaluation request. The save functionality will allow you
to return to that same form at any point in the future.
Once you complete all required information and correct all items failing validation, the system
will allow the Risk Evaluation request to be successfully submitted.
10.1

TSCA Certification

Click the ‘Start Submission Process’ button from the ‘Submission of Referenced Information’
screen if there are no CBI claims, or the ‘Instructions for Substantiating Confidential Business
Information (CBI) Claims’ screen if there are CBI claims, to access the ‘TSCA Certification’
screen.
Exhibit 10-1 shows a screen capture of the ‘TSCA Certification’ screen:
Exhibit 10-1 TSCA Certification Screen

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
126

Navigation: Click the ‘Continue’ button to certify regarding the contents of the form and
navigate to the ‘Risk Evaluation Certification’ screen.
10.2

Risk Evaluation Certification

Click the ‘Continue’ button from the ‘TSCA Certification’ screen to access the ‘Risk Evaluation
Certification’ screen.
Exhibit 10-2 shows a screen capture of the ‘Risk Evaluation Certification’ screen:
Exhibit 10-2 Risk Evaluation Certification Screen

Navigation: Click the ‘Continue’ button to navigate to the ‘Validation’ screen.
10.3

Validation

Click the ‘Continue’ button from the ‘Risk Evaluation Certification’ screen to access the
‘Validation’ screen.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
127

Exhibit 10-3 shows a screen capture of the ‘Validation’ screen:
Exhibit 10-3 Validation Screen

Navigation: Click the ‘PDF Generation’ button to navigate to the ‘PDF Generation’ screen.
10.4

Risk Evaluation PDF Generation

Click the ‘PDF Generation’ button from the ‘Validation’ screen to access the ‘PDF Generation’
screen.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
128

Exhibit 10-4 shows a screen capture of the ‘PDF Generation’ screen:
Exhibit 10-4 PDF Generation Screen

Navigation: Click the ‘Regular PDF’ button to generate a regular version of the Risk Evaluation
PDF. Click the ‘Sanitized PDF’ button to generate a sanitized version of the Risk Evaluation
PDF. Click the ‘Sign, Encrypt and Submit’ button to begin the CROMERR certification process.
10.5

CROMERR Certification

Click the ‘Sign, Encrypt and Submit’ button from the ‘PDF Generation’ screen to generate the
‘CROMERR Certification’ window.
Exhibit10-5 shows a screen capture of the ‘CROMERR Certification’ window:

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
129

Exhibit10-5 CROMERR Certification Window

Navigation: Click the ‘Accept’ button to agree to the certification statement and generate the
‘eSignature Widget.’
10.6

eSignature Widget

Click the ‘Accept’ button on the ‘CROMERR Certification’ window to accept the certification
statement and generate the ‘eSignature Widget.’ The ‘eSignature Widget’ will prompt for the
CDX login password and an answer to one of your security questions. Click the ‘Sign’ button on
the ‘eSignature Widget’ to navigate to the ‘Submission Finished’ screen.
Exhibit 10-6 shows a screen capture of the ‘eSignature Widget’ window:
Exhibit 10-6 eSignature Widget Window

Navigation: Click the ‘Sign’ button on the ‘eSignature Widget’ to navigate to the ‘Submission
Finished’ screen.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
130

10.7

Submission Finished

Click the ‘Sign’ button on the ‘eSignature Widget’ to navigate to the ‘Submission Finished’
screen.
Exhibit 10-7 shows a screen capture of the ‘Submission Finished’ screen:
Exhibit 10-7 Submission Finished Screen

Navigation: Click the ‘Home’ button to navigate back to the TSCA Risk Evaluation ‘Home’
screen.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
131

Download Copy of Record

To download a Copy of Record, navigate to the Risk Evaluation ‘Home’ screen and locate a
form alias for which you have successfully completed a submission and which has a status of
‘Completed.’
Click the ‘Copy of Record’ icon ( ) from the ‘Submission History’ section of the Risk
Evaluation ‘Home’ screen to navigate to the ‘Enter Passphrase’ screen to login into CDX. The
‘Enter Passphrase’ screen requires you to enter the passphrase originally associated with the
form. If the passphrase is entered correctly, you will view the ‘CROMERR Certification’
message where you can acknowledge the certification. Once you accept the certification, the
‘eSignature Widget’ displays where you provide the correct CDX password, answer the 20-5-1
question, and click the ‘Sign’ button. The copy of record .zip file generates on the current page.
Exhibit 11-1 shows a screen capture of the ‘Download Copy of Record’ screen:
Exhibit 11-1 Download Copy of Record Screen

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
132

The screen displays the ‘File Name,’ ‘File Size,’ and ‘Action’ columns in a table format. The
screen also displays a section for communication documents. Click the ‘Copy of Record’ icon
( ) to automatically download the .zip file containing the individual regular and sanitized
PDFs.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
133

EPA Communications

EPA may send electronic communications related to specific CDX submissions. In the event
EPA sends an electronic communication, the original submitter will receive a notification to both
their registered email address and inbox within CDX. The notification will inform the user that
there is a new, submission-specific communication available from EPA. Example of EPA
communications include a Notice of Deficiency or an Invoice.
Exhibit 12-1 shows a screen capture of a sample Notice of Deficiency (Email Notification) from
CDX:
Exhibit 12-1 New EPA Communication Email Notification

Exhibit 12-2 shows a screen capture of a sample CDX Inbox Notification:

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
134

Exhibit 12-2 New EPA Communication CDX Inbox Notification

Users can access EPA communications by logging into CDX and navigating to the CSPP
application to which a communication applies. Within the Risk Evaluation Request application,
users should navigate to the TSCA Risk Evaluation ‘Home’ screen, to access EPA
communications. A ‘Closed Envelope’ icon ( ) appears under the ‘Action’ column for a
submission that contains a new EPA communication, and an ‘Open Envelope’ icon ( ) displays
for a submission that contains a previously downloaded EPA communication. To access a
communication, click either the ‘Closed Envelope,’ ‘Open Envelope,’ or ‘Copy of Record’ icon.
To ensure EPA communications are not improperly viewed, access to EPA communications is

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
135

restricted to users who may access the copy of record for a submission. Additionally, EPA
captures and stores CDX user and timestamp data each time an EPA communication is accessed.
Users can also access the invoice sent by personnel on the TSCA Risk Evaluation Home’ screen.
A red ‘Unpaid Invoice’ icon ( ) appears within the ‘Action column for a submission that is
awaiting payment. The invoice icon no longer appears after an invoice has been paid.
Exhibit 12-3 shows a screen capture of the TSCA Risk Evaluation ‘Home’ screen:
Exhibit 12-3 TSCA Risk Evaluation Home Screen

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
136

Navigation: Click the ‘Copy of Record’ or ‘Unpaid Invoice’ icon to navigate to the ‘Enter
Passphrase’ screen.Exhibit 12-4 shows a screen capture of the ‘Enter Passphrase’ screen:
Exhibit 12-4 Enter Passphrase Screen

Navigation: Enter the passphrase associated to this submission and click the ‘Continue’ button
to generate the ‘CROMERR Certification’ window.
Exhibit 12-5 shows a screen capture of the ‘CROMERR Certification’ window:
Exhibit 12-5 Cross-Media Electronic Reporting Regulation (CROMERR) Certification
Window

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
137

Navigation: Click the ‘Accept’ button to generate the ‘eSignature Widget’ window.
Exhibit 12-6 shows a screen capture of the ‘eSignature Widget’ window:
Exhibit 12-6 eSignature Widget

Navigation: Click the ‘Sign’ button on the ‘eSignature Widget’ window to navigate to the
‘Download Copy of Record page.
The ‘Download Communication Documents’ table is located in the middle of the ‘Download
Copy of Record’ screen and displays EPA communications associated with all versions of the
selected submission. The ‘Download Communication Documents’ table includes the following
columns of information:
 Communication Type: Displays the type of EPA communication.
 File Name: Displays the file name of the EPA communication.
 File Size: Displays the file size of the EPA communication.
 Status: Displays the status of the EPA communication. The ‘Closed Envelope’ icon ( )
indicates an un-accessed EPA communication, and the ‘Open Envelope’ icon ( ) indicates
an accessed EPA communication.
 Download: Click the ‘Download’ icon ( ) to download an EPA communication. The
communication file downloads as a PDF.
The ‘Payments’ table is located at the bottom of the ‘Download Copy of Record’ screen and
displays invoices sent to a Risk Evaluation Request. The ‘Payments’ table displays ‘Payment
Communication Type,’ ‘File Name,’ ‘File Status,’ ‘Download,’ ‘Payment Amount,’ ‘Due Date,’
‘Payment Status,’ Payment Received Date,’ and Make a Payment’ columns.
 Payment Communication Type: Displays ‘Invoice’ or ‘Cancelled Invoice.’
 File Name: Displays the file name of the fee invoice PDF.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
138

 File Status: Displays an icon that indicates the status of the invoice; a closed envelope icon
displays with a status of ‘New Communication Documents’ when a user initially accesses the
‘Download Copy of Record’ page.
 Download: Displays a green arrow for a user to download the invoice PDF.
 Payment Amount: Displays the amount of the invoice.
 Due Date: Displays the invoice due date.
 Payment Status: Displays the status of the payment; i.e. ‘Unpaid,’ ‘Payment Received,’ or
‘Invoice Cancelled.’ The status displays ‘Invoice Cancelled’ if an invoice has been cancelled
by EPA personnel.
 Payment Received Date: Displays the date of payment, if the invoice has been paid. ‘No
Payment Information Available’ displays if an invoice is unpaid
 Make a Payment: Displays a ‘Pay Your Invoice Now’ button; click the ‘Pay Your Invoice
Now’ button to generate the ‘CSPP Payment Processor’ window to remit a payment to the
invoice. The ‘Pay Your Invoice Now’ button is not displayed if a user has paid the invoice or
the invoice was cancelled.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
139

Exhibit 12-7 shows a screen capture of the ‘Download Copy of Record’ screen:
Exhibit 12-7 Download Copy of Record Screen

Navigation: Click the ‘Download’ icon ( ) under the ‘Download Communication Documents’
table to download an EPA communication file. Click the ‘Pay Your Invoice Now’ button to
generate the ‘CSPP Payment Processor’ window.
12.1

CSPP Payment Processor

The ‘CSPP Payment Processor’ window provides functionality for you to remit your fee via
debit/credit card or Automatic Clearing House (ACH) payment.
 Credit/Debit Card: Select the radio button to display the credit/debit card fields. This option
is only available for payment amounts less than or equal to $24,999.99.
 Payment Amount: Displays the fee amount the user will be paying.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
140

 Card Number: Enter the credit/debit card number. This is a required field.
 Expiration Date: Select the month and date of the expiration date of the credit/debit card.
This is a required field.
 Security Code: Enter the security code/CCV of the credit/debit card. This is a required field.
 First Name: Enter the first name of the cardholder. This is a required field.
 Last Name: Enter the last name of the cardholder. This is a required field.
 Billing Address 1: Enter line 1 of the billing address. This is a required field.
 Billing Address 2: Enter line 2 of the billing address, if applicable.
 City: Enter the city of the billing address. This is a required field.
 State: Select the state of the billing address from the drop-down menu. This is a required
field.
 Zip: Enter the zip code of the billing address. This is a required field.
 ACH Payment: Select the radio button to display the ACH fields.
 Account Type: Select ‘Business Checking,’ ‘Business Savings,’ ‘Personal Checking,’ or
‘Personal Savings’ to indicate the account type that will be used to remit the fee. This is a
required field.
 Check Number: Enter the check number.
 Use a Company Name: Check the check box to generate a ‘Company Name’ field and pay
on behalf of the reporting company’s name.
 Company Name: Enter the name of the company that is submitting the payment. This is a
required field.
 Routing Number: Enter the routing number of the bank account. This is a required field.
 Account Number: Enter the account number of the bank account. This is a required field.
 Confirm Account Number: Re-enter the account number of the bank account. This is a
required field.
 Submit Payment: Click the button to submit the payment credentials.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
141

Exhibit 12-8 shows a screen capture of the ‘CSPP Payment Processor’ window (ACH Payment):
Exhibit 12-8 CSPP Payment Processor (ACH Payment)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
142

Exhibit 12-9 shows a screen capture of the ‘CSPP Payment Processor’ window (Credit/Debit
Card):
Exhibit 12-9 CSPP Payment Processor (Credit/Debit Card)

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
143

Exhibit 12-10 shows a screen capture of the payment successful message:
Exhibit 12-10 Successful Payment

Navigation: Click the ‘Submit Payment’ button to submit the payment. The application displays
a payment successful message and sends a payment receipt to the submitter. Click the ‘OK’
button on the payment successful message to return to the ‘CSPP Payment Processor’ window.
Click the ‘Close Widget’ button on the ‘CSPP Payment Processor’ window to navigate back to
the ‘Copy of Record’ screen.
12.2

Invoice Communications

EPA may send an invoice communication related to a specific CDX submission. In the event
EPA sends an electronic communication, the original submitter will receive a notification to both
their registered email address and inbox within CDX. The notification will inform the user that
there is a new, submission-specific invoice communication sent from EPA.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
144

Exhibit 12-11 shows a screen capture of the email for Risk Evaluation Request Invoice Email:
Exhibit 12-11 Invoice Communication Email

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
145

Exhibit 12-12 shows a screen capture of the CDX Inbox text for Risk Evaluation Request
Invoices:
Exhibit 12-12 CDX Inbox Invoice Communication

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
146

Exhibit 12-13 shows a screen capture of the Risk Evaluation Request Invoice PDF:
Exhibit 12-13 Risk Evaluation Request Fee Invoice PDF

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
147

Exhibit 12-14 shows a screen capture of the Payment Receipt:
Exhibit 12-14 Risk Evaluation Request Payment Receipt

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
148

Create An Amendment

To amend a submitted Risk Evaluation request, navigate to the Risk Evaluation ‘Home’ screen
and locate a submission that you previously submitted with a status of ‘Completed’ within the
‘Submission History’ table. In addition to displaying a status of ‘Completed’ under the ‘Status’
column, the ‘Lock’ icon ( ) will be displayed under the ‘Action’ column. Click the ‘Lock’ icon
( ) under the ‘Action’ column to start an amendment.
A pop-up window will appear after clicking the ‘Lock’ icon ( ), confirming that you wish to
begin the amendment process. After you click the ‘OK’ button, you will be taken to the ‘Enter
Passphrase’ screen. You must enter the passphrase originally associated with the submission to
start the amendment process. After you enter the passphrase and click the ‘Next’ button, you will
be taken to the first screen in the specific Risk Evaluation request. Refer to Section 3.6 for
further instructions on the ‘Enter Passphrase’ screen.
After a submission has been unlocked, the Risk Evaluation ‘Submission History’ screen will
display a status of ‘In Progress’ under the ‘Status’ column, and the ‘Unlocked’ icon ( ) will
display under the ‘Action’ column; however, you will not see these changes until you navigate
back to the Risk Evaluation ‘Submission History’ screen. The only way to lock the submission
again is by resubmitting it to EPA.
 Refer to Section 4 through Section 4.11 for instructions on editing a revised Risk Evaluation
request.
 Refer to Section 5 through Section 5.5 for instructions on editing a revised Risk Evaluation
request.
 Refer to Section 6 through Section 6.9 for instructions on editing a revised Risk Evaluation
request.
 Refer to Section 7 through Section 7.10 for instructions on editing a revised Risk Evaluation
request.

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
149

Appendix A. Document Types and Subtypes

The following appendix displays the document types and document subtypes available within the
‘Attach Document’ window.
Document Type

Document Subtype

Aquatic Ecotoxicity

Algae Toxicity
Fish Acute Toxicity
Fish Chronic Toxicity
Invertebrate Acute Toxicity
Invertebrate Chronic Toxicity

Chemical Category Rationale

N/A

Chemical Category Substance
List

N/A

Chemical Structure Diagram

N/A

Condition of Use Rationale

N/A

Construct

Construct Data
Construct Methodology
Gene Sequence Data

Correspondence

N/A

Effects

Antibiotic Resistance
Environmental Effects
Human Health Effects
Metabolism
Pathogenicity Data

Fate

BCF/BAF
Biodegradation
Fugacity
Hydrolysis
Monitoring Data (e.g., air, water, soil, biota, human)
Partitioning (e.g., Koc, Kd, Kow, Koa, Henry’s law constant)
Photolysis

Genetic Toxicity

Chromosomal Aberrations Assay
Unscheduled DNA Synthesis
Genetic Mutation Assay

GPC

N/A

Health Toxicity

Acute Toxicity

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
150

Document Type

Document Subtype
Carcinogenicity
Combined Repeated-Dose/Development/Reproductive Toxicity
Dermal Irritation
Developmental Toxicity
Eye Irritation
Immunotoxicity
Neurotoxicity
Pharmacokinetics/Metabolism
Repeated-Dose Toxicity
Reproductive Toxicity
Sensitization

i5Z IUCLID

N/A

i6Z IUCLID

N/A

ID Sequence Data
Other ID Data
Strain History

IES Report

N/A

Inactivation Data

N/A

Interstate Commerce

N/A

Main Submission

N/A

Manufacturing Details

N/A

MSDS

N/A

OECD Harmonized Templates

N/A

Other

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

Process Diagram-Other

N/A

Process Diagram-Submitter

N/A

Published Literature

N/A

Regs and Certifications

N/A

Safety Datasheet (MSDS)

MSDS/SDS
Technical Datasheet

Terrestrial Ecotoxicity

Avian Toxicity
Invertebrate Toxicity
Plant Toxicity

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
151

Document Type

Document Subtype

Use Details

N/A

Risk Evaluation Rule User Guide
Primary Authorized Official

January 16, 2020
152

File Type	application/pdf
File Title	CDX User Guide Template
Author	Robert Parker
File Modified	2020-08-29
File Created	2020-01-21