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
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Table of Contents
Table of Contents i
List of Exhibits iv
1 Introduction 1
2 System Requirements 2
2.1 Supported Browsers 2
2.2 Screen Resolution 2
3 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
4 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
5 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
6 Initial Response 68
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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
7 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
8 Preview 123
9 Validate 125
10 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
11 Download Copy of Record 132
12 EPA Communications 134
12.1 CSPP Payment Processor 140
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12.2 Invoice Communications 144
13 Create An Amendment 149
14 AppendixA. Document Types and Subtypes 150
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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
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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
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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
Exhibitl0-5 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
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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
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1 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
helpdesk@epacdx.net or call 1-888-890-1995 between the hours of 8 am - 6 pm Eastern
Standard Time (EST).
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2 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.
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3 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.
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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
Legend
X=Can Perform Function
//
/
non-US
Create ail original main forms
Submit original main forms
Submit amendments (by editing the main forms)
Unlock all forms
Edit unlocked forms
Delete forms
Assign Supports
Recieve EPA Communications
Pay Invoices
Create all original main forms
Submit original main forms
Submit amendments (by editing the main forms)
Unlock all main forms
Edit unlocked main forms
Delete forms
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.
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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)
A Logged in as: Jane Doe, Primary Authorized Official
Log Out
CHEMICAL INFORMATION SUBMISSION SYSTEM
TSCA Risk Evaluation Rule
OK
The Toxic Substances Control Act as amended by the Frank R. Lautenberg Chemical Safety tor the 21 st Century Act (TSCA)
requires EPA conduct risk evaluations on existing chemicals to determine if the chemical presents an unreasonable risk to
health or the environment, under the conditions of use. While EPA ultimately determines which chemicals undergo evaluation,
TSCA does allow manufacturers, of a given chemical or category of chemicals, to request EPA conduct a risk evaluation on the
chemical or category. Requests for an EPA-conducted risk evaluation will be considered following the completion of this CDX
form.
EPA risk evaluations are required to be conducted on chemicals under their conditions of use, so the requesting manufacturer
{s) must request the condition(s) of use for which the risk evaluation be conducted, with the understanding that EPA may
determine other uses are necessary to consider in the risk evaluation. Conditions of use, as defined by TSCA, are the
circumstances "under which a chemical substance Is intended, known, or reasonably foreseen to be manufactured, processed,
distributed in commerce, used or disposed of."
The requester must provide a list of all the necessary existing information that is relevant to whether the chemical substance,
under the condition(s) of use identified the manufacturers), presents an unreasonable risk of injury to health or the
environment, that will allow the Agency to complete the risk evaluation. The list must be accompanied by an explanation as to
why such information is adequate to permit EPA to complete a risk evaluation addressing the circumstances identified by the
manufacturer(s). 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 the information on the health and environmental hazard(s), human
and environmental exposure(s), and exposed population(s) relevant to the conditions of use identified in the request. At a
minimum, this must include all the following as relevant to the circumstances identified:
The chemical substance's hazard and exposure potential;
The chemical substance's persistence and bioaccumulation;
Potentially exposed or susceptible subpopulations which the manufacturer(s) believes is relevant to the EPA risk
evaluation;
Whether there is any storage of the chemical substance near significant sources of drinking water, including the storage
facility location and the nearby drinking water source(s);
The chemical substance's production volume or significant changes in production volume: and
Any other information relevant to the potential risks of the chemical substance under the circumstances identified in the
request.
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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)
Logged in as: Jane Doe, Primary Authorized Official
Log Out
minimum, this must include all the following as relevant to the circumstances identified:
The chemical substance's hazard and exposure potential;
The chemical substance's persistence and bioaccumulation:
Potentially exposed or susceptible subpopulations which the manufacturer(s) believes is relevant to the EPA risk
evaluation;
Whether there is any storage of the chemical substance near significant sources of drinking water, Including the storage
facility location and the nearby drinking water source(s);
The chemical substance's production volume or significant changes In production volume; and
Any other information relevant to the potential risks of the chemical substance under the circumstances identified in the
request.
The request must include a commitment to provide to EPA any referenced Information upon request. The request may also
include any information that will Inform EPA's determination as to whether restrictions imposed by one or more States have the
potential to have a significant impact on interstate commerce or health or the environment and that as a consequence, the
request is entitled to be preferentially considered for a risk evaluation.
Paperwork Reduction Act Notice
Request for Risk Evaluation: Responses to this collection of information are voluntary but must comply with EPA's procedural
requirements in order to be eligible for EPA consideration (40 CFR 702). This collection of information is approved by OMB
under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0202; EPA ICR No. 2559). The annual
public reporting and recordkeeping burden for this collection of information is estimated to average 96 hours per response.
TSCA User Fee Payment: Responses to this collection of information are mandatory (40 CFR 700.45). This collection of
information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0208;
EPA ICR No. 2569). The annual public reporting and recordkeeping burden for this collection of information is estimated to
range between 5 and 10 minutes per response.
Burden is defined in 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to, respond to a
collection of information unless it displays a currently valid OMB control number. You may send comments regarding the EPA's
need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing
respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division,
U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Please include the
OMB Control No. in any correspondence. Send only comments to this address.
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.
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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.
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Exhibit 3-4 shows a screen capture of the Risk Evaluation 'Home' screen:
Exhibit 3-4 Risk Evaluation Home Screen
HOME USER MANAGEMENT
X Jane Doe, Jane's Company (Primary Authorized C
TSCA Risk Evaluation
Create New Request or Response
Submission History
Create a Risk Evaluation Request or Response to an EPA
Request
Initial Response: Select this form type if you are manufacturer/importer
required to respond to a preliminary list published by EPA in the Federal
Register. Please note that consortium leaders who are not a
manufacturer/importer do not need to submit this form.
EPA Initiated Risk Evaluation: 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.
Manufacturer Requested Risk Evaluation: Select this form type to begin
creating a request for EPA to conduct a Risk Evaluation on the chemical(s)
you manufacture/import.
Withdrawal Request: Select this form type to begin creating a request for
withdrawal of an EPA Initiated Risk Evaluation or Manufacturer Requested
Risk Evaluation. Please note that you may withdraw your request at any
time after the request is made, and within 30 days of receiving EPA's
notification that the request is granted.
Please select the appropriate form type and click the 'Create' button.
EPA Initiated Risk Evaluation [v]
Show 10 [v] entries
Form
Case
Submission
Alias J1
Form Type Number
Date
Status
Action
EIRE-
EPA Initiated Risk
In
X
20191212-
Evaluation
Progress
10:58:25
IR-20191217-
Initial Response
In
X
11:54:28
Progress
MRRE-
Manufacturer
In
X
20191216-
Requested Risk
Progress
16:09:00
Evaluation
WR-
Withdrawal
In
X
20191219-
Request
Progress
12:58:15
Export Options: XML
CSV PDF
Excel
Useful Resources
Risk Evaluation User Guide
Risk Evaluation Rule
Risk Evaluations for Existing Chemicals under TSCA
TSCA Risk Evaluation Guidance
Raise a Bug CDX Links - CDX Helpdesk (888) 890-199ฃ
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
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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 ( ฆ )
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
($) to begin the process of accessing the 'Copy of Record' screen to pay an invoice.
The 'Submission History' table displays the following fields and columns of information:
Show Entries: Select a value from the 'Entries' drop-down menu to specify the number of
entries that display on the current page.
Search: Enter search criteria to filter the submissions within the 'Submission History' table.
Form Alias: Displays the form alias of a Risk Evaluation request. Click the form alias link to
navigate to the 'Enter Passphrase' page and complete/edit a request.
Form Type: Displays 'EPA Initiated Risk Evaluation', 'Initial Response', 'Manufacturer
Requested Evaluation', and 'Withdrawal Request.'
Case Number: Displays the case number of a completed submission in the following format:
, , and . The ' YY' represents the
calendar year in which the request was submitted, and the 'XXXX' represents the order in
which the request was received. Each submitted request generates a single case number.
Submission Date: Displays the date that a form was successfully submitted to EPA via
CDX. This date populates only after the request has been submitted.
Status: Displays the status of a Risk Evaluation request (e.g., 'In Progress,' 'Submitted,'
'Completed,' 'Completed - Awaiting Payment,' or 'Completed - Payment Received').
Action: Click the 'Copy of Record' icon ( ) to navigate to the 'Enter Passphrase' screen to
continue to the 'Copy of Record' screen. The 'Copy of Record' icon displays only after the
request has been completed. Click the 'Delete' icon (<^) to delete an in-progress request.
Click the 'Lock' icon ( ฆ ) to unlock a request for an amendment. The request remains
unlocked and will display the 'Unlocked' icon ( ฆ ) until the request is resubmitted by the
AO. Click the red 'Unpaid Invoice' icon ($) 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.
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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
HOME USER MANAGEMENT
TSCA Risk Evaluation
Create New Request or Response
Submission History
A Jane Doe, TEST ORGANIZATION LLC (Primary Authorized Officials
Create a Risk Evaluation Request or Response to an EPA Request
Initial Response: Select this form type if you are manufacturer/importer required to
respond to a preliminary list published by EPA in the Federal Register. Please note
that consortium leaders who are not a manufacturer/importer do not need to submit
this form.
EPA Initiated Risk Evaluation: 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.
Manufacturer Requested Risk Evaluation: Select this form type to begin creating a
request for EPA to conduct a Risk Evaluation on the chemical(s) you
manufacture/import.
Withdrawal Request: Select this form type to begin creating a request for
withdrawal of an EPA Initiated Risk Evaluation or Manufacturer Requested Risk
Evaluation Please note that you may withdraw your request at any time after the
request is made, and within 30 days of receiving EPA's notification that the request is
granted.
Please select the appropriate form type and click the 'Create' button.
EPA Initiated Risk Evaluation [v] | I
Useful Resources
Risk Evaluation User Guide
Risk Evaluation Rule
Risk Evaluations for Existing Chemicals under TSCA
TSCA Risk Evaluation Guidance
Show 10 [Vj entries
Form Alias |=
Form Type
Case
Number
Submission
Date
Status
Action
RER-
20170608-
16:14:24
Manufacturer
Requested Risk
Evaluation
MRRE-17-
0053
07/19/2017
In Progress
RER-
20170823-
11:37:06
Manufacturer
Requested Risk
Evaluation
Processing
ฑ
RER-
20170911-
09:47:09
Manufacturer
Requested Risk
Evaluation
MRRE-17-
0071
09/11/2017
Completed
RER-
20180907-
10:48:16
Manufacturer
Requested Risk
Evaluation
MRRE-18-
0183
09/07/2018
Completed -
Awaiting
Payment
ฑ $ a
RER-
20180919-
16:18:15
Manufacturer
Requested Risk
Evaluation
MRRE-18-
0215
09/19/2018
Completed -
Payment
Received
ฑm
RER-
20181024-
14:10:06
Manufacturer
Requested Risk
Evaluation
MRRE-18-
0256
10/25/2018
Completed -
Awaiting
Payment
ฑE*j| $ gg
RER-
20181025-
11:51:53
Manufacturer
Requested Risk
Evaluation
MRRE-18-
0257
10/25/2018
In Progress
ฑ m
RER-
20181105-
10:32:09
Manufacturer
Requested Risk
Evaluation
In Progress
X
WR-20171109-
Withdrawal Request
In Progress
X
Raise a Bug CDX Links - CDX Helpdesk: (888) 890-1995
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.
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Primary Authorized Official
January 16, 2020
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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 ป'
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
ป' 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 'ซ 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 ป: Click the button to move selected Supports and/or Primary Agents/Consultants
from the 'Unassigned' box to the 'Assigned' box.
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ซ 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
HOME USER MANAGEMENT
ฑ Jane Doe, TEST ORGANIZATION LLC (Primary Authorized Official)
User Management
The Authorized Official is responsible for restricting a Support's access to select forms by assigning or un-assigning them. The Support can access and edit only
those forms for which the Authorized Official has granted access. Select a specific form from the Form ID drop-down menu and assign a Support to the form by
highlighting the individual and clicking the Add button. To un-assign a Support, highlight the individual and click the Remove button. To highlight and assign or
un-assign multiple Supports, hold down the Ctrl or Shift keys on the keyboard and click each Support before moving. You must click the Save button after each
assignment.
Form T
Alias:
Form Information
Assign Supports
Unassigned
ฆ
Add ป
I
ฆ
M Remove
ฆ
ฆ
Save
1
Assigned
Raise a Bug CDX Links - CDX Helpdesk: (888) 890-1995
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' drop-
down 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
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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
HOME USER MANAGEMENT
A. Jane Doe, TEST ORGANIZATION LLC (Primary Authorized Official)
TSCA Risk Evaluation
New Passphrase
Confirm Passphrase
A You are responsible for remembering your
passphrase!
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.
Raise a Bug CDX Links- CDX Helpdesk: (888)890-1995
Risk Evaluation Rule User Guide
Primary Authorized Official
January 16, 2020
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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
HOME USER MANAGEMENT
A Jane Doe, TEST ORGANIZATION LLC (Primary Authorized Official)
TSCA Risk Evaluation RER-20170821-16:00:15
Enter Passphrase
Form Alias
RER-20170821-16:00:15
Enter Passphrase
A You are responsible for remembering your
passphrase!
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.
Raise a Bug CDX Links- CDX Helpdesk: (888)890-1995
Risk Evaluation Rule User Guide
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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 right-
hand corner of the form in your browser to close the request without saving.
Exhibit 3-9 Action Bar - Save
H Save
a
Preview ~Validate 05 Submit
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
H Save
a
Preview ~\falidate Q Submit
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.
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Exhibit 3-11 Action Bar-Validate
H Save
Preview ~Validate Q Submit
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
H Save
a
Preview ~Validate 05 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
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Exhibit 3-13 CDX Links
CDX Homepage
MyCDX Homepage
EPA Homepage
Terms and Conditions
Privacy Notice
Raise a Bug CDX Links ^
CDX Helpdesk: (888) 890-1995
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4 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 auto-
generates a default alias comprised of a form type, date stamp, and time stamp in the following
format: |