Section 4(a)(2) of the Toxic Substances Control Act User Guide


CDXr

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 745-B-22-001

OMB Control No.: 2070-0030
Date Issued: December 21, 2021

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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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)(1), EPA may issue an order requiring the development of information on a chemical if they
find the chemical may present an unreasonable risk of injury to health or the environment and such
information is needed to determine whether the chemical presents such an unreasonable risk.

EPA may also issue an order under Section 4(a)(2) requiring the development of information:

• to review a notice submitted under TSCA Section 5 or to perform a risk evaluation under
TSCA Section 6(b);

• to implement a requirement imposed in a rule, order, or consent agreement under TSCA
Section 5(e) or (f), or in a rule promulgated under Section 6(a);

• at the request of a Federal implementing authority, under another Federal law, to meet the
regulatory testing needs of that authority with regard to toxicity and exposure;

• to determine if a chemical substance or mixture manufactured, processed, or distributed in
commerce solely for export presents an unreasonable risk of injury to health or the
environment in the U.S., pursuant to TSCA Section 12(a)(2); and

• to prioritize a chemical substance under TSCA Section 6(b) (subject to certain
limitations)1.

This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U. S.C.
3501 et seq. (OMB Control No. 2070-0033). 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), and 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).

1 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-4-test-orders.

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For questions concerning the Toxic Substances Control Act (TSCA) Section 4 software
requirements, please contact the Central Data Exchange (CDX) Help Desk at
helpdesk@epacdx.net or call 1-888-890-1995 between the hours of 8 am - 6 pm Eastern Standard
Time (EST).

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.

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© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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Table of Contents

OMB Control No.: 2070-0030	1

Date Issued: December 21,2021	1

1.	System Requirements	5

1.1	Supported Browsers	5

1.2	Screen Resolution	5

2.	User Roles	5

2.1 Primary Authorized Official (AO) Functions	5

3.	Accessing the Section 4 Application to submit a Test Order Response	7

3.1	New Users	7

3.2	Existing Users	8

3.3	Navigation Help	11

4.	Submit Response to a Test Order	14

4.1	Test Order Response Deadlines	14

4.2	Step 1: Submit an Identification Response	15

Determine how is your company going to respond to the Order	17

Step 2. Individual Initial Response to the Test Orders	19

Option 1: Develop the Information	20

Option 2: Submit Existing Information	22

Option 3: Request an Exemption	24

Option 4: Join a Consortium Response to Order	26

a. Creating a Consortium Initial Response to Order (Consortium Lead)	29

5.	Submit Draft and Final Study Plan and Final Study Report	34

Step 1: Submitting a Draft Study Plan	34

Step 2: Submitting a Final Study Plan	41

Step 3: Submitting a Final Study Report	48

6.	Submitting an Extension Request	51

6.1	Extension Request for the Identification Response	51

6.2	Extension Request for the Draft and Final Study Plan or Final Study Report	54

7.	Submitting a Response, Draft Study Plan, Final Study Plan or Final Study Report	59

8.	Glossary	64

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1.	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

1.1	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/en-
us/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/downlpads/

•	Vendor supported versions of Google Chrome

o Go to the following link to download: http://www.google.com/chrome

1.2	Screen Resolution

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

2.	User Roles

2.1 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.

© 2021 CGI Federal

5	EPA TO 47QFCA-18-F-0009

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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

US/Non-US

Primary Form





Create Identification Response Form

X



Creates Test Response Form

X



Submit Original ACM Forms

X



Generate Producing Company Unique ID

X



Edit Primary Form

X

X

Submit an original Forms

X



Unlock Form Submission (Create an
amendment)

X

X

Submit an Amendment of a Form

X



Assign Supports

X



Download CoR

X



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3. Accessing the Section 4 Application to submit a Test Order
Response

3.1 New Users

• Register in CDX (https://cdx.epa.gov/).

• To create a new CDX account, click on the green [Register with CDX] button.

• Follow the steps provided by CDX to complete registration for Primary Authorized Official
role.

e fra

!¦! United States Environmental Protection Agency

Home About

Recent Announcements Terms and Conditions

FAQ

Help

Virtual Assistant

CD)£r Central Data Exchange

S Contact Us

User ID

Password

1 Show Password
Log In Register with CDX

Forgot your Password?

Forgot your User ID?

Warning Notice and Privacy Policy

Welcome

Welcome to the Environmental Protection Agency (EPA) Central Data Exchange (CDX) - the Agency's electronic reporting site. The
Central Data Exchange concept has been defined as a central point which supplements EPA reporting systems by performing new
and existing functions for receiving legally acceptable data in various formats, including consolidated and integrated data.

Warning Notice and Privacy Policy

Warning Notice

In proceeding and accessing U.S. Government information and information systems, you acknowledge that you fully understand and consent to
all of the following:

1. you are accessing U.S. Government information and information systems that are provided for official U.S. Government purposes only;

2. unauthorized access to or unauthorized use of U.S. Government information or information systems is subject to criminal, civil,
administrative, or other lawful action;

3. the term U.S. Government information system includes systems operated on behalf of the U.S. Government;

4. you have no reasonable expectation of privacy regarding any communications or information used, transmitted, or stored on U.S.
Government information systems;

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3.2 Existing Users

• Log into CDX ( ttps://cdx.epa.gov/).

• For general questions about CDX, click the FAQ, Help, or Contact Us links at the top of
the screen.

• If you are already an existing CDX user, log in with your User ID and Password.

SEPA

United States Environmental Protection Agency

Home About Recent Announcements Terms and Conditions FAQ Help Virtual Assistant

CDXr Central Data Exchange

2 Contact Us

¦ Show Password
Log In Register with CDX

Forgot your Password?

Forgot your User ID?

Warning Notice and Privacy Policy

Welcome

Warning Notice and Privacy Policy

Warning Notice

In proceeding and accessing U.S. Government information and information systems, you acknowledge that you fully understand and consent to
all of the following:

1. you are accessing U.S. Government information and information systems that are provided for official U.S. Government purposes only;

2. unauthorized access to or unauthorized use of U.S. Government information or information systems is subject to criminal, civil,
administrative, or other lawful action;

3. the term U.S. Government information system includes systems operated on behalf of the U.S. Government;

4. you have no reasonable expectation of privacy regarding any communications or information used, transmitted, or stored on U.S.

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Select the Primary Authorized Official link, for CSPP: Submissions for Chemical
Safety and Pesticide Programs.

If you maintain one organization, choosing the Primary Authorized Official Role will take
you directly to the Chemical Information Submission System.

If you are associated with multiple organizations, choose the relevant Organization Name
and Subsequent Program Client ID.

Select Proceed.

United States Environmer>taJ Protection Agency

Home About Recent Announcements Terms and Conditions FAQ Help Virtual Assistant

CDY- Central Data Exchange

S Contact Us

Logged in as BRIGMANWK (Log out)

MyCDX

Inbox My Profile Role Sponsorship Submission History Payment History



Services

Qg Manage

Status

^ Prop ram Service Name '

Role *

&

CSPP: Submissions for Chemical
Safety and Pesticide Programs

Accreditation Bodv fAB)
Authorized Official

A

CSPP: Submissions for Chemical
Safety and Pesticide Programs

Accreditation Bodv fABl
Supoort







CSPP: Submissions for Chemical
Safety and Pesticide Programs

Primary Authorized Official







&

CSPP: Submissions for Chemical
Safety and Pesticide Programs

Primary Support

&

CSPP: Submissions for Chemical
Safety and Pesticide Programs

Secondary
Agent/Consultant

&

CSPP: Submissions for Chemical
Safety and Pesticide Programs

Secondary Authorized
Official

&

CSPP: Submissions for Chemical
Safety and Pesticide Programs

Secondary Support

A

CSPP: Submissions for Chemical
Safety and Pesticide Programs

Third-Party Certifier (TPG
Authorized Official

&

CSPP: Submissions for Chemical
Safety and Pesticide Programs

Third-Partv Certifier (TPO
Support







Add Program Service I Manage Your Program Services

CDX Service Availability

See the status for all program services

News and Updates

No news/updates.

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© 2021 CGI Federal
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• Select TSCA Section 4 from the drop-down menu and click the [OK] button.

Logged in as Jilliane Conley Primary Authorized Official

Log Out

CHEMICAL INFORMATION SUBMISSION SYSTEM

TSCA Section 4

The software includes embedded help flies and a downloadable user manual to guide you through the Section 4 submission
process

The Toxic Substances Control Act gives EPA authority to issue data development regulations that require manufacturers and
processors of existing chemicals to test their chemicals for health and environmental effects EPA has the broad authority under
the law to issue

Information collection regulations that require the submission of health and safety studies which are known or available to those
who manufacture process or distribute In commerce specified chemicals and regulations designed to gather information from
manufacturers and processor about production/import volumes, chemical uses and methods of disposal and the extent to
which people and the environment are exposed

TSCA also requires EPA to develop regulations that establish import/export requirements for chemicals which are subject to
certain requirements under TSCA.

Paperwork Reduction Act Notice

This collection o( Information is approved by OMB under the Paperwork Reduction Act, 44 (J S C. 3501 et seq (OMB Control
No. 2070-0033) Responses to this collection of information are mandatory under TSCA section 4 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 about 137
hours for the average response for a TSCA section 4 action on a per-chemieai basis not Including CDX registration, and 0 53
hours per CDX registration 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 including through the use of automated collection
techniques to the Director Regulatory Support Division. U.S. Environmental Protection Agency (2821T). 1200 Pennsylvania
Ave NW. Washington D C. 20460 Include tne OMB control number in any correspondence Do not send the completed form
to this address

Authority

The Government Paperwork Elimination Act (GPEA; (44 U S C. 3504) provides that, when practicable. Federal organizations
use electronic forms, electronic filings, and electronic signatures to conduct official business with the public. EPA's Cross-Media
Electronic Reporting Regulation (CROMERR) (40 CFR part 3)(Ref. 2), provides that any requirement in title 40 of the CFR to
submit a report directly to EPA can be satisfied wfth an electronic submission that meets certain conditions once the Agency
published a document in the Federal Register announcing that EPA is prepared to receive certain documents In electronic
form. For more information about CROMERR. go to *ittD:/fvrAV,.eoa.aov:cromerr.

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

CSPP

Home

Submissions

Section 4 Orders

User Management

TSCA Section 4 Home

Submissions

Create, modify, or delete a submission by clicking the Submissions tab.

User Management

Manage the access rights of Supports for each Section 4 submission. For every Support the Authorized Official may grant him/her the ability to edit (but not unlock, create, delete, or submit) the submission.

Resources

Section 4 Submission User Guide

This guide describes each screen of the Section 4 Submission application software and provides information on how to use the system to complete a Section 4 Submission. The guide also contains instructions for registei
previous submission. You can download and print the guide for quick reference.

Chemical Test Abbreviation Definitions

Click the link provided below to download and print the Section 4 Test Rules chemical test information guide for quick reference.

Toxic Substance Control Act (TSCA) Section 4 Submissions

Click the above link to access additional information related to Section 4 Submission.

CDX Home

Click the above link to access additional information related to Central Data Exchange (CDX).

TSCA Chemical Substances Inventory

Click the above link to access additional information related to the Toxic Substances Control Act (TSCA).

If you need assistance, please call (202) 564-3011 or e-mail the TSCA Hotline at TSCA-Hotline@epamail.epa.gov.

Authorized Official

An Authorized Official has the ability to create, delete, amend, unlock and submit all Section 4 submissions electronically to EPA. The Authorized Official also has the ability to assign Supports to individual submissions.

3.3 Navigation Help
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.

M Save

Preview ~Validate ©Submit

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

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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.

H Save

Preview ~Validate GSubmit

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' pop-
up window displays a report of all warning messages. Refer to Section Error! Reference source
not found, for more information on validating a form.

H Save

Preview ~ Validate G Submit

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.

H Save

Preview ~ Validate B Submit

CDX Links: Click any of the 'CDX Links,' located at the bottom of each screen within the
'CDX Links' drop-down menu, at any stage of completing a 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.

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CDX Homepage
My CDX Homepage
EPA Homepage
Terms and Conditions
Privacy Notice



Raise a Bug

CDX Links ^

CDX Helpdesk: (888) 890-1995

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© 2021 CGI Federal
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4. Submit Response to a Test Order

4.1 Test Order Response Deadlines

As Companies receive Test Order requests from EPA, the following deadlines apply:

Table 2: Test Order Response Deadlines

Order Requirement

Recipient's Deadline

EPA Response
Deadline*

•	Identify as a Manufacturer, Processor or Both

•	Submit Request to Modify Corporate Identity
Identified

•	Choose to Submit Existing Data (Option 2)

By 30 Days of effective
date

45 days of
effective date

• Claim that You Are Not Subject to this Order
(Option 4)

By 45 Days of effective
date

60 days of
effective date

•	Choose to Develop the Information - On Own
or as Part of a Consortium (Option 1)

•	Request an Exemption (Option 3)

By 65 Days of effective
date

80 days of
effective date

• Submit Draft Study Plan

By 80 Days of effective
date

95 days of
effective date

• Submit Final Study Plan

By 110 Days of
effective date

125 days of
effective date

• Submit Final Study Report

Deadline varies per Test
Requirement (See Unit
IV and Appendix E)



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4.2 Step 1: Submit an Identification Response

Companies receiving a Test Order request must identify themselves as Manufacturer, Processor
or both within 30 days after the effective date of the order.

1. Click the [Submission Type] dropdown menu to select the Identification Response

submission type and click [Start New Submission] to prepare the form. All companies
receiving a Test Order must complete this step regardless of how they intend to respond
to the order (e.g., Joining a Consortium).

ICSPP Home Submissions Section 4 Orders User Management	X Brooke Plaisance, Primary Authorized Official (CGI BP)

To download a Copy of Record, click on the plus (+) in the 'Order/Consortium Number* column, then click on the green arrow icon (*) in the Action column.

To search for entries, use the Search text box above the table. Note: Search will only work for the current page

"After you provide a response to the "Current Action," it can take up to 30 minutes for the display to update for the "Current Action" and "Next Action" columns. Note that upon submitting a "Current Action" response
that you should have received an email confirmation.

Search:

Items Per Page: 25 v |

6 items found.	Page 1 of 1

Order/Consortium Number

Last Action

Current Action

Current Action Due Date

Next Action

Next Action Due Date

Delete

+ TO-1234-9876-791614-01-A

Final Study Plan

Submit Study Report

11/11/2021 !jjg

N/A

N/A



+ TO-2021-1008-307895-01-A

N/A

Submit Initial Response

11/06/2021 J)

Submit Study Plan

12/27/2021

X

+ T0-8878-9876-485648-01-A

Identification Response

Submit Draft Study Plan

01/30/2022 3

Submit Final Study Plan

11/18/2021

X

+ TO-7777-7777-527723-01 -A

Identification Response

Submit Draft Study Plan

01/30/2022 ]3|

Submit Final Study Plan

11/12/2021

X

+ TO-8798-4897-981494-01-A

N/A

Submit Identification Response

12/12/2021 gg

Submit Draft Study Plan

01/31/2022

X

+ TO-8648-8648-659742-01-A

Identification Response

Submit Draft Study Plan

01/30/2022 J]

Submit Final Study Ran

11/17/2022

X

Export options: 61 CSV |« Excel | <2 XML | "3 PDF

Select the submission type and then click Start New Submission
Submission Type:

Start New Submission

Select the submission type and then click Start New Submission
Submission Type: Identification Response

Start New Submission

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

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15	EPA TO 47QFCA-18-F-0009

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Enter Test Order Number

Order Number:

Cancel

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.

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CSPP Home Submissions Section 4 Orders User Management

TSCA Section 4

New Passphrase

Confirm Passphrase

A You are responsible for remembering your passphrase!

If you lose or forget your passphrase, you will not be able to access your Section 4 form to print, submit, or make changes.
You will need to complete a new Section 4 form and create a new passphrase for the submission. For security reasons, the
system administrator will not have access to your passphrase and will not be able to retrieve it or reset it.

Determine how is your company going to respond to the Order

CSPP Home Submissions Section 4 Orders User Management

A Section 4 Test Orders

Order Number ¦ TO-2021-1208-
283259-01-A

¦ li Manufacturer/Processor Identification
"m Contact Information

li Technical Contact Information
|j Submitting Official information

X Brooke Plaisance, Primary Authorized Official (CGI BP)

Manufacturer/Processor Identification Response to Order

Order Information - TO-2021 -1208-283259-01 -A

Effective Date of
Order:

Identification	01-07-2022

Response Deadline:

Title of Action:	BrookeP	Docket Number:	EPA-HQ-OPPT-2021-1208

Indicate if you are a manufacturer, processor, or both. Review the Order for more information Q

Order Response	O Manufacturer

Options:	o Processor

O Both

®	Claim that You Are Not Subject to Test Order

Notes:

•	Hovering over the blue question mark on this page will give a detailed description to help the
user determine the correct response.

•	The answer provided will update and drive the Tests required for response in the
Indentification Response form.

Option 1: Identifying as Manufacturer for the Test Order

1.	Select the Manufacturer radio button.

2.	Select the Fees Certification that applies to your company.

3.	Click [Next] to continue.

4.	To complete the submission, navigate to the Submitting a Response, Draft Study Plan,
Final Study Plan or Final Study Report section.

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Option 2: Identifying as Processor for the Test Order

1. Select the Processor radio button.

2. Select the Fees Certification that applies to your company.

3. Click [Next] to continue.

4. To complete the submission, navigate to the Submitting a Response, Draft Study Plan,
Final Study Plan or Final Study Report section.

Option 3: Identifying as Both for the Test Order

1. S el ect the B oth radi o button.

2. Select the Fees Certification that applies to your company.

3. Click [Next] to continue.

4. To complete the submission, navigate to the Submitting a Response, Draft Study Plan,
Final Study Plan or Final Study Report section.

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 Identification Response in the CDX portal so that
EPA can evaluate the claim.

To claim Not Subject to Test Order:

1. Select "Claim that You Are Not Subject to Test Order" as your Order Response Option.

CSPP Home Submissions Section 4 Orders User Management X Brooke Piaisance, Primary Authorized Official (CGI BP)

Claim that You Are Not Subject to Test Order

Attachment

File Name

Document "type _ ,
Date

CBI

Action

Nothing found to display.

©Attach Document

2. Click the blue [Attach Document] link.

3. Select [Not Subject to Order] as the Document Type.

4. If the attachment has CBI, indicate this, and upload a sanitized document as well.

5. If no documents are uploaded, validation errors will prevent the user from moving forward.

6. Click [Next] to continue.

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7. To complete the submission, navigate to the Submitting a Response, Draft Study Plan,
Final Study Plan or Final Study Report section.

8. Once the Identification Response is completed, the Current Action on the Section 4 Orders
page should populate as Submit Initial Response.

Step 2. Individual Initial Response to the Test Orders

Manufacturers have four 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 tests required will display based on your Identification Response. If your
Identification 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 required test(s). You can:

a. Develop Information

b. Submit Existing Information

c. Request an Exemption

d. Join a Consortium

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.

A Section 4 Test Orders

Order Number - TO-2021-0423-
052519-01 -A

|j iniiidi Response To OldCf

|i Octanol Solubility OCCD 10b with EFWinoditicdtioi
b vvaiei Solubility ¦ OLCU 10b wiui U'A mixJilKJdUoiis
|i Paiocuidtes Net otnwwise Keguidteu Resptiable -
NIOSH 0600
' 2 Contact information

— |j Technical Contact Information
-1) Submitting Official Information

27_prepubcopy_tsca-fees-finalrule.pdf.

Chemical Information

Chemical Substance Identifier:

Chemical Substance Na
Chemical Group:
Chemical Category:
Alternate Names:

O Add Alternate Name

le (Regulatory Name):

at https://www.epa gov/sites/productionffiles/2018-09/documents/2018-09-

Test Response Information

Click the drop down menu arrow next to each

le to view a listing of the attached test documents.

Octanol Solubility - OECO 105 with EPA modifications (Select Response Type) 0
Water Solubility - OECD 105 with EPA modifications (Select Response Type) 0
Particulates Not Otherwise Regulated, Respirable - NIOSH 0600 (Select Response Type) 0

Select...

Develop Information
Submit Existing Information
Request an Exemption
Join Consortium

Study Plan Deadline Study Report Deadline

04-20-2021 04-20-2021

Status

Not Started

-------
CDXr

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 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:

Octanol Solubility - OECD 105 with EPA modifications Response

Order Information

Order Number:	TO-2021-0423-052519-01-A	Initial Response Deadline:	07-19-2021

Docket Number:	EPA-HQ-OPPT-2021-0423	Effective Date of Order:	04-20-2021

Title of Action:	users

Test Information

Octanol Solubility - OECD 105
with EPA modifications

Test Response:

Develop Information Change Response

Octanol Solubility - OECD 105 with EPA modifications Response Documents

File Name	Document Type	Attachment Date	CBI	Action

Nothing found to display.

O Attach Document
Previous I

2. Click [Attach Document]

© 2021 CGI Federal

20	EPA TO 47QFCA-18-F-0009

-------
CDX,

- Document Type:

Please select a document type.

Nothing selected

Other

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.

-	Document Type:

Please select a document type.

Other

-	Other Document Type Description:

DI claim the attachment as CBI.

-	Upload New Document:

I

- Sanitized Document Upload (will write over previously attached Sanitized file if present):

Attachments containing CBI data require a sanitized copy of the attachment not containing any CBI data.

d. Click the [OK] button to continue.

21

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CDX,

Test Information

Octanol Solubility - OECD 105
with EPA modifications

Test Response:

Develop Information Change Response

Octanol Solubility - OECD 105 with EPA modifications Response Documents

File Name
correct_epmn.pdf

O Attach Document

Document "Type

Other - test

Attachment Date

04-26-2021

CBI

N

Action
X

3.	Click [Next] to continue.

4.	To complete the submission, navigate to the Submitting a Response, Draft Study Plan,
Final Study Plan or Final Study Report section.

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 Identification 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.

1. To Submit Existing Information:

Water Solubility - OECD 105 with EPA modifications Response

Order Information

Order Number:
Docket Number:
Title of Action:

TO-2021-0423-052519-01-A
EPA-HQ-OPPT-2021-0423

Initial Response Deadline:
Effective Date of Order:

07-19-2021
04-20-2021

Test Information

Water Solubility - OECD 105 with Test Response:
EPA modifications

Submit Existing Information Change Response

Water Solubility - OECD 105 with EPA modifications Response Documents

File Name	Document "type	Attachment Date	CBI	Action

Nothing found to display.

O Attach Document

22

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CDXr

2. Click the blue [Attach Document] link

Upload Existing Information Document

- Document Type:

Please select a document type.



nng selected

Study Report
Rationale Document
Other

3. To attach a Study Report:

Upload Existing Information Document



• Document fypt:

Ptease sefccl a document type.

Stuoy Report

~ I claim the attachment as CBI.
- Upload New Document:

Date Study Completed:

Study Report Title:

Is Study Pubiisnec?

Q Ves 'f i Iste

Test Guideline Nurnber|s|:

Flease select

Chemical Titled

CA SRN'ACCitllOfi

Authors) or Study:

0-oJ

Search SRS

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.

23

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CDX,

b. If the attachment has CBI, indicate this, and upload a sanitized document as well. Note
that although only one row with the CBI document will display on the table, both the
CBI and Sanitized documents are stored in that upload.

Upload Existing Information Document

- Document "Type:

Please select a document type.

Rationale Document

~ I claim the attachment as CBI.
- Upload New Document:



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 proceed until the appropriate documents are uploaded for each
section.

Water Solubility - OECD 105 with EPA modifications Response Documents

Document lype	Attachment Date	CBI	Action

File Name

Nothing found to display.

©Attach Document

0 At least one Rationale document must be uploaded.
O At least one Study Report document must be uploaded.

Previous

5.	When the correct documents have been uploaded, click [Next] to continue.

6.	To complete the submission, navigate to the Submitting a Response, Draft Study Plan,
Final Study Plan or Final Study Report section.

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)).

1. To submit a Request an Exemption:

24

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CDX-

Test Information

Particulates Not Otherwise	Test Response:	Request an Exemption Change Response

Regulated, Respirable - NIOSH

0600

Exemption Reason

O Information has been submitted on an equivalent chemical and submission of information by the exemption applicant would be duplicative of information which has been submitted to the Administrator
O Information is being developed on an equivalent chemical in accordance with a rule, order, or consent agreement under TSCA section 4(a), and submission of information by the exemption applicant would be duplicative of
information which is being developed in accordance with such rule, order, or consent agreement.

Particulates Not Otherwise Regulated, Respirable - NIOSH 0600 Response Documents

File Name	Document Type	Attachment Date	CBI	Action

Nothing found to display.

O Attach Document

2.	Click the appropriate radio button that coincides with the correct Exemption Reason

3.	Click the blue [Attach Document] link.

- Document Type:

Please select a document type

Nothing selected

Rationale Document

Statement of Financial Responsibility

Other

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.

Exemption Reason

O Information has been submitted on an equivalent chemical and submission of information by the exemption applicant would be duplicative of information which has been submitted to the Administrator.

 Information is being developed on an equivalent chemical in accordance with a rule, order, or consent agreement under TSCA section 4(a), and submission of information by the exemption applicant would be duplicative of

information which is being developed in accordance with such rule, order, or consent agreement.

Particulates Not Otherwise Regulated, Respirable - NIOSH 0600 Response Documents

File Name	Document Type	Attachment Date	CBI	Action

Nothing found to display

O Attach Document

O At least one Rationale document must be uploaded

O At least one Statement of Financial Responsibility document must be uploaded.

25

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Exemption Reason

# Information has been submitted on an equivalent chemical and submission of information by the exemption applicant would be duplicative of information which has been submitted to the Administrator.

O Information is being developed on an equivalent chemical in accordance with a rule, order, or consent agreement under TSCA section 4(a), and submission of information by the exemption applicant would be duplicative of
information which is being developed in accordance with such rule, order, or consent agreement.

Particulates Not Otherwise Regulated, Respirable - NIOSH 0600 Response Documents

File Name
gencoms.html
8(d) Health &

Safety.pdf

O Attach Document
Previous~| I

4.	Click [Next] to continue.

5.	To complete the submission, navigate to the Submitting a Response, Draft Study Plan,
Final Study Plan or Final Study Report section.

Option 4: 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.

Document Type	Attachment Date	CBl	Action

Rationale Document	04-26-2021	N	X

statement or Financial	N

Responsibility

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CDXr

1.	To submit a response as Join Consortium:

2.	Select "Join Consortium" as your Order Response Option.

Order Information

07-19-2021
04-20-2021

8-18-2021
10-17-2021
2-18-2023

Order Number:	TO-2021 -0423-052519-01 -A	Initial Response Deadline:

Docket Number:	EPA-HQ-OPPT-2021-0423	Effective Date of Order:

Title of Action:	users	Consortium Initial Response Deadline:

Consortium Study Plan Deadline:
Consortium Study Report Deadline:

Test Information

Test Name:	Octanol Solubility - OECD 105	Test Response:	Join Consortium Change Response

with EPA modifications

~ I claim my organization's membership in this consortium CBI

Octanol Solubility - OECD 105 with EPA modifications Response Documents

File Name	Document Type	Attachment Date	CBI	Action

Nothing found to display.

O Attach Document
Previous I

1. In Test Information, click the checkbox to claim membership in the Consortium as CBI.

Test Information

Test Name:	Octanol Solubility - OECD 105	Test Response:	Join Consortium Change Response

with EPA modifications

QI claim my organization's membership in this consortium CBI	~ I wish to receive emails related to my consortium's submissions

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

27

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CDX,

* Document Type:

Please select a document type.

Other



Q

* Other Document Type Description:

test





~ 1 claim the attachment as CBI.





* Upload New Document:









Cancel







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],

3. 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.

Attention

Warning: changing response will clear all previously submitted
information. Press OK to continue

Cancel

4. To complete the submission, navigate to the Submitting a Response, Draft Study Plan,
Final Study Plan or Final Study Report section.

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a. Creating a Consortium Initial Response to Order (Consortium Lead)

After submitting the Individual Initial Response for the company, if you are the Consortium
Lead, select [Consortium Initial Response to Order] and 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)

Submission Type:

Select the submission ty pe and then dick Start New Submission
Consortium Initial Response to Order

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.

CSPP Home Submissions Section 4 Orders User Management

TSCA Section 4

New Passphrase

Confirm Passphrase

A You are responsible for remembering your passphrase!

If you lose or forget your passphrase, you will not be able to access your Section 4 form to print, submit, or make changes.
You will need to complete a new Section 4 form and create a new passphrase for the submission. For security reasons, the
system administrator will not have access to your passphrase and will not be able to retrieve it or reset it.

Cancel

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CDX,

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.

c. For each test, select how you intend to respond to the required test(s). You can:

i. Develop Information

ii. Submit Existing Information

iii. Defer to Recipient

4. Click [Next],

Consortium Initial Response to Order

Consortium Information

Order Number

Consortium Member Name

Action

TO-2021-0526-816084-01-A

CGI FEDERAL

Order Information

Chemical Substance NamefRegulatory Name): Benzene, 1-chloro-4-nitro-
Chemical Substance Identifier 100-00-5

Consortium Initial Response Deadline: 09-22-2021

Test Response Information

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.

Test

Test Response

Status

Study Plan Deadline

Study Report Deadline

OECD 307 Aerobic and Anaerobic Transformation in Soil O

Develop Information

In Progress

11-21-2021

03-25-2023

OECD 302B Inherent Biodegradability: Zahn-Wellens/EVPATest 0

Develop Information

In Progress

11-21-2021

03-25-2023

OECD 314 Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater O

Submit Existing Information *

In Progress

11-21-2021

03-25-2023

Option 1: If Submitting 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.

-------
CDX,

* Document Type:

Please select a document type.

Study Report

~ I claim the attachment as CBI.
* Upload New Document:

* Date Study Completed: Q

Study Report Title:

Is Study Published?

O Yes ® No

Chemical Tested

CASRN/Accession

Test Guideline Number(s):

Please select...

Author(s) of Study:

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.

Upload Existing Information Document

* Document Type:

Please select a document type.

a

Rationale Document

~ I claim the attachment as CBI.
* Upload New Document:

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.

31

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CDX.

Upload Existing Information Document

* Document Type:

Please select a document type.

* Other Document Type Description:

~ I claim the attachment as CBI.
* Upload New Document:

5.	Once all Test Responses are completed, click [Next].

6.	To complete the submission, navigate to the Submitting a Response, Draft Study Plan,
Final Study Plan or Final Study Report section.

7.	Once the form has processed and migrated, the Current Action will become Submit Draft
Study Plan.

Option 2: If Developing 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.

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Consortium Information

OECD 307 Aerobic and Anaerobic Transformation in Soil Response

Consortium Name:

TESTING CONSORTIUM

Consortium Initial Response Deadline:

Test Information

OECD 307 Aerobic and Anaerobic
Transformation in Soil

Develop Information Change Response

OECD 307 Aerobic and Anaerobic Transformation in Soil Response Documents

File Name Document Type Attachment Date CBI

Nothing found to display.

O Attach Document

1. To complete the submission, navigate to the Submitting a Response, Draft Study Plan,
Final Study Plan or Final Study Report section.

Option 3: If Defer to Recipient

1. If the test required is not a test your consortium will provide documentation for, please
defer the applicable test to the Individual Company so they can provide the test
information.

2. Choose Defer to Recipient, navigating to the Test Response will offer the choice to
Change Response or Attach Document for deferring 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.

-------
CDX,

5. Submit Draft and Final Study Plan and Final Study Report

Step 1: Submitting a Draft Study Plan

If you choose to develop the required information to comply with the Order, you must obtain and
review the required protocols/methodologies. You may not modify the required
protocols/methodologies unless you first consult with the Agency and obtain Agency approval of
any planned modification prior to submitting your initial study plan. The draft study plan is due to
the Agency 80 days after the effective date of the Order.

The Draft Study Plan must contain the following information:

1. The Order number, excluding the unique 6-digit company number so as to protect each
company's private access to the reporting module via Central Data Exchange
(https://www.epa.gov/sites/production/files/2021-

01/documents/cdx user guide faq page includes breaks.pdf). This should look similar
to the following example with Xs used in place of the unique company number: TO-2020-
OOOO-XXXXXX-OO-O. The remainder of the Order number should be identical to the
number received with the Order.

2. Name of test to be covered by the test protocol/methodology.

3. The name/number of the protocol/methodology identified by Table 1.1 in the Order which
you intend to follow, or a copy of the identified protocol/methodology with your
modifications that the EPA has approved, or a copy of the protocol/methodology you
requested to use which EPA has approved. If approval for the identified
protocol/methodology with your modifications or the use of a protocol/methodology you
requested to use is not granted by EPA in time to be included in the study plan, they must
be referenced as "submitted and pending approval" and the final protocol/methodology
submitted later, once approved, in final form in an amended study plan.

4. The rationale for any modification, or pending modification, of the identified
protocol/methodology. The rationales do not have to be listed in a separate document in
the study plan if they are included and clearly identified in the relevant
protocol s/methodol ogi es.

5. The identity and supporting data on the chemical substance to be tested including physical
constants, spectral and chromatographic data, chemical analysis, and stability under test
and storage, and test conditions required by the protocol. Per the respective protocol, the
purity and Certificate of Analysis of the test substance should be included.

6. The sampling and analytical method that will be used, including whether the sampling
method was validated by an approved organization (e.g., NIOSH, OSHA, the American
Society for Testing and Materials (ASTM), the International Standards Organization (ISO)
) or an industrial hygiene/analytical laboratory.

-------
CDX,

7.	For dermal exposure monitoring, the procedures used to optimize collection efficiency and
extraction of the test chemical to ensure that 60% to 125% of the test chemical will be
analyzed using the analytical method identified.

8.	A description of the preparation and processing of samples that will be done before
sampling and during sampling, including equilibration, weighing, calibration, test
conditions (temperature, humidity), number and type of samples, and identification of
equipment and accessories used (make, model, size/capacity, and operating conditions),
including the specific sampling media and sampling instruments that will be used.

9.	The sampling strategy that will be used for sample collection, including sample location,
flow rates, sampling time, field blanks and sample replication; the sample handling, storage
and transport procedures and whether they will be followed; the sample pumps and other
instruments and whether they will be properly calibrated with primary standard equipment.

10.	For exposure-related testing, the number of samples to be taken for each similar exposure
group, and how the workers or others will be selected for sampling (e.g., random sampling,
select workers with highest likelihood of exposure or some other statistically valid
sampling strategy, and other relevant information suggested by the American Industrial
Hygiene Association (AIHA)2). Also include the number of samples and length of
sampling periods that will be taken to ensure the results are statistically significant for
worker and ONU exposure groups, and indicate the statistical method used to demonstrate
that the number of samples and length are statistically significant. A list must be included
to contain all job descriptions/titles and work activities where workers and ONUs may be
exposed and the total number of workers and ONUs per shift and number of shifts per day,
length of shifts, length of shifts if not full, number of operating days/year for job
description/title or work activities, and information on industrial hygiene (IH) programs
(e.g., respirator testing program).

11.	The specific number of quality assurance field samples (including sample volume for limits
of detection and quantification) and analytical QA/QC protocols to be followed (e.g.,
specific number of field blanks, replicates of field samples, and replicate samples). NIOSH
95-117 (Kennedy et al., 1995) provides guideline for sampling and analytical method
development and evaluation.

12.	The rationale for any combination of protocols/methodologies; the rationale for
species/strain selection, dose selection (and supporting data), and route or method of
exposure; description of diet to be used and its source (including nutrients and
contaminants and their concentration); for in-vitro and/or ex-vivo test systems, a

2 The strategy for assessing occupational exposures recommended by the AIHA for successful evaluation include the
following: a) collecting information and data to characterize the project site (or facility), process, operations, work
force, and enviromnent; b) defining similar exposure groups by process, task, enviromnent, and engineering
controls; c) developing exposure profile (e.g., by assigning qualitative ratings on exposure, health effects, and
uncertainty to each similar exposure groups); d) determine the acceptability of exposure and need for additional
exposure monitoring; and e) re-assess the exposure profiles and data collection, as needed (AIHA, 2015).

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description of culture medium and its source; and a summary of expected spontaneous
chronic diseases (including tumors), genealogy, and life span.

13. The name(s) and address(es) of the company(ies) sponsoring the test and whether they
comprise a testing consortium.

14. The names, mailing addresses, phone numbers, and e-mail addresses of the appropriate
individual(s) for EPA to contact concerning the planned test.

15. The name of the testing facility and the names, mailing addresses, telephone numbers, and
email addresses of the testing facility's administrative officials, study director/project
managers and quality control officer responsible for ensuring the testing protocol follows
appropriate quality assurance and quality control procedures.

16. Description of data and results that contain data supporting information that facilitate
quality review of the results, e.g., facility process descriptions, operation and process
parameters, sampling and monitoring parameters, sample populations, job description/title
and the number of workers for each job description or activity and the total daily duration
of exposure, engineering controls (e.g. local exhaust ventilation), room volume, air
exchange rates, air changes per hour of work area, ventilation rates, air speeds, work
practices, and personal protective equipment used.

Prior to initiating any test, the Company/Consortium must first address EPA's input on the initial
study plan and receive EPA's acceptance of the final study plan. EPA's acceptance of a final study
plan does not constitute pre-acceptance of any future test results.

All testing must follow the EPA accepted final study plan. If problems occur during testing, the
Company/Consortium must request EPA's approval before modifying the accepted final study
plan.

You must also secure EPA's approval prior to submitting the initial study plan, if you wish to use
a protocol/methodology not listed in the Order. Within your initial study plan, you must submit a
detailed description of the protocol/methodology you are requesting to use or your requested
modifications of the required protocol/methodology and your reason(s) for using a different or
modified protocol/methodology. Indicate whether and how the requested protocol/methodology is
appropriate and whether its deviations from the protocol/methodology required by the Order are
such that they could alter the validity of the study. If EPA has concerns about the requested
protocol/methodology or your requested modifications of the required protocol/methodology, the
Agency will inform you of concerns that must be addressed before EPA will approve your request.
If testing conducted according to a requested protocol/methodology or requested modifications of
the required protocol/methodology is initiated prior to EPA approval, that testing will not satisfy
the requirements of the Company under the Order. Development of information required by its
Order, which does not fully comply with the terms of the Order, may result in a violation of TSCA
section 15.

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CDX,

EPA has identified the protocols/methodologies that must be followed to perform each required
test. They are listed in Table 1.1 and may include protocols/methodologies (also known as test
guidelines) from OECD or OCSPP/OPPTS. These protocols/methodologies are available via the
Internet. It is highly recommended that your final test report be submitted along with the data in
the associated OECD harmonized template format which can be located at
https://www.oecd.org/ehs/templates/harmonised-templates.htmr1. If questions and /or issues arise
during Study Plan development, EPA encourages consultation with the Agency prior to submitting
the Study Plan.

If, after the study plan has been submitted or after testing is underway, you need to make a
modification to an identified protocol/methodology or need to use a different
protocol/methodology, you must submit a request to EPA.

For purposes of satisfying the requirements of the Order, you are required to follow the Good
Laboratory Practice (GLP) standards described in 40 CFR part 792, as specified in the CFR on the
day the Order is signed. You are also required to provide a statement of compliance with these
GLP standards when submitting information to EPA pursuant to the Order.

After the 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 Plan 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 https://www.oecd.org/ehs/templates/harmonised-templates.htm.

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CDXr

CSPP Home Submissions Section 4 Orders User Management

TSCA Section 4

New Passphrase
Confirm Passphrase

A You are responsible for remembering your passphrase!

if you lose or forget your passphrase, you will not be able to access your Section 4 form to print, submit, or make changes.
You will need to complete a new Section 4 form and create a new passphrase for the submission. For security reasons, the
system administrator will not have access to your passphrase and will not be able to retrieve it or reset it.

Cancel

3. Click the blue Attach Study Plan Document link.

Test Order Study Plan

Order Information - TO-8088-1565-307458-01 -A

Title of Action:	learning

Docket Number:

EPA-HQ-OPPT-8088-1565

Chemical Information

Chemical Substance Identifier:

Chemical Substance Name
(Regulatory Name):

67875-37-0

1,6-Hexanediamine, N1-(6-aminohexyl)-, homopolymer

Chemical Group:

Work Plan Chemicals
TRI Chemicals List

Chemical Category:

Cinnamyl Derivatives Category
Higher Olefins Category
Peroxides

Substituted Diphenylamines Category

Study Plan Documents

O Attach Study Plan Document

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.

OECD 316 Phototransformation of Chemicals in Water - Direct Photolysis 0

Study Plan
Deadline

Study Report

Deadline	Status

38

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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CDX,

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],

39

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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CDX-

Upload Study Plan Document

*	Associate Document to Tests:

OECD 316 Phototransformation o*

~ I claim the attachment as CBl.

*	Document "type

Please select a document type... -





Please select a document type ...

Study Plan

Modification

Correspondence

Study Plan - OHT Template File

1 Browse





Cancel

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

Study Plan Documents

O Attach Study Plan Document

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.

Test

OECD 316 Phototransformation of Chemicals in Water - Direct Photolysis O
O All Tests must have at least one Study Plan document uploaded.

Study Plan
Deadline

Study Report
Deadline

Status

Not Started

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.

Study Plan Documents

O Attach Study Plan Document

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.

OECD 316 Phototransformation of Chemicals in Water - Direct Photolysis 0

File Name	Document Type	Attachment Date	CBI Action

Study Plan
Deadline

Study Report

Deadline	Status

03/31/2021	Passes Validation

5.	Click [Next] to continue.

6.	To complete the submission, navigate to the Submitting a Response section.

40

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EPA TO 47QFCA-18-F-0009

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Step 2: Submitting a Final Study Plan

The final study plan is due to the Agency 110 days after the effective date of the Order.

The Final Study Plan must contain the following information:

1.	The Order number, excluding the unique 6-digit company number so as to protect each
company's private access to the reporting module via Central Data Exchange
(https://www.epa.gov/sites/production/files/2021-

01/documents/cdx user guide faq page includes breaks.pdf). This should look similar
to the following example with Xs used in place of the unique company number: TO-2020-
OOOO-XXXXXX-OO-O. The remainder of the Order number should be identical to the
number received with the Order.

2.	Name of test to be covered by the test protocol/methodology.

3.	The name/number of the protocol/methodology identified by Table 1.1 in the Order which
you intend to follow, or a copy of the identified protocol/methodology with your
modifications that the EPA has approved, or a copy of the protocol/methodology you
requested to use which EPA has approved. If approval for the identified
protocol/methodology with your modifications or the use of a protocol/methodology you
requested to use is not granted by EPA in time to be included in the study plan, they must
be referenced as "submitted and pending approval" and the final protocol/methodology
submitted later, once approved, in final form in an amended study plan.

4.	The rationale for any modification, or pending modification, of the identified
protocol/methodology. The rationales do not have to be listed in a separate document in
the study plan if they are included and clearly identified in the relevant
protocol s/methodol ogi es.

5.	The identity and supporting data on the chemical substance to be tested including physical
constants, spectral and chromatographic data, chemical analysis, and stability under test
and storage, and test conditions required by the protocol. Per the respective protocol, the
purity and Certificate of Analysis of the test substance should be included.

6.	The sampling and analytical method that will be used, including whether the sampling
method was validated by an approved organization (e.g., NIOSH, OSHA, the American
Society for Testing and Materials (ASTM), the International Standards Organization
(ISO)) or an industrial hygiene/analytical laboratory.

7.	For dermal exposure monitoring, the procedures used to optimize collection efficiency and
extraction of the test chemical to ensure that 60% to 125% of the test chemical will be
analyzed using the analytical method identified.

8.	A description of the preparation and processing of samples that will be done before
sampling and during sampling, including equilibration, weighing, calibration, test
conditions (temperature, humidity), number and type of samples, and identification of

41

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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equipment and accessories used (make, model, size/capacity, and operating conditions),
including the specific sampling media and sampling instalments that will be used.

9.	The sampling strategy that will be used for sample collection, including sample location,
flow rates, sampling time, field blanks and sample replication; the sample handling, storage
and transport procedures and whether they will be followed; the sample pumps and other
instruments and whether they will be properly calibrated with primary standard equipment.

10.	For exposure-related testing, the number of samples to be taken for each similar exposure
group, and how the workers or others will be selected for sampling (e.g., random sampling,
select workers with highest likelihood of exposure or some other statistically valid
sampling strategy, and other relevant information suggested by the American Industrial
Hygiene Association (AIHA)4). Also include the number of samples and length of
sampling periods that will be taken to ensure the results are statistically significant for
worker and ONU exposure groups, and indicate the statistical method used to demonstrate
that the number of samples and length are statistically significant. A list must be included
to contain all job descriptions/titles and work activities where workers and ONUs may be
exposed and the total number of workers and ONUs per shift and number of shifts per day,
length of shifts, length of shifts if not full, number of operating days/year for job
description/title or work activities, and information on industrial hygiene (IH) programs
(e.g., respirator testing program).

11.	The specific number of quality assurance field samples (including sample volume for limits
of detection and quantification) and analytical QA/QC protocols to be followed (e.g.,
specific number of field blanks, replicates of field samples, and replicate samples). NIOSH
95-117 (Kennedy et al., 1995) provides guideline for sampling and analytical method
development and evaluation.

12.	The rationale for any combination of protocols/methodologies; the rationale for
species/strain selection, dose selection (and supporting data), and route or method of
exposure; description of diet to be used and its source (including nutrients and
contaminants and their concentration); for in-vitro and/or ex-vivo test systems, a
description of culture medium and its source; and a summary of expected spontaneous
chronic diseases (including tumors), genealogy, and life span.

13.	The name(s) and address(es) of the company(ies) sponsoring the test and whether they
comprise a testing consortium.

14.	The names, mailing addresses, phone numbers, and e-mail addresses of the appropriate
individual(s) for EPA to contact concerning the planned test.

4 The strategy for assessing occupational exposures recommended by the AIHA for successful evaluation include the
following: a) collecting information and data to characterize the project site (or facility), process, operations, work
force, and enviromnent; b) defining similar exposure groups by process, task, enviromnent, and engineering
controls; c) developing exposure profile (e.g., by assigning qualitative ratings on exposure, health effects, and
uncertainty to each similar exposure groups); d) determine the acceptability of exposure and need for additional
exposure monitoring; and e) re-assess the exposure profiles and data collection, as needed (AIHA, 2015).

42

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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All testing must follow the EPA accepted final study plan. If problems occur during testing, the
Company/Consortium must request EPA's approval before modifying the accepted final study
plan.

You must also secure EPA's approval prior to submitting the initial study plan if you wish to use
a protocol/methodology not listed in the Order. Within your initial study plan, you must submit a
detailed description of the protocol/methodology you are requesting to use or your requested
modifications of the required protocol/methodology and your reason(s) for using a different or
modified protocol/methodology. Indicate whether and how the requested protocol/methodology is
appropriate and whether its deviations from the protocol/methodology required by the Order are
such that they could alter the validity of the study. If EPA has concerns about the requested
protocol/methodology or your requested modifications of the required protocol/methodology, the
Agency will inform you of concerns that must be addressed before EPA will approve your request.
If testing conducted according to a requested protocol/methodology or requested modifications of
the required protocol/methodology is initiated prior to EPA approval, that testing will not satisfy
the requirements of the Company under the Order. Development of information required by its
Order, which does not fully comply with the terms of the Order, may result in a violation of TSCA
section 15.

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CDX,

https:/Avww.oecd.org/ehs/templates/harmonised-templates.htm5. If questions and /or issues arise
during Study Plan development, EPA encourages consultation with the Agency prior to submitting
the Study Plan.

After the Draft Study Plan has been submitted (Step 4a), the next action is to submit a Final
Study Plan.

1. On the Home page, click the blue link Submit Final Study Plan 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.

CSPP Home Submissions Section 4 Orders User Management

TSCA Section 4

New Passphrase

Confirm Passphrase

A You are responsible for remembering your passphrase!

if you lose or forget your passphrase, you will not be able to access your Section 4 form to print, submit, or mate changes.
You will need to complete a new Section 4 form and create a new passphrase for the submission. For security reasons, the
system administrator will not have access to your passphrase and will not be able to retrieve it or reset it.

Cancel

https://www.oecd.org/ehs/templates/harmonised-templates.htm.

-------
CDX-

3. Click the blue Attach Study Plan Document link.

Test Order Study Plan

Order Information - TO-8088-1565-307458-01 -A

Title of Action:	learning	Docket Number:

EPA-HQ-OPPT-8088-1565

Chemical Information

Chemical Substance Identifier: 67875-37-0

1.6-Hexanediamine, Nl-(6-aminohexyl)-, homopolymer

Chemical Substance Name
(Regulatory Name):

Work Plan Chemicals
TRI Chemicals List

Chemical Category:

Cinnamyl Derivatives Category
Higher Olefins Category
Peroxides

Substituted Diphenylamines Category

Study Plan Documents

O Attach Study Plan Document

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.

OECD 316 Phototransformation of Chemicals in Water - Direct Photolysis 0

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

Study Plan
Deadline

Study Report
Deadline

Upload Study Plan Document

-	Associate Document to Tests:

Nothing selected

~ I claim the attachment as CBI.

-	Document Type

Please select a document type ...

* Document Upload



Cancel

a. The dropdown menu will list options applicable to the test(s) associated with the
documents.

45

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

-------
CDX,

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],

Upload Study Plan Document

*	Associate Document to Tests:

OECD 316 Pfiototransformation o' ~

~ I claim the attachment as CBI.

*	Document "type

Please select a document type ... "•

|[ Please select a document type . .. ||
Study Plan
Modification
Correspondence
Study Plan - OHT Template File



Browse

Cancel

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

Study Plan Documents

O Attach Study Plan Document

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.
Test

OECD 316 Phototransformation of Chemicals in Water - Direct Photolysis 0
O All Tests must have at least one Study Plan document uploaded.

Study Plan
Deadline

Study Report
Deadline

Status

Not Started

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.

46

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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CDX,

Study Plan Documents

O Attach Study Plan Document

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.

OECD 316 Phototransformation of Chemicals in Water - Direct Photolysis 0

File Name	Document lype	Attachment Date	CBI Action

Sec4.docx	Study Plan	04-26-2021	N X

Study Plan	Study Report

Deadline	Deadline	Status

Passes Validation

5.	Click [Next] to continue.

6.	To complete the submission, navigate to the Submitting a Response section.

47

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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CDX-

Step 3: Submitting a Final Study Report

4. 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.

TO-1565-1654-233703-01 -A 0

Submission Type

Submit Study Report

Submission Status

Submission Date

04-20-2021

5. 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.

CSPP Home Submissions Section 4 Orders User Management

TSCA Section 4

New Passphrase
Confirm Passphrase

A You are responsible for remembering your passphrase!

If you lose or forget your passphrase, you will not be able to access your Section 4 form to print, submit or make changes.
You will need to complete a new Section 4 form and create a new passphrase for the submission. For security reasons, the
system administrator will not have access to your passphrase and will not be able to retrieve it or reset it.

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

Test Order Study Report

Order Information - T0-1565-1654-233703-01-A

:Pft-t3CPPT-S6M5H

Chemical Information

cneroical Substance SO-KM

Chemical Substance Kame f-crmaterra:
|Regul»oi> Name);

Ctean VGter Ac (C'WA) irony Pctuan
CfcanAr.»£! -azs rcojiAr PohranK
HI**1 Cietncas Lsi

saerctspica ingrcflEtiti Le

ten Cnetnca Suteta-csiw nte Rffit Evsuanr

uMBfTBCA

mi ciem casus:

rscA§i2;bl Boot Nrihcstoi CIkt ca's List
Milk 3t3i Cnemtas

A urate Honoes® rs Calory
Ate«f5ian«

AfcylAXfatK CS - C'3 CotB JDT/

ARyi AJtcltMs C6-CtJ Caiegoiy

AW! CWiht#i c««e ;;

Vttter SMiKHv - ceco 10S -«tn EPA mrtKittms B
WDSH1 x>3' ttytccartwos, racgensxtf 1C03 0

a isira o*mc 5fla:n»3 tea txtrcrrr,

32126.5021
:th ¦jaor.n
32>2a5C21

48 EPA TO 47QFCA-18-F-0009

-------
CDX,

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.

Upload Study Report Document

¦ Associate Document to Tests:

Octanol Solubility - OECD 105 witl -

~ I claim the attachment as CBI.
* Document Type

a

Please select a document type ...
Study Report

Study Plan - OHT Template File
Other

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

Study Report Documents

O Attach Study Report Document
Click the drop down menu arrow ne>

Octanol Solubility - OECD 105 with EPA modifications 0
Water Solubility - OECD 105 with EPA modifications 0
Particulates Not Otherwise Regulated, Respirable - NIOSH 0600 0
NIOSH 1003* Hydrocarbons, halogenated 1003 0

Study Report Deadline

02/28/2021
02/28/2021
02/28/2021
02/28/2021

Status

Not Started
Not Started
Not Started
Not Started

le Study Report document uploaded.

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

Octanol Solubility - OECD 105 witl -

~ l claim the attachment as CBI.

-	Document Type

Study Report

-	Document Upload

- Date Study Completed:	H

• Study Report Title:

Chemical "tested

CASRN/Accession

a. If the attachment has CBI, indicate this. Click [OK] to continue.

49

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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CDX,

7. When the documents have been successfully uploaded, the Status will change to Passes
Validation. Click [Next] to continue.

Study Report Documents

O Attach Study Report Document

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.

Octanol Solubility - OECD 105 with EPA modifications 0
Water Solubility - OECD 105 with EPA modifications 0
Particulates Not Otherwise Regulated, Respirable - NIOSH 0600 0
NIOSH 1003" Hydrocarbons, halogenated 1003 0

Study Report Deadline

02/28/2021
02/28/2021
02/28/2021
02/28/2021

Status

Passes Validation
Passes Validation
Passes Validation
Passes Validation

8.	To complete the submission, navigate to the Submitting a Response section.

9.	When all submissions are completed, you will be able to download or unlock to edit the
document from the main queue.

TO-8O88-1565-393116-O1-A0	Submit Study Report

Submission Type

individual Initial Response To Order
Study Plan
Study Report

Submission Status

Completed
Completed
Completed

N/A

Submission Date

02-24-2021

03-03-2021
03-03-2021

Action

+ S
~ I
+ i

50

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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CDXr

6. Submitting an Extension Request

Should EPA fail to respond within 15 days, an automatic extension will be provided only to
those deadlines for submissions that were received by the original specified deadline.

6.1 Extension Request for the Identification Response

1. Click the [Submission Type] dropdown menu to select the Identification Response
submission type and click [Start New Submission] to prepare the form. All companies
receiving a Test Order must complete this step regardless of how they intend to respond to
the order (e.g., Joining a Consortium).

CSPP Home Submissions Section 4 Orders User Management

A, Brooke Plaisance, Primary Authorized Official (CGI BP)

To download a Copy of Record, click on the plus (+) in the 'Order/Consortium Number* column, then click on the green arrow icon (-S-) in the Action column.

To search for entries, use the Search text box above the table. Note: Search will only work for the current page

"After you provide a response to the "Current Action," it can take up to 30 minutes for the display to update for the "Current Action" and "Next Action" columns. Note that upon submitting a "Current Action" response
that you should have received an email confirmation.

Search:

Items Per Page: 25 v]

6 items found. Page 1 of 1

Order/Consortium Number Last Action Current Action Current Action Due Date Next Action Next Action Due Date Delete

+ TO-1234-9876-791614-01-A Final Study Plan Submit Study Report 11/11/2021 33 N/A N/A

+ TO-2021-1008-307895-01-A N/A Submit Initial Response 11/06/2021 ]! Submit Study Plan 12/27/2021 X

+ TO-8878-9876-485648-01-A Identification Response Submit Draft Study Plan 01/30/2022 §3| Submit Final Study Plan 11/18/2021 X

+ TO-7777-7777-527723-01-A Identification Response Submit Draft Study Plan 01/30/2022 g§) Submit Final Study Plan 11/12/2021 X

+ TO-8798-4897-981494-01-A N/A Submit Identification Response 12/12/2021 g| Submit Draft Study Plan 01/31/2022 X

+ TO-8648-8648-659742-01-A Identification Response Submit Draft Study Plan 01/30/2022]! Submit Final Study Plan 11/17/2022 X

Export options: £l CSV | Kl Excel | Q XML | H PDF

Select the submission type and then click Start New Submission
Submission Type:

Start New Submission

Select the submission type and then click Start New Submission

Submission Type: Identification Response

Start New Submission

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

-------
CDX,

Enter Test Order Number

Order Number:

Cancel

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.

-------
CDXr

CSPP Home Submissions Section 4 Orders User Management

TSCA Section 4

New Passphrase

Confirm Passphrase

A You are responsible for remembering your passphrase!

If you lose or forget your passphrase, you will not be able to access your Section 4 form to print, submit, or make changes.
You will need to complete a new Section 4 form and create a new passphrase for the submission. For security reasons, the
system administrator will not have access to your passphrase and will not be able to retrieve it or reset it.

4. After creating the passphrase, click on the [Save] button on the Manufacturer/Processor
Identification Response page and click on the [Home] tab to return to the home page.

5. Click the calendar icon next to the due date icon next to the due date in the [Current Action
Due Date] column for the Identification Response you are trying to extend.

Order/Consortium Number

+ TO-2021-0401-081025-01-A

+ TO-1 -1-672592-01 -A
+ TO-8523-8523-945519-01-A

Current Action
Submit Initial Response

Sutimn Study Plan

Submit Identification Response

Current Action Due Date -

07/24/2021 U
08/05/20201

02011

ozQl

submit study Plan
Submit Study Report
Submit Initial Response

Next Action Due Date

10/22/2021
08/20/2020

6. 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.

CSPP Home Submissions Section 4 Orders User Management

TSCA Section 4

New Passphrase

Confirm Passphrase

A You are responsible for remembering your passphrase!

7. Attach the Rational Document to justify the request for Extension.

-------
CDX,

Associate Document to Tests:

OECD 316 Ptiototransformation of Chemicals in Water - Direct Photolysis

~ I claim the attachment as CBI.
Document "type

Rationale Document

Rationale

Document Upload

Browse

^ Cancel j

8.	Type in the dates that you are proposing to have as the new deadline. Click [Next] to continue.

9.	To complete the submission, navigate to Step 7: Submitting a Response.

6.2 Extension Request for the Draft and Final Study Plan or Final Study Report

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

Order/Consortium Number

Last Action:

Current Action

Current Action Dy^ate

Next Action

Next Action Due Date

TO-8088-1565-307458-01 -A 0

Initial Response

Submit Study Plan

03/01/202[il

Submit Study Report

03/3112021



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.

54

© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

-------
CDXr

CSPP Home Submissk)ns Section 4 Orders User Management

TSCA Section 4

New Passphrase

Confirm Passphrase

A You are responsible for remembering your passphrase!

If you lose or forget your passphrase, you will not be able to access your Section 4 form to pnnt. submit, or make changes.
You will need to complete a new Section 4 form and create a new passphrase for the submission. For security reasons, the
system administrator will not have access to your passphrase and will not be able to retrieve it or reset it.

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

Extension Request to Order

Order Information

Order Number: TO-8088-1565-307458-01-A

Chemical Substance Name (Regulatory Name): 1,6-Hexanediamine, Nl-(6-aminohexyl)-. homopolymer

Chemical Substance identifier: 67875-37-0 (CASRN)

Selected Tests:

Please select the test(s) for which you would like to request an extension.

| Nothing selected |

I OECD 316 Phototransformatlon of Chemicals in Water - Direct Photolysis

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.

Test Study Plan Deadline Proposed Study Plan Deadline Study Report Deadline

Nothing found to display.

Proposed Study Report Deadline

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

Order Information

Order Number: TO-8088-1565-307458-01-A

Chemical Substance Name (Regulatory Name): 1,6-Hexanediamine, N1-(6-aminohexyl)-, homopolymer
Chemical Substance Identifier: 67875-37-0 (CASRN)

Selected Tests:

Please select the test(s) for which you would like to request an extension.

O Attach Extension Document

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.

OECD 316 Phototransformation of Chemicals in Water - Direct 03-01-2021
Photolysis 0

Proposed Study Plan Deadline

[ |1S

Study Report

Deadline Proposed Study Report Deadline

Status

Not Started

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CDX.

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

Upload Extension Request Document

Associate Document to Tests:

OECD 316 Phototransformation of Chemicals in Water - Direct Photolysis

~ I claim the attachment as CBI.

Document Type



Please select a document typ "





| Please select a document type ... |

1 Rationale Document
Correspondence
Other

1 Browse



b. For a Rationale Document:

Associate Document to Tests:

OECD 316 Phototransformation of Chemicals in Water - Direct Photolysis

~ I claim the attachment as CBI.

Document type

Rationale Document	~

Rationale

Document Upload

Cancel

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© 2021 CGI Federal
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c. For a Correspondence:

Upload Extension Request Document

Associate Document to Tests:

OECD 316 Phototransformation of Chemicals in Water - Direct Photolysis

~ I claim the attachment as CBI.

Document Type

Correspondence ~

Document Upload

Cancel

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.

Order Information

Order Number: TO-8088-1565-307458-01-A

Chemical Substance Name (Regulatory Name): 1,6-Hexanediamine, N1-(6-aminohexyl)-, homopolymer

Chemical Substance Identifier: 67875-37-0 (CASRN)

Selected Tests:

Please select the test(s) for which you would like to request an extension.

OECD 316 Phototransformati»

O Attach Extension Document

Click the drop down menu arrow next to each test name to view a listing of the attached test documents.

Study Plan

Test Deadline

OECD 316 Phototransformation of Chemicals in Water - Direct 03-01-2021
Photolysis 0

Proposed Study Plan Deadline

{05/05/2021 l||

Study Report

Deadline Proposed Study Report Deadline

Status

In Progress

6. To complete the submission, navigate to Step 7: Submitting a Response.

7. When the Extension Request has been completed, it will show in the main queue.

TO-1565-1654-233703-01 -A 0

Submission Type

Study Plan
Extension Request

Submit Study Report

Submission Status

Completed
Completed

Submission Date

04-20-2021

~ fl

• i

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.

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TO-1565-1654-714919-01 -A 0

Submit Initial Response

Submission Type
Individual Initial Response To Order

Submission Status

Completed

Submit Study Plan
Submission Date

02/22/2021

* a

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

TO-1565-1654-614567-01 -A 0

Submission Type
Individual Initial Response To Order
Study Plan
Study Report

Submit Study Report

Submission Status

Completed - Payment Received
Completed - Payment Received
Completed - Payment Received

Submission Date

02-26-2021

a

+13 m

•§-E3a

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

TO-1500-8367-311558-01-A 0	Initial Response

Submission Type
Individual Initial Response To Order

Submission Status

Completed

Submission Date

04-01-2021

*a

8. To complete the submission, navigate to Step 7: Submitting a Response.

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EPA TO 47QFCA-18-F-0009

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7. Submitting a Response, Draft Study Plan, Final Study Plan or
Final Study Report

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

c.	Fill out all required Technical Contact Information denoted by red asterisk or
click [Copy CDX Registration] to fill in with the information from CDX.

d.	If Technical Contact Information is CBI, please check the CBI checkbox.

Technical Contact Information

I<}oo1i»v the technical contact wtw is capable of ansnming questions related to the chemicali's) submitted to EPA within Itus sutwnrssicn Click the "Copy COX Registration' button to copy your information from CDX Registration
cut* nere to copy your tntartrutnn from COX Regivai
CBI ~

•	First Nam*

MKM I* initial
¦ Last Nam*

•	Company Nam#

•	Phone Number

I Ext

Do nc; enter dashes ( '¦ m Phone faumMr field above

-	Email Address

I

-	Mailing Address 1
Mailing Address 2

~	~l

Apartment Kilt*- etc.

•	City

|

-	State

•	Postal Code

- Country

United Stales

e. 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.

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© 2021 CGI Federal
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d. If you are submitting on behalf of another company, indicate that by clicking the
checkbox.

3. Click [Submit] to continue.

Submitting Official Information

The information below has been pre-populated from CDX registration, if the information listed is incorrect please make the appropriate edits to your user information in CDX registration.

~ submitier is CBJ

Prefix:

First Name:
Middle initial:
Last Name:

Job Title:

Company Name:
Phone Number;
Email Address:
Mailing Address 1:
Mailing Address 2:
City:

State:

Postal Code:

Mrs
Jiltiane

C

Conley

jewetstestmg
3374841699
jiiliane.conley@cgi.com
684 wylie Dr

Baton Rouge
LA

70808

This confirmation is required to proceed with the submission process (

- Please confirm that you are the legally responsible party from tne submitting company

~







Please select it you are submitting on behalf of another company ~







j Submit ^

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© 2021 CGI Federal
EPA TO 47QFCA-18-F-0009

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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.

Instructions for Substantiating Confidential Business Information (CBI) Claims

The Frank R lautenberg Chemical Safely tor toe 31st Century Ad created a number of new requirements (or those making confidential business information (C8I) claims In TSCA submissions Among these requirements is an obligation to
substantiate most CBI claims at the tine ot submission

information which may be claimed as CSi wiinout substantiation is «enti«ted at TSCA 14(CX2) Tim mtormasion includes

A Specif* mformanon describing the processes used in manufacture a processing of a chemical substance. mixture or article.

B Marketing and sates Womrwtion.

C Information identifying a suppHer or customer

D In the case of a mtxture. details ofttverm composition o(tne mature and the respective percentages ot constituents
6 Specific ^formation regarding the use function claims and subsequent
public release of information it you hove any questions concerning the options on me substantiation process, please contact

• Scott Shertoc* 202-SG442S7 sneftocti scotiQefNi gov

• Jessica Baitras 202-JSO4M0 banuts 1e-.ir3.tepa gov

If you beaeve aa ot the information you have claimed as CBI Is exempt ttom substantiation under TSCA section UjcK!) Of has been pieviously substantiated select the toaowtng ¦Substantiation Opt Out* checkbox and provide a detailed
explanation why you believe substantiation is not required

iNManWtion Opt-Out

Select a Ma to attach (will write over previously attach

ed file if present):

Check it the Substantiation Document Is CBI:

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

TSCA Certification

I hereby certify to the best of my knowledge and belief that all information entered on this form is complete and accurate.

I further certify that, pursuant to 15 U-S.C. § 2613(c), for all claims for protection for any confidential information made with this submission, all information submitted to substantiate such
claims is true and correct, and that it is true and correct that the person submitting the claim has
i taken reasonable measures to protect the confidentiality of the information;

ii. determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;

iii. a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person; and

iv. a reasonable basis to believe that the information is not readily discoverable through reverse engineering.

Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.

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.

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Validation

No validation errors were found. Click the "PDF Generation" button to continue the submission process

PDF Generation

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

PDF Generation

Click the "Regular PDF" or "Sanitized PDF" button to view a PDF of the Section 4 form.

If you make no CBI claims, the two versions will be the same Please do NOT send a copy of the PDF to the EPA Click the "Sign, Encrypt and Submit" button to complete the submission
process.

Regular PDF I Sanitized PDF I Sign, Encrypt and Submit

7. Click [Accept]

I certify under penalty of law that the information provided ii
this document is, to the best of my knowledge and belief,
true, accurate, and complete. 1 am aware that there are
significant penalties for submitting false information,
including the possibility of fines and imprisonment for
knowing violations.

AcceptlDecline

a. Complete the eSignature Widget.

b. Enter the Authentication Password and enter the Answer to the Verification Question.

c. Click the [Sign] button to complete the submission.

d. Click the [X] in the upper right corner of the eSignature Widget window to cancel the
submission.

eSignature Widget

1. Authentication

Log into CDX
User:

JI LLIANE.COM LEY
Password:

Show Password O

Welcome Jilliane Conley

2. Verification
Question:

What was your high school's mascot?
Answer:

Show Answer LI

Correct Answer

3. Sign File

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Submission Finished

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.

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8. Glossary

Consortia -_Persons that form or join a consortium typically execute an agreement with
the other members of the consortium concerning how costs will be shared and how the
consortium will operate.

Exemptions - Persons that receive exemptions from testing have an obligation to
reimburse the person(s) who perform the testing and submit the required information that
is the basis for the exemption for a portion of the costs incurred in complying with the
requirement to submit such information, and any other person required to contribute to a
portion of such costs. Apportionment of costs between persons receiving exemptions and
the person who actually conducts the test(s) is ideally negotiated between the companies
involved, without EPA participation. EPA has promulgated regulations that explain how
EPA views fair and equitable reimbursement in the context of TSCA section 4(a) test rules.
In general, those regulations (40 CFR § 791.40 through § 791.52) make a presumption that
a person's fair share of the test costs is in proportion to their share of the total production
volume of the test chemical over a specified period of time that begins one calendar year
before the effective date of the rule and continues up to the latest data available upon
resolution of a dispute. While those regulations do not apply to TSCA section 4 Orders,
you may wish to consider them as you decide how to share the costs.

If persons subject to an Order include a person that has been granted an exemption and
agreement cannot be reached on the amount and method of sharing the cost of developing
the information, the person whose information is the basis for the exemption may request
that the Administrator order the person(s) granted the exemption to provide fair and
equitable reimbursement after considering all relevant factors, including the share of the
market and the effect on the competitive position of the person required to provide
reimbursement in relation to the person to be reimbursed. See TSCA section 4(c)(3)(A).
Upon receipt of such a request, EPA will determine fair and equitable reimbursement and
issue an order accordingly. The Agency may, at its discretion, make use of procedures and
standards applicable to data reimbursement regarding TSCA section 4 rules, contained in
40 CFR §791.

Manufacturer - The term "manufacture" means to import into the customs territory of the
United States, produce, or manufacture. 15 U.S.C. § 2602(9). Import also includes
importing the chemical as an impurity in an article.

Processor - The term "process" means the preparation of a chemical substance or mixture,
after its manufacture, for distribution in commerce (A) in the same form or physical state
as, or in a different form or physical state from, that in which it was received by the person
so preparing such substance or mixture, or (B) as part of an article containing the chemical
substance or mixture. 15 U.S.C. § 2602(13).

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