Pre-Issuance Outreach

Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirement (Revision)

1139.44_2070-0033_CDX_Guidancepdf

Pre-Issuance Outreach

OMB: 2070-0033

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 2070-0033 can be found here:

2023-12-28 - Extension without change of a currently approved collection

Document [pdf]

Download: pdf | pdf

Section 4(a)(2) of the
Toxic Substances
Control Act User
Guide
United States Environmental Protection Agency
Office of Pollution Prevention and Toxics

EPA #: EPA 705-G-2021-3735
OMB Control No.: 2070-0033
Date Issued: Month Day, 2021

Section 4 of the Toxic Substances Control Act (TSCA) allows the United States Environmental
Protection Agency (EPA) to require chemical manufacturers (including importers) and processors
to develop information on existing chemicals and submit such information to EPA.
Under Section 4(a) (15 U.S.C. 2603(a)), pursuant to specific statutory requirements, EPA may
issue an order requiring the development of information on a chemical.
This collection of information is approved by the United States Office of Management and Budget
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 20700033). Responses to this collection of information are mandatory for certain persons, as specified
at 15 U.S.C. 2601 et. seq. An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB control number.
The public reporting and recordkeeping burden for this collection of information is estimated to
be 137 hours per response. Send comments on the Agency’s need for this information, the accuracy
of the provided burden estimates and any suggested methods for minimizing respondent burden to
the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200
Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any
correspondence. Do not send the completed form to this address.
This document presents the user guide for the Office of Pollution Prevention and Toxics (OPPT)
Section 4 Test Order Submissions. The TSCA section 4 application is the electronic, web-based
tool provided by Environmental Protection Agency (EPA) for the submission of data. As a Primary
Authorized Official, you can create, modify, and submit. You can also delete data, create
amendments, and download the Copy of Record (CoR).
For questions concerning the Toxic Substances Control Act (TSCA) Section 4 software
requirements, please contact the Central Data Exchange (CDX) Help Desk at
[email protected] or call 1-888-890-1995 between the hours of 8 am – 6 pm Eastern Standard
Time (EST).
The contents of this document do not have the force and effect of law and are not meant to bind
the public in any way. This document is intended only to provide clarity to the public regarding
existing requirements under the law or agency policies. The statements in this document are
intended solely as guidance to aid in complying with EPA regulation.

Table of Contents

OMB Control No.: 2070-0030 .................................................................................................................................... 1
Date Issued: Month Day, 2021 ................................................................................................................................... 1
1.

Table of Contents ................................................................................................................................................ 3

System Requirements ......................................................................................................................................... 4
2.1 Supported Browsers ............................................................................................................................................ 4
2.2 Screen Resolution ................................................................................................................................................ 4

User Roles ............................................................................................................................................................ 4
3.1 Primary Authorized Official (AO) Functions ...................................................................................................... 4

Accessing the Section 4 Application to submit a Test Order Response.......................................................... 6
4.1 New Users ........................................................................................................................................................... 6
4.2 Existing Users ..................................................................................................................................................... 7

Submit an Initial Response to a Test Order ................................................................................................... 10
Step 1: Individual Initial Response to Order ........................................................................................................... 15
Step 1bc: Submitting an Extension Request ............................................................................................................ 15
Step 2. Determine How to Respond to the Test Order ............................................................................................ 20
Option 1: Develop the Information .................................................................................................................... 21
Option 2: Submit Existing Information .............................................................................................................. 23
Option 3: Request an Exemption ........................................................................................................................ 26
Option 4: Claim that You Are Not Subject to the Order ..................................................................................... 28
Option 5: Cease the Manufacture or Processing of the Chemical ....................................................................... 29
Option 6: Join a Consortium Response to Order................................................................................................. 30
Step 3: Test Order Response Deadlines .................................................................................................................. 41
Step 4: Submit Study Plans(s) and Final Study Report ........................................................................................... 41
Step 4a: Submitting a Draft Study Plan .............................................................. Error! Bookmark not defined.
Step 4b: Submitting a Final Study Plan .............................................................................................................. 45
Step 4c: Submitting a Final Study Report ........................................................................................................... 48
Step 5: Submitting a Response ................................................................................................................................ 51

Glossary ................................................................................................................. Error! Bookmark not defined.

System Requirements

To use the Section 12(b) Export Notification application to submit a Section 12(b) form, the
following are required:
•
•
•
•
•

An e-mail account
JavaScript enabled web browser
Internet access
Adobe Acrobat Reader 5.0 or higher
CDX username and password

2.1 Supported Browsers
One of the following supported browsers is required to access the Section 4 application:
•

Vendor supported versions of Internet Explorer (IE) or Edge
o Go to the following link to download: https://support.microsoft.com/enus/help/17621/internet-explorer-downloads
• Vendor supported versions of Mozilla Firefox
o Go to the following link to download: https://www.mozilla.org/en-US/firefox/new/
• Vendor supported versions of Safari
o Go to the following link to download: https://support.apple.com/downloads/
• Vendor supported versions of Google Chrome
o 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.
3.

User Roles

3.1 Primary Authorized Official (AO) Functions
This section describes how to:
•
•
•
•
•
•
•

Access the application
Navigate the Section 4 ‘Home’ screen
Assign Supports to complete a form
Start, complete, and submit an information for a Section 4 Test Order
Upload an extensible markup language (XML) file
Download a Copy of Record
Create an amendment

The Primary AO is responsible for the submission of main forms. As a Primary AO, you can create
a new form. You are also responsible for submitting amendments, unlocking submissions, and
deleting forms. You can assign Supports (or other authorized individuals) to edit and complete a

form on your behalf. The Primary AO can be thought of as a primary company authorized official,
specifically in regard to any sponsored individuals.
You can save the form at any point during the data entry process. The save functionality allows
you to return to that same form at any point in the future. You can print the form at any point;
however, the ‘Not for Submission’ watermark will be placed on the form anytime the form is
printed prior to actual submission.
Figure 1, displays a table of the user role capabilities within the Section 4 application:

Table 1: Section 4 User Roles Matrix
Legend
X=Can Perform Function

Primary
AO

Primary
Support

US/Non-US

Primary Form
Create Initial Response Form

Create Test Response Form

Submit Original ACM Forms

Generate Producing Company Unique ID

Edit Primary Form

Submit an original Forms

Unlock Form Submission (Create an
amendment)

Submit an Amendment of a Form

Assign Supports

Download CoR

Accessing the Section 4 Application to submit a Test Order Response

4.1 New Users
1. Register in CDX (https://cdx.epa.gov/).
2. To create a new CDX account, click on the green [Register with CDX] button.
3. Follow the steps provided by CDX to complete registration for Primary Authorized
Official role.

4.2 Existing Users
1. Log into CDX (https://cdx.epa.gov/).
2. For general questions about CDX, click the FAQ, Help, or Contact Us links at the top of
the screen.
3. If you are already an existing CDX user, log in with your User ID and Password.

4. Select the Primary Authorized Official link, for CSPP: Submissions for Chemical
Safety and Pesticide Programs.
5. If you maintain one organization, choosing the Primary Authorized Official Role will take
you directly to the Chemical Information Submission System.
6. If you are associated with multiple organizations, choose the relevant Organization Name
and Subsequent Program Client ID.
7. Select Proceed.

8. Select TSCA Section 4 from the drop-down menu and click the [OK] button.

9. Click the [Section 4 Orders] link on the Home page upper banner.

Submit an Initial Response to a Test Order

Manufacturers receiving a Test Order request must identify themselves as Manufacturer,
Processor or both within the 30 days after the effective date of the order.
1. Select [Start New Submission] to prepare the Individual Initial Response. All
manufacturers receiving a Test Order must complete this step regardless of how they
intend to respond to the order.

2. A text box will appear. Enter the Test Order number that was provided to your institution,
then click [Ok].

3. Choose a secure passphrase that can be remembered for the purposes of accessing the form
while it is In Progress or the Copy of Record and Communications after submission is
completed. The ‘Create Passphrase’ screen, allows you to create a passphrase and associate
that passphrase with your newly created form.
The application uses the passphrase as an encryption key to protect the contents of the
form. You are responsible for remembering the passphrase and distributing it to the
appropriate individuals.
If you lose or forget your passphrase, you will not be able to access your submission to
print, submit, or make changes. You will need to complete a new submission and create a
new passphrase. For security reasons, the system administrator will not have access to your
passphrase and will not be able to retrieve it or reset it.
New Passphrase: Enter a passphrase that is between 8 and 20 characters. For maximum
security, your passphrase should contain a combination of letters and numbers. Your
passphrase should not contain special characters (for example, +, ?, and *).
Confirm Passphrase: Enter the same passphrase that was entered into the ‘New
Passphrase’ field. The same passphrase may be associated with multiple forms. The user
can choose to have the same passphrase for all forms. Supports do not have the ability to
start a new form or create a passphrase for a form.

Action Bar
The action bar is located at the top and bottom of the form on each screen. You can perform the
following functions using the top action bar:
Home: Click the ‘Home’ link to navigate to the Section 4 ‘Home’ screen.
Help: Click the ‘Help’ link to generate a drop-down menu, which displays a link to the user
guide.
User ID: Click the user ID link to log out of the application.
The following exhibits, show screen captures for the bottom action bar:
Save: Click the ‘Save’ link at any stage of completing a Section 4 Test Order submission to save
the form. To generate and access links to other pages of the form within the navigation tree,
you must click the ‘Save’ link within the action bar. After you click the ‘Save’ link, you will
receive a message indicating that all data entered in the form has been saved successfully. The
save function does not validate any entered data. Click the ‘Previous’ and ‘Next’ buttons on a
form to save the data entered within a form. Click the ‘X’ button in the upper right-hand corner
of the form in your browser to close the form without saving.

Preview: Click the ‘Preview’ link after uploading a minimum of one chemical to preview the
form. After you click the ‘Preview’ link, you will be given the option to view a regular version
of the PDF(s) or a sanitized version of the PDF(s). Choosing either option will download (a)
watermarked PDF version(s) of each chemical identified within the form in a .zip file.

Validate: Click the ‘Validate’ link at any stage of completing a Section 4 Notice of Activity
form. A ‘TSCA Section 4 Validation’ window generates when you click the ‘Validate’ link if
you disable the pop-up blocker within your internet browser. The ‘Section 4 Validation’ popup window displays a report of all warning messages. Refer to Section Error! Reference source
not found. for more information on validating a form.

Submit: Click the ‘Submit’ link to submit a Section 4 form after completing all sections of a
Section 4 form. After you click the ‘Submit’ link a pop-up message displays to confirm the
submission process. The form validates during the submission process and displays any
applicable warning or error messages. You can continue with the submission process only after
clearing all validation errors. Upon successful submission of the form, the application
generates and sends an email indicating the successful submission of the form to the
submitter’s email address.

CDX Links: Click any of the ‘CDX Links,’ located at the bottom of each screen within the
‘CDX Links’ drop-down menu, at any stage of completing a Section 4 Test Order submission.
o Click the ‘CDX Homepage’ link to navigate to the ‘CDX’ homepage.
o Click the ‘MyCDX Homepage’ link to navigate to the ‘MyCDX’ page.
o Click the ‘EPA Homepage’ link to navigate to the EPA Homepage.
o Click the ‘Terms and Conditions’ link to navigate to the CDX Terms and
Conditions screen.
o Click the ‘Privacy Notice’ link to navigate to the CDX Privacy and Security Notice
screen.

Step 1: Individual Initial Response to Order
1.

Test Order Recipient submits the Individual Initial Response to Order
a. User should identify if they are responding to the order as a Manufacturer, Processor,
or Both.
b. The answer provided will drive the Test required for the Test Order.
c. Note: The mockup below may change.

2. To complete the submission, go to Step 5: Submitting a Response.
3. When the Initial Response is completed, the user will see:

Step 1b: Submitting an Extension Request
1. To submit an Extension Request, click the calendar icon next to the due date in the
[Current Action Due Date] column.

2. Choose a secure passphrase that can be remembered for the purposes of accessing the form
while it is in pprogress or the Copy of Record and Communications after submission is
completed.

3. Click the [Selected Tests] drop down, to choose which test(s) that is requesting an
extension.

4. Click the blue [Attach Extension Document] link to upload appropriate documentation.

a. Select the Test to which the documents relate and select the [Document Type] drop
down to indicate what documents are being uploaded.

b. For a Rationale Document:

c. For a Correspondence:

d. If the information is CBI, indicate by marking the checkbox and uploading a sanitized
version as well.
5. Type in the dates that you are proposing to have as the new deadline. Click [Next] to
continue.

6. To complete the submission, navigate to Step 5: Submitting a Response.
7. When the Extension Request has been completed, it will show in the main queue.

a. If at any point a document has been completed, but has been opened to be edited, the
Submission Type will turn blue and the lock icon will be unlocked.

b. When a communication from the EPA is received an envelope will show alongside the
submission type under the Test Order number.

c. If you have submitted a Test Order to Join Consortium, once it is completed in your
queue you will see:

8. To complete the submission, go to Step 5: Submitting a Response.

Step 2. Determine How to Respond to the Test Order
Manufacturers have six options from which to choose to comply with the Order. You will receive
an e-mail from EPA that provides the CDX Order number you will use for purposes of responding
to the Order. Consult the Order you received for details on each of these options.
1. The list of Test required will display based on your Individual Initial Response. If your
Individual Initial Response was “Manufacturer” you will see test(s) required for
Manufacturers only; if you selected “Processor” you will only see tests that are required
when acting or responding as Processor. If the test is required for both or your response
was Both, Manufacturer and Processor, you will see all the tests that are required for
both.
2. For each test, select how you intend to respond to the Test Order. You can Develop
Information, Submit Existing Information, or Request an Exemption; Claim That
You are Not Subject to this Order; indicate that your company Ceased the
Manufacture or Processing of the Chemical or Join a Consortium.
For clarification in regards to these responses go back to Step 2.

3. Verify the Chemical Information that the test order applies to. Determine which selection
applies best to each Test Response, select the appropriate value from the drop-down
menu under the Test Response column. This step must be completed for each test.
4. Click [Next] to continue.

Option 1: Develop the Information
If you choose to develop information in response to the Order, you must select this option in the
CDX portal form. The Order provides information on the required tests, required
protocols/methodologies, and deadlines for the Order.
1. To submit a response as Develop Information:

2. Click [Attach Document]

a. The Upload Develop Information Document pops up. Click the drop-down menu
under Document Type and select Other.
b. Provide the Document Type Description. Fill out the information highlighted by the
red asterisk.

c. If the attachment contains Confidential Business Information (CBI), indicate this
by selecting the I claim the attachment as CBI checkbox, and upload a sanitized
(marked up version that covers the information that is confidential) of the document
as well.

d. Click the [OK] button to continue.

3. Click [Next] to continue.
4. To complete the submission, navigate to Step 5: Submitting a Response.

Option 2: Submit Existing Information
If you choose to respond to the Order by submitting an existing study and/or other relevant
information that you believe EPA has not considered, your Initial Response in EPA’s CDX portal
must include the study and/or other relevant information, along with supporting rationale that
explains how the study and/or other relevant information meets part or all of the information
described as necessary in the Order. See the Order for more details on this response option.
1. To Submit Existing Information:

2. Click the blue [Attach Document] link

3. To attach a Study Report:

a. Fill out the information highlighted by the red asterisk.
b. If the attachment has CBI, indicate this, and upload a sanitized document as well.
4. To add a Rationale Document:
a. Fill out the information highlighted by the red asterisk.
b. If the attachment has CBI, indicate this, and upload a sanitized document as well.

c. The type of test response that is indicated will affect what Response Documents are
needed. If something is needed and not uploaded you will see the following alerts.

You will not be able to progress until the appropriate documents are uploaded for each
section.

5. When the correct documents have been uploaded, click [Next] to continue.
6. To complete the submission, navigate to Step 5: Submitting a Response.

Option 3: Request an Exemption
Any person required by the Order to conduct tests and submit information on a chemical may
apply for an exemption from such requirement (TSCA section 4(c)(1)). EPA will grant an
exemption provided information on an equivalent chemical has been submitted in accordance with
a rule, order, or consent agreement under TSCA section 4(a), or is being developed in accordance
with such a rule, order, or consent agreement, and submission of information by the exemption
applicant would be duplicative of information which has been submitted or is being developed in
accordance with such rule, order, or consent agreement. See the Order for more information on
and requirements of this response option.
1. To submit a Request an Exemption:

2. Click the appropriate radio button that coincides with the correct Exemption Reason
3. Click the blue [Attach Document] link.

a. Select the appropriate document type. Fill out the information highlighted by the red
asterisk.
b. If the attachment has CBI, indicate this, and upload a sanitized document as well.
c. If no documents are uploaded, validation errors will prevent the user from moving forward.

4. Click [Next] to continue.
5. To complete the submission, navigate to Step 5: Submitting a Response.

Option 4: Claim that You Are Not Subject to the Order
You may claim that you are not subject to the Order if you do not manufacture or process the
chemical(s) identified in the Order or you believe the Order was otherwise sent to you in error. An
explanation of the basis for your claim, along with appropriate supporting information to
substantiate that claim, must accompany your Initial Response in the CDX portal so that EPA can
evaluate the claim. See the Order for an explanation of this response option and related
requirements.

Option 5: Cease the Manufacture or Processing of the Chemical
If, within 90 days of the effective date of the Order, you intend to cease the manufacture, import
or processing of the chemical(s) for which you are subject to by the Order, you may satisfy the
requirements of the Order by certifying your intention to the Agency. The Order provides more
information on this response option and requirements thereof.
a. The response chosen in Order Response Options will affect the following pages.
b. If your institution uses an Alternate Name for the chemical identified, click [Add
Alternate Name] and a text box will appear to fill out.

1. To complete the submission, navigate to Step 5: Submitting a Response.

Option 6: Join a Consortium Response to Order
If you choose to form or join a consortium to share in the cost of developing the required
information, you (as well as the other participants of the consortium) must individually in CDX,
state your intention to participate in a testing consortium for each specific chemical and specific
test.
For your obligations under the Order to be satisfied, the designated lead for the consortium must
submit a consortium response to EPA through CDX for the consortium. The response must confirm
the formation of the consortium, identify its member companies, and list the testing obligations
that the consortium plans to fulfill on behalf of each company by indicating each specific test. The
letter must also include contact information for the designated lead of the consortium, who must
be domiciled in the U.S. The designated lead for the consortium must submit the Initial Response
and required information on behalf of the consortium and its member companies by the deadlines
listed the Order. After the results of the last required test of the Order is submitted and EPA accepts
the information as complying with the Order, or EPA accepts existing information submitted by
the Consortium, EPA will then provide notification of compliance with the Order to the Order
Recipients and the designated lead of the consortium.
Even if you agree to jointly submit the information as part of a consortium, each Order Recipient
is still required to comply with the Order and is individually liable in the event of any failure to
comply with the Order. If the consortium fails to submit the information or meet any of the
requirements of the Order on your behalf, you will be in violation of the Order unless you submit
the required information or meet the requirement individually.
The Agency has provided a list of the manufacturers and processors that have received the Order
at the top of the Order in the Summary Information section. This list of manufacturers and
processors can be used to help Order Recipients form a consortium to jointly develop information,
consolidate testing and share the cost of testing.

1. Select Join Consortium, then click [Start New Submission].

2. In Test Information, click the checkbox to claim membership.

a. If you wish to receive emails related to the consortium, click the related checkbox.
3. Click the blue [Attach Document] link.

a. Select the Document Type drop down. Fill out the information highlighted by the red
asterisk.
b. If the attachment has CBI, indicate this, and upload a sanitized document as well.
c. Click [OK].
4. Click [Next] to continue.
If at some point during a submission you wish to change the Test Response, all originally
uploaded documents will be erased.

5. To complete the submission, navigate to Step 5: Submitting a Response.

Creating a Consortium Initial Response to Order
After submitting the Individual Initial Response, if you selected Join a Consortium follow the
steps below to complete the submission.
For Consortium Initial Response to Order Submission Type:
1. Select Consortium Initial Response to Order, then click [Start New Submission]

2. Choose a secure passphrase that can be remembered for the purposes of accessing the form
while it is in progress or the Copy of Record and Communications after submission is
completed.

3. Fill out all relevant information on Consortium Initial Response to Order screen
a. Add Consortium Name and all Order Numbers associated with the Consortium in
question.
i. Once the Order Number is added to the field, click [Add Member] to load
the Member into the form
b. Add Test Responses via the drop-down list in the Test Response Information
section.
i. These Test Response options include Develop Information and Submit
Existing Information

4. Click [Next].

If Test Response is Develop Information:
1. Choose Develop Information, navigating to the Test Response will offer the choice to
Change Response or Attach Document for responding to the Test.
a. Choosing [Change Response] will return the user to the Consortium Information
page where they will be able to change their drop-down choice.
b. Clicking [Attach Document] will open a pop-up window for attaching a Test
Response document.
i. Once in the pop-up window, choose Document Type and add Document
Type Description.
ii. Click [Browse] to upload attachment for response and click checkbox if
claiming the attachment as CBI.
iii. If attachment is claimed CBI, a sanitized version is required to be attached
as well.
iv. If the same attachment(s) will be used for other Test Responses in the
Consortium, the user can check the box to Associate Documents to Other
Tests.

If Test Response is Submit Existing Information:
1. Choose Submit Existing Information, navigating to the Test Response will offer the
choice to Change Response or Attach Document for responding to the Test.
a. Choosing [Change Response] will return the user to the Consortium Information
page where they will be able to change their drop-down choice.
b. Clicking [Attach Document] will open a pop-up window for attaching a Test
Response document.
i. Once in the pop-up window, choose Document Type, which depending on
choice will open different options.
2. If user selects Study Report as the Document Type, they will be required to upload an
attachment and complete other fields related to the study being reported.
a. Fill out all required fields denoted by the red asterisk.

3. If the user selects Rationale Document, they will be required to upload the Rationale
Document as an attachment to the Test Response.

a. Click [Browse] to upload attachment for response and click checkbox if claiming
the attachment as CBI.
b. If attachment is claimed CBI, a sanitized version is required to be attached as well.
c. Click [OK] to exit pop-up window.

4. If the user selects Other, they will be required to upload an attachment to the Test
Response.
a. Add Document Type Description for attachment.
b. Click [Browse] to upload attachment for response and click checkbox if claiming
the attachment as CBI.
c. If attachment is claimed CBI, a sanitized version is required to be attached as well.
d. Click [OK] to exit pop-up window.

5. Once all Test Responses are completed, click [Next].
6. To complete the submission, navigate to Step 5: Submitting a Response.
7. Once the form has processed and migrated, the Current Action will become Submit
Study Plan.
For Submit Study Plan:
1. Choose a secure passphrase that can be remembered for the purposes of accessing the form
while it is in progress or the Copy of Record and Communications after submission is completed.

2. For any Tests with previous answers of Develop Information, the user will need to respond
to the Test in the Study Plan form

3. On the first page of the form, the user should click Attach Study Plan Document to open
pop-up window for attachments.
a. Select Test(s) for Attachment in Associate Document to Tests drop-down list.
b. Select relevant Document Type from drop-down list.

c. Click [Browse] to upload attachment for response and click checkbox if claiming
the attachment as CBI.
i. If attachment is claimed CBI, a sanitized version is required to be attached
as well.
d. Click [OK] to exit pop-up window.

e. Once all Tests have Study Plan responses, click [Next].
4. To complete the submission, navigate to Step 5: Submitting a Response.
5. Once the form has processed and migrated, the Current Action will become Submit
Study Report.
For Submit Study Report:
1. Choose a secure passphrase that can be remembered for the purposes of accessing the form
while it is In Progress or the Copy of Record and Communications after submission is completed.

2. For any Tests in the previous Study Plan form, the user will need to respond to the Test in
the Study Report form

3. On the first page of the form, the user should click Attach Study Report Document to
open pop-up window for attachments.
a. Select Test(s) for Attachment in Associate Document to Tests drop-down list.
b. Select relevant Document Type from drop-down list.
c. Click [Browse] to upload attachment for response and click checkbox if claiming
the attachment as CBI.
i. If attachment is claimed CBI, a sanitized version is required to be attached
as well.

d. If user selects Study Report as the Document Type, they will be required to upload
an attachment and complete other fields related to the study being reported.
i. Fill out all required fields denoted by the red asterisk.
e. Click [OK] to exit pop-up window.
4. Once all tests have responses, click [Next].
5. To complete the submission, navigate to Step 5: Submitting a Response.

Step 3: Test Order Response Deadlines
Depending on the Order requirement, users will be subject to differing deadlines. please refer to
the deadlines provided in the Order. Further, not all deadlines listed in the deadline will appear in
the CDX application. Consult the Order for all deadlines and associated requirements.
Step 4: Submit Study Plans(s) and Final Study Report
After the Individual Initial Response to Order is completed, the next step is to Submit Draft
Study Plan for the tests that are required based on the identification the user submitted to EPA
on Step 1.
1. On the Home page, click the blue link Submit Draft Study Report in the Next Action
column.
2. Choose a secure passphrase that can be remembered for the purposes of accessing the form
while it is In Progress or the Copy of Record and Communications after submission is
completed.

3. Click the blue Attach Study Plan Document link.

4. Click the [Associate Documents to Tests] drop down.

a. The dropdown menu will list options applicable to the test(s) associated with the
documents.
b. Click the [Document Type] drop down to select the type of document that will be
uploaded; Study Plan, Modification, Correspondence, or Study Plan – OHT Template File.
c. If the attachment has CBI, indicate this, and upload a sanitized document as well.
d. Click [OK].

e. If no documents are uploaded, this alert will show
43

f. When documents are uploaded, the user is able to click the blue arrow button to see what
has been uploaded, the type, the attachment date, and CBI information.

5. Click [Next] to continue.
6. To complete the submission, navigate to Step 5: Submitting a Response.

Step 4b: Submitting a Final Study Plan
After the Draft Study Plan have been submitted (Step 4a), the next action is to submit a Final
Study Plan.
1. On the Home page, click the blue link Submit Draft Study Report in the Next Action
column.
2. Choose a secure passphrase that can be remembered for the purposes of accessing the form
while it is In Progress or the Copy of Record and Communications after submission is
completed.

3. Click the blue Attach Study Plan Document link.

4. Click the [Associate Documents to Tests] drop down.

a. The dropdown menu will list options applicable to the test(s) associated with the
documents.
b. Click the [Document Type] drop down to select the type of document that will be
uploaded; Study Plan, Modification, Correspondence, or Study Plan – OHT Template
File.
c. If the attachment has CBI, indicate this, and upload a sanitized document as well.
d. Click [OK].

e. If no documents are uploaded, this alert will show

f. When documents are uploaded, the user is able to click the blue arrow button to see
what has been uploaded, the type, the attachment date, and CBI information.

5. Click [Next] to continue.
6. To complete the submission, navigate to Step 5: Submitting a Response.

Step 4c: Submitting a Final Study Report
1. Once the Final Study Plan has been completed a blue Submit Final Study Report will
appear. Click the blue Submit Final Study Report to begin.

2. Choose a secure passphrase that can be remembered for the purposes of accessing the form
while it is In Progress or the Copy of Record and Communications after submission is
completed.

3. Under Study Report Documents, click the blue Attach Study Report Documents link.

a. Click the Associate Documents to Tests: drop down to select the appropriate test.
b. Click the Document Type drop down to select the document type associated with the
test.

c. If nothing is uploaded a red alert message will appear.

d. For Document Type: Study Report, fill out the information highlighted by the red
asterisk.

a. If the attachment has CBI, indicate this. Click [OK] to continue.
4. When the documents have been successfully uploaded, the Status will change to Passes
Validation. Click [Next] to continue.

5. To complete the submission, navigate to Step 5: Submitting a Response.
6. When all submissions are completed, you will be able to download or unlock to edit the
document from the main queue.

Step 5: Submitting a Response
The submission steps are common and required across all the different forms and stages of the
response process. Please follow these steps to complete the submission process to EPA.
1. Technical Contact Information
b. Fill out all required Technical Contact Information denoted by red asterisk or
click [Copy CDX Registration] to fill in with the information from CDX.
c. If Technical Contact Information is CBI, please check the CBI checkbox.

d. Click [Next] to continue.
2. Submitting Official Information:
a. If this is CBI, indicate this by clicking the CBI checkbox.
b. Fill out Job Title of this page.
c. Click the checkbox to Confirm and Proceed.
d. If you are submitting on behalf of another company, indicate that by clicking the
checkbox.

3. Click [Submit] to continue.

4. Instructions for Substantiating Confidential Business Information (CBI) Claims, if
necessary.
a. If any CBI claims have been made, the [Continue] button on the Submitting Official
Information page will display the CBI Substantiation page.
b. To add the corresponding substantiation documents, select the [Attach Document for
CBI Substantiation] link.
c. To opt-out from providing the CBI Substantiation documents, check the Substantiation
Opt.

5. Once this has been completed, the buttons [Previous] and [Submit] will appear.

a. Click the [Confirm] button to begin the submission process.
b. The form validation will identify any errors in the form. Otherwise, No Validation
Errors Found will display
c. Click the [PDF Generation] button to generate the PDF for the submission. The
[Regular PDF] button will display any information marked as CBI while the
[Sanitized PDF] button will provide such information, masked. The PDF(s) can be
downloaded for external storage.

6. Click the [Sign, Encrypt and Submit] button to access the eSignature Widget

7. Click [Accept]

a.
b.
c.
d.

Complete the eSignature Widget.
Enter the Authentication Password and enter the Answer to the Verification Question.
Click the [Sign] button to complete the submission.
Click the [X] in the upper right corner of the eSignature Widget window to cancel the
submission.

8. Click the [Home] button to return to the Section 4 Home Page.
a. Select Submissions at the top to view the Status of a submitted form.

File Type	application/pdf
File Modified	2022-02-15
File Created	2021-10-15