Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies TSCA section 8(d)

Section 8 of the Toxic Substances Control Act (New)

CDX Section 8(d) Health Safety Data Re

Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies TSCA section 8(d)

OMB: 2070-0224

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Section 8(d) Health Safety Data
Reporting User Guide – Primary
Support
Environmental Protection Agency
Office of Pollution Prevention and Toxics
Manage Toxic Substances

Table of Contents
List of Exhibits ............................................................................................................................ iii
1

Introduction ........................................................................................................................ 1
1.1

2

Labeling Confidential Information ................................................................................. 1
System Requirements ........................................................................................................ 3

2.1

Supported Browsers ..................................................................................................... 3

2.2

Screen Resolution ........................................................................................................ 3

3

Primary Support Functions ................................................................................................. 4
3.1

Log into Section 8(d) Health & Safety Data Reporting application ................................ 4

3.2

Home Screen Navigation .............................................................................................. 6

3.3

Access New Submission .............................................................................................. 7

3.3.1

Section 8(d) Health & Safety Data Reporting Submissions ..................................... 7

3.3.2

Enter Passphrase Screen ....................................................................................... 9

3.3.3

Navigation Tree .................................................................................................... 10

3.3.4

Action Bar ............................................................................................................. 13

3.3.5

General Submission Information Screen ............................................................... 14

3.3.6

Technical Contact Information Screen .................................................................. 15

3.3.7

Submitting on Behalf Of Company Screen ............................................................ 17

3.3.8

Chemical Substance Identity of Impurities Screen ................................................ 19

3.3.9

Study Identification Screen ................................................................................... 24

3.3.10

Full Study Report Screen ...................................................................................... 27

3.3.11

Initiated Studies Screen ........................................................................................ 29

3.3.12

Ongoing Studies Screen ....................................................................................... 35

3.3.13

Robust Summary Screen ...................................................................................... 40

3.3.14

Studies Which Are Known But Without Possession of Copies Screen .................. 42

3.3.15

Studies Previously Sent to Federal Agencies without Confidentiality Claims Screen47

3.4

EPA Request for Further Information .......................................................................... 52

3.4.1

Underlying Data Screen ........................................................................................ 52

3.4.2

Preliminary Report of Ongoing Studies Screen ..................................................... 54

3.4.3

Copies of Studies Screen ..................................................................................... 59

3.5

Submitter Requests Screen ........................................................................................ 64

3.6

Substantiation Summary............................................................................................. 65

4

Validate ............................................................................................................................ 68

5

Complete an Amendment ................................................................................................. 70

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6

Resources ........................................................................................................................ 71

Appendix A. Definitions, Acronyms, and Abbreviations ............................................................. 73
Appendix B. Submission Types, Effects, and Endpoints ........................................................... 74

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List of Exhibits
Exhibit 3-1: Chemical Information Submission System Screen ................................................... 5
Exhibit 3-2: Section 8(d) Health & Safety Data Reporting Home Screen ..................................... 7
Exhibit 3-3: Section 8(d) Health & Safety Data Reporting Submissions Screen........................... 9
Exhibit 3-4: Enter Passphrase Screen ....................................................................................... 10
Exhibit 3-5: Navigation Prompt .................................................................................................. 11
Exhibit 3-6: Navigation Tree ...................................................................................................... 12
Exhibit 3-7: Action Bar – Validate .............................................................................................. 13
Exhibit 3-8: Action Bar – Save ................................................................................................... 13
Exhibit 3-9: Action Bar – Preview .............................................................................................. 13
Exhibit 3-10: Action Bar – Links ................................................................................................ 14
Exhibit 3-11: General Submission Information Screen .............................................................. 14
Exhibit 3-12: Technical Contact Information Screen .................................................................. 17
Exhibit 3-13: Submitting on Behalf of Company Screen ............................................................ 19
Exhibit 3-14: Chemical Substance Identity of Impurities Screen ................................................ 21
Exhibit 3-15: Search Substance Registry Services Pop-Up Window ......................................... 22
Exhibit 3-16: Chemical Not Found in Substance Registry Services Pop-Up Window ................ 24
Exhibit 3-17: Study Identification Screen ................................................................................... 26
Exhibit 3-18: Study Identification Screen for an Amendment ..................................................... 27
Exhibit 3-19: Full Study Report Screen ..................................................................................... 28
Exhibit 3-20: Full Study Report Pop-Up Window ....................................................................... 29
Exhibit 3-21: Initiated Studies Screen (Add Document) ............................................................. 32
Exhibit 3-22: Initiated Studies Pop-Up Window ......................................................................... 33
Exhibit 3-23: Initiated Studies Screen (Add Study) .................................................................... 34
Exhibit 3-24: Ongoing Studies Screen (Add Document) ............................................................ 37
Exhibit 3-25 Ongoing Studies Pop-Up Window ......................................................................... 38
Exhibit 3-26: Ongoing Studies Screen (Add Study) ................................................................... 39
Exhibit 3-27: Robust Summary Screen ..................................................................................... 41
Exhibit 3-28: Robust Summary Pop-Up Window ....................................................................... 42
Exhibit 3-29: Studies Which Are Known but without Possession of Copies (Add Document)..... 44
Exhibit 3-30: Studies Which Are Known but without Possession of Copies Pop-Up Window ..... 45
Exhibit 3-31: Studies Which Are Known but without Possession of Copies Screen (Add Study) 46
Exhibit 3-32: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Screen (Add Document) ............................................................................................................ 49
Exhibit 3-33: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Pop-Up Window ........................................................................................................................ 50
Exhibit 3-34: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Screen (Add Study) ................................................................................................................... 51
Exhibit 3-35: Underlying Data Screen ....................................................................................... 53
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Exhibit 3-36: Underlying Data Pop-Up Window (with Sanitized Document Attached) ................ 54
Exhibit 3-37: Preliminary Reports of Ongoing Studies Screen (Add Document) ........................ 56
Exhibit 3-38: Preliminary Report of Ongoing Studies Pop-Up Window (with Sanitized Document
Attached) .................................................................................................................................. 57
Exhibit 3-39: Preliminary Report of Ongoing Studies Screen (Add Study) ................................. 58
Exhibit 3-40: Copies of Studies Screen (Add Document) .......................................................... 61
Exhibit 3-41: Copies of Studies Pop-up Window (with Sanitized Document Attached) .............. 62
Exhibit 3-42: Copies of Studies Screen (Add Study) ................................................................. 63
Exhibit 3-43: Submitter Requests Screen .................................................................................. 64
Exhibit 3-44: Submitter Request Pop-Up Window ..................................................................... 65
Exhibit 3-45: Substantiation Summary Screen .......................................................................... 66
Exhibit 3-46: Submission of Studies Substantiation Screen ...................................................... 67
Exhibit 4-1: Section 8(d) Health & Safety Data Reporting Validation Pop-Up Window ............... 69
Exhibit 6-1: Resources Screen .................................................................................................. 72

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1

Introduction

This document presents the user guide for the Office of Pollution Prevention and Toxics (OPPT)
Section 8(d) Health & Safety Data Reporting application. This document is the user guide for the
Primary Support user of the Section 8(d) Health & Safety Data Reporting tool.
As a Primary Support, you can edit a form created by your Primary Authorized Official (AO).
You are only able to access submissions to which your Primary AO has granted you access.
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.
General information on Section 8(d) Health & Safety Data Reporting 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 8(d) Health & Safety Data Reporting 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 8(d) Health & Safety Data Reporting application is an electronic, web-based tool
provided by the Environmental Protection Agency (EPA) for the submission of Section 8(d)
Health & Safety Data Reporting data. As a Primary Support, you will only have access to those
Section 8(d) Health & Safety Data Reporting submissions able to edit the Section 8(d) Health &
Safety Data Reporting submission.
For questions concerning the Toxic Substances Control Act (TSCA) Section 8(d) Health &
Safety Data Reporting software requirements, please contact the Central Data Exchange (CDX)
Help Desk at helpdesk@epacdx.net or call 1-888-890-1995 between the hours of 8am – 6pm
Eastern Standard Time (EST). For TSCA Section 8(d) Health & Safety Data reporting
requirements, please contact the TSCA Hotline at TSCA-Hotline@epamail.epa.gov or call 202554-1404.
1.1

Labeling Confidential Information

This user guide presents instructions and screenshots for the ‘Section 8(d) Health & Safety Data
Reporting’ electronic application as if you were logged in as the Primary Support. As the
Primary Support you are able to modify an 8(d) 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.
This TSCA Section 8(d) Health & Safety Data Reporting 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.,

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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 8(d) Health & Safety Data Reporting. 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 8(d) Health & Safety Data Reporting 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 8(d) Health & Safety Data
Reporting’ application:
 Technical Contact Information
 Submitting on Behalf of Company information
 A single chemical substance that is not on the public TSCA Inventory
 Any document uploaded on the following screens:
o Full Study
o Initiated Studies
o Ongoing Studies
o Studies which are known but without possession of copies
o Underlying Data
o Preliminary Reports of Ongoing Studies
o Copies of Studies
 Laboratory information on the following screens:
o Initiated Studies
o Ongoing Studies
o Studies Which are Known but Without Possession of Copies
o Studies Previously Sent to Federal Agencies Without Confidentiality Claims
o Preliminary Reports of Ongoing Studies
 Contact information on the following screens:
o Studies Which are Known but Without Possession of Copies
o Studies Previously Sent to Federal Agencies Without Confidentially Claims
o Copies of Studies

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2

System Requirements

To use the Section 8(d) Health & Safety Data Reporting application to submit a Section 8(d)
Health & Safety Data Reporting submission, the following are required:
 An e-mail account
 A supported web browser (see Section Error! Reference source not found. below) with
Java Script enabled Internet access
 Adobe Acrobat Reader 5.0 or higher
 CDX username and password
2.1

Supported Browsers

 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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3

Primary Support Functions

This section describes how to:
 Access the application
 Navigate to the Section 8(d) Health & Safety Data Reporting ‘Home’ screen
 Complete a Section 8(d) Health & Safety Data Reporting form
 Complete an amendment
As a Primary Support, you can edit a form created by your Primary Authorized Official (AO).
You are only able to access submissions to which your Primary AO has granted you access.
You can save the 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
document at any point; however, the ‘Not For Submission’ watermark will be placed on the
portable document format (PDF) document each time the submission is printed.
3.1

Log into Section 8(d) Health & Safety Data Reporting application

After you create an account in CDX and click the ‘Primary Authorized Official’ link under the
Chemical Safety and Pesticide Programs (CSPP) program service, 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
8(e) Notice, is available at http://cdx.epa.gov/About/UserGuide.

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Exhibit 3-1 shows a screen capture of the ‘Chemical Information Submission System’ screen.
Exhibit 3-1: Chemical Information Submission System Screen

Navigation: Select ‘TSCA Section 8(d) Health & Safety Data Reporting’ from the drop-down
menu and click the ‘OK’ button to navigate to the Section 8(d) Health & Safety Data Reporting
‘Home’ screen.

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3.2

Home Screen Navigation

You can access the Section 8(d) Health & Safety Data Reporting ‘Home’ screen by selecting
‘Section 8(d) Health & Safety Data Reporting’ from the ‘Chemical Information Submission
System’ screen drop-down menu and by clicking the ‘OK’ button.
The Section 8(d) Health & Safety Data Reporting ‘Home’ screen is the first screen within the
Section 8(d) Health & Safety Data Reporting application. The ‘Home’ screen provides you with
links and tabs to access the ‘Section 8(d) Health & Safety Data Reporting’ submissions screen
and ‘Resources’ screens. To navigate to any of these screens, click the screen link (in blue text),
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 8(d) Health &
Safety Data Reporting’ submissions screen. You can create or modify a Section 8(d) Health
& Safety Data Reporting submission using the ‘Section 8(d) Health & Safety Data
Reporting’ submissions screen. For additional details about the ‘Section 8(d) Health & Safety
Data Reporting’ submissions screen, please refer to Section 3.3.1.
 Resources: Click the ‘Resources’ link or tab to navigate to the ‘Resources’ screen. You can
find the Section 8(d) Health & Safety Data Reporting user guides, as well as useful links for
further usability instruction on the ‘Resources’ screen. For additional details about the
‘Resources’ screen, please refer to Section 6.

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Exhibit 3-2 shows a screen capture for the Section 8(d) Health & Safety Data Reporting ‘Home’
screen:
Exhibit 3-2: Section 8(d) Health & Safety Data Reporting Home Screen

Navigation: Click the ‘Submission’ link or tab to access the ‘Section 8(d) Health & Safety Data
Reporting’ submissions screen to edit an existing submission.
3.3

Access New Submission

As a Primary Support, you can edit a Section 8(d) Health & Safety Data Reporting submission.
You will be able to access only those submissions for which your Primary AO has assigned you
to complete.
3.3.1

Section 8(d) Health & Safety Data Reporting Submissions

You can access the ‘Section 8(d) Health & Safety Data Reporting’ submissions screen by
clicking the ‘Submissions’ link from the Section 8(d) Health & Safety Data Reporting ‘Home’
screen or by clicking the ‘Submissions’ tab located within the application header.
Each column within the table of the ‘Section 8(d) Health & Safety Data Reporting’ submissions
screen can be sorted by clicking the column headers.
Edit a Submission: To modify an existing Section 8(d) Health & Safety Data Reporting
submission, click the submission alias link for a submission that has a status of ‘In Progress’
within the ‘Status’ column. You will be required to enter the passphrase associated with that
particular submission to access and continue editing the submission.

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The ‘Section 8(d) Health & Safety Data Reporting’ submissions screen displays the following
column headers:
 Submission Alias: Displays a clickable link for submissions with a status of ‘In Progress.’
Clicking this link will navigate you to the ‘Enter Passphrase’ screen.
 FRN/CFR: Displays the FRN or CFR.
 CASRN: Displays the Chemical Abstract Services Registry Number (CASRN). The
‘CASRN’ column will display as blank until you have identified the submission type and
started a new submission.
 Status: Displays the status of the submission.
 Last Modified: Displays the date the submission was last accessed.
 Submission Date: Displays the date the submission was submitted to CDX. This date
populates only after you complete the submission.
Items per page: The ‘Section 8(d) Health & Safety Data Reporting’ submissions screen allows
you to display a specific number of submissions per page. The ‘Items per page’ drop-down menu
allows you to view ‘25,’ ‘50,’ ‘75,’ or ‘100’ submissions per page.
Export options: Displays export options, which allow you to export the ‘Section 8(d) Health &
Safety Data Reporting’ submissions screen in the following formats: Comma Separated Values
(CSV), Excel, Extensible Mark-up Language (XML), and Portable Document Format (PDF).

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Exhibit 3-3 shows a screen capture of the ‘Section 8(d) Health & Safety Data Reporting’
submissions screen:
Exhibit 3-3: Section 8(d) Health & Safety Data Reporting Submissions Screen

Navigation: Click the submission alias link within the ‘Submission Alias’ column to navigate to
the ‘Enter Passphrase’ screen.
3.3.2

Enter Passphrase Screen

To edit a submission click the submission alias link within the ‘Submission Alias’ column with a
status of ‘In Progress’ on the ‘Section 8(d) Health & Safety Data Reporting’ submissions screen.
The ‘Enter Passphrase’ screen allows you to enter the passphrase associated with the form.
Enter Passphrase: Enter the passphrase associated with the form; the passphrase for the form
you have authority to edit will be given to you by your Primary AO.

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Exhibit 3-4 shows a screen capture of the ‘Enter Passphrase’ screen:
Exhibit 3-4: Enter Passphrase Screen

Navigation: Enter the passphrase originally created and associated with the form by your AO
and click the ‘Next’ button to navigate to the ‘General Submission Information’ screen.
3.3.3

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
submission content. Likewise, click the arrow ( ) on the closed navigation tree to open the
navigation tree.
 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
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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 3-5 shows a screen capture of the navigation prompt window:
Exhibit 3-5: Navigation Prompt

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Exhibit 3-6 shows the screen capture of the navigation tree:
Exhibit 3-6: Navigation Tree

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3.3.4

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 8(d)
Health & Safety Data Reporting submission to check for certain types of errors in a
submission. A ‘Section 8(d) Health & Safety Data Reporting Validation’ pop-up window
generates when you click the ‘Validate’ icon ( ). The ‘Section 8(d) Health & Safety Data
Reporting Validation’ pop-up window displays a report of all validation errors relating to a
failed validation. Refer to Section 4 for more information on validating a submission.
The following exhibits Exhibit 3-7, Exhibit 3-8, and Exhibit 3-9 show the screen captures for the
action bar:
Exhibit 3-7: Action Bar – Validate

 Save: You can click the ‘Save’ icon ( ) at any stage of completing a Section 8(d) Health &
Safety Data Reporting 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 3-8: Action Bar – Save

 Preview: You can click the ‘Preview’ icon ( ) at any stage of completing a Section 8(d)
Health & Safety Data Reporting submission to preview the submission. After you click the
‘Preview’ icon ( ), a watermarked PDF version of the submission will generate.
Exhibit 3-9: Action Bar – Preview

 Help Links: You can click any of the ‘Help’ links, located at the bottom of each screen, at
any stage of completing a Section 8(d) Health & Safety Data Reporting submission.
 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 screen.
 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.
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If you click the ‘Privacy Health & Safety Data Reporting’ link, you will be taken to the
CDX Privacy and Security Health & Safety Data Reporting screen.
Exhibit 3-10 shows the screen capture of the action bar ‘Help’ links:


Exhibit 3-10: Action Bar – Links

3.3.5

General Submission Information Screen

You can access the ‘General Submission Information’ screen by clicking the submission alias of
an ‘In Progress’ submission and entering the passphrase associated with the Section 8 (d) Health
& Safety Data Reporting submission.
The system allows you to edit the submission alias associated with the submission. If you choose
not to edit the submission alias, the field remains populated with a date and time stamp for when
the submission was created.
The following field is displayed on the ‘General Submission Information’ screen:


Submission Alias: This field is auto-populated with a date and time stamp and displays
on the ‘Section 8(d) Health & Safety Data’ submission screen within the ‘Submission
Alias’ column. This field is editable should you choose to provide your own submission
alias.

Exhibit 3-11 shows the screen capture for the ‘General Submission Information’ screen:
Exhibit 3-11: General Submission Information Screen

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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.
3.3.6

Technical Contact Information Screen

You can access the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from
the ‘General Submission Information’ screen or by clicking the ‘Technical Contact Information’
link within the navigation tree.
The ‘Technical Contact Information’ screen provides a checkbox to indicate that you will submit
on behalf of another company. To identify if you are submitting on behalf of another entity, the
system provides a ‘This is a submission on behalf of another company’ checkbox.
If you are submitting on behalf of another company, check the ‘This is a submission on behalf of
another company’ checkbox. This functionality has been implemented to accommodate a
company that may use an agent or another individual to submit on their behalf. If this checkbox
is checked, the information of the manufacturing or processing establishment is entered into the
‘Submitting on Behalf Of Company’ screen. To claim contact information as Confidential
Business Information (CBI), check the ‘CBI’ checkbox.
 This is a submission on behalf of another company: Check the ‘This is a submission on
behalf of another company’ check box to identify that you are submitting on behalf of
another company.
 Copy CDX Registration: Click the ‘Copy CDX Registration’ button to identify that you are
the technical contact. The system will populate the fields with your contact information
provided during CDX registration.
 CBI: Check the ‘CBI’ checkbox to claim the technical contact information as CBI.
 Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix. If you click 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 clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This is a required field.
 Middle Initial: Enter the technical contact’s middle initial. If you 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 clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This is a required field.
 Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes. If applicable, select the
appropriate suffix. If you 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 clicked the ‘Copy
CDX Registration’ button, the fields populate with information entered during CDX
registration. This is a required field.

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 Phone Number: Enter the technical contact’s daytime phone number; U.S. or international.
If you clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration. This is a required field.
 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: john.doe@abc.com. If you clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This is a required field.
 Mailing Address 1: Enter the first line of the technical contact’s mailing address. If you
clicked the ‘Copy CDX Registration’ button, the fields populate with information entered
during CDX registration. This is a required field.
 Mailing Address 2: Enter the second line of the technical contact’s mailing address. If you
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 clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This is a required field.
 State: Displays all available states. Enter the state of the technical contact’s mailing address.
If you 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 clicked
the ‘Copy CDX Registration’ button, the fields populate with information entered during
CDX registration. This is a required field.
 Country: Displays all available countries. Select the country of the technical contact’s
mailing address. If you 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 3-12 shows the screen capture of the ‘Technical Contact Information’ screen:
Exhibit 3-12: Technical Contact Information Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Chemical Substance Identity of
Impurities’ screen. You can also access this screen by clicking the ‘Chemical Substance Identity
of Impurities’ link within the navigation tree. If you are submitting on behalf of another
company, click the ‘Next’ button to navigate 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 after clicking the ‘Save’ icon located within the bottom action bar.
3.3.7

Submitting on Behalf Of Company Screen

You can access the ‘Submitting on Behalf of Company’ screen by checking the ‘This is a
submission on behalf of another company’ check box and 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.

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The ‘Submitting on Behalf of Company’ screen presents a list of fields for 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 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: john.doe@abc.com. 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.
Exhibit 3-13 shows the screen capture of the ‘Submitting on Behalf of Company’ screen:

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Exhibit 3-13: Submitting on Behalf of Company Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Chemical Substance Identity of
Impurities’ screen. You can also access this screen by clicking the ‘Chemical Substance Identity
of Impurities’ link within the navigation tree.
3.3.8

Chemical Substance Identity of Impurities Screen

You can access the ‘Chemical Substance Identity of Impurities’ screen by clicking the ‘Next’
button from the ‘Submitting on Behalf Of Company’ screen, or the ‘Technical Contact
Information’ screen. You can also access this screen by clicking the ‘Chemical Substance
Identity of Impurities’ link within the navigation tree.
The ‘Chemical Substance Identity of Impurities’ screen provides fields for you to identify
impurities or additives known to have been present in the substance or listed mixtures as studied.
To identify chemical impurities you must access the Substance Registry Services (SRS). The
system leverages the services provided by SRS. To search SRS, click the ‘Search’ icon ( )

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within the ‘SRS’ column of the Chemical Substance Identity of Impurities table. Clicking the
‘Search’ icon ( ) generates the SRS pop-up window. You can search for the chemical(s) being
reported by the ‘CASRN,’ ‘CAS Index Name or Synonym,’ ‘Accession Number,’ or ‘Generic
Name.’
 Not Applicable: Check the ‘Not Applicable’ checkbox and click the ‘Next’ button to
navigate to the ‘Study Identification’ screen. If the ‘Not Applicable’ checkbox is unchecked
and you click the ‘Next’ button, the system will prompt you with an error message indicating
a chemical must be populated by searching for a chemical or to check the ‘Not Applicable’
checkbox.
 Search SRS: Clicking the ‘Search’ icon (

) will generate a ‘Search SRS’ pop-up window.

 Chemical Identifying Number: Displays the chemical identifying number for the specified
chemical substance.
 Chemical Name (descriptor): Displays the chemical name (or descriptor) of the chemical(s)
being reported on..
 Synonym: Displays the chemical synonym(s) identified by the user within the ‘Chemical
Not Found in Substance Registry Services’ window.
 CBI: Displays the CBI status of the identified chemical substance by displaying either a ‘Y’
or an ‘N.’ A chemical substance retrieved via CASRN or CA Index Number or Other
Synonym cannot be claimed as CBI. Only chemical substances retrieved via accession
number or generic name, or chemical substances not found within the SRS search can be
claimed as CBI.
 Actions: Click the ‘Delete’ icon ( ) to remove the chemical within the specific row. A
warning message displays to confirm removal of the chemical substance.

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Exhibit 3-14 shows the screen capture of the ‘Chemical Substance Identity of Impurities’ screen:
Exhibit 3-14: Chemical Substance Identity of Impurities Screen

Navigation: Click the ‘Next’ button to navigate to the ‘Study Identification’ screen. You can
also access this screen by clicking the ‘Study Identification’ link within the navigation tree.
3.3.8.1

Search Substance Registry Services

To access SRS, click the ‘Search’ icon ( ). Clicking the ‘Search’ icon ( ) generates the
‘Search SRS’ pop-up window. You can search for the chemical(s) being reported by the
‘CASRN,’ ‘CA Index Name or Other Synonym,’ ‘Accession Number,’ or ‘Generic Name.’ After
you have searched, selected a chemical, and clicked the ‘OK’ button, the selected chemical
information will populate the Chemical Substance Identity of Impurities table. If the chemical is
not listed on the public TSCA Inventory list, you may claim the chemical as CBI, once the
chemical is displayed on the Chemical Substance Identity of Impurities table. See Section 3.3.8.2
below if you don’t know the CAS or Accession Number.
 CASRN: Enter the CASRN of the chemical.
 CA Index Name or Other Synonym: Enter the CA Index Name or Other Synonym.
Displays the following search options: ‘Contains,’ ‘Begins With,’ and ‘Matches Exactly.’
 Accession Number: Enter the accession number. Displays the following search options:
‘Contains,’ ‘Begins With,’ and ‘Matches Exactly.’
 Generic Name: Enter the generic name. Displays the following search options: ‘Contains,’
‘Begins With,’ and ‘Matches Exactly.’

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Exhibit 3-15 shows the screen capture for the ‘Search Substance Registry Services’ pop-up
window:
Exhibit 3-15: Search Substance Registry Services Pop-Up Window

Navigation: Clicking the ‘Search’ button will generate search results Clicking the ‘OK,’
‘Cancel,’ and ‘X’ buttons will close the ‘Search SRS’ pop-up window.
3.3.8.2

Chemical Not Found in Substance Registry Services

You can access the ‘Chemical Not Found in Substance Registry Services’ screen by entering
known information into the SRS window and performing a search. If there are no results, a
message will be returned stating ‘There were no results returned.’ If you are sure the chemical
does not exist in SRS, please click the ‘Create New Chemical’ button to enter the chemical
information. Clicking the ‘Create New Chemical’ button on the ‘Search Substance Registry
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Services’ screen takes you to the ‘Chemical Not Found in Substance Registry Services’ screen.
Click the ‘Cancel’ button to go back to the ‘Search Substance Registry Services’ screen. When
entering information into the ‘Chemical Not Found in Substance Registry Services’ screen at
least one of the following four fields is required; ‘Accession Number,’ ‘CASRN,’
‘Premanufacture Notice (PMN) Number,’ or ‘International Union of Pure and Applied
Chemistry (IUPAC) Name’
If you do not know the accession number, CASRN, PMN number, or IUPAC name, check the
‘Unknown’ checkbox. Once you check the ‘Unknown’ checkbox, the above mentioned fields are
disabled and you are only required to enter a chemical name (or descriptor).
 Unknown: Checking the ‘Unknown’ checkbox disables the ‘Accession Number,’
‘CASRN,’ ‘PMN Number,’ and ‘IUPAC Name’ fields and requires you to enter the
chemical name in the ‘Chemical Name (descriptor)’ field.
 Accession Number: If known, enter the accession number of the chemical.
 CASRN: If known, enter the CASRN of the chemical.
 PMN Number: If known, enter the PMN number of the chemical.
 IUPAC Name: If known, enter the IUPAC name of the chemical.
 Chemical Name (descriptor): Enter the chemical name/descriptor of the chemical being
reported. This is a required field when the ‘Unknown’ checkbox is checked.
Exhibit 3-16 shows the screen capture for the ‘Chemical Not Found in Substance Registry
Services’ pop-up window:

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Exhibit 3-16: Chemical Not Found in Substance Registry Services Pop-Up Window

Navigation: Clicking the ‘OK,’ ‘Cancel,’ and ‘X’ buttons will close the ‘Chemical Not Found In
SRS’ pop-up window. Clicking the ‘OK’ button, if all fields have been properly filled out, will
populate the table on the ‘Chemical Substance Identity of Impurities’ screen. Clicking the
‘Cancel’ button will bring you back to the ‘Search Substance Registry Service’ pop-up window.
Clicking the ‘X’ will close the pop-up window and your information will not be saved.
3.3.9

Study Identification Screen

You can navigate to the ‘Study Identification’ screen by clicking the ‘Next’ button from the
‘Chemical Substance Identity of Impurities’ screen. You can also access this screen by clicking
the ‘Study Identification’ link within the navigation tree.
The ‘Study Identification’ screen provides fields for you to identify the study type(s) being
submitted. To identify the submission study type, check each option that applies to the Section
8(d) Health & Safety Data Reporting submission. The following checkbox options are displayed
within the ‘Study Identification’ screen:
 Not Applicable: Check the ‘Not Applicable’ checkbox to claim that there are no applicable
studies.
 Full Study Report: Check the ‘Full Study Report’ checkbox to indicate the desired
submission study type.
 Initiated Studies: Check the ‘Initiated Studies’ checkbox to indicate the desired submission
study type.
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 Ongoing Studies: Check the ‘Ongoing Studies’ checkbox to indicate the desired submission
study type.
 Robust Summary: Check the ‘Robust Summary’ checkbox to indicate the desired
submission study type.
 Studies which are known but without possession of copies: Check the ‘Studies Which are
Known but without Possession of Copies’ checkbox to indicate the desired submission study
type.
 Studies Previously Sent to Federal Agencies without Confidentiality Claims: Check the
‘Studies Previously Sent to Federal Agencies without Confidentiality Claims’ checkbox to
indicate the desired submission study type.
The following checkbox options are only available when you are amending a previous
submission. Please refer to Section 3.4 for additional information:
 EPA Request for Submission of Further Information
 Underlying Data: Check the ‘Underlying Data’ checkbox to indicate the desired
submission study type.
 Preliminary Report of Ongoing Studies: Check the ‘Preliminary Report of Ongoing
Studies’ checkbox to indicate the desired submission study type.
 Copies of Studies: Check the ‘Copies of Studies’ checkbox to indicate the desired
submission study type.
Once you have checked all appropriate submission study types and saved your selections by
either clicking the ‘Save,’ ‘Previous,’ or ‘Next’ buttons, the navigation tree is populated with the
selected study type screen titles.
Each study type is dynamically related to specific metadata and each study type chosen from the
‘Study Identification’ screen populates within the navigation tree as a new screen. Only the study
type options you select are displayed within the navigation tree. You can navigate to each
selected study type screen by clicking the desired link within the navigation tree or navigating
using the ‘Previous’ and ‘Next’ buttons. Each study type screen will display all entered
information as well as all attached documentation.
Exhibit 3-17 shows the screen capture for the ‘Study Identification’ screen:

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Exhibit 3-17: Study Identification Screen

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Exhibit 3-18 shows the screen capture for the ‘Study Identification’ screen:
Exhibit 3-18: Study Identification Screen for an Amendment

Navigation: Check the appropriate study type checkboxes for the studies you wish to submit and
click the ‘Next’ button to navigate to the next screen from the ‘Study Identification’ screen. The
screen following the ‘Study Identification’ screen depends on the item(s) selected. If you are not
submitting any of the indicated study types, check the ‘Not Applicable’ checkbox and click the
‘Next’ button to navigate to the ‘Submitter Request’ screen.
3.3.10

Full Study Report Screen

You can access the ‘Full Study Report’ screen by checking the ‘Full Study Report’ checkbox on
the ‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen
by clicking the ‘Full Study Report’ link in the navigation tree.
To attach full study report documentation, click the ‘Add Document’ button displayed on the
‘Full Study Report’ screen. Clicking the ‘Add Document’ button generates the ‘Full Study
Report’ pop-up window for you to upload all desired documentation. You can browse for a
document from your hard drive and attach one document at a time. If you claim a document as
CBI, then a sanitized copy of the document must be attached. If you fail to attach a sanitized
copy of the document, the system will prompt you with an error.
To attach multiple documents, click the ‘Add Document’ button on the ‘Full Study Report’
screen. If you claim the document as CBI then a sanitized file will need to be uploaded. Clicking
the ‘Browse’ button will generate a pop-up window allowing you to attach a document from
your hard drive. You can delete unwanted attached documents by clicking the ‘Delete’ icon
located within the ‘Action’ column of the full study report table. To attach a replacement
document for a document that was previously attached, click the file name link for the desired
document under the ‘File Name’ column. Once you click the file name link of the desired
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document, the attachment pop-up window generates for you to attach a new document. Attaching
a new document will overwrite the existing document. The changes will commit once you click
the ‘OK’ button.
After all required information has been completed, click the ‘Next’ button to navigate to the next
study type screen that you identified on the ‘Study Identification’ screen. If you have not
indicated an additional study type you will be taken to the ‘Submitter Requests’ screen.
Exhibit 3-19 shows the screen capture of the ‘Full Study Report’ screen:
Exhibit 3-19: Full Study Report Screen

Navigation: Click the ‘Next’ button to navigate to the next screen. The next screen is dependent
upon your selection of submission types on the ‘Study Identification’ screen. If you have not
selected another study type you will be taken to the ‘Submitter Requests’ screen upon clicking
the ‘Next’ button.
The ‘Full Study Report’ 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 ‘Full Study
Report’ screen, click the ‘OK’ button within the ‘Full Study Report’ pop-up window.
 CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field. A sanitized document is required if the ‘CBI’ checkbox
is checked.
 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. The drop-down menu 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. Submission Types, Effects, and Endpointsfor a complete list of values displayed
within each of the drop-down menus on the ‘Full Study Report’ 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 3-20 shows the screen capture of the ‘Full Study Report’ pop-up window:
Exhibit 3-20: Full Study Report Pop-Up Window

Navigation: Click the ‘OK’ button to close the ‘Full Study Report’ pop-up window and save the
attached documents to the full study report table. Clicking the ‘Cancel’ or ‘X’ will close the popup window and no information will be saved.
3.3.11

Initiated Studies Screen

You can access the ‘Initiated Studies’ screen by checking the ‘Initiated Studies’ checkbox on the
‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen by
clicking the ‘Initiated Studies’ link within the navigation tree.
The ‘Initiated Studies’ screen provides ‘Add Documents’ and ‘Add Studies’ radio buttons.
Selecting the ‘Add Documents’ radio button option will generate the ‘Add Document’ button
and the initiated studies table. Clicking the ‘Add Document’ button generates the ‘Initiated
Studies’ pop-up window for you to upload documentation pertaining to the initiated studies. You
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can claim the uploaded document as CBI by checking the ‘CBI’ checkbox within the ‘Initiated
Studies’ pop-up window. A sanitized version of the document is required if you claim the
attached document as CBI.
If you select the ‘Add Documents’ radio button option, the system generates an ‘Add Document’
button. To attach multiple documents, click the ‘Add Document’ button from the ‘Initiated
Studies’ screen. You can delete unwanted attached documents by clicking the ‘Delete’ icon
located within the ‘Action’ column of the initiates studies table. To attach a replacement
document for a document that was previously attached, click the file name link for the desired
document under the ‘File Name’ column. Once you click the file name link of the desired
document, the attachment pop-up window generates for you to attach a new document. Attaching
a new document will overwrite the existing document. The changes will commit once you click
the ‘OK’ button.
If you select the ‘Add Studies’ radio button, the system generates an ‘Add Study’ button.
Clicking the ‘Add Study’ button generates a field set to enter all required study information. You
are required to identify the beginning date of the study, the purpose of the study, types of data to
be collected, the anticipated date of completion, and the name and address of the laboratory
conducting the study. This information must accompany each listed entry.
The system provides the following text fields for you to enter information:
 Add Documents: Select the radio button to attach an initiated studies document.
 Add Studies: Select the radio button to enter initiated studies information.
 Add Study: Click the button to generate the study expandable/collapsible field set.
 Study Title: Enter the title of the study. This is a required field.
 Study Start Date: Enter the start date of the study. You can use the calendar widget to enter
a date. This is a required field.
 Study End Date: Enter the end date of the study. You can use the calendar widget to enter a
date. This is a required field.
 Study Purpose: Enter the purpose of the study. This is a required field.
 Data to be Collected: Enter the type data that will be collected throughout the duration of
the specified study. This is a required field.
 CBI: Check the ‘CBI’ checkbox to claim the information of the laboratory conducting the
study as confidential.
 Laboratory Name: Enter the name of the laboratory conducting the study. This is a required
field.
 Mailing Address 1: Enter the first line of the mailing address of the laboratory conducting
the study. This is a required field.
 Mailing Address 2: Enter the second line of the mailing address of the laboratory
conducting the study.
 City: Enter the city of the mailing address of the laboratory conducting the study. This is a
required field.

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 State: Select the state of the mailing address of the laboratory conducting the study. The
‘State’ field is required when ‘United States’ is selected from the ‘Country’ drop-down
menu.
 Postal Code: Enter the postal code of the mailing address of the laboratory conducting the
study. This is a required field.
 Country: Select the country of the mailing address of the laboratory conducting the study.
This is a required field.
The system allows you to associate multiple studies to a single laboratory. Once you enter the
laboratory contact information and save the entered data within the field set by clicking the
‘Save’ button, that laboratory contact information is saved to the ‘Create a new laboratory or
select an existing one from the drop-down’ menu. Click the ‘Delete’ icon to delete any unwanted
studies. The ‘Delete’ icon is located in the top right corner of the specified field set. Clicking the
‘Expand All’ link will expand all field sets. Likewise, clicking the ‘Collapse All’ link will
collapse all field sets. To expand or collapse a field set individually, click the toggle arrow
located in the top left corner of the specified field set.

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Exhibit 3-21 shows the screen capture of the ‘Initiated Studies’ screen when you select the ‘Add
Documents’ radio button:
Exhibit 3-21: Initiated Studies Screen (Add Document)

Navigation: Click the ‘Next’ button to navigate to the next screen. The next screen is dependent
upon your selection of submission types on the ‘Study Identification’ screen. If no other studies
were selected you will be taken to the ‘Submitter Requests’ screen upon clicking the ‘Next’
button.
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 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: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field. A sanitized document is required if the ‘CBI’ checkbox
is checked.

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 Document Upload: Click the ‘Browse’ button to 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. The drop-down menu 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. Submission Types, Effects, and Endpoints 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 3-22 shows the screen capture of the ‘Initiated Studies’ pop-up window:
Exhibit 3-22: Initiated Studies Pop-Up Window

Navigation: Click the ‘OK’ button to close the ‘Initiated Studies’ pop-up window and save the
attached document to the initiated studies table. Clicking the ‘Cancel’ or ‘X’ button will close the
‘Initiated Studies’ pop-up window but no entered information will be saved or displayed on the
‘Initiated Studies’ screen.
Exhibit 3-23 shows the screen capture of the ‘Initiated Studies’ pop-up window when the ‘Add
Studies’ radio button is selected:

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Exhibit 3-23: Initiated Studies Screen (Add Study)

Navigation: Click the ‘Next’ button to proceed to the next screen. The next screen is dependent
upon the selections you made on the ‘Study Identification’ screen. If no other studies were

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selected on the ‘Study Identification’ screen, the user will be taken to the ‘Submitter Requests’
screen upon clicking the ‘Next’ button.
3.3.12

Ongoing Studies Screen

You can access the ‘Ongoing Studies’ screen by checking the ‘Ongoing Studies’ checkbox on
the ‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen
by clicking the ‘Ongoing Studies’ link within the navigation tree.
The ‘Ongoing Studies’ screen provides you with ‘Add Documents’ and ‘Add Studies’ radio
buttons. Clicking the ‘Add Documents’ radio button generates the ‘Add Document’ button and
the ongoing studies table. Clicking the ‘Add Document’ radio button generates the ‘Ongoing
Studies’ pop-up window for you to upload documentation relating to the reported ongoing
studies. To attach multiple documents, click the ‘Add Document’ button on the ‘Ongoing
Studies’ screen. You can delete unwanted attached documents by clicking the ‘Delete’ icon
located within the ‘Action’ column of the ongoing studies table. To attach a replacement
document, click the file name link for the desired document under the ‘File Name’ column. Once
you click the file name link of the desired document, the attachment pop-up window generates
for you to attach a new document. Attaching a new document will overwrite the existing
document. The changes will commit once you click the ‘OK’ button.
If you select the ‘Add Studies’ radio button, the system generates the ‘Add Study’ button.
Clicking the ‘Add Study’ button generates a field set to enter all required study information. You
are required to identify the beginning date of the study, the purpose of the study, types of data to
be collected, the anticipated date of completion, and the name and address of the laboratory
conducting the study. This information must accompany each listed entry.
The system provides the following text fields to complete:
 Add Documents: Select the radio button to attach an ongoing studies document. At least one
radio button must be selected.
 Add Studies: Select the radio button to enter ongoing studies information. At least one radio
button must be selected.
 Add Study: Click the button to generate the study expandable/collapsible field set.
 Study Title: Enter the title of the study. This is a required field.
 Study Start Date: Enter the start date of the study. You can use the calendar widget to enter
a date. This is a required field.
 Study End Date: Enter the end date of the study. You can use the calendar widget to enter a
date. This is a required field.
 Study Purpose: Enter the purpose of the study. This is a required field.
 Data to be Collected: Enter the type of data to be collected throughout the duration of the
specified study. This is a required field.
 CBI: Check the ‘CBI’ checkbox to claim the information of the laboratory conducting the
study as confidential.
 Laboratory Name: Enter the name of the laboratory conducting the study. This is a required
field.

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 Mailing Address 1: Enter the first line of the mailing address of the laboratory conducting
the study. This is a required field.
 Mailing Address 2: Enter the second line of the mailing address of the laboratory
conducting the study.
 City: Enter the city of the mailing address of the laboratory conducting the study. This is a
required field.
 State: Select the state of the mailing address of the laboratory conducting the study. This is a
require field if the Country is set to the ‘United States.’
 Postal Code: Enter the postal code of the mailing address of the laboratory conducting the
study. This is a required field.
 Country: Select the country of the mailing address of the laboratory conducting the study.
This is a required field.
The system provides functionality for you to associate multiple studies to a single laboratory.
Once you enter the laboratory contact information and save the entered data within the field set
by clicking the ‘Save’ button, that contact information is saved to the ‘Create a new laboratory or
select an existing one from the drop-down’ menu. You can click the ‘Delete’ icon located in the
top right corner of the specified field set to delete any unwanted studies. Clicking the ‘Expand
All’ link will expand all field sets. Likewise, clicking the ‘Collapse All’ link will collapse all
field sets. To expand or collapse a field set individually, click the toggle arrow located in the top
left corner of the specified field set.
After all required information has been entered into the ‘Ongoing Studies’ screen, you can
navigate to the next study identified on the ‘Study Identification’ screen by clicking the ‘Next’
button or by clicking the next study link within the navigation tree.
Exhibit 3-24 shows the screen capture of the ‘Ongoing Studies’ screen when you select the ‘Add
Documents’ radio button:

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Exhibit 3-24: Ongoing Studies Screen (Add Document)

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 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: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field. A sanitized document is required if the ‘CBI’ checkbox
is checked.
 Document Upload: Click the ‘Browse’ button to 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. Click the ‘Browse’ button to 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. The drop-down menu 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. Submission Types, Effects, and Endpoints for a complete list of values that are
found within each of the drop-down menus on the ‘Ongoing Studies’ 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 3-25 shows the screen capture of the ‘Ongoing Studies’ pop-up window:
Exhibit 3-25 Ongoing Studies Pop-Up Window

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Exhibit 3-26 shows the screen capture of the ‘Ongoing Studies’ Screen when you select the ‘Add
Studies’ radio button:
Exhibit 3-26: Ongoing Studies Screen (Add Study)

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Navigation: Once all required information is entered, click the ‘Next’ button to navigate to the
next submission type screen. The next screen is dependent upon the selections you made on the
‘Study Identification’ screen. If no other study types were identified on the ‘Study Identification
screen,’ the user will be taken to the ‘Submitter Request’ screen upon clicking the ‘Next’ button.
3.3.13

Robust Summary Screen

You can access the ‘Robust Summary’ screen by checking the ‘Robust Summary’ checkbox on
the ‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen
by clicking the ‘Robust Summary’ link within the navigation tree.
You can upload robust summary documentation by clicking the ‘Add Document’ button.
Clicking the ‘Add Document’ button generates the ‘Robust Summary’ pop-up window for you to
upload documents. To add additional documents, click the ‘Add Document’ button on the
‘Robust Summary’ screen. You can delete unwanted attached documents by clicking the ‘Delete’
icon located in the ‘Action’ column of the robust summary table. To attach a replacement
document for a document that was previously attached, click the file name link for the desired
document under the ‘File Name’ column. Once you click the file name link of the desired
document, the attachment pop-up window generates for you to attach a new document. Attaching
a new document will overwrite the existing document. The changes will commit within the table
once you click the ‘OK’ button and display the file name, CBI claim, and possible action.
After all desired documents have been attached, click the ‘Next’ button to navigate to the next
study type identified on the ‘Study Identification’ screen or the ‘Submitter Request’ screen if no
other study types were identified. At least one document must be uploaded.

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Exhibit 3-27 shows the screen capture of the ‘Robust Summary’ screen:
Exhibit 3-27: Robust Summary 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 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. To save the attached document to the ‘Document
Management’ screen, click the ‘OK’ button within the ‘Document Management’ pop-up
window.
 Document Upload: Click the ‘Browse’ button to 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. The drop-down menu 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. Submission Types, Effects, and Endpoints 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 3-28 shows the screen capture of the ‘Robust Summary’ pop-up window:

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Exhibit 3-28: Robust Summary Pop-Up Window

Navigation: Once all required documentation has been attached, click the ‘Next’ button to
navigate to the next submission type screen. The next screen is dependent upon the selections
made on the ‘Study Identification’ screen. If no other study types were identified on the ‘Study
Identification’ screen you will be taken to the ‘Submitter Request’ screen upon clicking the
‘Next’ button.
3.3.14

Studies Which Are Known But Without Possession of Copies Screen

You can access the ‘Studies Which are Known but without Possession of Copies’ screen by
checking the ‘Studies Which are Known but without Possession of Copies’ checkbox on the
‘Study Identification’ screen and clicking the ‘Next’ button if no other study types were selected.
You can also access this screen by clicking the ‘Studies Which are known but without
Possession of Copies’ link within the navigation tree.
The ‘Studies Which Are Known but Without Possession of Copies’ screen provides you with
‘Add Documents’ and ‘Add Studies’ radio buttons. Selecting the ‘Add Documents’ radio button
generates the ‘Add Document’ button and the studies which are known but without possession of
copies table. Clicking the ‘Add Document’ button generates the ‘Studies which are known but
Without Possession of Copies’ pop-up window for you to upload related documentation. To add
additional documents, click the ‘Add Document’ button on the ‘Studies Which Are Known but
without Possession of Copies’ screen. You can delete unwanted attached documents by clicking
the ‘Delete’ icon located in the ‘Action’ column of the studies which are known but without
possession of copies table. To attach a replacement document for a document that was previously
attached, click the file name link for the desired document under the ‘File Name’ column. Once
you click the file name link of the desired document, the attachment pop-up window generates
for you to attach a new document. Attaching a new document will overwrite the existing
document. The changes will commit once you click the ‘OK’ button.
If you select the ‘Add Studies’ radio button, the system generates the ‘Add Study’ button.
Clicking the ‘Add Study’ button generates a field set to enter required study information. You
are required to identify the study title, and the name and address of the contact possessing a copy
of the study. This information must accompany each listed entry.
The system provides the following text fields to complete:
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 Add Documents: Select the radio button to attach studies which are known but without
possession of copies documents. At least one radio button must be selected.
 Add Studies: Select the radio button to enter information regarding studies, which are
known, but without possession of copies. At least one radio button must be selected.
 Add Study: Click the button to generate the study expandable/collapsible field set.
 File Name: Displays the file name and file extension of the document attached on the
‘Studies Which are Known but Without Possession of Copies’ pop-up window.
 CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’
 Actions: Click the ‘Delete’ icon ( ) to remove the attachment. A warning message displays
to confirm the removal of the attachment.
 Study Title: Enter the title of the study. This field is required.
 Prefix: If applicable, select the prefix of the contact possessing a copy of the study.
 First Name: Enter the first name of the contact possessing a copy of the indicated study.
This field is required.
 Last Name: Enter the last name of the contact possessing a copy of the indicated study. This
field is required.
 Suffix: If applicable, select the suffix of the contact possessing a copy of the indicated study.
 Phone Number: Enter the phone number of the contact possessing a copy of the indicated
study. This field is required.
 Ext: Enter the extension to the phone number of the contact possessing a copy of the
indicated study.
 Email Address: Enter the email address of the contact possessing a copy of the indicated
study. The email address must follow the standard email address format: john.doe@abc.com.
This field is required.
 Mailing Address 1: Enter the first line of the mailing address of the laboratory possessing a
copy of the indicated study. This field is required.
 Mailing Address 2: Enter the second line of the mailing address of the laboratory possessing
a copy of the indicated study.
 City: Enter the city of the mailing address of the contact possessing a copy of the indicated
study. This field is required.
 State: Select the state of the mailing address of the contact possessing a copy of the indicated
study. This field is required if ‘United States’ is selected as the country.
 Postal Code: Enter the postal code of the mailing address of the contact possessing a copy of
the indicated study. This field is required.
 Country: Select the country of the mailing address of the contact possessing a copy of the
indicated study. This field is required.
The system allows you to associate multiple studies to a single contact. Once you enter the
contact information and save the entered information within the field set by clicking the ‘Save’
button, that contact information is saved to the ‘Create a new contact or select an existing one

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from the drop-down’ menu. Click the ‘Save’ button to navigate to the ‘Studies Which Are
Known but without Possession of Copies’ screen where all the added studies would be displayed.
You can click the ‘Delete’ icon located in the top right corner of the specified field set to delete
any unwanted studies you have previously entered. Clicking the ‘Expand All’ link will expand
all field sets. Likewise, clicking the ‘Collapse All’ link will collapse all field sets. To expand or
collapse all field set individually, click the toggle arrow located in the top left corner of the
specified field set.
After all information has been entered into the ‘Studies Which Are Known but without
Possession of Copies’ screen, navigate to the next study identified on the ‘Study Identification’
screen by clicking the ‘Next’ button or by clicking the next study link within the navigation tree.
If no additional study types were selected the user will be taken to the ‘Submitter Request’
screen by clicking the ‘Next’ button.
Exhibit 3-29 shows the screen capture of the ‘Studies Which Are Known but without Possession
of Copies’ screen:
Exhibit 3-29: Studies Which Are Known but without Possession of Copies (Add
Document)

The ‘Studies Which are Known but without Possession of Copies’ 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.

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 CBI: Checking the ‘CBI’ checkbox will claim the uploaded document as CBI and
generate a sanitized document upload field. A sanitized document is required if the ‘CBI’
checkbox is checked.
 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. The drop-down menu 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. Submission Types, Effects, and Endpoints for a complete list of values that are
found within each of the drop-down menus on the ‘Studies Which are Known but without
Possession of Copies’ 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 3-30 shows the screen capture of the ‘Studies Which Are Known but without Possession
of Copies’ pop-up window:
Exhibit 3-30: Studies Which Are Known but without Possession of Copies Pop-Up
Window

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Exhibit 3-31 shows the screen capture of the ‘Studies Which Are Known but without Possession
of Copies’ screen when you select the ‘Add Studies’ radio button:
Exhibit 3-31: Studies Which Are Known but without Possession of Copies Screen (Add
Study)

Navigation: Once all required information is entered, click the ‘Next’ button to proceed to the
next submission study type screen. The next screen is dependent upon the selections you made
on the ‘Study Identification’ screen. If no other study types were identified on the ‘Study
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Identification’ screen, you will be taken to the ‘Submitter Requests’ screen upon clicking the
‘Next’ button.
3.3.15 Studies Previously Sent to Federal Agencies without Confidentiality Claims
Screen
You can access the ‘Studies Previously Sent to Federal Agencies without Confidentiality Claims’
screen by checking the ‘Studies Previously Sent to Federal Agencies without Confidentiality
Claims’ checkbox on the ‘Study Identification’ screen and clicking the ‘Next’ button. You can
also access this screen by clicking the ‘Studies Previously Sent to Federal Agencies without
Confidentiality Claims’ link within the navigation tree.
The ‘Studies Previously Sent to Federal Agencies without Confidentiality Claims’ screen
provides you with ‘Add Documents’ and ‘Add Studies’ radio buttons. Selecting the ‘Add
Documents’ radio button generates the ‘Add Document’ button and the studies previously sent to
federal agencies without confidentiality claims table. Clicking the ‘Add Document’ button
generates the ‘Studies Previously Sent to Federal Agencies without Confidentiality Claims’ popup window for you to upload associated documentation. To add additional documents, click the
‘Add Document’ button as needed from the ‘Studies Previously Sent to Federal Agencies
without Confidentiality Claims’ screen. You can delete unwanted attached documents by
clicking the ‘Delete’ icon within the ‘Actions’ column of the studies previously sent to federal
agencies without confidentiality claims table. To attach a replacement document for a document
that was previously attached, click the file name link for the desired document under the ‘File
Name’ column. Once you click the file name link of the desired document, the attachment popup window generates for you to attach a new document. Attaching a new document will
overwrite the existing document. The changes will commit once you click the ‘OK’ button.
If you click the ‘Add Studies’ radio button, the system generates the ‘Add Study’ button.
Clicking the ‘Add Study’ button generates a field set where you can enter required study
information. You are required to identify the study title, the agency in which the study was sent,
and the name and address of the contact possessing a copy of the indicated study. This
information must accompany each listed entry.
The system provides the following text fields to complete:
 Add Documents: Select the radio button to attach a studies previously sent to federal
agencies without confidentiality claims document. One radio button must be selected.
 Add Studies: Select the radio button to enter studies previously sent to federal agencies
without confidentiality claims information. One radio button must be selected.
 Add Study: Click the button to generate the study expandable/collapsible field set.
 Study Title: Enter the title of the study. This is a required field.
 Study Submission Date: Enter the submission date of the study. You may use the calendar
widget to help find a date. This is a required field.
 Agency: Select an agency from the drop down menu. This is a required field.
 CBI: Check the ‘CBI’ checkbox to claim the information of the contact possessing a copy of
the study as confidential.
 Prefix: If applicable, select the prefix of the contact possessing a copy of the study.

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 First Name: Enter the first name of the contact possessing a copy of the study. This is a
required field.
 Last Name: Enter the last name of the contact possessing a copy of the study. This is a
required field.
 Suffix: If applicable, select the suffix of the contact possessing a copy of the study.
 Phone Number: Enter the phone number of the contact possessing a copy of the study. This
is a required field.
 Ext: Enter the extension to the phone number of the contact possessing a copy of the study.
 Email Address: Enter the email address of the contact possessing a copy of the study. The
email address must follow the standard email address format: john.doe@abc.com. This is a
required field.
 Mailing Address 1: Enter the first line of the mailing address of the contact possessing a
copy of the study. This is a required field.
 Mailing Address 2: Enter the second line of the mailing address of the contact possessing a
copy of the study.
 City: Enter the city of the mailing address of the contact possessing a copy of the study. This
is a required field.
 State: Select the state of the mailing address of the contact possessing a copy of the study.
This is a required field if ‘United States’ is selected as the country.
 Postal Code: Enter the postal code of the mailing address of the contact possessing a copy of
the study. This is a required field.
 Country: Select the country of the mailing address of the contact possessing a copy of the
study. This is a required field.
The system provides functionality for you to associate multiple studies to a single contact. Once
you enter the contact information and save the entered data within the field set by clicking the
‘Save’ button, that contact information is saved to the ‘Create a new contact or select an existing
one from the drop-down’ menu. You can click the ‘Delete’ icon located in the top right corner of
the specified field setto delete any unwanted studies. Clicking the ‘Expand All’ link will expand
all field sets. Likewise, clicking the ‘Collapse All’ link will collapse all field sets. To expand or
collapse a field set individually, click the toggle arrow located in the top left corner of the
specified field set.
After all required information has been entered into the ‘Studies Previously Sent To Federal
Agencies Without Confidentiality Claims’ screen, you are ready to submit. If any information
has been claimed CBI, you will be required to complete substantiation before initiating the
submission process.

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Exhibit 3-32 shows the screen capture of the ‘Studies Previously Sent to Federal Agencies
without Confidentiality Claims’ screen:
Exhibit 3-32: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Screen (Add Document)

The ‘Studies Previously Sent to Federal Agencies without Confidentiality Claims’ 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 must be
attached. To save the attached document to the ‘Studies Previously Sent to Federal Agencies
without Confidentiality Claims’ screen, click the ‘OK’ button within the ‘Studies Previously
Sent to Federal Agencies without Confidentiality Claims’ pop-up window.
 CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload. A sanitized document is required if the ‘CBI’ checkbox is
checked.
 Document Upload: Click the ‘Browse’ button to 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. The drop-down menu 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. Submission Types, Effects, and Endpoints for a complete list of values that are
found within each of the drop-down menus on the ‘Studies Previously Sent to Federal Agencies
without Confidentiality Claims’ 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 3-33 shows the screen capture of the ‘Studies Previously Sent To Federal Agencies
Without Confidentiality Claims’ pop-up window:
Exhibit 3-33: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Pop-Up Window

Exhibit 3-34 shows the screen capture of the ‘Studies Previously Sent To Federal Agencies
Without Confidentiality Claims’ screen when you select ‘Add Studies’ radio button:

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Exhibit 3-34: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Screen (Add Study)

Navigation: Once all required information has been entered, you are finished with the data entry
process. If information has been claimed as CBI, you will be required to complete the
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substantiation screen for the AO to submit the form successfully. Please refer to Section 3.6 for
information regarding the substantiation section.
3.4

EPA Request for Further Information

The following screens are only available to you when you are amending a submission.
3.4.1

Underlying Data Screen

You can access the ‘Underlying Data’ screen by checking the ‘Underlying Data’ checkbox on
the ‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen
by clicking the ‘Underlying Data’ link within the navigation tree.
You can upload underlying data documents by clicking the ‘Add Document’ button. Clicking the
‘Add Document’ button generates a pop-up window for you to upload a document. To add
additional documents, click the ‘Add Document’ button each time from the ‘Underlying Data’
screen. You can delete any unwanted attached documents by clicking the ‘Delete’ icon within
the ‘Actions’ column of the Underlying Data table on the ‘Underlying Data’ screen. To attach a
different document after one has previously been attached, click the file name link for the desired
document under the ‘File Name’ column. Once you click the file name link of the desired
document, this generates the pop-up window that will display where you can attach the new
document. Attaching a new document will overwrite the existing document. The changes will
commit once you click the ‘OK’ button.
After all desired documents have been attached, click the ‘Next’ button to navigate to the next
study type identified on the ‘Study Identification’ screen. If no other study types have been
identified then you will be taken to the ‘Submitter Requests’ screen upon clicking the ‘Next’
button.
Exhibit 3-35 shows the screen capture of the ‘Underlying Data’ screen:

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Exhibit 3-35: Underlying Data Screen

The ‘Underlying Data’ 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 ‘Underlying Data’
screen, click the ‘OK’ button within the ‘Underlying Data’ pop-up window.
 CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field. A sanitized document is required if the ‘CBI’ checkbox
is checked.
 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. The drop-down menu 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. Submission Types, Effects, and Endpoints for a complete list of values that are
found within each of the drop-down menus on the ‘Underlying Data’ pop-up window. If you

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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 3-36 shows the screen capture of the ‘Underlying Data’ pop-up window:
Exhibit 3-36: Underlying Data Pop-Up Window (with Sanitized Document Attached)

Navigation: Upload all required documents and click the ‘OK’ button to close the window and
populate the underlying data table. If you click ‘Cancel’ or the ‘X’ button, the window will close
but no data will be saved. Once all documents have been uploaded, click the ‘Next’ button to
move to the next screen from the ‘Underlying Data’ screen.
3.4.2

Preliminary Report of Ongoing Studies Screen

You can access the ‘Preliminary Reports of Ongoing Studies’ screen by checking the
‘Preliminary Reports of Ongoing Studies’ checkbox on the ‘Study Identification’ screen and
clicking the ‘Next’ button. You can also access this screen by clicking the ‘Preliminary Reports
of Ongoing Studies’ link within the navigation tree.
The ‘Preliminary Reports of Ongoing Studies’ screen is required for users who list studies as
ongoing or initiated. The ‘Preliminary Reports of Ongoing Studies’ screen provides the user with
‘Add Documents’ and ‘Add Studies’ radio buttons. If you select the ‘Add Documents’ radio
button the system generates the ‘Add Document’ button and the preliminary reports of ongoing
studies table. Clicking the ‘Add Document’ button generates a pop-up window for you to upload
documents. To add additional documents click the ‘Add Document’ button as needed from the
‘Preliminary Reports of Ongoing Studies’ screen. You can delete unwanted attached documents
by clicking the ‘Delete’ icon within the ‘Actions’ column of the preliminary reports of ongoing
studies table. To attach a replacement document for a document that was previously attached,
click the file name link for the desired document under the ‘File Name’ column. Once you click
the file name link of the desired document, the attachment pop-up window generates for you to

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attach a new document. Attaching a new document will overwrite the existing document. The
changes will commit once you click the ‘OK’ button.
If you select the ‘Add Study’ radio button the system will generate the ‘Add Study’ button.
Clicking the ‘Add Study’ button will generate a field set that displays text fields for you to enter
required study information. You are required to identify the beginning date of the study, the
purpose of the study, types of data to be collected, the anticipated date of completion, and the
name and address of the laboratory conducting the study. This information must accompany each
listed entry.
The system provides the following text fields to complete:
 Add Documents: Select the radio button to attach a preliminary reports of ongoing studies
document.
 Add Studies: Select the radio button to enter preliminary reports of ongoing studies
information.
 Study Title: Enter the title of the study. This is a required field.
 Study Start Date: Enter the start date of the study. You can use the calendar widget to help
find a specific date. This is a required field.
 Study End Date: Enter the end date of the study. You can use the calendar widget to help
find a specific date. This is a required field.
 Study Purpose: Enter the purpose of the study. This is a required field.
 Data to be Collected: Enter the type of data to be collected throughout the duration of the
specified study. This is a required field.
 Create a new Laboratory or select an existing one from the drop-down: This drop-down
menu displays laboratories which have previously been entered within the same form, or
allows you to enter a new laboratory. This field is optional.
 CBI: Check the ‘CBI’ checkbox to claim the information of the laboratory conducting the
study as confidential.
 Laboratory Name: Enter the name of the laboratory conducting the study. This is a required
field.
 Mailing Address 1: Enter the first line of the mailing address of the laboratory conducting
the study. This is a required field.
 Mailing Address 2: Enter the second line of the mailing address of the laboratory
conducting the study.
 City: Enter the city of the mailing address of the laboratory conducting the study. This is a
required field.
 State: Select the state of the mailing address of the laboratory conducting the study. This is a
required field if the country is identified as ‘United States.’
 Postal Code: Enter the postal code of the mailing address of the laboratory conducting the
study. This is a required field.
 Country: Select the country of the mailing address of the laboratory conducting the study.
This is a required field.
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The system provides functionality for you to associate multiple studies to a single laboratory.
Once you enter laboratory contact information and save the data entered within the field set by
clicking the ‘Save’ button, that contact information is saved to the ‘Create a new laboratory or
select an existing one from the drop-down’ menu. You can click the ‘Delete’ icon to delete any
unwanted studies by clicking the ‘Delete’ icon, which is located in the top right corner of the
specified field set. Clicking the ‘Expand All’ link will expand all field sets. Likewise, clicking
the ‘Collapse All’ link will collapse all field sets. To expand or collapse a field set individually,
click the toggle arrow located in the top left corner of the specified field set.
After all information has been entered into the ‘Preliminary Reports of Ongoing Studies’ screen,
navigate to the next study identified on the ‘Study Identification’ screen by clicking the ‘Next’
button or by clicking the next study link in the navigation tree. If no other study types were
identified, you will be taken to ‘Submitter Request’ screen upon clicking the ‘Next’ button.
Exhibit 3-37 shows the screen capture of the ‘Preliminary Reports of Ongoing Studies’ screen:
Exhibit 3-37: Preliminary Reports of Ongoing Studies Screen (Add Document)

The ‘Preliminary Reports of Ongoing Studies’ 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 ‘Preliminary Reports of Ongoing Studies’ screen, click the ‘OK’ button within
the ‘Preliminary Reports of Ongoing Studies’ pop-up window.
 CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field. A sanitized document is required if the ‘CBI’ checkbox
is checked.
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 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. The drop-down menu 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. Submission Types, Effects, and Endpoints for a complete list of values that are
found within each of the drop-down menus on the ‘Preliminary Reports of Ongoing Studies’
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 3-38 shows the screen capture of the ‘Preliminary Reports of Ongoing Studies’ pop-up
window:
Exhibit 3-38: Preliminary Report of Ongoing Studies Pop-Up Window (with Sanitized
Document Attached)

Exhibit 3-39 shows the screen capture of the ‘Preliminary Reports of Ongoing Studies’ screen
when you select the ‘Add Studies’ radio button:

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Exhibit 3-39: Preliminary Report of Ongoing Studies Screen (Add Study)

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Navigation: Once all required information is entered, click the ‘Next’ button to navigate to the
next screen. The next screen is dependent upon the study types you identified on the ‘Study
Identification’ screen.
3.4.3

Copies of Studies Screen

You can access the ‘Copies of Studies’ screen by checking the ‘Copies of Studies’ checkbox on
the ‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen
by clicking the ‘Copies of Studies’ link within the navigation tree.
The ‘Copies of Studies’ screen provides you with ‘Add Documents’ and ‘Add Studies’ radio
buttons. Selecting the ‘Add Documents’ radio button generates the ‘Add Document’ button and
the copies of studies table. Clicking the ‘Add Document’ button generates the ‘Copies of
Studies’ pop-up window for you to upload documents. To add additional documents you can
click the ‘Add Document’ button as needed from the ‘Copies of Studies’ screen. You can delete
unwanted attached documents by clicking the ‘Delete’ icon located in the ‘Actions’ column of
the copies of studies table. To attach a replacement document for a document that was previously
attached, click the file name link for the desired document under the ‘File Name’ column. Once
you click the file name link of the desired document, the attachment pop-up window generates
for you to attach a new document. Attaching a new document will overwrite the existing
document. The changes will commit once you click the ‘OK’ button.
If you select the ‘Add Study’ radio button the system generates the ‘Add Studies’ field set.
Clicking the ‘Add Studies’ radio button generates a field set that displays text fields for you to
enter required study information. You are required to identify the study title, and the name and
address of the contact who possesses a copy of the indicated study. This information must
accompany each listed entry.
The system provides the following text fields to complete:
 Study Title: Enter the title of the study. This field is required.
 CBI: Check the ‘CBI’ checkbox to identify the information of the individual who possesses a
copy of the indicated study as confidential.
 Prefix: If applicable, select the prefix of the individual who possesses a copy of the indicated
study.
 First Name: Enter the first name of the individual who possesses a copy of the indicated
study. This field is required.
 Last Name: Enter the last name of the individual who possesses a copy of the indicated
study. This field is required.
 Suffix: If applicable, select the suffix of the individual who possesses a copy of the indicated
study.
 Phone Number: Enter the phone number of the individual who possesses a copy of the
indicated study. This field is required.
 Ext: Enter the extension to the phone number of the individual who possesses a copy of the
indicated study.

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 Email Address: Enter the email address of the individual who possesses a copy of the study.
The email address must follow the standard email address format: john.doe@abc.com. This
field is required.
 Mailing Address 1: Enter the first line of the mailing address of the individual who
possesses a copy of the study. This field is required.
 Mailing Address 2: Enter the second line of the mailing address of the individual who
possesses a copy of the study.
 City: Enter the city of the mailing address of the individual who possesses a copy of the
study. This field is required.
 State: Select the state of the mailing address of the individual who possesses a copy of the
study. This field is required if the country selected is ‘United States.’
 Postal Code: Enter the postal code of the mailing address of the individual who possesses a
copy of the study. This field is required.
 Country: Select the country of the mailing address of the individual who possesses a copy of
the study. This field is required.
The system provides functionality for you to associate multiple studies to a single contact. Once
you enter contact information and save the data entered within the field set by clicking the ‘Save’
button, that contact information is saved to the ‘Create a new contact or select an existing one
from the drop-down’ menu. You can click the ‘Delete’ icon located in the top right corner of the
specified field set to delete any unwanted studies. Clicking the ‘Expand All’ link will expand all
field sets. Likewise, clicking the ‘Collapse All’ link will collapse all field sets. To expand or
collapse a field set individually, you can click the toggle arrow located in the top left corner of
the specified field set.
After all required information has been entered into the ‘Copies of Studies’ screen, you can
navigate to the next study identified on the ‘Study Identification’ screen by clicking the ‘Next’
button or by clicking the next study link from within the navigation tree.

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Exhibit 3-40 shows the screen capture of the ‘Copies of Studies’ screen:
Exhibit 3-40: Copies of Studies Screen (Add Document)

The ‘Copies of Studies’ 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 ‘Copies of
Studies’ screen, click the ‘OK’ button within the ‘Copies of Studies’ pop-up window.
 CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload. A sanitized document is required if the ‘CBI’ checkbox is
checked.
 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. The drop-down menu 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. Submission Types, Effects, and Endpoints 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 3-41 shows the screen capture of the ‘Copies of Studies’ pop-up window:
Exhibit 3-41: Copies of Studies Pop-up Window (with Sanitized Document Attached)

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Exhibit 3-42 shows the screen capture of the ‘Copies of Studies’ screen when you select the
‘Add Studies’ radio button:
Exhibit 3-42: Copies of Studies Screen (Add Study)

Navigation: Once all required information is entered, click the ‘Next’ button to navigate to the
next screen. The next screen is dependent upon the study types you identified on the ‘Study
Identification’ screen. If no other study types were identified you will navigate to the ‘Submitter
Requests’ screen upon clicking ‘Next.’

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3.5

Submitter Requests Screen

You can access the ‘Submitter Requests’ screen by clicking the ‘Submitter Requests’ link within
the navigation tree, or by clicking the ‘Next’ button from the previous screen.
The ‘Submitter Requests’ screen provides functionality for you to request a time extension or
withdrawal of a submission. Clicking the ‘Add Document’ button generates the ‘Submitter
Request’ pop-up window. You can delete unwanted attached documents by clicking the ‘Delete’
icon located in the ‘Actions’ column of the submitter requests table. To attach or edit a
previously attached document, click the file name link of the desired document under the ‘File
Name’ column. Once you click the file name link of the desired document, the attachment popup window generates for you to attach a new document. Attaching a new document will
overwrite the existing document. The changes will commit once you click the ‘OK’ button.
 File Name: Displays the file name and file extension of the document attached on the
‘Submitter Request’ pop-up window.
 Request Type: Displays the request type selected from the ‘Submitter Request’ pop-up
window.
 Actions: Click the ‘Delete’ icon ( ) to remove the document from the system. A warning
message displays to confirm removal of the document.
Exhibit 3-43 shows the screen capture of the ‘Submitter Requests’ screen:
Exhibit 3-43: Submitter Requests Screen

Exhibit 3-44 shows the screen capture of the ‘Submitter Request’ pop-up window:
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Exhibit 3-44: Submitter Request Pop-Up Window

Navigation: Click the ‘OK’ button to close the ‘Submitter Request’ pop-up window and save the
selected document. Clicking the ‘Cancel’ or ‘X’ button will close the window however, no data
will be saved. Once all documentation has been uploaded, click ‘Submit’ button to begin the
submission process. If data has been claimed as CBI, click the ‘Next’ button to complete the
‘Substantiation Summary’ screen.
3.6
Substantiation Summary
You can access the ‘Substantiation Summary’ screen by identifying CBI claims within the
application.
If a user claims any item as CBI, a prompt will display informing the user ‘Substantiation is
required.’ Please complete the substantiation by clicking the link within the navigation tree on
the left to complete substantiation for this item, or by clicking the ‘Next’ button from the
‘Submitter Request’ screen. To pass validation, substantiation must be completed for all items
claimed as CBI before submission.’ The ‘Substantiation Summary’ link within the navigation
tree provides navigation to the ‘Substantiation Summary’ screen. The values in the
‘Substantiation Status’ column indicate whether the user has completed substantiation. If the
status is ‘Pending’ you must complete substantiation prior to submission. Click the ‘Pending’
link within the ‘Substantiation Status’ column. Once the substantiation has been completed the
status will change to ‘Complete.’
Exhibit 3-45 shows the screen capture for the ‘Substantiation Summary’ screen:

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Exhibit 3-45: Substantiation Summary Screen

Exhibit 3-46 shows the screen capture of the ‘Submission of Studies Substantiation’ screen:

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Exhibit 3-46: Submission of Studies Substantiation Screen

Navigation: Once all substantiation statuses are complete, click the ‘Save’ icon located in the
bottom action bar to save all entered data. Click the log out button, located in the upper right
hand corner to sign out of the application.

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4

Validate

You can click the ‘Validate’ icon ( ) at any stage of completing a Section 8(d) Health & Safety
Data Reporting submission. The ‘Section 8(d) Health & Safety Data Reporting Validation’ popup window displays when you click the ‘Validate’ icon ( ). The ‘Section 8(d) Health & Safety
Data Reporting Validation’ pop-up window displays a report of all validation errors and warning
messages. During the validation process, the application validates each screen of the Section 8(d)
Health & Safety Data Reporting 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 8(d) Health & Safety Data Reporting
Validation’ pop-up window. If the information you fixed passes validation, the error will be
removed from the ‘Section 8(d) Health & Safety Data Reporting Validation’ pop-up window.
You must fix all validation errors in order to submit the submission to CDX successfully.
You can close the ‘Section 8(d) Health & Safety Data Reporting Validation’ pop-up window by
clicking the ‘X’ button located at the top right of the window.

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Exhibit 4-1 shows the screen capture for the ‘Section 8(d) Health & Safety Data Reporting
Validation’ pop-up window:
Exhibit 4-1: Section 8(d) Health & Safety Data Reporting Validation Pop-Up Window

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5

Complete an Amendment

Only the Primary AO can unlock a submission to create an amendment. After the AO has
unlocked the submission and logged out, you (the Primary Support) can login and edit the form.
At this point, the ‘Section 8(d) Health & Safety Data Reporting’ submissions screen will display
a status of ‘In Progress’ under the ‘Status’ column; however, you will not see these changes until
you navigate back to the ‘Section 8(d) Health & Safety Data Reporting’ submissions screen.
Click the link in the ‘Submission Alias’ column for the form that you are amending to navigate
to the ‘Enter Passphrase’ screen. You must enter the passphrase originally associated with the
form to complete the amendment process.

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6

Resources

You can access the ‘Resources’ screen by clicking the ‘Resources’ tab located in the application
header. You can also access the ‘Resources’ screen by clicking the ‘Resources’ link from the
Section 8(d) Health & Safety Data Reporting ‘Home’ screen. The ‘Resources’ screen provides
you with links to all of the Section 8(d) Health & Safety Data Reporting application user guides
as well as additional helpful links. Click the ‘User Guide’ links to access the Section 8(d) Health
& Safety Data Reporting application user guide document.
Section 8(d) Health and Safety Data Reporting Homepage: If you click this link, a new
internet browser window will generate displaying the ‘Section 8(d) Health and Safety Data
Reporting’ screen.
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.

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Exhibit 6-1 shows the screen capture of the ‘Resources’ screen:
Exhibit 6-1: Resources Screen

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Appendix A. Definitions, Acronyms, and Abbreviations
The following is a list of 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

Code of Federal Regulations

CSPP

Chemical Safety and Pesticide Programs

CSV

Comma Separated Values

EPA

Environmental Protection Agency

EST

Eastern Standard Time

FRN

Federal Register Notice

IUPAC

International Union of Pure and Applied Chemistry

OPPT

Office of Pollution Prevention and Toxics

PDF

Portable Document Format

PMN

Premanufacture Notice

SRS

Substance Registry Services

TSCA

Toxic Substances Control Act

XML

Extensible Markup Language

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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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File Typeapplication/pdf
AuthorMulvey, Sarah E (CGI Federal)
File Modified2022-08-19
File Created2013-10-28

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