TDD 9.21 OPPT MTS Section 4 User Guide - Primary Authorized Official v1.0

Section 4 User Guide – Primary
Authorized Official
Environmental Protection Agency
Office of Pollution Prevention and Toxics
Manage Toxic Substances

Delivery Order # GS00Q09BGD0022
Task Order # EP-G11H-00154
Project # TDD 9.21
Version v1.0
October 22, 2013

Table of Contents
1

Introduction ........................................................................................................................8
1.1

2

Labeling Confidential Information .................................................................................8
System Requirements ......................................................................................................11

2.1

Supported Browsers ...................................................................................................11

2.2

Screen Resolution ......................................................................................................11

3

Primary Authorized Official Functions ...............................................................................12
3.1

Log into Section 4 application .....................................................................................12

3.2

Home Screen Navigation ............................................................................................13

3.3

User Management ......................................................................................................15

3.4

Create New Submission .............................................................................................17

3.4.1

Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766 Submissions Screen ......... 17

3.4.2

Create Passphrase Screen ...................................................................................20

3.4.3

Enter Passphrase Screen .....................................................................................21

3.4.4

Navigation Tree ....................................................................................................21

3.4.5

Action Bar .............................................................................................................26

4

Test Rules ........................................................................................................................29
4.1

Submission Information Type Screen .........................................................................29

4.2

Technical Contact Information Screen ........................................................................30

4.3

Submitting on Behalf of Consortium Screen ...............................................................34

4.4

Submitting on Behalf of Company Screen ..................................................................36

4.5

Letter of Intent ............................................................................................................38

4.5.1

Chemical Identification and Test Rules Screen .....................................................39

4.5.2

Sponsoring Firms Screen .....................................................................................42

4.5.3

Additional Information and Submitter Requests Screen ........................................ 44

4.6

Study Plan ..................................................................................................................51

4.6.1

Document Management Screen ...........................................................................51

4.6.2

Additional Information and Submitter Requests Screen ........................................ 54

4.7

Test Rules Substantiation ...........................................................................................61

4.7.1

Test Rules Substantiation Part 1 Screen...............................................................61

4.7.2

Test Rules Substantiation Part 2 Screen...............................................................64

4.8
4.8.1
4.9

Results .......................................................................................................................66
Document Management Screen ...........................................................................67
Optional Substantiation...............................................................................................70

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Primary Authorized Official

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4.9.1
5

Optional Document Management Screen .............................................................70

Enforceable Consent Agreements (ECAs)........................................................................73
5.1

Submission Information Type Screen .........................................................................73

5.2

Technical Contact Information Screen ........................................................................74

5.3

Submitting on Behalf of Company Screen ..................................................................78

5.4

Study Plans ................................................................................................................80

5.4.1

Principal Test Sponsor Screen..............................................................................80

5.4.2

Principal Sponsor Organization Screen ................................................................81

5.4.3

Testing Facilities Screen .......................................................................................83

5.4.4

Study Professionals Screen ..................................................................................87

5.5

Results .......................................................................................................................90

5.5.1
5.6
6

Document Management Screen ...........................................................................90
ECA Additional Information Screen.............................................................................94

Memorandum of Understanding (MOU) ............................................................................98
6.1

Submission Information Type Screen .........................................................................98

6.2

Technical Contact Information Screen ........................................................................99

6.3

Submitting on Behalf of Company Screen ................................................................ 103

6.4

Study Plans & Conduct of Testing ............................................................................ 104

6.4.1

Principal Test Sponsor Screen............................................................................ 104

6.4.2

Principal Sponsor Organization Screen .............................................................. 106

6.4.3

Testing Facilities Screen .....................................................................................108

6.4.4

Study Professionals Screen ................................................................................111

6.5

Results .....................................................................................................................114

6.5.1
6.6
7

Document Management Screen ......................................................................... 114
MOU Additional Information Screen.......................................................................... 116

40 CFR 766 Dibenzodioxins/Dibenzofurans ................................................................... 119
7.1

Submission Information Type Screen ....................................................................... 119

7.2

Technical Contact Information Screen ...................................................................... 121

7.3

Submitting on Behalf of Consortium Screen ............................................................. 124

7.4

Submitting on Behalf of Company Screen ................................................................ 126

7.4.1
7.5
7.5.1
7.6
7.6.1

Chemical Identification Screen............................................................................ 127
Letter of Intent ..........................................................................................................128
Sponsoring Firms Screen ...................................................................................128
Protocol ....................................................................................................................130
Protocol Document Management Screen............................................................ 130

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Primary Authorized Official

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7.7

Results .....................................................................................................................133

7.7.1
7.8

Document Management Screen ......................................................................... 133
User Requests ..........................................................................................................136

7.8.1

Waiver Screen ....................................................................................................136

7.8.2

Exclusion Screen ................................................................................................139

7.8.3

Exemption Screen ..............................................................................................142

8

Validate ..........................................................................................................................145

9

Submit to EPA via CDX ..................................................................................................147
9.1

Submitting Official Information Screen ...................................................................... 147

9.2

Submission Process: Validation Screen ................................................................... 148

9.3

Cross-Media Electronic Reporting Regulation (CROMERR) Certification Screen ..... 149

9.4

Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen ............... 150

9.5

Cross-Media Electronic Reporting Regulation (CROMERR) Security Question Screen151

9.6

Submit to CDX Screen..............................................................................................152

9.7

Cross-Media Electronic Reporting Regulation (CROMERR) Submission Screen...... 153

10

Download Copy of Record ..............................................................................................155

11

Create an Amendment ...................................................................................................158

12

Resources ......................................................................................................................161

Appendix A. Definitions, Acronyms, and Abbreviations ........................................................... 162
Appendix B. Submission Types, Effects, and Endpoints ......................................................... 163

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Primary Authorized Official

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List of Exhibits
Exhibit 3-1 Chemical Information Submission System Screen ..................................................13
Exhibit 3-2: Section 4 Home Screen..........................................................................................15
Exhibit 3-3: User Management Screen ......................................................................................16
Exhibit 3-4: Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766 Submissions Screen .......... 19
Exhibit 3-5: Create Passphrase Screen.....................................................................................20
Exhibit 3-6 Enter Passphrase Screen........................................................................................21
Exhibit 3-7: Navigation Prompt ..................................................................................................22
Exhibit 3-8: Test Rules Navigation Tree ....................................................................................23
Exhibit 3-9: ECA Navigation Tree ..............................................................................................24
Exhibit 3-10: MOU Navigation Tree ...........................................................................................25
Exhibit 3-11: 40 CFR 766 Navigation Tree ................................................................................26
Exhibit 3-12: Action Bar – Validate ............................................................................................27
Exhibit 3-13: Action Bar – Save .................................................................................................27
Exhibit 3-14: Action Bar – Preview ............................................................................................27
Exhibit 3-15: Action Bar – Submit ..............................................................................................27
Exhibit 3-16: Action Bar – Help Links ........................................................................................28
Exhibit 4-1: Submission Information Type Screen .....................................................................30
Exhibit 4-2: Technical Contact Information Screen ....................................................................33
Exhibit 4-3: Submitting on Behalf of Consortium Screen ...........................................................36
Exhibit 4-4: Submitting on Behalf of Company Screen ..............................................................38
Exhibit 4-5: Chemical Identification and Test Rules Screen.......................................................40
Exhibit 4-6: Chemical Management Pop-Up Window ................................................................41
Exhibit 4-7: Chemical Identification and Test Rules Screen (Populated) ................................... 42
Exhibit 4-8: Sponsoring Firms Screen .......................................................................................44
Exhibit 4-9: Additional Information and Submitter Requests Screen .......................................... 47
Exhibit 4-10: Amendment to the Study Plan Pop-Up Window....................................................48
Exhibit 4-11: Exemption Application Pop-Up Window................................................................48
Exhibit 4-12 Extension of Time to Submit Study Plan Pop-Up Window ..................................... 49
Exhibit 4-13: Modification of Test Standards or Schedules during Conduct of Test Pop-Up
Window .....................................................................................................................................49
Exhibit 4-14: Submission of Equivalence Data Pop-Up Window................................................ 50
Exhibit 4-15: Appeal of Denial of Exemption Application Pop-Up Window ................................. 50
Exhibit 4-16 Document Management Screen ............................................................................52
Exhibit 4-17 Document Management Pop-Up Window ..............................................................54
Exhibit 4-18 Additional Information and Submitter Requests Screen ......................................... 57
Exhibit 4-19 Amendment to the Study Plan Pop-Up Window.....................................................58
Exhibit 4-20 Exemption Application Pop-Up Window.................................................................58
Exhibit 4-21 Extension of Time to Submit Study Plan Pop-Up Window ..................................... 59
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Primary Authorized Official

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Exhibit 4-22 Modification of Test Standards or Schedules during Conduct of Test Pop-Up
Window .....................................................................................................................................59
Exhibit 4-23 Submission of Equivalence Data Pop-Up Window.................................................60
Exhibit 4-24 Appeal of Denial of Exemption Application Pop-Up Window .................................. 61
Exhibit 4-25: Test Rules Substantiation Part 1 Screen ..............................................................63
Exhibit 4-26: Test Rules Substantiation Part 2 Screen (Scroll 1) ............................................... 65
Exhibit 4-27: Test Rules Substantiation Part 2 Screen (Scroll 2) ............................................... 66
Exhibit 4-28 Results Document Management Screen ...............................................................68
Exhibit 4-29 Results Document Management Pop-Up Window .................................................70
Exhibit 4-30: Optional Document Management Screen .............................................................71
Exhibit 4-31: Optional Substantiation Document Management Pop-Up Window ....................... 72
Exhibit 5-1 Submission Information Type Screen ......................................................................74
Exhibit 5-2 Technical Contact Information Screen .....................................................................77
Exhibit 5-3 Submitting on Behalf of Company Screen ...............................................................79
Exhibit 5-4 Principal Test Sponsor Screen ................................................................................81
Exhibit 5-5 Principal Sponsor Organization Screen ...................................................................83
Exhibit 5-6 Testing Facilities Screen (Scroll 1) ..........................................................................86
Exhibit 5-7: Testing Facilities Screen (Scroll 2) .........................................................................87
Exhibit 5-8 Study Professionals Screen (Scroll 1) .....................................................................89
Exhibit 5-9: Study Professionals Screen (Scroll 2) ....................................................................90
Exhibit 5-10 Document Management Screen ............................................................................92
Exhibit 5-11 Document Management Pop-Up Window ..............................................................94
Exhibit 5-12 ECA Additional Information Screen .......................................................................96
Exhibit 5-13 Amendment to the Study Plan Pop-Up Window.....................................................96
Exhibit 5-14 Modification of ECAs Pop-Up Window ...................................................................97
Exhibit 6-1: Submission Information Type Screen ..................................................................... 99
Exhibit 6-2 Technical Contact Information Screen ................................................................... 102
Exhibit 6-3 Submitting on Behalf of Company Screen ............................................................. 104
Exhibit 6-4 Principal Test Sponsor Screen .............................................................................. 106
Exhibit 6-5 Principal Sponsor Organization Screen ................................................................. 108
Exhibit 6-6 Testing Facilities Screen (Scroll 1) ........................................................................ 110
Exhibit 6-7: Testing Facility Screen (Scroll 2) .......................................................................... 111
Exhibit 6-8 Study Professionals Screen...................................................................................113
Exhibit 6-9 Document Management Screen ............................................................................ 115
Exhibit 6-10 Document Management Pop-Up Window ............................................................ 116
Exhibit 6-11 MOU Additional Information Screen .................................................................... 117
Exhibit 6-12 Amendment to the Study Plan Pop-Up Window................................................... 118
Exhibit 6-13 Modification of MOUs Pop-Up Window ................................................................ 118
Exhibit 7-1 Submission Information Type Screen .................................................................... 120
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Primary Authorized Official

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Exhibit 7-2 Technical Contact Information Screen ................................................................... 123
Exhibit 7-3 Submitting on Behalf of Consortium Screen .......................................................... 125
Exhibit 7-4 Submitting on Behalf of Company Screen ............................................................. 127
Exhibit 7-5 Chemical Identification Screen ..............................................................................128
Exhibit 7-6 Sponsoring Firms Screen ......................................................................................130
Exhibit 7-7 Document Management Screen ............................................................................ 132
Exhibit 7-8 Protocol Document Management Pop-Up Window ................................................ 133
Exhibit 7-9 Document Management Screen ............................................................................ 135
Exhibit 7-10 Document Management Pop-Up Window ............................................................ 136
Exhibit 7-11 Waiver Screen .....................................................................................................138
Exhibit 7-12 Waiver Document Management Pop-Up Window ................................................ 139
Exhibit 7-13 Exclusion Screen.................................................................................................141
Exhibit 7-14 Exclusion Document Management Pop-Up Window ............................................ 142
Exhibit 7-15 Exemption Screen ...............................................................................................143
Exhibit 7-16 Exemption Document Management Pop-Up Window .......................................... 144
Exhibit 8-1 Section 4 Validation Pop-Up Window .................................................................... 146
Exhibit 9-1 Submitting Official Information Screen................................................................... 147
Exhibit 9-2 Submission Process: Validation Screen ................................................................ 148
Exhibit 9-3 Submission Process: PDF Generation Screen ...................................................... 149
Exhibit 9-4 Cross-Media Electronic Reporting Regulation (CROMERR) Certification Screen .. 150
Exhibit 9-5 Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen ............ 151
Exhibit 9-6 Cross-Media Electronic Reporting Regulation (CROMERR) Security Question
Screen ....................................................................................................................................152
Exhibit 9-7 Submit to CDX Screen ..........................................................................................153
Exhibit 9-8 Cross-Media Electronic Reporting Regulation (CROMERR) Submission Screen .. 154
Exhibit 10-1 Download Copy of Record Screen....................................................................... 156
Exhibit 10-2 Download Prompt Pop-Up Window ..................................................................... 157
Exhibit 11-1 Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766 Submissions – Amendment159
Exhibit 11-2 Unlock Prompt Message .....................................................................................160
Exhibit 12-1 Resources Screen ...............................................................................................161

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Primary Authorized Official

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1

Introduction

This document represents the user guide for the Office of Pollution Prevention and Toxics
(OPPT) Section 4 application submission process. This document is the user guide for the
Primary Authorized Official (AO) user of the Section 4 tool.
The Primary AO is the person legally responsible for the submission of Section 4 Test Rules,
ECA, MOU, and 40 CFR 766 for the reporting company. The AO, typically, is a senior official
for the reporting company and may be the supervisor of the person (or persons) completing the
form.
As a Primary AO, you can create a new form. You can also assign Supports to edit and complete
forms on your behalf. You are responsible for submitting all required information and are legally
responsible for the information submitted to EPA within each Section 4 Test Rules, ECA, MOU,
and 40 CFR 766 submission.
General information on Section 4 is available at
http://www.epa.gov/oppt/chemtest/ereporting/index.html. Information on CDX registration,
including user roles that apply to completing a Section 4 is available at
http://cdx.epa.gov/About/UserGuide
Toxic Substances Control Act (TSCA) regulations require industry to provide the Environmental
Protection Agency (EPA) with documentation regarding chemical production, manufacture,
distribution, use, disposal, import, and export. As a result, the implementation of TSCA has
generated a large volume of documents submitted to the Agency by the regulated community.
The Section 4 application is the electronic, web-based tool provided by the Environmental
Protection Agency (EPA) for the submission of Section 4 data. As a Primary AO, you can create
or modify a Section 4 submission as well as submit it to EPA via the Central Data Exchange
(CDX). You can also create Section 4 submission amendments and download the Copy of
Record (CoR).
For questions concerning the Toxic Substances Control Act (TSCA) Section 4 software
requirements, please contact the CDX Help Desk at [email protected] or call 1-888-8901995 between the hours of 8am – 6pm Eastern Standard Time (EST). For TSCA Section 4
requirements, please contact the TSCA Hotline at [email protected] or call 202554-1404
Please note: Any person who submits a positive test result for a specific chemical substance
listed under section 766.25 must submit to EPA, no later than 90 days after the date of
submission, a completed 7710-51 form. The form can be downloaded from the following link:
http://www.epa.gov/oppt/chemtest/pubs/7710-51.pdf.
1.1

Labeling Confidential Information

This user guide presents instructions and screenshots for the ‘Section 4 Test Rules, ECA, MOU,
and 40 CFR 766 submission’ electronic application as if you were logged in as the Primary AO.
As the Primary AO you are able to create, modify, delete, and submit a Section 4 submission.
The user may claim certain information as Confidential Business Information (CBI). If the data
is claimed as CBI, it will be treated in accordance with Agency confidentiality regulations at 40
CFR part 2, subpart B.

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Primary Authorized Official

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This TSCA Section 4 Test Rules, ECA, MOU, and 40 CFR 766 submission electronic
application is optional for the production and submission of these filings. The paper option for
filing will continue to be allowed.
Potential users may find that the use of this application saves time, burden and, because it is in an
electronic format, provides easy access to reporting forms. Potential users are reminded to
carefully read and follow application instructions. Persons who wish to use this application must
address all provisions in the application, including those relating to indexing information (i.e.,
company name, address, chemical name etc.) and those related to CBI submissions, including the
requirement for the submission of sanitized or redacted filings.
Please note that certain CBI claims will not be accepted if you choose to use this electronic
application for TSCA Section 4 Test Rules, ECA, MOU, and 40 CFR 766 submission. For
example, chemical name and/or chemical identity, if the chemical is listed on the public portion
of the TSCA Inventory, may not be claimed as CBI in a submission using this application.
If the user believes that these or other data elements should be treated as CBI, then the user may
use the paper option to file the Section 4 submission form and assert CBI claims.
If the user claims an uploaded document as CBI, a sanitized document must be provided.
The following fields can be claimed as CBI within the ‘Section 4 Test Rules, ECA, MOU, and
40 CFR 766’ submission application:
• Test Rules:
o Technical Contact Information
o Submitting on Behalf of Consortium information
o Submitting on Behalf of Company information
o A single chemical substance and associated chemical test(s)
o Sponsoring Firm information
o Study Plan document(s)
o Submission of Equivalence Data document(s)
o Result document(s)
o Official Submitter Information
• ECA:
o
o
o
o
o
o
o

Technical Contact Information
Submitting on Behalf of Company information
Principal Test Sponsor information
Principal Sponsor Organization information
Testing facility’s contact role information
Study Professional information
Results document(s)

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Primary Authorized Official

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o Official Submitter Information
• MOU:
o
o
o
o
o
o
o
o

Technical Contact Information
Submitting on Behalf of Company information
Principal Test Sponsor information
Principal Sponsor Organization information
Testing facility’s contact role information
Study Professional information
Results document(s)
Official Submitter Information

• 40 CFR 766:
o Technical Contact Information
o Submitting on Behalf of Consortium information
o Submitting on Behalf of Company information
o A single chemical substance
o Sponsoring Firm
o Protocol document(s)
o Results document(s)
o Waiver document(s)
o Exclusion document(s)
o Exemption document(s)
o Official Submitter Information

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Primary Authorized Official

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2

System Requirements

To use the Section 4 application the following are required:
• An e-mail account
• A supported web browser (see Section 2.1 below) with Java Script enabled
• 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 Section 4 application:
• Internet Explorer 7 or above
− Go to the following link to download:
http://windows.microsoft.com/en-US/internet-explorer/downloads/ie
• Mozilla Firefox 3.5 or above
− Go to the following link to download:
http://www.mozilla.com/en-US/firefox/all-older.html
• Safari 4 or above
− Go to the following link to download:
http://support.apple.com/kb/dl877
• Google Chrome
− Go to the following link to download:
http://www.google.com/chrome
2.2
Screen Resolution
• Screen resolution should be set to 1024 x 768 or greater.

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Primary Authorized Official

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3

Primary Authorized Official Functions

This section describes how to:
• Access the application
• Navigate the Section 4 ‘Home’ screen
• Assign Support users to complete a submission
• Start and complete a Section 4 submission
• Submit to EPA via CDX
• Download the Copy of Record
• Create an amendment
The Primary AO is the person legally responsible for the submission of Section 4 data for the
reporting company. The Primary AO is typically a senior official for the reporting company and
may be the supervisor of the person (or persons) completing the submission.
As a Primary AO, you can create a new submission and assign Supports to edit and complete the
submission on your behalf. You are responsible for submitting all required information and are
legally responsible for the information submitted to EPA within each Section 4 submission.
You can save a submission at any point during the data entry process. The save functionality will
allow you to return to that same submission at any point in the future. You can print the
submission document at any point; however, the ‘Not for Submission’ watermark will be placed
on the portable document format (PDF) each time the submission is printed.
3.1

Log into Section 4 application

After you create an account in CDX and click the ‘Primary Authorized Official’ link, you will be
taken to the ‘Chemical Information Submission System’ screen.
Note: Information on CDX registration, including user roles that apply to completing a Section 4
is available at http://cdx.epa.gov/About/UserGuide.
Exhibit 3-1 shows a screen capture of the ‘Chemical Information Submission System’ screen:

OPPT MTS Section 4 User Guide
Primary Authorized Official

October 22, 2013
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Exhibit 3-1 Chemical Information Submission System Screen

Navigation: Select ‘TSCA Section 4’ from the drop-down menu and click the ‘OK’ button to
navigate to the Section 4 ‘Home’ screen.
3.2

Home Screen Navigation

You can access the Section 4 ‘Home’ screen by selecting the ‘TSCA Section 4’ submission type
from the ‘Chemical Information Submission System’ screen drop-down menu and clicking the
‘OK’ button.
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Primary Authorized Official

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The Section 4 ‘Home’ screen is the first screen within the Section 4 application. It provides you
with links and tabs to access the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766,’ ‘User
Management,’ and ‘Resources’ screens as shown in Exhibit 3-3, Exhibit 3-4, and Exhibit 12-1.
To navigate to any of these screens, click the screen link (located in the middle of the Section 4
‘Home’ screen highlighted in blue), or click the screen tab (located within the application
header). The links and tabs provide the same functionality.
• Submissions: Click the ‘Submissions’ link or tab to navigate to the ‘Section 4 Test Rules,
ECAs, MOUs, and 40 CFR 766’ submissions screen. You can create or modify a Section 4
submission using the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions
screen. For additional details about the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR
766’ submissions screen, please refer to Section 3.4.1.
• User Management: Click the ‘User Management’ link or tab to navigate to the ‘User
Management’ screen. You can manage the access rights of Supports per submission using
the ‘User Management’ screen. For additional details about the ‘User Management’ screen,
please refer to Section 3.3.
• Resources: Click the ‘Resources’ link or tab to navigate to the ‘Resources’ screen. You
can view the Section 4 user guide, as well as useful links for further usability instructions
on the ‘Resources’ screen. For additional details about the ‘Resources’ screen, please refer
to Section 12.

OPPT MTS Section 4 User Guide
Primary Authorized Official

October 22, 2013
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Exhibit 3-2 shows a screen capture for the Section 4 ‘Home’ screen:
Exhibit 3-2: Section 4 Home Screen

Navigation: Click the ‘User Management’ link or tab to access the ‘User Management’ screen
and assign Supports.
3.3

User Management

You can access the ‘User Management’ screen by clicking the ‘User Management’ link or tab
from the Section 4 ‘Home’ screen.
On the ‘User Management’ screen, you can assign your Supports to fill out the Section 4
submission for a given submission type. You have the ability to assign access to one or more
Supports to modify any of the Section 4 submissions you have created. To grant a Support access
to a Section 4 submission, you must create a new submission and assign a passphrase to that
submission. You can also assign different Supports to fill out the Section 4 submission for each
submission type.
Section 4 Submission: A submission type will not be available in this menu until it has been
created. Select a submission type from the drop-down menu to begin assigning Supports. Once a
submission type has been selected, the ‘Assign Users’ group box will update to display only the
Supports who have identified you as their Primary AO during CDX registration.
Assign Users: This box shows all the Supports you can assign to complete a Section 4
submission for the submission type selected. To move Supports from the ‘Unassigned’ group
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Primary Authorized Official

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box to the ‘Assigned’ group box, highlight the individual or multiple Supports and click the ‘add
>>’ button.
• Unassigned: This box contains the registered Supports associated to the Authorized
Official who can be assigned to access and edit the selected submission. To highlight
multiple Supports hold down the key on your keyboard while clicking each Support.
To highlight multiple consecutive Supports, hold down the key on your keyboard
while clicking the first and last Support.
• Assigned: This box contains the registered Supports who have been given permission, by
the Authorized Official, to access and edit the selected submission. To move Supports from
the ‘Assigned’ group box to the ‘Unassigned’ group box highlight individual or multiple
Supports and click the ‘<< remove’ button. To highlight multiple Supports hold down the
key on your keyboard and click each Support. To highlight multiple consecutive
Supports hold down the key on your keyboard and click the first and last Support.
When you have finished assigning Supports, click the ‘Save’ button to save the assignments.
Exhibit 3-3 shows a screen capture of the ‘User Management’ screen:
Exhibit 3-3: User Management Screen

OPPT MTS Section 4 User Guide
Primary Authorized Official

October 22, 2013
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Navigation: Click the ‘Submissions’ tab located within the application header to navigate to the
‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen and start or access a
submission.
3.4

Create New Submission

As a Primary AO, you can start a new submission and assign your Supports to complete the
submission.
3.4.1

Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766 Submissions Screen

You can access the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen
by clicking the ‘Submissions’ link from the Section 4 ‘Home’ screen, or by clicking the
‘Submissions’ tab located within the application header.
Only one Section 4 submission is created per submission type. Each column within the table of
the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen can be sorted by
clicking the column headers.
Start a New Submission: To create a new Section 4 submission, select the submission type
from the ‘Submission Type’ drop-down menu and click the ‘Start New Submission’ button. You
will be required to create a passphrase that will be associated with that particular submission.
Make sure to create a passphrase that you will remember, as it cannot be retrieved or reset. Refer
to Section 3.4.2 for further instructions on creating a new passphrase.
Edit a Submission: To modify an existing Section 4 submission, click the submission alias link
for a submission that has a status of ‘In Progress.’ You will be required to enter the passphrase
associated with that particular submission to access and continue editing the submission. Refer to
Section 3.4.3 for further instructions on viewing and modifying a submission that is ‘In
Progress.’
Submitted Submission: To edit a submission that has previously been submitted (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 to amend the submission. All changes will be submitted as
an amendment. Refer to Section 11 for further instructions on creating an amendment.
The ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submission screen displays the
following columns:
• Submission Alias: Displays the submission alias that is generated from the ‘Submission
Information Type’ screen. The ‘Submission Alias’ column will display as a time stamp
unless a unique alias was provided on the ‘Submission Information Type’ screen. The
purpose of the submissions alias is to help identify each Section 4 submission when there is
more than one.
• CFR/FRN: Displays the Code of Federal Regulation/Federal Register Notice (CFR/FRN)
that was selected on the ‘Submission Information Type’ screen.
• Status: Displays the status of the Section 4 submission. The column will display values as
either ‘In Progress’ or ‘Submitted.’
• Modify Date: Displays the date the submission was last modified.
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• Submission Date: Displays the date when you submitted the form to CDX. This date is
populated only after you submit.
• Copy of Record: Click the ‘Copy of Record’ icon to continue the download copy of record
process. The ‘Copy of Record’ icon displays only after you submit to EPA via CDX. The
‘Copy of Record’ icon is confirmation that your submission has been successfully received
by EPA. Note that the ‘Copy of Record’ icon may take 15-20 minutes to display on the
‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen. Refer to
Section 10 for further instructions on downloading the copy of record.
• Action: Displays a ‘Delete’ icon ( ) for all forms with a status of ‘In Progress.’ Displays
a ‘Lock’ icon ( ) for all forms that have been submitted. Only an AO can unlock a form
by clicking the ‘Lock’ icon ( ) and unlocking the form. The form will remain unlocked
and display the ‘Unlocked’ icon (
) until the form is resubmitted by the AO.
• Export Options: Displays ‘CSV,’ ‘Excel,’ ‘XML,’ and ‘PDF’ links for you to export the
‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen in one of the
specified formats as an Excel spreadsheet, Comma-Separated Values (CSV), Extensible
Markup Language (XML), or PDF.
• Submission Type: Displays the four types of submission you may report on. This dropdown menu contains the following values: ‘Test Rules,’ ‘ECA,’ ‘MOU,’ and ‘40 CFR 766
Dibenzodioxins/Dibenzofurans.’ This field is required.
• Start New Submission: Click the ‘Start New Submission’ button once a submission type
has been selected from the drop-down menu. You will be taken to the ‘Create New
Passphrase’ screen.

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Exhibit 3-4 shows a screen capture of the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’
submissions screen:
Exhibit 3-4: Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766 Submissions Screen

Navigation: Select a submission type from the drop-down menu and click the ‘Start New
Submission’ button to navigate to the ‘Create Passphrase’ screen.

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3.4.2

Create Passphrase Screen

To start a new Section 4 submission, select a submission type from the ‘Submission Type’ dropdown menu and click the ‘Start New Submission’ button on the ‘Section 4 Test Rules, ECAs,
MOUs, and 40 CFR 766’ submissions screen. The ‘Create Passphrase’ screen allows you to
create a passphrase and associate that passphrase with the submission.
The application uses the passphrase as an encryption key to protect the contents of the
submission. You are responsible for remembering the passphrase and distributing it to the
appropriate individuals.
New Passphrase: To associate a passphrase with a submission, enter a passphrase that is at least
8 characters in length. To protect your account, your passphrase should contain a combination of
letters and numbers. The passphrase you create may include spaces, but should not contain
special characters (for example, +, and *). You can associate the same passphrase with multiple
submissions.
You will be responsible for remembering the passphrase and distributing it to only authorized
Supports for the submission. If you forget the passphrase, you will not be able to access the
Section 4 submission to print, submit, or make changes. If you lose or forget the passphrase, you
must create a new submission and passphrase. For security reasons, the system administrator
does not have access to the passphrase and will not be able to retrieve it or reset it to a new one.
Exhibit 3-5 shows a screen capture of the ‘Create Passphrase’ screen:
Exhibit 3-5: Create Passphrase Screen

Navigation: Create a passphrase and click the ‘Next’ button to navigate to the ‘Submission
Information Type’ screen.
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3.4.3

Enter Passphrase Screen

To edit a submission click the submission alias link for a submission with a status of ‘In
Progress’ on the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen. The
‘Enter Passphrase’ screen allows you to enter the passphrase associated with the submission.
Enter Passphrase: Enter the passphrase that you originally created and associated with the
submission.
Exhibit 3-6 shows a screen capture of the ‘Enter Passphrase’ screen:
Exhibit 3-6 Enter Passphrase Screen

Navigation: Enter the passphrase that you originally created and associated with the submission
and click the ‘Next’ button to navigate to the ‘Submission Information Type’ screen.
3.4.4

Navigation Tree

The navigation tree is located on the left hand side of each screen. You can perform the
following functions using the navigation tree:
• Collapse and Expand folders: Each section of the submission falls under a collapsible
folder within the navigation tree, which allows you to save space or easily view items in the
navigation tree. When a folder is expanded, you can click the minus sign (-), the folder icon
( ), or the folder title link to collapse that section of the navigation tree. When a folder is
collapsed, you can click the plus sign (+), the folder icon ( ), or the folder title link to
expand that section of the navigation tree. When you place your cursor over a folder title
link, it will highlight in red.
• Open and Close the Navigation Tree: To provide more visual form space, a navigation
arrow ( ) that opens and closes the navigation tree is located to the right of the navigation
tree. Click the arrow ( ) to close the navigation tree and increase the space of the form
content. Likewise, click the arrow ( ) on the closed navigation tree to open the navigation
tree.
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• Navigate between screens: You can use the navigation tree to navigate between the
various screens within the application. Each screen of the submission is denoted with a
form icon ( ). You can click the form icon ( ) or the screen title link to navigate to the
selected screen. You are required to save all information entered on a particular screen
before navigating to the next screen or all entered information will be lost. A prompt will
appear after you click a link in the navigation tree indicating, ‘Are you sure you want to
leave the current page? Any unsaved changes will be lost.’ If you click the ‘OK’ button,
you will be taken to the requested screen without saving any of the data in the previous
screen. If you click the ‘Cancel’ button, the prompt will close and you will not be taken to
the requested screen.
Exhibit 3-7 shows a screen capture of the navigation prompt window:
Exhibit 3-7: Navigation Prompt

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Exhibit 3-8, Exhibit 3-9, Exhibit 3-10, and Exhibit 3-11 show the screen captures of the
navigation tree for the Test Rules, ECA, MOU and 40 CFR 766 submissions:
Exhibit 3-8: Test Rules Navigation Tree

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Exhibit 3-9: ECA Navigation Tree

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Exhibit 3-10: MOU Navigation Tree

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Exhibit 3-11: 40 CFR 766 Navigation Tree

3.4.5

Action Bar

The action bar is located at the bottom of each screen. You can perform the following functions
using the action bar:
• Validate: You can click the ‘Validate’ icon ( ) at any stage of completing a Section
4submission to check for certain types of errors in a submission. A ‘Section 4 Validation’
pop-up window generates when you click the ‘Validate’ icon ( ). The ‘Section 4
Validation’ pop-up window displays a report of all validation errors relating to a failed
validation. Refer to Section 8 for more information on validating a submission.
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The following exhibits, Exhibit 3-12, Exhibit 3-13, Exhibit 3-14, and Exhibit 3-15 show the
different screen captures for the action bar:
Exhibit 3-12: Action Bar – Validate

• Save: You can click the ‘Save’ icon ( ) at any stage of completing a Section 4
submission. After you click the ‘Save’ icon ( ), the data entered on the screen will save.
The ‘Save’ function does not validate any data entered.
Exhibit 3-13: Action Bar – Save

• Preview: You can click the ‘Preview’ icon ( ) at any stage of completing a Section 4
submission to preview the submission. After you click the ‘Preview’ icon ( ), you will be
taken to the ‘Preview Section 4 Submission’ screen. This screen allows you to view the
regular or sanitized PDF. Clicking the ‘Regular’ or ‘Sanitized’ button will generate the
‘Not for Submission’ watermarked PDF version of the submission.
Exhibit 3-14: Action Bar – Preview

• Submit: You can click the ‘Submit’ icon ( ) to submit the Section 4 submission after you
or the Support have completed all required sections of the Section 4 submission. After you
click the ‘Submit’ icon ( ), the validation process is initiated. Refer to Section 9 for
further instructions on validation errors. You can continue with the submission process
only after clearing all validation errors. Refer to Section 9 for more information on
submitting a Section 4 submission.
Exhibit 3-15: Action Bar – Submit

• Help Links: You can click any of the Help links, located at the bottom of each screen, at
any stage of completing a Section 4 submission.
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−

If you click the ‘CDX Homepage’ link, you will be taken to the CDX Homepage.
− If you click the ‘MyCDX Homepage’ link, you will be taken to the CDX Login.
− If you click the ‘EPA Homepage’ link, you will be taken to the EPA Homepage.
− If you click the ‘Terms and Conditions’ link, you will be taken to the CDX Terms and
Conditions screen.
− If you click the ‘Privacy Notice’ link, you will be taken to the CDX Privacy and Security
Notice screen.
Exhibit 3-16 shows the screen capture of the action bar ‘Help’ links:
Exhibit 3-16: Action Bar – Help Links

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4

Test Rules

4.1

Submission Information Type Screen

You can access the ‘Submission Information Type’ screen by clicking the ‘Next’ button from
either the ‘Create New Passphrase’ or ‘Enter Passphrase’ screen. Once you are in the ‘Test
Rules’ flow of the Section 4 application, the ‘Submission Information Type’ screen is displayed.
The ‘Submission Information Type’ screen allows you to select the submission information type
that you will be submitting to EPA. This screen consists of the following fields:
• Federal Register Notice: Allows the user to select a FRN. The selected FRN will dictate
which chemicals the user will be able to report on. If you change the FRN at any point
while completing the submission, a warning message will display indicating that all data
associated with the current FRN will be deleted. This field is required.
• Submission Alias: This field is auto-populated with a date and time stamp and is displayed
on the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen within
the ‘Submission Alias’ column. The ‘Submission Alias’ is also used to differentiate
between submission types within the ‘User Management’ screen. This field is editable
should you choose to provide your own submission alias. This field is required.
• Study Plan: The ‘Study Plan’ checkbox will only be available after the Letter of Intent has
been submitted. Checking the ‘Study Plan’ checkbox identifies that you are fulfilling the
requirements to submit a study plan to EPA. Once you have checked the ‘Study Plan’
checkbox and either saved the information on this screen by clicking the ‘Save’ icon or by
clicking the ‘Next’ button, the ‘Study Plan’ folder is generated within the navigation tree
allowing you to access the study plans screens required to be completed.
• Results: The ‘Results’ checkbox will only be available after the study plan has been
submitted. Checking the ‘Results’ checkbox identifies that you are fulfilling the
requirements to submit results to EPA. Once you have checked the ‘Results’ checkbox and
either saved the information on this screen by clicking the ‘Save’ icon or by clicking the
‘Next’ button, the ‘Results’ folder is generated within the navigation tree allowing you to
access the results screens required to be completed.
If you have previously identified a submission type, have accessed the submission type screens,
and then unchecked the previously checked submission information type (i.e. Study Plan), you
will receive a prompt indicating that all associated information will be lost. Clicking the ‘OK’
button within the prompt will delete all data associated with that submission information type.
To close the prompt without losing associated information, click the ‘Cancel’ button.
Once you have identified the type(s) of information you will be submitting to EPA, you are able
to access the screen required for completion.
Exhibit 4-1 shows the screen capture of the ‘Submission Information Type’ screen:

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Exhibit 4-1: Submission Information Type Screen

Navigation: If this is the first submission, select a federal register notice from the ‘Federal
Register Notice’ drop-down menu and click the ‘Next’ button to navigate to the ‘Technical
Contact Information’ screen. If you have previously submitted a Letter of Intent, check the
‘Study Plan’ checkbox and click the ‘Save’ or ‘Next’ button to generate the study plan screens
and links within the navigation tree. If you have previously submitted a study plan, check the
‘Results’ checkbox and click the ‘Save’ or ‘Next’ button to generate the results screens and links
within the navigation tree.
4.2

Technical Contact Information Screen

You can access the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from
the ‘Submission Information Type’ screen, or by clicking the ‘Technical Contact Information’
link located within the navigation tree.
The ‘Technical Contact Information’ screen allows you to submit on behalf of another company
or submit on behalf of a consortium. To identify if you are submitting on behalf of another
entity, the system provides the radio button for ‘This is a submission on behalf of a consortium.’
To identify if you are submitting on behalf of another company, the system provides the radio
button ‘This is a submission on behalf of another company.’ The system will not allow you to
select more than one radio button per submission.
If you are submitting on behalf of another company, select the ‘This is a submission on behalf of
another company’ radio button. This functionality has been implemented to accommodate a
company that may use an agent or another individual. If this radio button is selected, you can
enter the contact information for the manufacturing or processing establishment on whose behalf
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the submission is being made into the ‘Submitting on Behalf Of Company’ screen upon clicking
the ‘Next’ button. If you select the radio button for ‘This is a submission on behalf of a
consortium,’ you are taken to the ‘Submitting on Behalf of Consortium’ screen upon clicking the
‘Next’ button.
If you are not submitting on behalf of another company or on behalf of a consortium, you must
select the ‘N/A’ radio button.
The following fields are displayed on the ‘Technical Contact Information’ screen:
• CBI: Checking this checkbox will claim the contact information as Confidential Business
Information (CBI).
• N/A: Selecting the ‘N/A’ radio button allows you to signify that you are neither making a
submission on behalf of a consortium nor making a submission on behalf of another
company.
• This is a submission on behalf of a consortium: Selecting the ‘This is a submission on
behalf of a consortium’ radio button allows you to identify yourself as an individual
submitting on behalf of a consortium.
• This is a submission on behalf of another company: Selecting the ‘This is a submission
on behalf of another company’ radio button allows you to identify yourself as an individual
submitting on behalf of another company.
• Copy CDX Registration: Clicking the ‘Copy CDX Registration’ button will automatically
populate the fields with your contact information provided during CDX registration.
• Prefix: Displays all optional prefixes. If applicable, select the appropriate prefix. If you
have clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration.
• First Name: Enter the technical contact’s first name. If you have clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This field is required.
• Middle Initial: Enter the technical contact’s middle initial. If you have clicked the ‘Copy
CDX Registration’ button, the fields populate with information entered during CDX
registration.
• Last Name: Enter the technical contact’s last name. If you have clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This field is required.
• Suffix: Displays all optional suffixes. If applicable, select the appropriate suffix. If you
have clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration.
• Company Name: Enter the technical contact’s company name. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• Phone Number: Enter the technical contact’s daytime phone number; U.S. or
international. This field does not accept dashes. If you have clicked the ‘Copy CDX

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Registration’ button, the fields populate with information entered during CDX registration.
This field is required.
• Ext: Enter the extension to the technical contact’s daytime phone number.
• Email Address: Enter the technical contact’s email address. The email address must
follow the standard email address format: [email protected]. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• Mailing Address 1: Enter the first line of the technical contact’s mailing address. If you
have clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration. This field is required.
• Mailing Address 2: Enter the second line of the technical contact’s mailing address. If you
have clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration.
• City: Enter the city of the technical contact’s mailing address. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• State: Enter the state of the technical contact’s mailing address. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This is a required field if the ‘Country’ field is ‘United States.’
• Postal Code: Enter the postal code of the technical contact’s mailing address. If you have
clicked the ‘Copy CDX Registration’ button, the fields populate with information entered
during CDX registration. This field is required.
• Country: Displays all available countries. Select the country of the technical contact’s
mailing address. If you have clicked the ‘Copy CDX Registration’ button, the fields
populate with information entered during CDX registration. This is a required field.

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Exhibit 4-2 shows the screen capture of the ‘Technical Contact Information’ screen:
Exhibit 4-2: Technical Contact Information Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Chemical Identification and Test Rules’
screen if you are not submitting on behalf of a consortium or another company. You can also
access this screen by clicking the ‘Chemical Identification and Test Rules’ link within the
navigation tree. If you are submitting on behalf of a consortium, you are taken to the ‘Submitting
on Behalf of Consortium’ screen. You can also access this screen by clicking the ‘Submitting on
Behalf of Consortium’ link within the navigation tree. If you are submitting on behalf of another

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company, you are taken to the ‘Submitting on Behalf of Company’ screen. You can also access
this screen by clicking the ‘Submitting on Behalf of Company’ link within the navigation tree.
4.3

Submitting on Behalf of Consortium Screen

You can access the ‘Submitting on Behalf of Consortium’ screen by selecting the ‘This is a
submission on behalf of a consortium’ radio button and by clicking the ‘Next’ button from the
‘Technical Contact Information’ screen. You can also access this screen by clicking the
‘Submitting on Behalf of Consortium’ link within the navigation tree.
The ‘Submitting on Behalf of Consortium’ screen allows you to enter contact information for
each consortium member. The system provides you with the ability to identify the consortium
name. The contact information of the logged in user will pre-populate the first consortium field
set; this information is editable. To add a consortium member, click the ‘Add’ button to display
fields that can be populated and saved. You can click the ‘Save’ button for each consortium
member added to capture all information entered on the screen. A minimum of two consortium
members must be added to pass validation.
The following fields are displayed on the ‘Submitting on Behalf of Consortium’ screen:
• Consortium Name: Enter the name of the consortium.
• CBI: Checking this checkbox will claim the consortium information as CBI.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes and captures the
consortium member contact’s prefix. If applicable, select the appropriate prefix.
• First Name: Enter the consortium member contact’s first name. This field is required.
• Middle Initial: Enter the consortium member contact’s middle initial.
• Last Name: Enter the consortium member contact’s last name. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the
consortium member contact’s suffix. If applicable, select the appropriate suffix.
• Company Name: Enter the consortium member contact’s company name. This field is
required.
• Phone Number: Enter the consortium member contact’s day time phone number, US or
international. This field does not accept dashes. This field is required.
• Ext: Enter the extension to the contact’s daytime phone number.
• Email Address: Enter the consortium member contact’s email address. The email address
must follow the standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the consortium member contact’s mailing
address. This field is required.
• Mailing Address 2: Enter the second line of the consortium member contact’s mailing
address.
• City: Enter the city of the consortium member contact’s mailing address. This is a required
field.
• State: Enter the state of the consortium member contact’s mailing address. This field is
required if the ‘Country’ field is set to United States.

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• Postal Code: Enter the postal code of the consortium member contact’s mailing address.
This field is required.
• Country: Enter the country of the consortium member contact’s mailing address. This field
is required.

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Exhibit 4-3 shows the screen capture for the ‘Submitting on Behalf of Consortium’ screen:
Exhibit 4-3: Submitting on Behalf of Consortium Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Chemical Identification and Test Rules’
screen. You can also access this screen by clicking the ‘Chemical Identification and Test Rules’
link within the navigation tree.
4.4

Submitting on Behalf of Company Screen

You can access the ‘Submitting on Behalf of Company’ screen by selecting the ‘This is a
submission on behalf of another company’ radio button and clicking the ‘Next’ button from the
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‘Technical Contact Information’ screen. You can also access this screen by clicking the
‘Submitting on Behalf of Company’ link within the navigation tree.
The ‘Submitting on Behalf Of Company’ screen presents you with a list of fields that allows you
to input the contact information for the manufacturing or processing establishment on whose
behalf the submission is being made.
The following fields are displayed on the ‘Submitting on Behalf of Company’ screen:
• CBI: Checking this checkbox will claim the manufacturing or processing establishment
contact for which the submission is being made as CBI.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes and captures the prefix
of the manufacturing or processing establishment contact for which the submission is being
made. If applicable, select the appropriate prefix.
• First Name: Enter the first name of the manufacturing or processing establishment contact
for which the submission is being made. This field is required.
• Middle Initial: Enter the middle initial of the manufacturing or processing establishment
contact for which the submission is being made.
• Last Name: Enter the last name of the manufacturing or processing establishment contact
for which the submission is being made. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the suffix
of the manufacturing or processing establishment contact for which the submission is being
made. If applicable, select the appropriate suffix.
• Company Name: Enter the company name of the manufacturing or processing
establishment. This field is required.
• Phone Number: Enter the daytime phone number of the manufacturing or processing
establishment contact for whom the submission is being made, U.S. or international. This
field is required.
• Ext: Enter the extension to the contact’s daytime phone number.
• Email Address: Enter the email address of the manufacturing or processing establishment
contact for which the submission is being made. The email address must follow the
standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the mailing address of the manufacturing or
processing establishment contact. This field is required.
• Mailing Address 2: Enter the second line of the mailing address of the manufacturing or
processing establishment contact.
• City: Enter the city of the mailing address of the manufacturing or processing
establishment contact. This field is required.
• State: Enter the state of the mailing address of the manufacturing or processing
establishment contact. This is a required field if the ‘Country’ field is defined as ‘United
States.’
• Postal Code: Enter the postal code of the mailing address of the manufacturing or
processing establishment contact. This field is required.
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• Country: Enter the country of the mailing address of the manufacturing or processing
establishment contact. This field is required.
Exhibit 4-4 shows the screen capture of the ‘Submitting on Behalf of Company’ screen:
Exhibit 4-4: Submitting on Behalf of Company Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Chemical Identification and Test Rules’
screen. You can also access this screen by clicking the ‘Chemical Identification and Test Rules’
link within the navigation tree.
4.5

Letter of Intent

The ‘Letter of Intent’ section within the navigation tree must be submitted to EPA before you
can complete the ‘Study Plan’ and ‘Results’ screens.

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4.5.1

Chemical Identification and Test Rules Screen

You can access the ‘Chemical Identification and Test Rules’ screen by clicking the ‘Next’ button
from the ‘Technical Contact Information,’ ‘Submitting on Behalf of Company,’ or the
‘Submitting on Behalf of Consortium’ screen. The ‘Chemical Identification and Test Rules’
screen can also be accessed by clicking the ‘Chemical Identification and Test Rules’ link located
within the navigation tree under the ‘Letter of Intent’ folder.
The ‘Chemical Identification and Test Rules’ screen requires you to identify the chemical
substance(s) the sponsor(s) intends to use in each of their tests. To identify the chemical
substances click the ‘Assign Chemicals’ button. Clicking the ‘Assign Chemicals’ button will
generate the ‘Chemical Management’ pop-up window.
The ‘Chemical Management’ pop-up window displays all chemical substances you are able to
select. You can select each chemical by checking the checkbox that is located to the left of the
chemical. Once the chemical(s) has been checked, click the ‘Save’ button to close the ‘Chemical
Management’ pop-up window and display the data on the ‘Chemical Identification and Test
Rules’ screen. The chemicals displayed in the ‘Chemical Management’ pop-up window are
specific to the FRN selected.
The system allows you to edit previous chemical assignments. To delete a chemical, click the
‘Assign Chemical’ button and uncheck the chemical’s associated checkbox. Click the ‘Save’
button to close the ‘Chemical Management’ pop-up window and save all changes.
Each chemical substance assigned using the ‘Chemical Management’ tool will be displayed on
the ‘Chemical Identification and Test Rules’ screen within a field set. Each chemical substance
field set requires you to identify a minimum of one test per substance. The system provides a
‘CBI’ checkbox allowing you to claim those tests as CBI.
The system provides a ‘Chemical Test’ drop-down menu for each identified substance. The
‘Actions’ column provides buttons that allow you to save, delete, and add the data entered within
the ‘Chemical Test’ text field. To save entered data click the ‘Save’ icon ( ). To delete entered
data click the ‘Delete’ icon ( ). To add chemical tests click the ‘Add’ icon ( ).
• Chemical Identification and Test Rules Screen
o CBI: The ‘CBI’ checkbox allows you to claim information as confidential.
o Assign Chemicals: The ‘Assign Chemicals’ button generates the ‘Chemical
Management’ window.
o Chemical Test: The ‘Chemical Test’ drop-down menu allows you to select the
test to be performed using the assign chemical substance. At least one chemical
test must be selected.
o Actions: The ‘Actions’ column provides you with ‘Save,’ ‘Delete,’ and ‘Add,’
icons that allow you to perform desired functions to the entered chemical test.
• Chemical Management Pop-Up Window
o Save: Clicking the ‘Save’ button will save all delegated assignments to the
‘Chemical Identification and Test Rules’ screen.
o Cancel: Clicking the ‘Cancel’ button will close the ‘Chemical Management’ popup window and will not save any changes.
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Exhibit 4-5 shows the screen capture of the ‘Chemical Identification and Test Rules’ screen:
Exhibit 4-5: Chemical Identification and Test Rules Screen

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Exhibit 4-6 shows the screen capture for the ‘Chemical Management’ pop-up window:
Exhibit 4-6: Chemical Management Pop-Up Window

Navigation: Click the ‘Save’ button to return to the ‘Chemical Identification and Test Rules’
screen.

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Exhibit 4-7 shows the screen capture of the ‘Chemical Identification and Test Rules’ screen
populated:
Exhibit 4-7: Chemical Identification and Test Rules Screen (Populated)

Navigation: Click the ‘Next’ button to navigate to the ‘Sponsoring Firms’ screen. You can also
access this screen by clicking the ‘Sponsoring Firms’ link within the navigation tree.
4.5.2

Sponsoring Firms Screen

To access the ‘Sponsoring Firms’ screen click the ‘Next’ button from the ‘Chemical
Identification and Test Rules’ screen. You can also access the ‘Sponsoring Firms’ screen by
clicking the ‘Sponsoring Firms’ link located within the navigation tree under the ‘Letter of
Intent’ folder.

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The ‘Sponsoring Firms’ screen requires you to identify each sponsoring firm involved in the
testing of the identified chemical substances. To identify a sponsoring firm click the ‘Add
Sponsoring Firm’ button. Clicking the ‘Add Sponsoring Firm’ button generates a sponsoring
firm field set. Once you have entered data into a sponsoring firm field set, you must click the
‘Save’ button located within that field set prior to adding another firm. If the data previously
entered and saved within a field set needs to be edited, you can click the ‘Edit’ button located in
the upper right corner of that field set. If a sponsoring firm needs to be deleted, you can click the
‘Delete’ icon that is also located in the upper right corner of each field set.
The system allows you to expand/collapse each field set by clicking the sponsoring firm field set
header. If you wish to expand/collapse all field sets simultaneously, click the ‘Expand All’ or
‘Collapse All’ links located at the top right of all consortium field sets.
• CBI: Check the ‘CBI’ checkbox to claim the sponsoring firm as CBI. If you claim
information as CBI, you are required to complete substantiation.
• Firm Name: Enter the sponsoring firm’s company name. This field is required.
• Phone Number: Enter the sponsoring firm’s daytime phone number; U.S. or international.
This field does not accept dashes. This field is required.
• Ext: Enter the extension to the contact’s daytime phone number.
• Mailing Address 1: Enter the first line of the sponsoring firm’s mailing address. This field
is required.
• Mailing Address 2: Enter the second line of the sponsoring firm’s mailing address.
• City: Enter the city of the sponsoring firm’s mailing address. This field is required.
• State: Enter the state of the sponsoring firm’s mailing address. This field is required when
‘United States’ is identified as the country.
• Postal Code: Enter the postal code of the sponsoring firm’s mailing address. This field is
required.
• Country: Enter the country of the sponsoring firm’s mailing address. This field is required.

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Exhibit 4-8 shows the screen capture of the ‘Sponsoring Firms’ screen:
Exhibit 4-8: Sponsoring Firms Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Additional Information and Submitter
Requests’ screen. You can also access this screen by clicking the ‘Additional Information and
Submitter Requests’ link within the navigation tree.
4.5.3

Additional Information and Submitter Requests Screen

The ‘Additional Information and Submitter Requests’ screen allows you to submit additional
information or special requests. This is not a required screen and does not need to be completed
prior to submitting information to EPA.
The system provides you with an ‘Information/Request Type’ drop-down menu that contains the
following values:
• Amendment to the Study Plan
• Exemption Application
• Extension of Time to Submit a Study Plan

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• Modification of Test Standards or Schedules during Conduct of Test
• Submission of Equivalence Data
• Appeal of Denial of Exemption Application
To submit additional information or a special request select the desired value from the
‘Information/Request Type’ drop-down menu and click the ‘Add Information’ button.
Depending on your information or request selection, this choice dictates the pop-up window that
generates upon clicking the ‘Add Information’ button.
If you select ‘Amendment to the Study Plan’ from the ‘Information/Request Type’ drop-down
menu and click the ‘Add Information’ button, the ‘Amendment to the Study Plan’ pop-up
window generates. The ‘Amendment to the Study Plan’ pop-up window allows you to attach
documentation. To attach documentation click the ‘Browse’ button. Clicking the ‘Browse’
button will generate the ‘File Upload’ window on your hard drive. Search for your desired
document and click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’
window and populate the ‘Browse’ field with the attached document. Click the ‘OK’ button
within the ‘Amendment to the Study Plan’ pop-up window to return to the ‘Additional
Information and Submitter Requests’ screen. The attached document will be displayed within the
table.
If you select ‘Exemption Application’ from the ‘Information/Request Type’ drop-down menu
and click the ‘Add Information’ button, the ‘Exemption Application’ pop-up window generates.
The ‘Exemption Application’ pop-up window allows you to identify the testing requirement(s)
from which you seek exemption. The ‘Exemption Application’ pop-up window also allows you
to provide the basis for the exemption request within a text box. Click the ‘OK’ button within the
‘Exemption Application’ pop-up window to return to the ‘Additional Information and Submitter
Requests’ screen. The previously entered data will be displayed within the table.
If you select ‘Extension of Time to Submit Study Plan’ from the ‘Information/Request Type’
drop-down menu and click the ‘Add Information’ button, the ‘Extension of Time to Submit
Study Plan’ pop-up window is generated. The ‘Extension of Time to Submit Study Plan’ pop-up
window provides a text box that allows you to identify why EPA should grant the extension.
Click the ‘OK’ button within the ‘Extension of Time to Submit Study Plan’ pop-up window to
return to the ‘Additional Information and Submitter Requests’ screen. The previously entered
data will be displayed within the table.
If you select ‘Modification of Test Standards or Schedules During Conduct of Test’ from the
‘Information/Request Type’ drop-down menu and click the ‘Add Information’ button, the
‘Modification of Test Standards or Schedules During Conduct of Test’ pop-up window
generates. The ‘Modification of Test Standards or Schedules During Conduct of Test’ pop-up
window provides a text box that allows you to enter an explanation and rationale for the
modification. Click the ‘OK’ button within the ‘Modification of Test Standards or Schedules
During Conduct of Test’ pop-up window to return to the ‘Additional Information and Submitter
Requests’ screen. The previously entered data will be displayed within the table.
If you select ‘Submission of Equivalence Data’ from the ‘Information/Request Type’ drop-down
menu and click the ‘Add Information’ button, the ‘Submission of Equivalence Data’ pop-up
window generates. The ‘Submission of Equivalence Data’ pop-up window allows you to attach
documentation. To attach documentation click the ‘Browse’ button. Clicking the ‘Browse’
button will generate the ‘File Upload’ window on your hard drive. Search for your desired
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document and click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’
window and populate the ‘Browse’ field with the attached document. The system allows you to
claim the attached documentation as CBI. When information is claimed as CBI, substantiation of
that information is optional. Click the ‘OK’ button within the ‘Amendment to the Study Plan’
pop-up window to return to the ‘Additional Information and Submitter Requests’ screen. The
previously attached document will be displayed within the table.
If you select ‘Appeal of Denial of Exemption Application’ from the ‘Information/Request Type’
drop-down menu and click the ‘Add Information’ button, the ‘Appeal of Denial of Exemption
Application’ pop-up window generates. The ‘Appeal of Denial of Exemption Application’ popup window provides a text box that allows you to identify the basis for the reconsideration. The
system also allows you to claim a hearing by checking the ‘Check here if you wish to request a
hearing’ checkbox. If you request a hearing, a second text box generates and requires you to
explain why a hearing is necessary. Click the ‘OK’ button within the ‘Appeal of Denial of
Exemption Application’ pop-up window to return to the ‘Additional Information and Submitter
Requests’ screen. The previously entered data will be displayed within the table.
The table on the ‘Additional Information and Submitter Requests’ screen displays the following
columns:
• File Name: Displays the file name of the attached document if applicable. If text was
entered within the information/request type pop-up window the ‘File Name’ column will
display as ‘N/A.’ The system allows you to click the ‘File Name’ link for each
information/request type to edit previously attached documentation or text.
• Information/Request Type: Displays the information/request type selected from the
‘Information/Request Type’ drop-down menu.
• Attachment Date: Displays the date the information/request type was attached.
• Action: Displays the ‘Delete’ icon ( ), which allows you to delete a desired row within
the table and all associated information that pertained to the information/request type.

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Exhibit 4-9 shows the screen capture for the ‘Additional Information and Submitter Requests’
screen:
Exhibit 4-9: Additional Information and Submitter Requests Screen

Navigation: If you are completing a letter of intent, click the ‘Submit’ icon located in the footer
to begin the submission process. If you have previously submitted a letter of intent and checked
the ‘Study Plan’ checkbox, click the ‘Next’ button to navigate to the ‘Document Management’
screen located under the ‘Study Plan’ folder within the navigation tree. You can also access this
screen by clicking the ‘Document Management’ link under the ‘Study Plan’ folder within the
navigation tree.

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Exhibit 4-10 shows the screen capture of the ‘Amendment to the Study Plan’ pop-up window:
Exhibit 4-10: Amendment to the Study Plan Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.
Exhibit 4-11 shows the screen capture of the ‘Exemption Application’ pop-up window:
Exhibit 4-11: Exemption Application Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.

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Exhibit 4-12 shows the screen capture of the ‘Extension of Time to Submit Study Plan’ pop-up
window:
Exhibit 4-12 Extension of Time to Submit Study Plan Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.
Exhibit 4-13 shows the screen capture of the ‘Modification of Test Standards or Schedules
during Conduct of Test’ pop-up window:
Exhibit 4-13: Modification of Test Standards or Schedules during Conduct of Test Pop-Up
Window

Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.

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Exhibit 4-14 shows the screen capture of the ‘Submission of Equivalence Data’ pop-up window:
Exhibit 4-14: Submission of Equivalence Data Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.
Exhibit 4-15 shows the screen capture of the ‘Appeal of Denial of Exemption Application’ popup window:
Exhibit 4-15: Appeal of Denial of Exemption Application Pop-Up Window

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Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.
4.6

Study Plan

If you have identified you are submitting a study plan, you are required to complete the
following screens to satisfy the reporting requirements.
4.6.1

Document Management Screen

You can access the ‘Document Management’ screen by clicking the ‘Next’ button from the
‘Additional Information and Test Rules’ screen or by clicking the ‘Document Management’ link
within the navigation tree under the ‘Study Plan’ folder. This screen is only available once a
letter of intent has been submitted and you have selected the ‘Study Plan’ checkbox on the
‘Submission Information Type’ screen.
The ‘Document Management’ screen allows you to upload documents related to Section 4
reporting requirements. To add Section 4 study plan documentation, click the ‘Attach Document’
button. Clicking the ‘Attach Document’ button displays the ‘Document Management’ pop-up
window.
The ‘Document Management’ pop-up window requires you to identify the document type by
selecting ‘Phase I’ or ‘Phase II’ from the ‘Document Type’ drop-down menu. Once you have
identified the document type to be attached, click the ‘Browse’ button. Clicking the ‘Browse’
button will generate the ‘File Upload’ window where you can select the desired document from
your hard drive. Once you have identified the document to be attached, click the ‘Open’ button.
Clicking the ‘Open’ button will close the ‘File Upload’ window and display the attached
document within the ‘Browse’ field. To claim attached documentation as CBI, check the ‘CBI’
checkbox. If you claim the attached documentation as CBI you are required to attach the
sanitized version of the attached document. To do so, follow the steps outlined above. Once you
have attached all desired documentation, click the ‘OK’ button to return to the ‘Document
Management’ screen.
The ‘Document Management’ table displays the file name of the document, the document type,
the date the document was attached, and whether the document was claimed as CBI. The system
allows you to delete unwanted documents by clicking the ‘Delete’ icon located under the
‘Action’ column for a given row. Clicking the file name links within the ‘File Name’ column
generates the ‘Document Management’ pop-up window. This allows you to view and edit
previously attached documents.
• Attach Document: Clicking the ‘Attach Document’ button displays the ‘Document
Management’ pop-up window.
• File Name: Displays the name of the attached file. Clicking the file name link generates the
‘Document Management’ pop-up window and allows you to view and edit the attached
document.
• Document Type: Displays the document type of the attached document.
• Attachment Date: Displays the date the document was attached.
• CBI: Displays whether the attached document was claimed CBI.

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• Action: Clicking the ‘Delete’ icon will generate a prompt confirming the command. If you
click the ‘OK’ button within the prompt, this will delete the specified row and all contents
within.
Exhibit 4-16 shows the screen capture of the ‘Document Management’ screen:
Exhibit 4-16 Document Management Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Additional Information and Submitter
Requests’ screen.
The ‘Document Management’ pop-up window allows you to browse for a document from your
hard drive and attach one document at a time. You must attach at least one document. Clicking
the ‘Browse’ button will generate the ‘File Upload’ window on your hard drive. Select the
document you wish to attach and click the ‘Open’ button. If a document is marked as ‘CBI’ then
a sanitized copy of the document can be attached. To save the attached document to the
‘Document Management’ screen, click the ‘OK’ button within the ‘Document Management’
pop-up window.
• Document Type: Select the document type specific to the uploaded document. Displays
the following options: ‘Phase I’ and ‘Phase II.’
• CBI: Checking the ‘CBI’ checkbox will claim the uploaded document as CBI and
generate a sanitized document upload field.
• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.

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• Sanitized Document Upload: This field will only be displayed when the ‘CBI’ checkbox
is checked. Clicking the ‘Browse’ button will generate the ‘File Upload’ window for you
to search for a particular file on your hard drive.
• Effects: Select the effect specific to the chemical report. Displays the following options:
‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values that are found within each of the drop-down
menus on the ‘Document Management’ pop-up window. If you have multiple documents that
share the same effects and/or endpoints, you must upload each individual document separately
and select values from the drop-down menus.

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Exhibit 4-17 shows the screen capture of the ‘Document Management’ pop-up window:
Exhibit 4-17 Document Management Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Document Management’ screen.
4.6.2

Additional Information and Submitter Requests Screen

You can access the ‘Additional Information and Submitter Requests’ screen by clicking the
‘Next’ button from the ‘Document Management’ screen. The ‘Additional Information and
Submitter Requests’ screen can also be accessed by clicking the ‘Additional Information and
Submitter Requests’ link within the navigation tree under the ‘Study Plan’ folder.
The ‘Additional Information and Submitter Requests’ screen allows you to submit additional
information or special requests. This screen is not a required screen and does not need to be
completed prior to submitting information to EPA.
The system provides you with an ‘Information/Request Type’ drop-down menu that contains the
following values:
• Amendment to the Study Plan
• Exemption Application
• Extension of Time to Submit a Study Plan
• Modification of Test Standards or Schedules During Conduct of Test

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• Submission of Equivalence Data
• Appeal of Denial of Exemption Application
To submit additional information or a special request select the desired value from the
‘Information/Request Type’ drop-down menu and click the ‘Add Information’ button.
Depending on your information or request selection, this dictates the pop-up window that will be
generated upon clicking the ‘Add Information’ button.
If you select ‘Amendment to the Study Plan’ from the ‘Information/Request Type’ drop-down
menu and click the ‘Add Information’ button, the ‘Amendment to the Study Plan’ pop-up
window generates. The ‘Amendment to the Study Plan’ pop-up window allows you to attach
documentation. To attach documentation click the ‘Browse’ button. Clicking the ‘Browse’
button will generate the ‘File Upload’ window. Search for your desired document on your hard
drive and click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’
window and populate the ‘Browse’ field with the attached document. Click the ‘OK’ button
within the ‘Amendment to the Study Plan’ pop-up window to return to the ‘Additional
Information and Submitter Requests’ screen. The previously attached document will be
displayed within the table.
If you select ‘Exemption Application’ from the ‘Information/Request Type’ drop-down menu
and click the ‘Add Information’ button, the ‘Exemption Application’ pop-up window generates.
The ‘Exemption Application’ pop-up window allows you to identify the testing requirement(s)
from which you seek exemption. The ‘Exemption Application’ pop-up window also allows you
to provide the basis for the exemption request within a text box. Click the ‘OK’ button within the
‘Exemption Application’ pop-up window to return to the ‘Additional Information and Submitter
Requests’ screen. The previously entered data will be displayed within the table.
If you select ‘Extension of Time to Submit Study Plan’ from the ‘Information/Request Type’
drop-down menu and click the ‘Add Information’ button, the ‘Extension of Time to Submit a
Study Plan’ pop-up window is generated. The ‘Extension of Time to Submit Study Plan’ pop-up
window provides a text box that allows you to identify why EPA should grant the extension.
Click the ‘OK’ button within the ‘Extension of Time to Submit Study Plan’ pop-up window to
return to the ‘Additional Information and Submitter Requests’ screen. The previously entered
data will be displayed within the table.
If you select ‘Modification of Test Standards or Schedules During Conduct of Test’ from the
‘Information/Request Type’ drop-down menu and click the ‘Add Information’ button, the
‘Modification of Test Standards or Schedules During Conduct of Test’ pop-up window
generates. The ‘Modification of Test Standards or Schedules During Conduct of Test’ pop-up
window provides a text box that allows you to enter an explanation and rationale for the
modification. Click the ‘OK’ button within the ‘Modification of Test Standards or Schedules
During Conduct of Test’ pop-up window to return to the ‘Additional Information and Submitter
Requests’ screen. The previously entered data will be displayed within the table.
If you select ‘Submission of Equivalence Data’ from the ‘Information/Request Type’ drop-down
menu and click the ‘Add Information’ button, the ‘Submission of Equivalence Data’ pop-up
window generates. The ‘Submission of Equivalence Data’ pop-up window allows you to attach
documentation. To attach documentation click the ‘Browse’ button. Clicking the ‘Browse’
button will generate the ‘File Upload’ window. Search for your desired document on your hard
drive and click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’

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window and populate the ‘Browse’ field with the attached document. The system allows you to
claim the attached documentation as CBI. When information is claimed as CBI, substantiation of
that information is then required. Click the ‘OK’ button within the ‘Amendment to the Study
Plan’ pop-up window to return to the ‘Additional Information and Submitter Requests’ screen.
The previously attached document will be displayed within the table.
If you select ‘Appeal of Denial of Exemption Application’ from the ‘Information/Request Type’
drop-down menu and click the ‘Add Information’ button, the ‘Appeal of Denial of Exemption
Application’ pop-up window generates. The ‘Appeal of Denial of Exemption Application’ popup window provides a text box that allows you to identify the basis for the reconsideration. The
system also allows you to claim a hearing by checking the ‘Check here if you wish to request a
hearing’ checkbox. If you request a hearing, a second text box generates and requires you to
explain why a hearing is necessary. Click the ‘OK’ button within the ‘Appeal of Denial of
Exemption Application’ pop-up window to return to the ‘Additional Information and Submitter
Requests’ screen. The previously entered data will be displayed within the table.
The table on the ‘Additional Information and Submitter Requests’ screen displays the following
columns:
• File Name: Displays the file name of the attached document if applicable. If text was
entered within the information/request type pop-up window the ‘File Name’ column will
display as ‘N/A.’ The system allows you to click the file name link for each
information/request type to edit previously attached documentation or text.
• Document Type: Displays the information/request type selected from the
‘Information/Request Type’ drop-down menu.
• Attachment Date: Displays the date the information/request type was attached.
• Action: Displays the ‘Delete’ icon ( ) which allows you to delete a desired row within
the table and all associated information that pertained to the information/request type.
Clicking the ‘Delete’ icon ( ) will generate a prompt confirming the command. Clicking
the ‘OK’ button within the prompt will delete the desired row and all contents within.

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Exhibit 4-18 shows the screen capture for the ‘Additional Information and Submitter Requests’
screen:
Exhibit 4-18 Additional Information and Submitter Requests Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Test Rules Substantiation Part 1’ screen
if information has been claimed CBI. If information has not been claimed CBI and you have not
identified other submission information types on the ‘Submission Information Type’ screen, you
are ready to submit the Section 4 test rules submission to EPA. If you have identified you are
submitting results, you will be taken to the ‘Document Management’ screen under the ‘Results’
folder within the navigation tree.
Exhibit 4-19 shows the screen capture of the ‘Amendment to the Study Plan’ pop-up window:

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Exhibit 4-19 Amendment to the Study Plan Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.
Exhibit 4-20 shows the screen capture of the ‘Exemption Application’ pop-up window:
Exhibit 4-20 Exemption Application Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the

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‘Additional Information and Submitter Requests’ screen without saving the entered information.
Exhibit 4-21 shows the screen capture of the ‘Extension of Time to Submit Study Plan’ pop-up
window:
Exhibit 4-21 Extension of Time to Submit Study Plan Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.
Exhibit 4-22 shows the screen capture of the ‘Modification of Test Standards or Schedules
during Conduct of Test’ pop-up window:
Exhibit 4-22 Modification of Test Standards or Schedules during Conduct of Test Pop-Up
Window

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Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.
Exhibit 4-23 shows the screen capture of the ‘Submission of Equivalence Data’ pop-up window:
Exhibit 4-23 Submission of Equivalence Data Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.

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Exhibit 4-24 shows the screen capture of the ‘Appeal of Denial of Exemption Application’ popup window:
Exhibit 4-24 Appeal of Denial of Exemption Application Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Additional Information and Submitter
Requests’ screen. Click the ‘Cancel’ or ‘X’ button to close the window and return to the
‘Additional Information and Submitter Requests’ screen without saving the entered information.
4.7

Test Rules Substantiation

If you claim items within study plan as CBI that require substantiation, you must complete the
‘Test Rules Substantiation Part 1 and Part 2’ screens prior to submission.
4.7.1

Test Rules Substantiation Part 1 Screen

You navigate to the ‘Test Rules Substantiation Part 1’ screen by clicking the ‘Next’ button from
the ‘Document Management’ screen or the ‘Additional Information and Submitter Requests’
screen. You can also navigate to the ‘Test Rules Substantiation Part 1’ screen by clicking the
‘Test Rules Substantiation Part 1’ link within the navigation tree.
• Substantiation Question 1: Question 1 requires you to identify whether the information
has been disclosed in a patent. To complete substantiation for question 1 the system
provides ‘Yes’ and ‘No’ radio buttons.
o Question 1 of the ‘Test Rules Substantiation Part 1’ screen states as follows:
 Has the information been disclosed in a patent?

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• Substantiation Question 2: Question 2 requires you to identify whether the disclosure of
the study plan information would disclose processes used in the manufacture of a chemical.
To complete substantiation for question 2 the system provides ‘Yes’ and ‘No’ radio
buttons. If you select the ‘Yes’ radio button, you are required to identify how the process
would occur.
o Question 2 of the ‘Test Rules Substantiation Part 1’ screen states as follows:
 Would disclosure of the study plan information disclose processes used in
the manufacture or processing of a chemical substance or mixture?
Describe how this would occur.
• Substantiation Question 3: Question 3 requires you to identify whether disclosure of the
study plan information would disclose the portion of a mixture. To complete substantiation
for question 3 the system provides ‘Yes’ and ‘No’ radio buttons. If you select the ‘Yes’
radio button, you are required to identify how the disclosure would occur.
o Question 3 of the ‘Test Rules Substantiation Part 1’ screen states as follows:
 Would disclosure of the study plan information disclose the portion of a
mixture comprised by any of the substances in the mixture? Describe how
this would occur.
• Substantiation Question 4: Question 4 of the ‘Test Rules Substantiation Part 1’ screen
requires you to identify if the information claimed as CBI has been disclosed to the public.
To complete substantiation for question 4 the system provides ‘Yes’ and ‘No’ radio
buttons. If you select the ‘Yes’ radio button, you are required to identify the circumstances
in which the information has been disclosed to the public.
o Question 4 of the ‘Test Rules Substantiation Part 1’ screen states as follows:
 Has this information been disclosed to the public in any form? Describe
the circumstances.

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Exhibit 4-25 shows the screen capture of ‘Test Rules Substantiation Part 1’ screen:
Exhibit 4-25: Test Rules Substantiation Part 1 Screen

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Navigation: Click the ‘Next’ button to navigate to the ‘Test Rules Substantiation Part 2’ screen.
You can also access this screen by clicking the ‘Test Rules Substantiation part 2’ link within the
navigation tree.
4.7.2

Test Rules Substantiation Part 2 Screen

You navigate to the ‘Test Rules Substantiation Part 2’ screen by clicking the ‘Next’ button from
the ‘Test Rules Substantiation Part 1’ screen. You can also navigate to the ‘Test Rules
Substantiation Part 2’ screen by clicking the ‘Test Rules Substantiation Part 2’ link within the
navigation tree.
• Substantiation Question 5: The system provides a text box to enter information pertaining
to question 5. The system also provides a calendar widget to identify the date to which the
claim of confidentiality should extend and a text box to provide an explanation as to why
confidential treatment should be given. At least one radio button must be selected.
o Question 5 of the ‘Test Rules Substantiation Part 2’ screen states as follows:
 For what period of time should confidentiality treatment be given? Until a
specific date, the occurrence of a specific event, or permanently? Why
should confidential treatment be given?
• Substantiation Question 6: The system provides a text box to enter information pertaining
to question 6.
o Question 6 of the ‘Test Rules Substantiation Part 2’ screen states as follows:
 What harmful effects to your competitive position, if any, do you think
would result from disclosure of this information? How would a competitor
use such information? How substantial would the harmful effects be?
What is the causal relationship between disclosure and the harmful
effects?
• Substantiation Question 7: Question 7 requires you to identify what measure you have
taken to guard against disclosure of the information and provides a text box to enter
information pertaining to the question.
o Question 7 of the ‘Test Rules Substantiation Part 2’ screen states as follows:
 What measures have you taken to guard against disclosure of this
information to others?
• Substantiation Question 8: Question 8 requires you to identify the extent to which the
information has been disclosed and the precautions that have been taken to safeguard it.
Question 8 provides a text box to enter information pertaining to the question.
o Question 8 of the ‘Test Rules Substantiation Part 2’ screen states as follows:
 To what extent has this information been disclosed to others? What
precautions have been taken in connection with such disclosures?
• Substantiation Question 9: Question 9 requires you to identify if EPA or another Federal
Agency or any Federal court has made any confidentiality determinations. If you select the
‘Yes’ radio button, the system requires you to attach such documentation. If you select the
‘No’ radio button, you are not required to provide documentation.
o Question 9 of the ‘Test Rules Substantiation Part 2’ screen states as follows:
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

Has EPA, another Federal Agency, or any Federal court made any
pertinent confidentiality determination regarding this information? Click
the Browse button and search the appropriate document(s). Click the
Upload button to attach copies of such determinations.

Exhibit 4-26 and Exhibit 4-27 show the screen captures of the ‘Test Rules Substantiation Part 2’
screen:
Exhibit 4-26: Test Rules Substantiation Part 2 Screen (Scroll 1)

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Exhibit 4-27: Test Rules Substantiation Part 2 Screen (Scroll 2)

Navigation: If you are completing the study plan submission, click the ‘Submit’ icon to begin
the submission process. If you have checked the ‘Results’ checkbox on the ‘Submission
Information Type’ screen, click the ‘Next’ button to navigate to the ‘Document Management’
screen under the ‘Results’ folder within the navigation tree.
4.8

Results

If you have identified you are submitting results, you are required to complete the following
screens to satisfy the reporting requirements.
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4.8.1

Document Management Screen

The ‘Document Management’ screen allows you to upload documents related to Section 4
reporting requirements. To add Section 4 results documentation, click the ‘Attach Document’
button. Clicking the ‘Attach Document’ button initiates the ‘Document Management’ pop-up
window.
The ‘Document Management’ pop-up window allows you to attach documentation by clicking
the ‘Browse’ button. This will generate the ‘File Upload’ window where you can select the
desired document from your hard drive. Once you have identified the document to be attached,
click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’ window and
display the attached document within the ‘Browse’ field. To claim attached documentation as
CBI, check the ‘CBI’ checkbox. If you claim the attached documentation as CBI you are
required to attach the sanitized version of the attached document. To do so, follow the steps
outlined above. Once you have attached all desired documentation, click the ‘OK’ button to
return to the ‘Document Management’ screen.
The ‘Document Management’ table displays the file name of the document, the date the
document was attached, and whether the document was claimed as CBI. The system allows you
to delete unwanted documents by clicking the delete icon located under the ‘Action’ column for
a given row. Clicking the file name links within the ‘File Name’ column generates the
‘Document Management’ pop-up window. This allows you to view and edit previously attached
documents.
• Attach Document: Clicking the ‘Attach Document’ button displays the ‘Document
Management’ pop-up window.
• File Name: Displays the name of the attached file. Clicking the file name link generates the
‘Document Management’ pop-up window and allows you to view the attached document.
• Attachment Date: Displays the date the document was attached.
• CBI: Displays whether the attached document was claimed as CBI.
• Test Type: Displays the test that is associated with the chemical and the result’s document.
• Action: Clicking the ‘Delete’ icon will generate a prompt confirming the command. To
delete the specified row and all contents within click the ‘OK’ button within the prompt.

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Exhibit 4-28 shows the screen capture of the ‘Results Document Management’ screen:
Exhibit 4-28 Results Document Management Screen

Navigation: Once all documentation has been uploaded, click the ‘Submit’ button to begin the
submission process. If multiple chemicals have been selected on the ‘Chemical Identification and
Test Rules’ screen, complete all required fields prior to submitting.
The ‘Document Management’ pop-up window allows you to browse for a document from your
hard drive and attach one document at a time. You must attach one document. Clicking the
‘Browse’ button will generate the ‘File Upload’ window on your hard drive. Select the document
you wish to attach and click the ‘Open’ button. If a document is marked as ‘CBI’ then a sanitized
copy of the document can be attached. To save the attached document to the ‘Document
Management’ screen, click the ‘OK’ button within the ‘Document Management’ pop-up
window.
• CBI: Checking the ‘CBI’ checkbox will claim the uploaded document as CBI and
generate a sanitized document upload field.
• Test Type: Displays the tests that are specific to the chemical that was selected on the
‘Chemical Identification and Test Rules’ screen.
• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.
• Sanitized Document Upload: This field will only be displayed when the ‘CBI’ checkbox
is checked. Clicking the ‘Browse’ button will generate the ‘File Upload’ window for you
to search for a particular file on your hard drive.

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• Effects: Select the effect specific to the chemical report. Displays the following options:
‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values that are found within each of the drop-down
menus on the ‘Document Management’ pop-up window. If you have multiple documents that
share the same effects and/or endpoints, you must upload each individual document separately
and select values from the drop-down menus.

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Exhibit 4-29 shows the screen capture of the ‘Results Document Management’ pop-up window:
Exhibit 4-29 Results Document Management Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Results Document Management’ screen.
4.9

Optional Substantiation

If you have claimed any information other than a chemical or a document as CBI, and wish to
upload a substantiation version, you can click on the ‘Document Management’ link within the
navigation tree.
4.9.1

Optional Document Management Screen

You can access this screen by clicking the ‘Document Management’ link under the ‘Optional
Substantiation’ folder.
You can upload substantiation documentation by clicking the ‘Attach Document’ button.
The ‘Document Management’ pop-up window allows you to attach documentation by clicking
the ‘Browse’ button. This will generate the ‘File Upload’ window where you can select the
desired document from your hard drive. Once you have identified the document to be attached,
click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’ window and
display the attached document within the ‘Browse’ field. Once you have attached all desired
documentation, click the ‘OK’ button to return to the ‘Optional Document Management’ screen.
The optional document management table displays the file name of the document and the date
the document was attached. The system allows you to delete unwanted documents by clicking
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the ‘Delete’ icon located under the ‘Action’ column for a given row. Clicking the file name links
within the ‘File Name’ column generates the ‘Document Management’ pop-up window. This
allows you to view and edit previously attached documents.
• Attach Document: Clicking the ‘Attach Document’ button displays the ‘Optional
Substantiation Document Management’ pop-up window.
• File Name: Displays the name of the attached file. Clicking the file name link generates the
‘Optional Substantiation Document Management’ pop-up window and allows you to view
the attached document.
• Attachment Date: Displays the date the document was attached.
• Action: Clicking the ‘Delete’ icon ( ) will generate a prompt confirming the command.
To delete the specified row and all contents within click the ‘OK’ button within the prompt.
Exhibit 4-30 shows the screen capture of the ‘Optional Document Management’ screen:
Exhibit 4-30: Optional Document Management Screen

Navigation: Click the ‘Attach Document’ button to generate the ‘Optional Substantiation
Document Management’ pop-up window. Once all documents have been uploaded and you have
completed all required screen you may click the ‘Submit’ icon and begin the submission process.

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Exhibit 4-31 shows the screen capture of the ‘Optional Substantiation Document Management’
pop-up window.
Exhibit 4-31: Optional Substantiation Document Management Pop-Up Window

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5

Enforceable Consent Agreements (ECAs)

5.1

Submission Information Type Screen

You can access the ‘Submission Information Type’ screen by clicking the ‘Next’ button from
either the ‘Create New Passphrase’ or the ‘Enter Passphrase’ screen. Once you are within the
‘Enforceable Consent Agreement’ flow of the Section 4 application, the ‘Submission
Information Type’ screen can also be accessed by clicking the ‘Submission Information Type’
link located within the navigation tree.
The ‘Submission Information Type’ screen allows you to select the submission information type
that you will be submitting to EPA. This screen consists of the following fields:
• Please select, or start entering, a chemical in the drop-down menu below: Displays all
chemicals associated with ECA. This field is required.
• Submission Alias: This field is auto-populated with a date and time stamp and is displayed
on the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen within
the ‘Submission Alias’ column. The ‘Submission Alias’ is also used to differentiate
between submission types within the ‘User Management’ screen. This field is editable
should you choose to provide your own submission alias.
• Study Plans & Conduct of Testing: Checking the ‘Study Plans & Conduct of Testing’
checkbox identifies that you are fulfilling the requirements to submit a study plan to EPA.
Once you have checked the ‘Study Plans & Conduct of Testing’ checkbox and either saved
the information on this screen by clicking the ‘Save’ icon or by clicking the ‘Next’ button,
the ‘Study Plans & Conduct of Testing’ folder is generated within the navigation tree
allowing you to access the study plan screen required to be completed.
• Results: Checking the ‘Results’ checkbox indicates that you are fulfilling the requirements
to submit results to EPA. Once you have checked the ‘Results’ checkbox and either saved
the information on this screen by clicking the ‘Save’ icon or by clicking the ‘Next’ button,
the ‘Results’ folder is generated within the navigation tree allowing you to access the
results screens required to be completed.
If you have previously identified a submission type, have accessed the submission type screens,
and then unchecked the previously checked submission information type (i.e. Study Plans), you
will receive a prompt indicating that all associated information will be lost. Clicking the ‘OK’
button within the prompt will delete all data associated with that submission information type.
Once you have identified the type(s) of information you will be submitting to EPA, you are able
to access the screens required to be completed.

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Exhibit 5-1 shows the screen capture of the ‘Submission Information Type’ screen:
Exhibit 5-1 Submission Information Type Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Technical Contact Information’ screen.
You can also access this screen by clicking the ‘Technical Contact Information’ link within the
navigation tree.
5.2

Technical Contact Information Screen

The ‘Technical Contact Information’ screen allows you to submit on behalf of another company.
To identify if you are submitting on behalf of another company, the system provides the radio
button ‘This is a submission on behalf of another company.’ The system will not allow you to
select more than one radio button per submission.
If you are submitting on behalf of another company, select the ‘This is a submission on behalf of
another company’ radio button. This functionality has been implemented to accommodate a
company that may use an agent or another individual. If this radio button is selected, the
information of the contractor/consultant’s company is to be entered into the ‘Submitting on
Behalf Of Company’ screen. If you are not submitting on behalf of another company and have
selected the ‘N/A’ radio button, you are taken to the ‘Principal Test Sponsor’ screen.
• N/A: Selecting the ‘N/A’ radio button allows you to signify that you are not making a
submission on behalf of a company.
• This is a submission on behalf of another company: Selecting the ‘This is a submission
on behalf of another company’ radio button allows you to identify yourself as an individual
submitting on behalf of another company.
• Copy CDX Registration: Clicking the ‘Copy CDX Registration’ button will automatically
populate the fields with your contact information provided during CDX registration.
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• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix. If you have clicked the ‘Copy CDX Registration’ button, the fields
populate with information entered during CDX registration.
• First Name: Enter the technical contact’s first name. If you have clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This field is required.
• Middle Initial: Enter the technical contact’s middle initial. If you have clicked the ‘Copy
CDX Registration’ button, the fields populate with information entered during CDX
registration.
• Last Name: Enter the technical contact’s last name. If you have clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes. If applicable, select the
appropriate suffix. If you have clicked the ‘Copy CDX Registration’ button, the fields
populate with information entered during CDX registration.
• Company Name: Enter the technical contact’s company name. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• Phone Number: Enter the daytime phone number of the manufacturing or processing
establishment contact for whom the submission is being made, U.S. or international. This
field does not accept dashes. If you have clicked the ‘Copy CDX Registration’ button, the
fields populate with information entered during CDX registration. This field is required.
• Ext: Enter the extension to the daytime phone number of the manufacturing or processing
establishment contact for whom the submission is being made.
• Email Address: Enter the technical contact’s email address. The email address must
follow the standard email address format: [email protected]. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• Mailing Address 1: Enter the first line of the technical contact’s mailing address. If you
have clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration. This field is required.
• Mailing Address 2: Enter the second line of the technical contact’s mailing address. If you
have clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration.
• City: Enter the city of the technical contact’s mailing address. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• State: Enter the state of the technical contact’s mailing address. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This is a required field if the ‘Country’ field is defined as ‘United States.’

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• Postal Code: Enter the postal code of the technical contact’s mailing address. If you have
clicked the ‘Copy CDX Registration’ button, the fields populate with information entered
during CDX registration. This field is required.
• Country: Displays all available countries. Enter the country of the technical contact’s
mailing address. If you have clicked the ‘Copy CDX Registration’ button, the fields
populate with information entered during CDX registration. This is a required field.

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Exhibit 5-2 shows the screen capture of the ‘Technical Contact Information’ screen:
Exhibit 5-2 Technical Contact Information Screen

Navigation: If you are submitting on behalf of another company, select the ‘This is a submission
on behalf of another company’ radio button and click the ‘Next’ button to navigate to the
‘Submitting on Behalf of Company’ screen. If you are submitting study plan information and are
not submitting on behalf of another entity, you are taken to the ‘Principal Test Sponsor’ screen.
If you are not submitting either study plan information or results information and are not

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submitting on behalf of another entity, the application navigates to the ‘ECA Additional
Information’ screen.
5.3

Submitting on Behalf of Company Screen

You can access the ‘Submitting on Behalf of Company’ screen by selecting the ‘This is a
submission on behalf of another company’ radio button and by clicking the ‘Next’ button from
the ‘Technical Contact Information’ screen. You can also access this screen by clicking the
‘Submitting on Behalf of Company’ link within the navigation tree.
The ‘Submitting on Behalf of Company’ screen presents a list of fields that allow you to input
the contact information for the manufacturing or processing establishment on whose behalf the
submission is being made.
• CBI: Checking this checkbox will claim the information as CBI.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix.
• First Name: Enter the first name of the manufacturing or processing establishment contact
for which the submission is being made. This field is required.
• Middle Initial: Enter the middle initial of the manufacturing or processing establishment
contact for which the submission is being made.
• Last Name: Enter the last name of the manufacturing or processing establishment contact
for which the submission is being made. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the suffix
of the manufacturing or processing establishment contact for which the submission is being
made. If applicable, select the appropriate suffix.
• Company Name: Enter the company name of the manufacturing or processing
establishment. This field is required.
• Phone Number: Enter the daytime phone number of the manufacturing or processing
establishment contact for whom the submission is being made; U.S. or international. This is
a required field.
• Ext: Enter the extension to the daytime phone number of the manufacturing or processing
establishment contact for whom the submission is being made.
• Email Address: Enter the email address of the manufacturing or processing establishment
contact for which the submission is being made. The email address must follow the
standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the mailing address of the manufacturing or
processing establishment contact. This field is required.
• Mailing Address 2: Enter the second line of the mailing address of the manufacturing or
processing establishment contact.
• City: Enter the city of the mailing address of the manufacturing or processing
establishment contact. This field is required.

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• State: Enter the state of the mailing address of the manufacturing or processing
establishment contact. This is a required field if the ‘Country’ field is defined as ‘United
States.’
• Postal Code: Enter the postal code of the mailing address of the manufacturing or
processing establishment contact. This field is required.
• Country: Enter the country of the mailing address of the manufacturing or processing
establishment contact. This field is required.
Exhibit 5-3 shows the screen capture of the ‘Submitting on Behalf of Company’ screen:
Exhibit 5-3 Submitting on Behalf of Company Screen

Navigation: If you are submitting study plans click the ‘Next’ button to navigate to the
‘Principal Test Sponsor’ screen. If you only checked the ‘Results’ checkbox, click the ‘Next’
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button to navigate to the ‘Document Management’ screen under the ‘Results’ folder within the
navigation tree. If you are only completing the letter of intent, click the ‘Submit’ icon located in
the action bar to begin the submission process.
5.4

Study Plans

If you have identified you are submitting information for study plans, you are required to
complete the following screens to satisfy the reporting requirements.
5.4.1

Principal Test Sponsor Screen

The ‘Principal Test Sponsor’ screen presents a list of fields that allow you to input the contact
information for the principal test sponsor.
• CBI: Check the ‘CBI’ checkbox to claim the principal test sponsor contact information as
CBI.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix.
• First Name: Enter the first name of the principal test sponsor contact. This field is
required.
• Middle Initial: Enter the middle initial of the principal test sponsor contact.
• Last Name: Enter the last name of the principal test sponsor contact. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the suffix
of the principal test sponsor contact. If applicable, select the appropriate suffix.
• Company Name: Enter the company name of the principal test sponsor contact. This field
is required.
• Phone Number: Enter the daytime phone number of the principal test sponsor contact;
U.S. or international. This field is required.
• Ext: Enter the extension to the daytime phone number of the principal test sponsor contact.
• Email Address: Enter the email address of principal test sponsor contact. The email
address must follow the standard email address format: [email protected]. This field is
required.
• Mailing Address 1: Enter the first line of the mailing address of the principal test
sponsor’s company. This field is required.
• Mailing Address 2: Enter the second line of the mailing address of the principal test
sponsor’s company.
• City: Enter the city of the mailing address of the principal test sponsor’s company. This
field is required.
• State: Enter the state of the mailing address of the principal test sponsor contact’s
company. This is a required field if the ‘Country’ field is defined as ‘United States.’
• Postal Code: Enter the postal code of the principal test sponsor contact’s company. This
field is required.
• Country: Enter the country of the mailing address of principal test sponsor contact’s
company. This field is required.
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Exhibit 5-4 shows the screen capture of the ‘Principal Test Sponsor’ screen:
Exhibit 5-4 Principal Test Sponsor Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Principal Sponsor Organization’ screen.
You can also access this screen by clicking the ‘Principal Sponsor Organization’ link within the
navigation tree.
5.4.2

Principal Sponsor Organization Screen

The ‘Principal Sponsor Organization’ screen allows you to enter the contact information for each
administrative official and project manager within the principal test sponsor’s organization. To
add each professional click the ‘Add Sponsor Organization’ button. This will generate a new set
of text fields. Once you have entered data into one field set, you must click the ‘Save’ button
located within that field set prior to adding another member. If the data previously entered and
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saved within a field set needs to be edited, you can click the ‘Edit’ button located in the upper
right corner of that field set. If a field set needs to be deleted, you can click the ‘Delete’ icon (
) that is also located in the upper right corner of each field set.
The system allows you to expand/collapse each field set by clicking the field set header. If you
wish to expand/collapse all field sets simultaneously, click the ‘Expand All’ or ‘Collapse All’
links located at the top right of all field sets.
• CBI: Check the checkbox to claim the member contact information as CBI.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes and captures the
member contact’s prefix. If applicable, select the appropriate prefix.
• First Name: Enter the member contact’s first name. This field is required.
• Middle Initial: Enter the member contact’s middle initial.
• Last Name: Enter the member contact’s last name. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the
member contact’s suffix. If applicable, select the appropriate suffix.
• Company Name: Enter the member contact’s company name. This field is required.
• Job Title: Enter the member contact’s job title. This field is required.
• Phone Number: Enter the member contact’s daytime phone number; U.S. or international.
This field is required.
• Ext: Enter the extension to the contact’s daytime phone number.
• Email Address: Enter the member contact’s email address. The email address must follow
the standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the member contact’s mailing address. This field
is required.
• Mailing Address 2: Enter the second line of the member contact’s mailing address.
• City: Enter the city of the member contact’s mailing address. This is a required field.
• State: Enter the state of the member contact’s mailing address. This field is required when
‘United States’ is identified as the country.
• Postal Code: Enter the postal code of the member contact’s mailing address. This field is
required.
• Country: Enter the country of the mailing address of the contact. This is a required field.

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Exhibit 5-5 shows the screen capture of the ‘Principal Sponsor Organization’ screen:
Exhibit 5-5 Principal Sponsor Organization Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Testing Facilities’ screen. You can also
access this screen by clicking the ‘Testing Facilities’ link within the navigation tree.
5.4.3

Testing Facilities Screen

The ‘Testing Facilities’ screen allows you to enter the contact information for each facility
responsible for testing as well as that facility’s contact. To add each facility and contact, click the
‘Add Testing Facility’ button. This will generate a new set of text fields. Once you have entered
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data into one field set, you must click the ‘Save’ button located within that field set prior to
adding another facility and contact. If the data previously entered and saved within a field set
needs to be edited, you can click the ‘Edit’ button located in the upper right corner of that field
set. If a facility needs to be deleted, you can click the ‘Delete’ icon ( ) that is also located in the
upper right corner of each field set.
The system allows you to expand/collapse each field set by clicking the field set header. If you
wish to expand/collapse all field sets simultaneously, click the ‘Expand All’ or ‘Collapse All’
links located at the top right of all field sets.
• Testing Facility: Enter the name of the testing facility. This field is required.
• Phone Number: Enter the phone number of the testing facility. This field is required.
• Ext: Enter the extension to the phone number of the testing facility.
• Mailing Address 1: Enter the first line of the mailing address of the testing facility. This
field is required.
• Mailing Address 2: Enter the second line of the mailing address of the testing facility.
• City: Enter the city of the testing facility’s mailing address. This is a required field.
• State: Enter the state of the testing facility’s mailing address. This field is required when
‘United States’ is identified as the country.
• Postal Code: Enter the postal code of the testing facility’s mailing address. This field is
required.
• Country: Enter the country of the mailing address of the testing facility. This is a required
field.
• Select the testing facility contact role: Select the job title of the contact of the testing
facility from the drop-down menu. This drop-down menu contains the following values:
‘Administrative Official,’ and ‘Project Manager.’ This field is required.
• CBI: Check the checkbox to claim the contact information of the testing facility as CBI.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes and captures the testing
facility’s contact’s prefix. If applicable, select the appropriate prefix.
• First Name: Enter the testing facility contact’s first name. This field is required.
• Middle Initial: Enter the testing facility contact’s middle initial.
• Last Name: Enter the testing facility contact’s last name. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the testing
facility contact’s suffix. If applicable, select the appropriate suffix.
• Phone Number: Enter the testing facility contact’s daytime phone number; U.S. or
international. This field is required.
• Ext: Enter the extension to the testing facility contact’s daytime phone number.
• Email Address: Enter the testing facility contact’s email address. The email address must
follow the standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the testing facility contact’s mailing address.
This field is required.
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• Mailing Address 2: Enter the second line of the testing facility contact’s mailing address.
• City: Enter the city of the testing facility contact’s mailing address. This is a required field.
• State: Enter the state of the testing facility contact’s mailing address. This field is required
when ‘United States’ is identified as the country.
• Postal Code: Enter the postal code of the testing facility contact’s mailing address. This
field is required.
• Country: Enter the country of the mailing address of the testing facility’s contact. This is a
required field.

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Exhibit 5-6 and Exhibit 5-7 shows the screen capture of the ‘Testing Facilities’ screen:
Exhibit 5-6 Testing Facilities Screen (Scroll 1)

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Exhibit 5-7: Testing Facilities Screen (Scroll 2)

Navigation: Click the ‘Next’ button to navigate to the ‘Study Professionals’ screen. You can
also access this screen by clicking the ‘Study Professionals’ link within the navigation tree.
5.4.4
Study Professionals Screen
The ‘Study Professionals’ screen allows you to provide the contact information and a summary
of the training and experience of each professional involved in the study. To add each
professional click the ‘Add Study Professional’ button. This will generate a new set of text
fields. Once you have entered data into one field set, you must click the ‘Save’ button located
within that field set prior to adding another professional. If the data previously entered and saved
within a field set needs to be edited, you can click the ‘Edit’ button located in the upper right

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corner of that field set. If a professional needs to be deleted, you can click the ‘Delete’ icon (
that is also located in the upper right corner of each field set.

)

The system allows you to expand/collapse each field set by clicking the field set header. If you
wish to expand/collapse all field sets simultaneously, click the ‘Expand All’ or ‘Collapse All’
links located at the top right of all field sets.
• Select the Study Professional Role: Select the study professional’s role from the dropdown menu. This drop-down menu contains the following values: ‘Chemist,’ ‘Laboratory
Assistant,’ ‘Microbiologist,’ ‘Pathologist,’ ‘Study Director,’ ‘Toxicologist,’ ‘Veterinarian,’
and ‘Other.’ This field is required.
• CBI: Check the checkbox to claim the professional’s contact information as CBI.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes and captures the
professional’s prefix. If applicable, select the appropriate prefix.
• First Name: Enter the professional’s first name. This field is required.
• Middle Initial: Enter the professional’s middle initial.
• Last Name: Enter the professional’s last name. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the
professional’s suffix. If applicable, select the appropriate suffix.
• Company Name: Enter the professional’s company name. This field is required.
• Phone Number: Enter the professional’s daytime phone number; U.S. or international.
This field is required.
• Ext: Enter the extension to the professional’s daytime phone number.
• Email Address: Enter the professional’s email address. The email address must follow the
standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the professional’s mailing address. This field is
required.
• Mailing Address 2: Enter the second line of the professional’s mailing address.
• City: Enter the city of the professional’s mailing address. This is a required field.
• State: Enter the state of the professional’s mailing address. This field is required when
‘United States’ is identified as the country.
• Postal Code: Enter the postal code of the professional’s mailing address. This field is
required.
• Country: Enter the country of the professional’s mailing address. This is a required field.
• Experience Summary: Enter the summary of the study professional’s experience. This
field is required.

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Exhibit 5-8 and Exhibit 5-9 show the screen captures of the ‘Study Professionals’ screen:
Exhibit 5-8 Study Professionals Screen (Scroll 1)

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Exhibit 5-9: Study Professionals Screen (Scroll 2)

Navigation: If you did not check the ‘Results’ checkbox on the ‘Submission Information Type’
screen, click the ‘Next’ button to navigate to the ‘ECA Additional Information’ screen. If you
checked the ‘Results’ checkbox on the ‘Submission Information Type’ screen, click the ‘Next’
button to navigate to the ‘Document Management’ screen.
5.5
Results
If you have identified you are submitting results, you are required to complete the following
screens to satisfy the reporting requirements.
5.5.1

Document Management Screen

The ‘Document Management’ screen allows you to upload documents related to Section 4
reporting requirements. To add Section 4 results documentation, click the ‘Attach Document’
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button. Clicking the ‘Attach Document’ button displays the ‘Document Management’ pop-up
window.
The ‘Document Management’ pop-up window allows you to attach documentation by clicking
the ‘Browse’ button. This will generate the ‘File Upload’ window where you can select the
desired document from your hard drive. Once you have identified the document to be attached,
click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’ window and
display the attached document within the ‘Browse’ field. To claim attached documentation as
CBI, check the ‘CBI’ checkbox. If you claim the attached documentation as CBI you are
required to attach the sanitized version of the attached document. To do so, follow the steps
outlined above. Once you have attached all desired documentation, click the ‘OK’ button to
return to the ‘Document Management’ screen.
The document management table displays the file name of the document, the date the document
was attached, and whether the document was claimed as CBI. The system allows you to delete
unwanted documents by clicking the ‘Delete’ icon located under the ‘Action’ column for a given
row. Clicking the file name links within the ‘File Name’ column generates the ‘Document
Management’ pop-up window. This allows you to view and edit previously attached documents.
• Add Document: Clicking the ‘Add Document’ button displays the ‘Document
Management’ pop-up window.
• File Name: Displays the name of the attached file. Clicking the file name link generates the
‘Document Management’ pop-up window and allows you to view the attached document.
• Attachment Date: Displays the date the document was attached.
• CBI: Displays whether the attached document was claimed CBI.
• Action: Clicking the ‘Delete’ icon ( ) will generate a prompt confirming deletion. To
delete the specified row and all contents within click the ‘OK’ button within the prompt.

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Exhibit 5-10 shows the screen capture of the ‘Document Management’ screen:
Exhibit 5-10 Document Management Screen

Navigation: Click the ‘Next’ button to navigate to the ‘ECA Additional Information’ screen.
You can also access this screen by clicking the ‘ECA Additional Information’ link within the
navigation tree.
The ‘Document Management’ pop-up window allows you to browse for a document from your
hard drive and attach one document at a time. You must attach at least one document. Clicking
the ‘Browse’ button will generate the ‘File Upload’ window on your hard drive. Select the
document you wish to attach and click the ‘Open’ button. If a document is marked as ‘CBI’ then
a sanitized copy of the document must be attached. To save the attached document to the
‘Document Management’ screen, click the ‘OK’ button within the ‘Document Management’
pop-up window.
• CBI: Checking the ‘CBI’ checkbox will claim the uploaded document as CBI and
generate a sanitized document upload field.
• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.
• Sanitized Document Upload: This field will only be displayed when the ‘CBI’ checkbox
is checked. Clicking the ‘Browse’ button will generate the ‘File Upload’ window for you
to search for a particular file on your hard drive.
• Effects: Select the effect specific to the chemical report. Displays the following options:
‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical Chemical Properties.’
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• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values that are found within each of the drop-down
menus on the ‘Document Management’ pop-up window. If you have multiple documents that
share the same effects and/or endpoints, you must upload each individual document separately
and select values from the drop-down menus.

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Exhibit 5-11 shows the screen capture of the ‘Document Management’ pop-up window:
Exhibit 5-11 Document Management Pop-Up Window

Navigation: Click the ‘OK’ or ‘Cancel’ buttons to return to the ‘Document Management’ screen.
5.6

ECA Additional Information Screen

You can access the ‘ECA Additional Information’ screen by clicking the ‘Next’ button from the
‘Document Management’ screen within the ‘Results’ folder of the navigation tree. If you did not
check the ‘Results’ checkbox on the ‘Submission Information Type’ screen, click the ‘Next’
button from the ‘Study Professionals’ screen. You can also access the ‘ECA Additional
Information’ screen by clicking the ‘ECA Additional Information’ link within the navigation
tree.
The ‘ECA Additional Information’ screen allows you to upload documents related to Section 4
reporting requirements. To add additional information select the appropriate additional
information type and click the ‘Attach Document’ button. Clicking the ‘Attach Document’
button displays the ‘ECA Additional Information’ pop-up window. If you select the
‘Amendments to the Study Plan’ radio button and click the ‘Attach Document’ button, the
‘Amendments to the Study Plan’ pop-up window generates. If you select the ‘Modification of
ECAs’ radio button and click the ‘Attach Document’ button, the ‘Modification of ECAs’ pop-up
window generates.
The ‘Amendment to the Study Plan’ pop-up window allows you to attach documentation by
clicking the ‘Browse’ button. This will generate the ‘File Upload’ window where you can select
the desired document from your hard drive. Once you have identified the document to be
attached, click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’
window and display the attached document within the ‘Browse’ field. Once you have attached all
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desired documentation, click the ‘OK’ button to return to the ‘ECA Additional Information’
screen.
The ‘Modification of ECAs’ pop-up window allows you to provide an explanation and rationale
for the modification of the ECA within a text box. Once you have provided an explanation click
the ‘OK’ button to return to the ‘ECA Additional Information’ screen.
The ‘ECA Additional Information’ table displays the file name of the document, the document
type, and the date the document was attached. The system allows you to delete unwanted
documents by clicking the ‘Delete’ icon located under the ‘Action’ column for a given row.
Clicking the file name links within the ‘File Name’ column generates the pop-up window. This
allows you to view and edit previously attached documents or information.
• Amendments to the Study Plan: Select the radio button to indicate the additional
information type.
• Modification of ECAs: Select the radio button to indicate the additional information type.
• Add Document: Clicking the ‘Add Document’ button displays the ‘Amendments to the
Study Plan’ or ‘Modification of ECAs’ pop-up window.
• File Name: Displays the name of the attached file if applicable. Clicking the file name link
generates the pop-up window and allows you to view the attached document or
information.
• Document Type: Displays the additional information type.
• Attachment Date: Displays the date the document was attached.
• Action: Clicking the ‘Delete’ icon ( ) will generate a prompt confirming deletion. To
delete the specified row and all contents within click the ‘OK’ button within the prompt.

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Exhibit 5-12 shows the screen capture of the ‘ECA Additional Information’ screen:
Exhibit 5-12 ECA Additional Information Screen

Navigation: Once all information has been uploaded, click the ‘Submit’ icon located within the
action bar to begin the submission process.
Exhibit 5-13 shows the screen capture of the ‘Amendment to the Study Plan’ pop-up window:
Exhibit 5-13 Amendment to the Study Plan Pop-Up Window

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Navigation: Click the ‘OK’ or ‘Cancel’ buttons to return to the ‘ECA Additional Information’
screen.
Exhibit 5-14 shows the screen capture of the ‘Modification of ECAs’ pop-up window:
Exhibit 5-14 Modification of ECAs Pop-Up Window

Navigation: Click the ‘OK’ or ‘Cancel’ buttons to return to the ‘ECA Additional Information’
screen.

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6

Memorandum of Understanding (MOU)

6.1

Submission Information Type Screen

You can access the ‘Submission Information Type’ screen by clicking the ‘Next’ button from
either the ‘Create New Passphrase’ or the ‘Enter Passphrase’ screen. Once you are within the
‘Memorandum of Understanding’ flow of the Section 4 application, the ‘Submission Information
Type’ screen can also be accessed by clicking the ‘Submission Information Type’ link located
within the navigation tree.
The ‘Submission Information Type’ screen allows you to select the submission information type
that you will be submitting to EPA. This screen consists of the following fields:
• Please select, or begin typing, a Chemical in the drop-down menu below: Displays all
chemicals associated with MOU. This field is required.
• Chemical Docket: This field displays once a chemical is selected. It displays the docket
number associated with the selected chemical.
• Submission Alias: This field is auto-populated with a date and time stamp and is displayed
on the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen within
the ‘Submission Alias’ column. The ‘Submission Alias’ is also used to differentiate
between submission types within the ‘User Management’ screen. This field is editable
should you choose to provide your own submission alias.
• Study Plans & Conduct of Testing: Checking the ‘Study Plans & Conduct of Testing’
checkbox identifies that you are fulfilling the requirements to submit a study plan to EPA.
Once you have checked the ‘Study Plans & Conduct of Testing’ checkbox and either saved
the information on this screen by clicking the ‘Save’ icon or by clicking the ‘Next’ button,
the ‘Study Plans & Conduct of Testing’ folder is generated within the navigation tree
allowing you to access the ‘Study Plans & Conduct of Testing’ screens required to be
completed.
• Results: Checking the ‘Results’ checkbox indicates that you are fulfilling the requirements
to submit results to EPA. Once you have checked the ‘Results’ checkbox and either saved
the information on this screen by clicking the ‘Save’ icon or by clicking the ‘Next’ button,
the ‘Results’ folder is generated within the navigation tree allowing you to access the
‘Results’ screens required to be completed.
If you have previously identified a submission type, have accessed the submission type screens,
and then unchecked the previously checked submission information type (i.e. Study Plans &
Conduct of Testing), you will receive a prompt indicating that all associated information will be
lost. Clicking the ‘OK’ button within the prompt will delete all data associated with that
submission information type.
Once you have identified the type(s) of information you will be submitting to EPA, you are able
to access the screens required to be completed.

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Exhibit 6-1 shows the screen capture of the ‘Submission Information Type’ screen:
Exhibit 6-1: Submission Information Type Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Technical Contact Information’ screen.
You can also access this screen by clicking the ‘Technical Contact Information’ link within the
navigation tree.
6.2

Technical Contact Information Screen

The ‘Technical Contact Information’ screen allows you to submit on behalf of another company
or if you are not submitting on behalf of another company. To identify if you are submitting on
behalf of another company, the system provides the radio button ‘This is a submission on behalf
of another company.’ The system will not allow you to select more than one radio button per
submission.
This functionality has been implemented to accommodate a company that may use an agent or
another individual. If this radio button is selected, the information of the contractor/consultant’s
company is to be entered into the ‘Submitting on Behalf Of Company’ screen. If you are not
submitting on behalf of another company and have selected the ‘N/A’ radio button, you are taken
to the ‘Principal Test Sponsor’ screen.
• N/A: Selecting the ‘N/A’ radio button allows you to signify that you are not making a
submission on behalf of another company.
• This is a submission on behalf of another company: Selecting the ‘This is a submission
on behalf of another company’ radio button allows you to identify yourself as an individual
submitting on behalf of another company.
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• Copy CDX Registration: Clicking the ‘Copy CDX Registration’ button will automatically
populate the fields with your contact information provided during CDX registration.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix. If you have clicked the ‘Copy CDX Registration’ button, the fields
populate with information entered during CDX registration.
• First Name: Enter the technical contact’s first name. If you have clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This field is required.
• Middle Initial: Enter the technical contact’s middle initial. If you have clicked the ‘Copy
CDX Registration’ button, the fields populate with information entered during CDX
registration.
• Last Name: Enter the technical contact’s last name. If you have clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes. If applicable, select the
appropriate suffix. If you have clicked the ‘Copy CDX Registration’ button, the fields
populate with information entered during CDX registration.
• Company Name: Enter the technical contact’s company name. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• Phone Number: Enter the technical contact’s daytime phone number; U.S. or
international. If you have clicked the ‘Copy CDX Registration’ button, the fields populate
with information entered during CDX registration. This field is required.
• Ext: Enter the extension to the technical contact’s daytime phone number.
• Email Address: Enter the technical contact’s email address. The email address must
follow the standard email address format: [email protected]. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• Mailing Address 1: Enter the first line of the technical contact’s mailing address. If you
have clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration. This field is required.
• Mailing Address 2: Enter the second line of the technical contact’s mailing address. If you
have clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration.
• City: Enter the city of the technical contact’s mailing address. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• State: Enter the state of the technical contact’s mailing address. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This is a required field if the ‘Country’ field is defined as ‘United States.’

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• Postal Code: Enter the postal code of the technical contact’s mailing address. If you have
clicked the ‘Copy CDX Registration’ button, the fields populate with information entered
during CDX registration. This field is required.
• Country: Enter the country of the technical contact’s mailing address. If you have clicked
the ‘Copy CDX Registration’ button, the fields populate with information entered during
CDX registration. This is a required field.

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Exhibit 6-2 shows the screen capture of the ‘Technical Contact Information’ screen:
Exhibit 6-2 Technical Contact Information Screen

Navigation: If you are submitting on behalf of another company and click the ‘Next’ button, you
are taken to the ‘Submitting on Behalf of Company’ screen. If you are submitting study plans &
conduct of testing information and are not submitting on behalf of another entity, you are taken
to the ‘Principal Test Sponsor’ screen. You can also access this screen by clicking the
‘Submitting on Behalf of Company’ link within the navigation tree.

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6.3

Submitting on Behalf of Company Screen

You can access the ‘Submitting on Behalf of Company’ screen by selecting the ‘This is a
submission on behalf of another company’ radio button and by clicking the ‘Next’ button from
the ‘Technical Contact Information’ screen. You can also access this screen by clicking the
‘Submitting on Behalf of Company’ link within the navigation tree.
The ‘Submitting on Behalf Of Company’ screen presents a list of fields that allow you to input
the contact information for the manufacturing or processing establishment on whose behalf the
submission is being made.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix.
• First Name: Enter the first name of the manufacturing or processing establishment contact
for which the submission is being made. This field is required.
• Middle Initial: Enter the middle initial of the manufacturing or processing establishment
contact for which the submission is being made.
• Last Name: Enter the last name of the manufacturing or processing establishment contact
for which the submission is being made. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the suffix
of the manufacturing or processing establishment contact for which the submission is being
made. If applicable, select the appropriate suffix.
• Company Name: Enter the company name of the manufacturing or processing
establishment. This field is required.
• Phone Number: Enter the daytime phone number of the manufacturing or processing
establishment contact for whom the submission is being made; U.S. or international. This
field is required.
• Email Address: Enter the email address of the manufacturing or processing establishment
contact for which the submission is being made. The email address must follow the
standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the mailing address of the manufacturing or
processing establishment contact. This field is required.
• Mailing Address 2: Enter the second line of the mailing address of the manufacturing or
processing establishment contact.
• City: Enter the city of the mailing address of the manufacturing or processing
establishment contact. This field is required.
• State: Enter the state of the mailing address of the manufacturing or processing
establishment contact. This is a required field if the ‘Country’ field is defined as ‘United
States.’
• Postal Code: Enter the postal code of the mailing address of the manufacturing or
processing establishment contact. This field is required.
• Country: Enter the country of the manufacturing or processing establishment contact’s
mailing address. This field is required.

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Exhibit 6-3 shows the screen capture of the ‘Submitting on Behalf of Company’ screen:
Exhibit 6-3 Submitting on Behalf of Company Screen

Navigation: If you are submitting study plans & conduct of testing information and click the
‘Next’ button, you are taken to the ‘Principal Test Sponsor’ screen.
6.4

Study Plans & Conduct of Testing

If you have identified you are submitting information for study plans and conduct of testing, you
are required to complete the following screens to satisfy the reporting requirements.
6.4.1

Principal Test Sponsor Screen

The ‘Principal Test Sponsor’ screen presents a list of fields that allow you to input the contact
information for the principal test sponsor.
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• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix.
• First Name: Enter the principal test sponsor contact’s first name. This field is required.
• Middle Initial: Enter the principal test sponsor contact’s middle initial.
• Last Name: Enter the principal test sponsor contact’s last name. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the
principal test sponsor contact’s suffix. If applicable, select the appropriate suffix.
• Company Name: Enter the principal test sponsor contact’s company name. This field is
required.
• Phone Number: Enter the principal test sponsor contact’s daytime phone number; U.S. or
international. This field is required.
• Email Address: Enter the principal test sponsor contact’s email address. The email address
must follow the standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the mailing address of the principal test
sponsor’s company. This field is required.
• Mailing Address 2: Enter the second line of the mailing address of the principal test
sponsor’s company.
• City: Enter the city of the mailing address of the principal test sponsor’s company. This
field is required.
• State: Enter the state of the mailing address of the principal test sponsor contact’s
company. This is a required field if the ‘Country’ field is defined as ‘United States.’
• Postal Code: Enter the postal code of the principal test sponsor contact’s company. This
field is required.
• Country: Enter the country of the mailing address of principal test sponsor contact’s
company. This field is required.

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Exhibit 6-4 shows the screen capture of the ‘Principal Test Sponsor’ screen:
Exhibit 6-4 Principal Test Sponsor Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Principal Sponsor Organization’ screen.
You can also access this screen by clicking the ‘Principal Sponsor Organization’ link within the
navigation tree.
6.4.2

Principal Sponsor Organization Screen

The ‘Principal Sponsor Organization’ screen allows you to enter the contact information for each
administrative official and project manager within the principal test sponsor’s organization. To
add each professional click the ‘Add Sponsor Organization’ button. This will generate a new set
of text fields. Once you have entered data into one field set, you must click the ‘Save’ button
located within that field set prior to adding another member. If the data previously entered and
saved within a field set needs to be edited, you can click the ‘Edit’ button located in the upper
right corner of that field set. If a field set needs to be deleted, you can click the ‘Delete’ icon (
) that is also located in the upper right corner of each field set.

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The system allows you to expand/collapse each field set by clicking the field set header. If you
wish to expand/collapse all field sets simultaneously, click the ‘Expand All’ or ‘Collapse All’
links located at the top right of all field sets.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes and captures the
member contact’s prefix. If applicable, select the appropriate prefix.
• First Name: Enter the member contact’s first name. This field is required.
• Middle Initial: Enter the member contact’s middle initial.
• Last Name: Enter the member contact’s last name. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the
member contact’s suffix. If applicable, select the appropriate suffix.
• Company Name: Enter the member contact’s company name. This field is required.
• Job Title: Enter the member contact’s job title. This field is required.
• Phone Number: Enter the member contact’s daytime telephone number; U.S. or
international. This field is required.
• Email Address: Enter the member contact’s email address. The email address must follow
the standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the member contact’s mailing address. This field
is required.
• Mailing Address 2: Enter the second line of the member contact’s mailing address.
• City: Enter the city of the member contact’s mailing address. This field is required.
• State: Enter the state of the member contact’s mailing address. This field is required when
‘United States’ is identified as the country.
• Postal Code: Enter the postal code of the member contact’s mailing address. This field is
required.
• Country: Enter the country of the member contact’s mailing address. This field is required.

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Exhibit 6-5 shows the screen capture of the ‘Principal Sponsor Organization’ screen:
Exhibit 6-5 Principal Sponsor Organization Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Testing Facilities’ screen. You can also
access this screen by clicking the ‘Testing Facilities’ link within the navigation tree.
6.4.3
Testing Facilities Screen
The ‘Testing Facilities’ screen allows you to enter the contact information for each facility
responsible for testing as well as that facility’s contact. To add each facility and contact, click the
‘Add Testing Facility’ button. This will generate a new set of text fields. Once you have entered
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data into one field set, you must click the ‘Save’ button located within that field set prior to
adding another facility and contact. If the data previously entered and saved within a field set
needs to be edited, you can click the ‘Edit’ button located in the upper right corner of that field
set. If a facility needs to be deleted, you can click the ‘Delete’ icon ( ) that is also located in the
upper right corner of each field set.
The system allows you to expand/collapse each field set by clicking the field set header. If you
wish to expand/collapse all field sets simultaneously, click the ‘Expand All’ or ‘Collapse All’
links located at the top right of all field sets.
• Testing Facility: Enter the testing facility’s name. This field is required.
• Phone Number: Enter the testing facility’s phone number. This field is required.
• Ext: Enter the extension to the testing facility’s phone number.
• Mailing Address 1: Enter the first line of the testing facility’s mailing address. This field is
required.
• Mailing Address 2: Enter the second line of the testing facility’s mailing address.
• City: Enter the city of the testing facility’s mailing address. This field is required.
• State: Enter the state of the testing facility’s mailing address. This field is required when
‘United States’ is identified as the country.
• Postal Code: Enter the postal code of the testing facility’s mailing address. This field is
required.
• Country: Enter the country of the testing facility’s mailing address. This field is required.
• Select the testing facility contact role: Select the job title of the testing facility’s contact
from the drop-down menu. This drop-down menu contains the following values:
‘Administrative Official,’ and ‘Project Manager.’ This field is required.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes and captures the testing
facility contact’s prefix. If applicable, select the appropriate prefix.
• First Name: Enter the testing facility contact’s first name. This field is required.
• Middle Initial: Enter the testing facility contact’s middle initial.
• Last Name: Enter the testing facility contact’s last name. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the testing
facility contact’s suffix. If applicable, select the appropriate suffix.
• Phone Number: Enter the testing facility’s contact’s daytime phone number; U.S. or
international. This field is required.
• Email Address: Enter the testing facility contact’s email address. The email address must
follow the standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the testing facility contact’s mailing address.
This field is required.
• Mailing Address 2: Enter the second line of the testing facility contact’s mailing address.
• City: Enter the city of the testing facility contact’s mailing address. This field is required.

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• State: Enter the state of the testing facility contact’s mailing address. This field is required
when ‘United States’ is identified as the country.
• Postal Code: Enter the postal code of the testing facility contact’s mailing address. This
field is required.
• Country: Enter the country of the mailing address of the testing facility’s contact. This
field is required.
Exhibit 6-6 and Exhibit 6-7 show the screen captures of the ‘Testing Facilities’ screen:
Exhibit 6-6 Testing Facilities Screen (Scroll 1)

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Exhibit 6-7: Testing Facility Screen (Scroll 2)

Navigation: Click the ‘Next’ button to navigate to the ‘Study Professionals’ screen. You can
also access this screen by clicking the ‘Study Professionals’ link within the navigation tree.
6.4.4

Study Professionals Screen

The ‘Study Professionals’ screen allows you to provide the contact information and a summary
of the training and experience of each professional involved in the study. To add each
professional click the ‘Add Study Professional’ button. This will generate a new set of text
fields. Once you have entered data into one field set, you must click the ‘Save’ button located
within that field set prior to adding another professional. If the data previously entered and saved
within a field set needs to be edited, you can click the ‘Edit’ button located in the upper right

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corner of that field set. If a professional needs to be deleted, you can click the ‘Delete’ icon (
that is also located in the upper right corner of each field set.

)

The system allows you to expand/collapse each field set by clicking the field set header. If you
wish to expand/collapse all field sets simultaneously, click the ‘Expand All’ or ‘Collapse All’
links located at the top right of all field sets.
• Select the Study Professional Role: Select the study professional’s role from the dropdown menu. This drop-down menu contains the following values: ‘Chemist,’ ‘Laboratory
Assistant,’ ‘Microbiologist,’ ‘Pathologist,’ ‘Study Director,’ ‘Toxicologist,’ ‘Veterinarian,’
and ‘Other.’ This field is required.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes and captures the study
professional’s prefix. If applicable, select the appropriate prefix.
• First Name: Enter the study professional’s first name. This field is required.
• Middle Initial: Enter the study professional’s middle initial.
• Last Name: Enter the study professional’s last name. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the study
professional’s suffix. If applicable, select the appropriate suffix.
• Company Name: Enter the study professional’s company name. This field is required.
• Phone Number: Enter the study professional’s daytime phone number; U.S. or
international. This field is required.
• Email Address: Enter the study professional’s email address. The email address must
follow the standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the study professional’s mailing address. This
field is required.
• Mailing Address 2: Enter the second line of the study professional’s mailing address.
• City: Enter the city of the study professional’s mailing address. This is a required field.
• State: Enter the state of the study professional’s mailing address. This field is required
when ‘United States’ is identified as the country.
• Postal Code: Enter the postal code of the study professional’s mailing address. This field is
required.
• Country: Enter the country of the study professional’s mailing address. This is a required
field.
• Experience Summary: Enter a summary of the study professional’s experience.

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Exhibit 6-8 shows the screen capture of the ‘Study Professionals’ screen:
Exhibit 6-8 Study Professionals Screen

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Navigation: Click the ‘Next’ button to navigate to the ‘Document Management’ screen. You can
also access this screen by clicking the ‘Document Management’ link within the navigation tree if
the ‘Results’ checkbox was checked on the ‘Submission Information Type’ screen.
6.5
Results
If you have identified you are submitting results, you are required to complete the following
screens to satisfy the reporting requirements.
6.5.1

Document Management Screen

The ‘Document Management’ screen allows you to upload documents related to Section 4
reporting requirements. To add Section 4 results documentation, click the ‘Attach Document’
button. Clicking the ‘Attach Document’ button displays the ‘Document Management’ pop-up
window.
The ‘Document Management’ pop-up window allows you to attach documentation by clicking
the ‘Browse’ button. This will generate the ‘File Upload’ window where you can select the
desired document from your hard drive. Once you have identified the document to be attached,
click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’ window and
display the attached document within the ‘Browse’ field.
The ‘Document Management’ table displays the file name of the document and the date the
document was attached. The system allows you to delete unwanted documents by clicking the
‘Delete’ icon located under the ‘Action’ column for a given row. Clicking the file name links
within the ‘File Name’ column generates the ‘Document Management’ pop-up window. This
allows you to view and edit previously attached documents.
• Add Document: Clicking the ‘Add Document’ button displays the ‘Document
Management’ pop-up window.
• File Name: Displays the name of the attached file. Clicking the file name link generates the
‘Document Management’ pop-up window and allows you to view the attached document.
• Attachment Date: Displays the date the document was attached.
• Action: Clicking the ‘Delete’ icon ( ) will generate a prompt confirming deletion. To
delete the specified row and all contents within click the ‘OK’ button within the prompt.

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Exhibit 6-9 shows the screen capture of the ‘Document Management’ screen:
Exhibit 6-9 Document Management Screen

Navigation: Click the ‘Next’ button to navigate to the ‘MOU Additional Information’ screen.
You can also access this screen by clicking the ‘MOU Additional Information’ link within the
navigation tree.
The ‘Document Management’ pop-up window allows you to browse for a document from your
hard drive and attach one document at a time. You must attach at least one document. Clicking
the ‘Browse’ button will generate the ‘File Upload’ window on your hard drive. Select the
document you wish to attach and click the ‘Open’ button. If a document is marked as ‘CBI’ then
a sanitized copy of the document must be attached. To save the attached document to the
‘Document Management’ screen, click the ‘OK’ button within the ‘Document Management’
pop-up window.
• Original Document: Clicking the ‘Browse’ button will generate the ‘File Upload’
window for you to search for a particular file on your hard drive.
• Effects: Select the effect specific to the chemical report. Displays the following options:
‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
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Refer to Appendix B for a complete list of values that are found within each of the drop-down
menus on the ‘Document Management’ pop-up window. If you have multiple documents that
share the same effects and/or endpoints, you must upload each individual document separately
and select values from the drop-down menus.
Exhibit 6-10 Document Management Pop-Up Window

Navigation: Click the ‘OK’ or ‘Cancel’ buttons to return to the ‘Document Management’ screen.
6.6

MOU Additional Information Screen

The ‘MOU Additional Information’ screen allows you to upload documents related to Section 4
reporting requirements. To add additional information select the appropriate additional
information type and click the ‘Attach Document’ button. Clicking the ‘Attach Document’
button displays the ‘MOU Additional Information’ pop-up window. If you select the
‘Amendments to the Study Plan’ radio button and click the ‘Attach Document’ button, the
‘Amendments to the Study Plan’ pop-up window generates. If you select the ‘Modification of
MOUs’ radio button and click the ‘Attach Document’ button, the ‘Modification of MOUs’ popup window generates.
The ‘Amendments to the Study Plan’ pop-up window allows you to attach documentation by
clicking the ‘Browse’ button. This will generate the ‘File Upload’ window where you can search
for the desired document from your hard drive. Once you have identified the document to be
attached, click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’
window and display the attached document within the ‘Browse’ field. Once you have attached all
desired documentation, click the ‘OK’ button to return to the ‘MOU Additional Information’
screen.
The ‘Modification of MOUs’ pop-up window allows you to provide an explanation and rationale
for the modification of the MOU within a text box. Once you have provided an explanation click
the ‘OK’ button to return to the ‘MOU Additional Information’ screen.

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The MOU additional information table displays the file name of the document, the document
type, and the date the document was attached. The system allows you to delete unwanted
documents by clicking the ‘Delete’ icon located under the ‘Action’ column for a given row.
Clicking the file name links within the ‘File Name’ column generates the pop-up window. This
allows you to view and edit previously attached documents or information.
• Amendments to the Study Plan: Select the radio button to indicate the additional
information type.
• Modification of MOUs: Select the radio button to indicate the additional information type.
• Attach Document: Clicking the ‘Attach Document’ button displays the ‘Amendments to
the Study Plan’ or ‘Modification of MOUs’ pop-up window.
• File Name: Displays the name of the attached file if applicable. Clicking the file name link
generates the pop-up window and allows you to view the attached document or
information.
• Document Type: Displays the additional information type indicated on the page.
• Attachment Date: Displays the date the document was attached.
• Action: Clicking the ‘Delete’ icon ( ) will generate a prompt confirming deletion. To
delete the specified row and all contents within click the ‘OK’ button within the prompt.
Exhibit 6-11 shows the screen capture of the ‘MOU Additional Information’ screen:
Exhibit 6-11 MOU Additional Information Screen

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Navigation: Click the ‘Previous’ button to navigate to the ‘Document Management’ screen. If
you have completed all required fields, click the ‘Submit’ icon located in the action bar to begin
the submission process.
Exhibit 6-12 shows the screen capture of the ‘Amendment to the Study Plan’ pop-up window:
Exhibit 6-12 Amendment to the Study Plan Pop-Up Window

Navigation: Click the ‘OK’ or ‘Cancel’ button to return to the ‘MOU Additional Information’
screen.
Exhibit 6-13 shows the screen capture of the ‘Modification of MOUs’ pop-up window:
Exhibit 6-13 Modification of MOUs Pop-Up Window

Navigation: Click the ‘OK’ or ‘Cancel’ button to return to the ‘MOU Additional Information’
screen.

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7

40 CFR 766 Dibenzodioxins/Dibenzofurans

7.1

Submission Information Type Screen

You can access the ‘Submission Information Type’ screen by clicking the ‘Next’ button from
either the ‘Create New Passphrase’ or the ‘Enter Passphrase’ screen. Once you are within the ’40
CFR 766’ flow of the Section 4 application, the ‘Submission Information Type’ screen can also
be accessed by clicking the ‘Submission Information Type’ link located within the navigation
tree.
The ‘Submission Information Type’ screen allows you to select the submission information type
that you will be submitting to EPA. This screen consists of the following fields:
• Submission Alias: This field is auto-populated with a date and time stamp and is displayed
on the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen within
the ‘Submission Alias’ column. The ‘Submission Alias’ is also used to differentiate
between submission types within the ‘User Management’ screen. This field is editable
should you choose to provide your own submission alias. This field is required.
• Letter of Intent: Checking the ‘Letter of Intent’ checkbox indicates that you are fulfilling
the requirements to submit a letter of intent to EPA. Once you have checked the ‘Letter of
Intent’ checkbox and either saved the information on this screen by clicking the ‘Save’ icon
or by clicking the ‘Next’ button, the ‘Letter of Intent’ folder is generated within the
navigation tree allowing you to access the letter of intent screens required to be completed.
• Protocol: Checking the ‘Protocol’ checkbox indicates that you are fulfilling the
requirements to submit protocols to EPA. Once you have checked the ‘Protocol’ checkbox
and either saved the information on this screen by clicking the ‘Save’ icon or by clicking
the ‘Next’ button, the ‘Protocol’ folder is generated within the navigation tree allowing you
to access the protocol screens required to be completed.
• Results: Checking the ‘Results’ checkbox indicates that you are fulfilling the requirements
to submit results to EPA. Once you have checked the ‘Results’ checkbox and either saved
the information on this screen by clicking the ‘Save’ icon or by clicking the ‘Next’ button,
the ‘Results’ folder is generated within the navigation tree allowing you to access the
results screens required to be completed.
• User Requests: Checking the ‘User Requests’ checkbox indicates that are you submitting a
request to EPA. Checking the ‘User Requests’ checkbox will enable the ‘Waiver,’
‘Exclusion,’ and ‘Exemption’ radio button options. If you indicate that are you submitting a
‘User Request’ the ‘Letter of Intent,’ ‘Protocol,’ and ‘Results’ checkboxes will become
disabled.
o Waiver: Selecting the ‘Waiver’ radio button indicates that you are fulfilling the
requirements to submit a waiver to EPA. Once you have checked the ‘User
Requests’ checkbox and selected the ‘Waiver’ radio button and either saved the
information on this screen by clicking the ‘Save’ icon or by clicking the ‘Next’
button, the ‘User Requests’ folder is generated within the navigation tree allowing
you to access the ‘Waiver’ screen.
o Exclusion: Selecting the ‘Exclusion’ radio button indicates that you are fulfilling
the requirements to submit an exclusion to EPA. Once you have checked the
‘User Requests’ checkbox and selected the ‘Exclusion’ radio button and either
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saved the information on this screen by clicking the ‘Save’ icon or by clicking the
‘Next’ button, the ‘User Requests’ folder is generated within the navigation tree
allowing you to access the ‘Exclusion’ screen.
o Exemption: Selecting the ‘Exemption’ radio button indicates that you are
fulfilling the requirements to submit an exemption to EPA. Once you have
checked the ‘User Requests’ checkbox and selected the ‘Exemption’ radio button
and either saved the information on this screen by clicking the ‘Save’ icon or by
clicking the ‘Next’ button, the ‘User Requests’ folder is generated within the
navigation tree allowing you to access the ‘Exemption’ screen.
If you have previously identified a submission type, have accessed the submission type screens,
and then uncheck the previously checked submission information type (i.e. Study Plan), you will
receive a prompt indicating that all associated information will be lost. Clicking the ‘OK’ button
within the prompt will delete all data associated with that submission information type.
Once you have identified the type(s) of information you will be submitting to EPA, you are able
to access the screens required to be completed.
Exhibit 7-1 shows the screen capture of the ‘Submission Information Type’ screen:
Exhibit 7-1 Submission Information Type Screen

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

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7.2

Technical Contact Information Screen

The ‘Technical Contact Information’ screen allows you to submit on behalf of another company
or submit on behalf of a consortium. To identify if you are submitting on behalf of another
entity, the system provides the radio button for ‘This is a submission on behalf of a consortium.’
To identify if you are submitting on behalf of another company, the system provides the radio
button ‘This is a submission on behalf of another company.’ The system will not allow you to
select more than one radio button per submission.
If you are not submitting on behalf of another entity and have selected the ‘N/A’ radio button,
you are taken to the ‘Chemical Identification’ screen. If you are submitting on behalf of a
consortium, select the ‘This is a submission on behalf of a consortium’ radio button. If the radio
button for ‘This is a submission on behalf of a consortium’ is selected, you are taken to the
‘Submitting on Behalf of Consortium’ screen. If you are submitting on behalf of another
company, select the ‘This is a submission on behalf of another company’ radio button. This
functionality has been implemented to accommodate a company that may use an agent or another
individual. If this radio button is selected, the information of the contractor/consultant’s company
is to be entered into the ‘Submitting on Behalf Of Company’ screen.
• N/A: Selecting the ‘N/A’ radio button allows you to signify that you are neither making a
submission on behalf of a consortium nor making a submission on behalf of another
company.
• This is a submission on behalf of a consortium: Selecting the ‘This is a submission on
behalf of a consortium’ radio button allows you to identify yourself as an individual
submitting on behalf of a consortium.
• This is a submission on behalf of another company: Selecting the ‘This is a submission
on behalf of another company’ radio button allows you to identify yourself as an individual
submitting on behalf of another company.
• Copy CDX Registration: Clicking the ‘Copy CDX Registration’ button will automatically
populate the fields with your contact information provided during CDX registration.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix. If you have clicked the ‘Copy CDX Registration’ button, the fields
populate with information entered during CDX registration.
• First Name: Enter the technical contact’s first name. If you have clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This field is required.
• Middle Initial: Enter the technical contact’s middle initial. If you have clicked the ‘Copy
CDX Registration’ button, the fields populate with information entered during CDX
registration.
• Last Name: Enter the technical contact’s last name. If you have clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes. If applicable, select the
appropriate suffix. If you have clicked the ‘Copy CDX Registration’ button, the fields
populate with information entered during CDX registration.

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• Company Name: Enter the technical contact’s company name. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• Phone Number: Enter the technical contact’s daytime phone number; U.S. or
international. If you have clicked the ‘Copy CDX Registration’ button, the fields populate
with information entered during CDX registration. This field is required.
• Email Address: Enter the technical contact’s email address. The email address must
follow the standard email address format: [email protected]. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• Mailing Address 1: Enter the first line of the technical contact’s mailing address. If you
have clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration. This field is required.
• Mailing Address 2: Enter the second line of the technical contact’s mailing address. If you
have clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration.
• City: Enter the city of the technical contact’s mailing address. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This field is required.
• State: Enter the state of the technical contact’s mailing address. If you have clicked the
‘Copy CDX Registration’ button, the fields populate with information entered during CDX
registration. This is a required field if the ‘Country’ field is defined as ‘United States.’
• Postal Code: Enter the postal code of the technical contact’s mailing address. If you have
clicked the ‘Copy CDX Registration’ button, the fields populate with information entered
during CDX registration. This field is required.
• Country: Enter the country of the technical contact’s mailing address. If you have clicked
the ‘Copy CDX Registration’ button, the fields populate with information entered during
CDX registration. This is a required field.

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Exhibit 7-2 shows the screen capture of the ‘Technical Contact Information’ screen:
Exhibit 7-2 Technical Contact Information Screen

Navigation: If you are submitting on behalf of a consortium, you are taken to the ‘Submitting on
Behalf of Consortium’ screen. If you are submitting on behalf of another company and click the
‘Next’ button, you are taken to the ‘Submitting on Behalf of Company’ screen. If you are
submitting a Letter of Intent and are not submitting on behalf of another entity, you are taken to
the ‘Chemical Identification’ screen. If you are submitting a protocol or results and are not
submitting on behalf of another entity, you are taken to the ‘Document Management’ screen.

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7.3

Submitting on Behalf of Consortium Screen

You can access the ‘Submitting on Behalf of Consortium’ screen by selecting the ‘This is a
submission on behalf of a consortium’ radio button and by clicking the ‘Next’ button from the
‘Technical Contact Information’ screen. You can also access this screen by clicking the
‘Submitting on Behalf of Consortium’ link within the navigation tree.
The ‘Submitting on Behalf of Consortium’ screen allows you to enter the contact information for
each consortium member. To add each consortium member click the ‘Add’ button. This will
generate a new set of consortium fields. Once you have entered data into one consortium field
set, you must click the ‘Save’ button located within that field set prior to adding another member.
If the data previously entered and saved within a consortium field set needs to be edited, you can
click the ‘Edit’ button located in the upper right corner of that field set. If a consortium member
needs to be deleted, you can click the ‘Delete’ icon that is also located in the upper right corner
of each field set. There must be at least two consortium members for an entered consortium.
The system allows you to expand/collapse each consortium field set by clicking the consortium
field set header. If you wish to expand/collapse all consortium field sets simultaneously, click the
‘Expand All’ or ‘Collapse All’ links located at the top right of all consortium field sets.
• Consortium Name: Enter the name of the consortium.
• Consortium CBI: Checking the CBI checkbox will claim the consortium as CBI.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes and captures the
consortium member contact’s prefix. If applicable, select the appropriate prefix.
• First Name: Enter the consortium member contact’s first name. This field is required.
• Middle Initial: Enter the consortium member contact’s middle initial.
• Last Name: Enter the consortium member contact’s last name. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the
consortium member contact’s suffix. If applicable, select the appropriate suffix.
• Company Name: Enter the consortium member contact’s company name. This field is
required.
• Phone Number: Enter the consortium member contact’s daytime phone number; U.S. or
international. This field is required.
• Ext: Enter the extension to the consortium member contact’s daytime phone number.
• Email Address: Enter the consortium member contact’s email address. The email address
must follow the standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the consortium member contact’s mailing
address. This field is required.
• Mailing Address 2: Enter the second line of the consortium member contact’s mailing
address.
• City: Enter the city of the consortium member contact’s mailing address. This field is
required.
• State: Enter the state of the consortium member contact’s mailing address. This field is
required when ‘United States’ is identified as the country.
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• Postal Code: Enter the postal code of the consortium member contact’s mailing address.
This field is required.
• Country: Enter the country of the consortium contact’s mailing address. This field is
required.
Exhibit 7-3 shows the screen capture for the ‘Submitting on Behalf of Consortium’ screen:
Exhibit 7-3 Submitting on Behalf of Consortium Screen

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Navigation: Click the ‘Next’ button to navigate to the ‘Chemical Identification’ screen if
submitting a letter of intent. You can also access this screen by clicking the ‘Chemical
Identification’ link within the navigation tree.
7.4

Submitting on Behalf of Company Screen

The ‘Submitting on Behalf of Company’ screen presents a list of fields that allow you to input
the contact information for the manufacturing or processing establishment on whose behalf the
submission is being made.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix.
• First Name: Enter the first name of the manufacturing or processing establishment contact
for which the submission is being made. This field is required.
• Middle Initial: Enter the middle initial of the manufacturing or processing establishment
contact for which the submission is being made.
• Last Name: Enter the last name of the manufacturing or processing establishment contact
for which the submission is being made. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the suffix
of the manufacturing or processing establishment contact for which the submission is being
made. If applicable, select the appropriate suffix.
• Company Name: Enter the company name of the manufacturing or processing
establishment. This field is required.
• Phone Number: Enter the daytime phone number of the manufacturing or processing
establishment contact for whom the submission is being made; U.S. or international. This
field is required.
• Email Address: Enter the email address of the manufacturing or processing establishment
contact for which the submission is being made. The email address must follow the
standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the mailing address of the manufacturing or
processing establishment contact. This field is required.
• Mailing Address 2: Enter the second line of the mailing address of the manufacturing or
processing establishment contact.
• City: Enter the city of the mailing address of the manufacturing or processing
establishment contact. This field is required.
• State: Enter the state of the mailing address of the manufacturing or processing
establishment contact. This is a required field if the ‘Country’ field is defined as ‘United
States.’
• Postal Code: Enter the postal code of the mailing address of the manufacturing or
processing establishment contact. This field is required.
• Country: Enter the country of the mailing address of the manufacturing or processing
establishment contact. This field is required.

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Exhibit 7-4 shows the screen capture of the ‘Submitting on Behalf of Company’ screen:
Exhibit 7-4 Submitting on Behalf of Company Screen

Navigation: If you are submitting a letter of intent and click the ‘Next’ button, you are taken to
the ‘Chemical Identification’ screen. If you are submitting a study plan or results, you are taken
to the ‘Document Management’ screen.
7.4.1

Chemical Identification Screen

The ‘Chemical Identification’ screen requires you to identify the chemical substance the
sponsor(s) intends to use in each of the tests. To identify the chemical substance select a
chemical from the ‘Please select, or being typing, a CASRN in the drop-down menu below.’ The
system allows you to claim the chemical as CBI, by checking the ‘CBI’ checkbox.
Exhibit 7-5 shows the screen capture of the ‘Chemical Identification’ screen:

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Exhibit 7-5 Chemical Identification Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Sponsoring Firms’ screen if you checked
the ‘Letter of Intent’ checkbox on the ‘Submission Information Type’ screen. If all information
has been completed please click the ‘Submit’ icon in the action bar to begin the submission
process.
7.5

Letter of Intent

If you have identified that you are submitting a letter of intent, you are required to complete the
following screens to satisfy the reporting requirements.
7.5.1

Sponsoring Firms Screen

To access the ‘Sponsoring Firms’ screen click the ‘Next’ button from the ‘Chemical
Identification’ screen. You can also access the ‘Sponsoring Firms’ screen by clicking the
‘Sponsoring Firms’ link located within the navigation tree under the ‘Letter of Intent’ folder.
The ‘Sponsoring Firms’ screen requires you to identify each sponsoring firm involved in the
testing of the identified chemical substances. To identify a sponsoring firm click the ‘Add
Sponsoring Firm’ button. Clicking the ‘Add Sponsoring Firm’ button generates a sponsoring
firm field set. Once you have entered data into a sponsoring firm field set, you must click the
‘Save’ button located within that field set prior to adding another firm. If the data previously
entered and saved within a field set needs to be edited, you can click the ‘Edit’ button located in
the upper right corner of that field set. If a sponsoring firm needs to be deleted, you can click the
‘Delete’ icon that is also located in the upper right corner of each field set.

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The system allows you to expand/collapse each field set by clicking the sponsoring firm field set
header. If you wish to expand/collapse all field sets simultaneously, click the ‘Expand All’ or
‘Collapse All’ links located at the top right of all consortium field sets.
• CBI: Check the checkbox to claim the sponsoring firm as CBI.
• Firm: Enter the sponsoring firm’s company name. This field is required.
• Phone Number: Enter the sponsoring firm’s daytime phone number; U.S. or international.
This field is required.
• Ext: Enter the sponsoring firm’s extension to the listed daytime phone number.
• Mailing Address 1: Enter the first line of the sponsoring firm’s mailing address. This field
is required.
• Mailing Address 2: Enter the second line of the sponsoring firm’s mailing address.
• City: Enter the city of the sponsoring firm’s mailing address. This field is required.
• State: Enter the state of the sponsoring firm’s mailing address. This field is required when
‘United States’ is identified as the country.
• Postal Code: Enter the postal code of the sponsoring firm’s mailing address. This field is
required.
• Country: Enter the country of the sponsoring firm’s mailing address. This field is required.

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Exhibit 7-6 shows the screen capture of the ‘Sponsoring Firms’ screen:
Exhibit 7-6 Sponsoring Firms Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Document Management’ screen if you
have identified that you are submitting a protocol or results. If you are only completing a ‘Letter
of Intent,’ click the ‘Submit’ icon located in the action bar to begin the submission process.
7.6

Protocol

If you have identified you are submitting a protocol, you are required to complete the following
screens to satisfy the reporting requirements.
7.6.1

Protocol Document Management Screen

The ‘Document Management’ screen allows you to upload documents related to Section 4
reporting requirements. To add protocol documentation, click the ‘Attach Document’ button.
Clicking the ‘Attach Document’ button displays the ‘Protocol Document Management’ pop-up
window.

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The ‘Protocol Document Management’ pop-up window allows you to upload files from your
hard drive. Click the ‘Browse’ button to generate the ‘File Upload’ window. The ‘File Upload’
window allows you to search for the desired document from your hard drive. Once you have
identified the document to be attached, click the ‘Open’ button. Clicking the ‘Open’ button will
close the ‘File Upload’ window and display the attached document within the ‘Browse’ field. To
claim attached documentation CBI, check the ‘CBI’ checkbox. If you claim the attached
documentation as CBI, you are able to attach the sanitized version of the attached document. To
do so, follow the steps outlined above. Once you have attached all desired documentation, click
the ‘OK’ button to return to the ‘Document Management’ screen.
The document management table displays the file name of the document, the date the document
was attached, and whether the document was claimed as CBI. The system allows you to delete
unwanted documents by clicking the ‘Delete’ icon located under the ‘Action’ column for a given
row. Clicking the file name links within the ‘File Name’ column generates the ‘Protocol
Document Management’ pop-up window. This allows you to view and edit previously attached
documents.
• Attach Document: Clicking the ‘Attach Document’ button displays the ‘Protocol
Document Management’ pop-up window.
• File Name: Displays the name of the attached file. Clicking the file name link generates the
‘Protocol Document Management’ pop-up window and allows you to view the attached
document.
• Document Type: Displays the type of document attached.
• Attachment Date: Displays the date the document was attached.
• CBI: Displays whether the attached document was claimed as CBI by displaying a ‘Y’ or
an ‘N.’
• Action: Clicking the ‘Delete’ icon ( ) will generate a prompt confirming deletion. To
delete the specified row and all contents within click the ‘OK’ button within the prompt.

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Exhibit 7-7 shows the screen capture of the ‘Protocol Document Management’ screen:
Exhibit 7-7 Document Management Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Document Management’ screen if you
have identified that you are submitting results to EPA. If you are only submitting a protocol click
the ‘Submit’ icon located in the action bar to begin the submission process.
The ‘Protocol Document Management’ pop-up window allows you to browse for a document
from your hard drive and attach one document at a time. You must attach at least one document.
Clicking the ‘Browse’ button will generate the ‘File Upload’ window on your hard drive. Select
the document you wish to attach and click the ‘Open’ button. If a document is marked as ‘CBI’
then a sanitized copy of the document must be attached. To save the attached document to the
‘Document Management’ screen, click the ‘OK’ button within the ‘Protocol Document
Management’ pop-up window.
• CBI: Checking this ‘CBI’ checkbox will claim the document as CBI and generate a
sanitized document upload field.
• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.
• Sanitized Document Upload: Clicking the ‘Browse’ button will generate the ‘File
Upload’ window for you to search for a particular file on your hard drive. This field is
only generated when the ‘CBI’ checkbox is checked and is optional.
• Effects: Select the effect specific to the chemical report. Displays the following options:
‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical Chemical Properties.’
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• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values that are found within each of the drop-down
menus on the ‘Document Management’ pop-up window. If you have multiple documents that
share the same effects and/or endpoints, you must upload each individual document separately
and select values from the drop-down menus.
Exhibit 7-8 shows the screen capture of the ‘Protocol Document Management’ pop-up window:
Exhibit 7-8 Protocol Document Management Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Document Management’ screen.
7.7

Results

If you have identified you are submitting results, you are required to complete the following
screens to satisfy the reporting requirements.
7.7.1

Document Management Screen

The ‘Document Management’ screen allows you to upload documents related to Section 4
reporting requirements. To add Section 4 results documentation, click the ‘Attach Document’
button. Clicking the ‘Attach Document’ button displays the ‘Document Management’ pop-up
window.
The ‘Document Management’ pop-up window allows you to attach documentation by clicking
the ‘Browse’ button. This will generate the ‘File Upload’ window where you can select the
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desired document from your hard drive. Once you have identified the document to be attached,
click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’ window and
display the attached document within the ‘Browse’ field. To claim attached documentation CBI,
check the ‘CBI’ checkbox. If you claim the attached documentation as CBI you are able to attach
the sanitized version of the attached document. To do so, follow the steps outlined above. Once
you have attached all desired documentation, click the ‘OK’ button to return to the ‘Document
Management’ screen.
The document management table displays the file name of the document, the date the document
was attached, and whether the document was claimed as CBI. The system allows you to delete
unwanted documents by clicking the ‘Delete’ icon located under the ‘Action’ column for a given
row. Clicking the file name links within the ‘File Name’ column generates the ‘Document
Management’ pop-up window. This allows you to view and edit previously attached documents.
• Attach Document: Clicking the ‘Attach Document’ button displays the ‘Document
Management’ pop-up window.
• File Name: Displays the name of the attached file. Clicking the file name link generates the
‘Document Management’ pop-up window and allows you to view the attached document.
• Attachment Date: Displays the date the document was attached.
• CBI: Displays whether the attached document was claimed as CBI by displaying a ‘Y’ or
an ‘N.’
• Action: Clicking the ‘Delete’ icon ( ) will generate a prompt confirming deletion. To
delete the specified row and all contents within click the ‘OK’ button within the prompt.
Exhibit 7-9 shows the screen capture of the ‘Document Management’ screen:

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Exhibit 7-9 Document Management Screen

Navigation: Click the ‘Previous’ button to navigate to the ‘Document Management’ screen if
you have identified you are submitting a protocol to EPA. If you have completed all required
fields, click the ‘Submit’ icon located in the action bar to begin the submission process.
The ‘Document Management’ pop-up window allows you to browse for a document from your
hard drive and attach one document at a time. You must attach at least one document. Clicking
the ‘Browse’ button will generate the ‘File Upload’ window on your hard drive. Select the
document you wish to attach and click the ‘Open’ button. If a document is marked as ‘CBI’ then
a sanitized copy of the document must be attached. To save the attached document to the
‘Document Management’ screen, click the ‘OK’ button within the ‘Document Management’
pop-up window.
• CBI: Checking this ‘CBI’ checkbox will claim the document as CBI and generate a
sanitized document upload field.
• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.
• Sanitized Document Upload: Clicking the ‘Browse’ button will generate the ‘File
Upload’ window for you to search for a particular file on your hard drive. This field is
only generated when the ‘CBI’ checkbox is checked and is optional.
• Effects: Select the effect specific to the chemical report. Displays the following options:
‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical Chemical Properties.’

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• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values that are found within each of the drop-down
menus on the ‘Document Management’ pop-up window. If you have multiple documents that
share the same effects and/or endpoints, you must upload each individual document separately
and select values from the drop-down menus.
Exhibit 7-10 shows the screen capture of the ‘Document Management’ pop-up window:
Exhibit 7-10 Document Management Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Document Management’ screen.
7.8

User Requests

If you have identified you are submitting a user request, you are required to complete the
following screens to satisfy the reporting requirements.
7.8.1

Waiver Screen

You can access the ‘Waiver’ screen by clicking the ‘Next’ button from the ‘Chemical
Identification’ screen. You can also access this screen by clicking the ‘Waiver’ link within the
navigation tree.
The ‘Waiver’ screen requires you to identify the appropriate qualifying waiver reason and allows
you to upload documents related to Section 4 reporting requirements. To add Section 4 waiver

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documentation, click the ‘Attach Document’ button. Clicking the ‘Attach Document’ button
displays the ‘Waiver Document Management’ pop-up window.
The ‘Waiver Document Management’ pop-up window allows you to attach documentation by
clicking the ‘Browse’ button. This will generate the ‘File Upload’ window where you can search
for the desired document from your hard drive. Once you have identified the document to be
attached, click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’
window and display the attached document within the ‘Browse’ field. To claim attached
documentation as CBI, check the ‘CBI’ checkbox. If you claim the attached documentation as
CBI you are required to attach the sanitized version of the attached document. To do so, follow
the steps outlined above. Once you have attached all desired documentation, click the ‘OK’
button to return to the ‘Waiver’ screen.
The waiver table displays the file name of the document, the date the document was attached,
and whether the document was claimed as CBI. The system allows you to delete unwanted
documents by clicking the ‘Delete’ icon located under the ‘Action’ column for a given row.
Clicking the file name links within the ‘File Name’ column generates the ‘Waiver Document
Management’ pop-up window. This allows you to view and edit previously attached documents.
• The chemical substance is produced only in quantities of 100 kilograms or less per
year, only for research and development purposes: Selecting this radio button option
identifies this as the qualifying reason for the Waiver request.
• The cost of testing would drive the chemical substance off the market, or prevent
resumption of manufacture or import of the chemical substance, if it is not currently
manufactured, and the chemical substance will be produced so that no unreasonable
risk will occur due to its manufacture, import, processing, distribution, use, or
disposal. (In this case, the manufacturer must submit to EPA all data supporting the
determination.): Selecting this radio button option identifies this as the qualifying reason
for the waiver request.
• Attach Document: Clicking the ‘Attach Document’ button displays the ‘Waiver Document
Management’ pop-up window.
• File Name: Displays the name of the attached file. Clicking the file name link generates the
‘Waiver Document Management’ pop-up window and allows you to view and edit the
attached document.
• Attachment Date: Displays the date the document was attached.
• CBI: Displays whether the attached document was claimed as CBI by displaying a ‘Y’ or
an ‘N.’
• Action: Clicking the ‘Delete’ icon ( ) will generate a prompt confirming deletion. To
delete the specified row and all contents within click the ‘OK’ button within the prompt.

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Exhibit 7-11 shows the screen capture of the ‘Waiver’ screen:
Exhibit 7-11 Waiver Screen

Navigation: Click the ‘Previous’ button to navigate to the ‘Chemical Identification’ screen.

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Exhibit 7-12 shows the screen capture of the ‘Waiver Document Management’ pop-up window:
Exhibit 7-12 Waiver Document Management Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Waiver’ screen.
7.8.2

Exclusion Screen

You can access the ‘Exclusion’ screen by clicking the ‘Next’ button from the ‘Chemical
Identification’ screen. You can also access this screen by clicking the ‘Exclusion’ link within the
navigation tree.
The ‘Exclusion’ screen requires you to identify the appropriate qualifying exclusion reason and
allows you to upload documents related to Section 4 reporting requirements. To add Section 4
exclusion documentation, click the ‘Attach Document’ button. Clicking the ‘Attach Document’
button displays the ‘Exclusion Document Management’ pop-up window.
The ‘Exclusion Document Management’ pop-up window allows you to attach documentation by
clicking the ‘Browse’ button. This will generate the ‘File Upload’ window where you can select
the desired document from your hard drive. Once you have identified the document to be
attached, click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’
window and display the attached document within the ‘Browse’ field. To claim attached
documentation CBI, check the ‘CBI’ checkbox. If you claim the attached documentation as CBI
you are able to attach the sanitized version of the attached document. To do so, follow the steps
outlined above. Once you have attached all desired documentation, click the ‘OK’ button to
return to the ‘Exclusion’ screen.
The exclusion table displays the file name of the document, the date the document was attached,
and whether the document was claimed as CBI. The system allows you to delete unwanted
documents by clicking the ‘Delete’ icon located under the ‘Action’ column for a given row.
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Clicking the file name links within the ‘File Name’ column generates the ‘Exclusion Document
Management’ pop-up window. This allows you to view and edit previously attached documents.
• Testing of the appropriate grade of the chemical substance has already been carried
out, either analytical testing at the lowest LOQ possible, with appropriate QA/QC, or
a well-designed bioassay with appropriate QA/QC: Selecting this radio button option
identifies this as the qualifying reason for the exclusion request.
• Process and reaction conditions of the chemical substance such that no HDDs/HDFs
could be produced under those conditions: Selecting this radio button option identifies
this as the qualifying reason for the exclusion request.
• Attach Document: Clicking the ‘Attach Document’ button displays the ‘Exclusion
Document Management’ pop-up window.
• File Name: Displays the name of the attached file. Clicking the file name link generates the
‘Exclusion Document Management’ pop-up window and allows you to view the attached
document.
• Attachment Date: Displays the date the document was attached.
• CBI: Displays whether the attached document was claimed as CBI by displaying a ‘Y’ or
an ‘N.’
• Action: Clicking the ‘Delete’ icon ( ) will generate a prompt confirming deletion. To
delete the specified row and all contents within click the ‘OK’ button within the prompt.

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Exhibit 7-13 shows the screen capture of the ‘Exclusion’ screen:
Exhibit 7-13 Exclusion Screen

Navigation: Click the ‘Previous’ button to navigate to the ‘Chemical Identification’ screen.

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Exhibit 7-14 shows the screen capture of the ‘Exclusion Document Management’ pop-up
window:
Exhibit 7-14 Exclusion Document Management Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Exclusion’ screen.
7.8.3

Exemption Screen

You can access the ‘Exemption’ screen by clicking the ‘Next’ button from the ‘Chemical
Identification’ screen. You can also access this screen by clicking the ‘Exemption’ link within
the navigation tree.
The ‘Exemption’ screen allows you to upload documents related to Section 4 reporting
requirements. To add Section 4 exemption documentation, click the ‘Attach Document’ button.
Clicking the ‘Attach Document’ button displays the ‘Exemption Document Management’ pop-up
window.
The ‘Exemption Document Management’ pop-up window allows you to attach documentation
by clicking the ‘Browse’ button. This will generate the ‘File Upload’ window where you can
select the desired document from your hard drive. Once you have identified the document to be
attached, click the ‘Open’ button. Clicking the ‘Open’ button will close the ‘File Upload’
window and display the attached document within the ‘Browse’ field. To claim attached
documentation as CBI, check the ‘CBI’ checkbox. If you claim the attached documentation as
CBI, you are required to attach the sanitized version of the attached document. To do so, follow
the steps outlined above. Once you have attached all desired documentation, click the ‘OK’
button to return to the ‘Exemption’ screen.
The exemption table displays the file name of the document, the date the document was attached,
and whether the document was claimed as CBI. The system allows you to delete unwanted
documents by clicking the ‘Delete’ icon located under the ‘Action’ column for a given row.
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Clicking the file name links within the ‘File Name’ column generates the ‘Exemption Document
Management’ pop-up window. This allows you to view and edit previously attached documents.
• Attach Document: Clicking the ‘Attach Document’ button displays the ‘Exemption
Document Management’ pop-up window.
• File Name: Displays the name of the attached file. Clicking the file name link generates the
‘Exemption Document Management’ pop-up window and allows you to view the attached
document.
• Attachment Date: Displays the date the document was attached.
• CBI: Displays whether the attached document was claimed as CBI by displaying a ‘Y’ or
an ‘N.’
• Action: Clicking the ‘Delete’ icon ( ) will generate a prompt confirming deletion. To
delete the specified row and all contents within click the ‘OK’ button within the prompt.
Exhibit 7-15 shows the screen capture of the ‘Exemption’ screen:
Exhibit 7-15 Exemption Screen

Navigation: Click the ‘Previous’ button to navigate to the ‘Chemical Identification’ screen.

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Exhibit 7-16 shows the screen capture of the ‘Exemption Document Management’ pop-up
window:
Exhibit 7-16 Exemption Document Management Pop-Up Window

Navigation: Click the ‘OK’ button to return to the ‘Exemption’ screen.

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8

Validate

You can click the ‘Validate’ icon ( ) at any stage of completing a Section 4 submission. The
‘Section 4 Validation’ pop-up window is displayed when you click the ‘Validate’ icon ( ). The
‘Section 4 Validation’ pop-up window displays a report of all validation errors. During the
validation process, the application validates each screen of the Section 4 submission to find
missing and invalid data.
Validation Errors: Errors are denoted by an ‘Error’ icon ( ) and can be fixed by clicking the
error link. The links will display the Screen Title Name (e.g., Technical Contact Information) 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, click the
‘Validate’ icon ( ) again to refresh the ‘Section 4 Validation’ pop-up window. If the
information you fixed passes validation, the error will be removed from the ‘Section 4
Validation’ pop-up window. You must fix all validation errors in order to submit the submission
to CDX successfully.
You can close the ‘Section 4 Validation’ pop-up window by clicking the ‘X’ button located at
the top right of the window.

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Exhibit 8-1 shows the screen captures for the ‘Section 4 Validation’ pop-up window:
Exhibit 8-1 Section 4 Validation Pop-Up Window

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9

Submit to EPA via CDX

As the Primary AO, you have the ability to sign and submit a Section 4 submission to EPA.
Assigned Supports for your submission cannot submit the Section 4 submission.
Once you complete all required information and correct all items failing validation, the system
will allow you to submit successfully.
9.1

Submitting Official Information Screen

Click the ‘Submit’ icon ( ) that is located in the bottom action bar of the Section 4 application
to access the ‘Submitting Official Information’ screen. This screen only displays to the Primary
AO upon submission.
After clicking the ‘Submit’ icon ( ), the system requires you to review your contact
information provided during CDX registration. The system also requires you to identify your job
title.
Exhibit 9-1 shows the screen capture of the ‘Submitting Official Information’ screen:
Exhibit 9-1 Submitting Official Information Screen

Navigation: Click the ‘Next’ button to continue with the submission process and proceed to the
‘Submission Process: Validation’ screen.

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9.2

Submission Process: Validation Screen

Once all information is entered within the ‘Submitting Official Information’ screen, click the
‘Next’ button to proceed to the ‘Submission Process: Validation’ screen.
The ‘Submission Process: Validation’ screen will validate the information entered within the
Section 4 submission.
Exhibit 9-2 shows the screen capture of the ‘Submission Process: Validation’ screen:
Exhibit 9-2 Submission Process: Validation Screen

After the Section 4 submission being submitted is verified, a PDF is generated for you to view.

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Exhibit 9-3 shows the screen capture of the ‘Submission Process: PDF Generation’ screen:
Exhibit 9-3 Submission Process: PDF Generation Screen

Navigation: Click the ‘Continue’ button to continue with your submission and proceed to the
‘Cross-Media Electronic Reporting Regulation (CROMERR) Certification’ screen.
9.3

Cross-Media Electronic Reporting Regulation (CROMERR) Certification Screen

Click the ‘Continue’ button on the ‘Submission Process: PDF Generation’ screen to access the
‘Cross-Media Electronic Reporting Regulation (CROMERR) Certification’ screen.
CROMERR provides the legal framework for electronic reporting under all of EPA’s
environmental regulations.
After clicking the ‘Continue’ button, the system requires you to certify that the submission is
CROMERR compliant. By clicking the ‘I Certify’ button on the ‘CROMERR Certification’
screen; you authenticate all of the information entered in the submission. Clicking the ‘Cancel’
button will allow you to navigate back to the Section 4 ‘Home’ screen.

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Exhibit 9-4 shows the screen capture for the ‘Cross-Media Electronic Reporting Regulation
(CROMERR) Certification’ screen:
Exhibit 9-4 Cross-Media Electronic Reporting Regulation (CROMERR) Certification
Screen

Navigation: Click the ‘I Certify’ button to continue with your submission and proceed to the
‘Cross-Media Electronic Reporting Regulation (CROMERR) Login’ screen.
9.4

Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen

You can access the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Login’ screen
by clicking the ‘I Certify’ button on the ‘Cross-Media Electronic Reporting Regulation
(CROMERR) Certification’ screen.
• Please login with your CDX password: Enter your CDX registration password.

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Exhibit 9-5 shows the screen capture of the ‘Cross-Media Electronic Reporting Regulation
(CROMERR) Login’ screen:
Exhibit 9-5 Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen

Navigation: Enter your CDX registration password and click the ‘Next’ button to navigate to the
‘Cross-Media Electronic Reporting Regulation (CROMERR) Security Question’ screen.
9.5

Cross-Media Electronic Reporting Regulation (CROMERR) Security Question
Screen

You can access the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Security
Question’ screen by entering your CDX registration password on the ‘Cross-Media Electronic
Reporting Regulation (CROMERR) Login’ screen and by clicking the ‘Next’ button.
The ‘Cross-Media Electronic Reporting Regulation (CROMERR) Security Question’ screen
randomly selects and displays one of the five CROMERR eSIG-PIN questions you answered on
the ‘20-5-1 Question’ screen during CDX registration.
eSIG-PIN Authorization Code: Provide one of the five secret answers to the questions that
were pulled from the list of 20 CDX security questions.

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Exhibit 9-6 shows the screen capture of the ‘Cross-Media Electronic Reporting Regulation
(CROMERR) Security Question’ screen:
Exhibit 9-6 Cross-Media Electronic Reporting Regulation (CROMERR) Security Question
Screen

Navigation: Answer the security question and click the ‘Next’ button to navigate to the ‘Submit
to CDX’ screen.
9.6

Submit to CDX Screen

You can access the ‘Submit to CDX’ screen after answering the 20-5-1 security question on the
‘Cross-Media Electronic Reporting Regulation (CROMERR) Security Question’ screen and by
clicking the ‘Next’ button.
On the ‘Submit to CDX’ screen, you will see a certification message. Read the message and
acknowledge by clicking the ‘Confirm’ button. Once you have clicked the ‘Confirm’ button,
your submission will be submitted to CDX.

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Exhibit 9-7 shows the screen capture of the ‘Submit to CDX’ screen:
Exhibit 9-7 Submit to CDX Screen

Navigation: Click the ‘Confirm’ button to navigate to the ‘Cross-Media Electronic Reporting
Regulation (CROMERR) Submission’ screen.
9.7

Cross-Media Electronic Reporting Regulation (CROMERR) Submission Screen

You can access the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Submission’
screen by acknowledging the certification to submit to CDX by clicking the ‘Confirm’ button on
the ‘Submit to CDX’ screen.
On the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Submission’ screen, you
will see a message indicating the submission has been successfully submitted to EPA.

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Exhibit 9-8 shows the screen capture of the ‘Cross-Media Electronic Reporting Regulation
(CROMERR) Submission’ screen:
Exhibit 9-8 Cross-Media Electronic Reporting Regulation (CROMERR) Submission
Screen

Navigation: Click the ‘Finish’ button to navigate to the Section 4 ‘Home’ screen. Then click the
‘Submissions’ link to find your locked submission. The ‘Section 4 Test Rules, ECAs, MOUs,
and 40 CFR 766’ submissions screen will display the submission with a ‘Lock’ icon ( ) under
the ‘Action’ column and will display a status of ‘Submitted.’

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10

Download Copy of Record

To download a copy of record, navigate to the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR
766’ submissions screen and locate the submission type for which you have successfully
completed a submission and which has a status of ‘Submitted.’ Note that if you have just
submitted to CDX the ‘Copy of record’ icon may take 15-20 minutes to display. Also, you must
refresh the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’ submissions screen by
clicking your browser’s refresh button for the ‘Copy of Record’ icon to display.
Click the ‘Copy of Record’ icon from the row located in the ‘Copy of Record’ column for the
submitted submission. You will be taken to the ‘Enter Passphrase’ screen where you will be
required to enter the passphrase originally associated with the submission. Once you enter the
correct passphrase and click the ‘Next’ button, you will be taken to the ‘Cross-Media Electronic
Reporting Regulation (CROMERR) Login’ screen. This screen requires you to enter the
password you use to login to CDX. Once the correct CDX password is entered and you click the
‘Next’ button from the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Login’
screen, you will be taken to the ‘Cross-Media Electronic Reporting Regulation (CROMERR)
Security Question’ screen. The ‘Cross-Media Electronic Reporting Regulation (CROMERR)
Security Question’ screen requires you to provide the answer to a randomly selected 20-5-1
security question. Once you provide the correct answer to the randomly selected 20-5-1 security
question and click the ‘Next’ button, you will be taken to the ‘Download Copy of Record’
screen.
The ‘Download Copy of Record’ screen displays the ‘Download Copy of Record’ and
‘Download Attachments’ tables. The ‘Download Copy of Record’ table displays the ‘File Name’
and ‘Actions’ column. The ‘Download Attachments’ table displays the ‘File Name,’ ‘File Type,’
‘File Size,’ and ‘Actions’ columns in a table format for all documentation that was attached
within your submission. You can click the ‘Download’ icon to download a PDF version of the
submission or a XML version of the submission. When you click the ‘Copy of Record’ icon, the
system will allow you to view or download the individual files that were uploaded during the
submission process.

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Exhibit 10-1 shows the screen capture of the ‘Download Copy of Record’ screen:
Exhibit 10-1 Download Copy of Record Screen

Once you click the ‘Copy of Record’ icon a window that allows you to select the appropriate
option to open the CoR is generated. You can choose the ‘Open with’ or ‘Save File’ option to
either open or save the CoR. If you chose the ‘Open With’ radio button option and open the CoR
with WinZip(default), a ‘WinZip’ window is generated where you are able to double click the
compressed file or XML file to view the CoR.

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Exhibit 10-2 shows a screen capture of the download prompt pop-up window:
Exhibit 10-2 Download Prompt Pop-Up Window

If you click the ‘Copy of Record’ icon you will download the zip file of the submission that
contains:
• A PDF version of the submission
• An XML version of the submission

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11

Create an Amendment

To amend a submission, navigate to the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’
submissions screen and locate the file type that you previously submitted with a status of
‘Submitted.’ In addition to displaying a status of ‘Submitted’ under the ‘Status’ column, the
‘Lock’ icon ( ) will be displayed under the ‘Actions’ column. Click the ‘Lock’ icon (
the ‘Actions’ column to begin the amendment process.

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Exhibit 11-1 shows the screen capture of the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR
766’ Submissions - Amendment screen:
Exhibit 11-1 Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766 Submissions –
Amendment

Navigation: After clicking the ‘Lock’ icon ( ), you will receive a prompt to confirm the
amendment process. Once your submission is unlocked, you will have the ability to update the
information within your submission. If you do not want to continue with the amendment, click
the ‘Cancel’ button to cancel the amendment process and return to the ‘Section 4 Test Rules,

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ECAs, MOUs, and 40 CFR 766’ submissions screen. Click the ‘OK’ button to close the prompt
and continue with the amendment process.
Exhibit 11-2 shows the screen capture of the ‘Unlock Prompt’ message:
Exhibit 11-2 Unlock Prompt Message

After you click the ‘OK’ button, you will be taken to the ‘Enter Passphrase’ screen. You must
enter the passphrase originally associated with the submission to start the amendment process.
After you enter the passphrase and click the ‘Next’ button you will be taken to the ‘Submission
Information Type’ screen. Refer to Section 3.4.3 for further instructions on the ‘Enter
Passphrase’ screen.
After a submission has been unlocked, the ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR
766’ submissions 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 ‘Section 4 Test Rules, ECAs, MOUs, and 40 CFR 766’
submissions screen.

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12

Resources

You can access the ‘Resources’ screen by clicking the ‘Resources’ tab located at the top of the
screen at any time during the submission process. You can also access the ‘Resources’ screen by
clicking the ‘Resources’ link from the Section 4 ‘Home’ screen. The ‘Resources’ screen provides
you with links to the Section 4 user guide as well as additional helpful links. Click the ‘User
Guide’ link to access the Section 4 user guide document.
Toxic Substance Control Act (TSCA) Section 4 Submission: If you click this link, a new
internet browser window will generate displaying the TSCA Section 4 Test Rules page.
CDX Home: If you click this link, a new internet browser window will generate displaying the
CDX Homepage.
TSCA Chemical Substances Inventory: If you click this link, a new internet browser window
will generate displaying the TSCA Chemical Substances Inventory screen.
Exhibit 12-1 shows the screen capture of the ‘Resources’ screen:
Exhibit 12-1 Resources Screen

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Appendix A. Definitions, Acronyms, and Abbreviations
The following table displays all the definitions, acronyms, and abbreviations used in this
document and their full name.
Definitions, Acronyms, and Abbreviations
Acronym

Full Name

AO

Authorized Official

CA

Chemical Abstract

CASRN

Chemical Abstract Service Registry Number

CBI

Confidential Business Information

CDX

Central Data Exchange

CFR
CoR

Code of Federal Regulations
Copy of Record

CROMERR

Cross-Media Electronic Reporting Regulation Security System

CSPP

Submissions for Chemical Safety and Pesticide Programs

ECA

Enforceable Consent Agreements

EPA

Environmental Protection Agency

EST

Eastern Standard Time

FRN

Federal Register Notice

MOU

Memorandum of Understanding

OPPT

Office of Pollution Prevention and Toxics

TSCA

Toxic Substances Control Act

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Appendix B. Submission Types, Effects, and Endpoints
The following appendix displays all possible options within each drop-down menu on the
‘Document Management’ pop-up window.
First Dropdown:
• Title: Submission Type
• Contains the following values
o Initial Submission
o Follow-Up Submission
o Final Submission
Second Dropdown
• Title: Summary/Abstract Submission
• Contains the following values
o Yes
o No
Third Dropdown
• Title: Effects
• Contains the following values
o Health Effect
o Ecotoxicity
o Environmental Fate
o Physical-Chemical Properties
Fourth Dropdown
• Title: Endpoints
• Contains the following values
o For Health Effect (shows when Health Effect is selected from third dropdown)
 Basic Toxic kinetics
 Dermal Absorption
 Acute Toxicity: oral
 Acute Toxicity: inhalation
 Acute Toxicity: dermal
 Acute Toxicity: other routes
 Skin irritation/corrosion
 Eye irritation
 Skin sensitization
 Respiratory sensitization
 Repeated Dose toxicity: oral
 Repeated Dose toxicity: inhalation
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 Repeated Dose Toxicity: dermal
 Repeated Dose Toxicity: other routes
 Genetic Toxicity in vitro
 Genetic Toxicity in vivo
 Carcinogenicity
 Toxicity to Reproduction
 Developmental Toxicity/teratogenicity
 Toxicity to reproduction: other studies
 Neurotoxicity
 Immunotoxicity
 Specific investigations: other studies
 Health surveillance data
 Epidemiological data
 Direct observations: clinical cases, poisoning incidents and other
 Sensitization data (humans)
 Exposure related observations in humans: other data
 Toxic effects on livestock and pets
 Additional toxicological information
 Other
o For Ecotoxicity (shows when Ecotoxicity is selected from third dropdown)
 Short-term toxicity to fish
 Long-term toxicity to fish
 Short-term toxicity to aquatic invertebrates
 Long-term toxicity to aquatic invertebrates
 Toxicity to aquatic algae and cyanobacteria
 Toxicity to aquatic plants other than algae
 Toxicity to microorganisms
 Toxicity to other aquatic organisms
 Sediment toxicity
 Toxicity to soil macroorganisms except arthropods
 Toxicity to terrestrial arthropods
 Toxicity to terrestrial plants
 Toxicity to soil microorganisms
 Toxicity to birds
 Toxicity to other above-ground organisms
 Biological effects monitoring
 Biotransformation and kinetics
 Additional ecotoxicological information
 Other

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o For Environmental Fate (shows when Environmental Fate is selected from third
dropdown)
 Photo transformation in air
 Hydrolysis
 Photo transformation in water
 Photo transformation in soil
 Biodegradation in water: screening test
 Biodegradation in water and sediment: simulation tests
 Biodegradation in soil
 Mode of degradation in actual use
 Bioaccumulation: aquatic/sediment
 Bioaccumulation: terrestrial
 Adsorption/desorption
 Henry's Law constant
 Distribution Modeling
 Other Distribution Data
 Monitoring Data
 Field Studies
 Additional Information on Environmental Fate and Behavior
 Other
o For Physical-Chemical Properties (shows when Physical-Chemical Properties is
selected from third dropdown)
 Appearance/Physical
 Melting Point
 Boiling Point
 Density
 Particle size distribution
 Vapor Pressure
 Partition Coefficient
 Water Solubility
 Solubility in Organic Solvent
 Surface Tension
 Flash Point
 Auto Flammability
 Flammability
 Explosiveness
 Oxidizing Properties
 Oxidation Reduction Potential
 Stability in organic solvents and identity of relevant degradation products
 Storage stability and reactivity towards container material

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






Stability: thermal, sunlight, metals
pH
Dissociation constant
Viscosity
Additional physic-chemical information
Other

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