9600-034 Section 4 Submission

Confidential Business Information Claims under the Toxic Substances Control Act (TSCA) – Proposed Rule

8223-01_ICR_SupportingStmt_Section4TestRulesSubmission

Rule Famiilarization

OMB: 2070-0223

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OMB Control No. 2070-0033
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United States Environmental Protection Agency
Washington, DC 20460
Section 4 Submission
This is an original submission:

This is an amendment:

CERTIFICATION

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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.
XXX
Contact Person:

fo

Signature:

XXX
Email Address:

XXX

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XXX

Official Title:

Date Signed:

N

06/06/2017

PART 1

Contact Information

Submission
Information

Submission Type:

TestRules
Federal Register Notice:

76 FR 65385
Submitter
Information

Company Name:

XXX
Contact Person:

XXX
EPA Form Number 9600-034

Form Alias:

TestRules-20141106-09:00:50 EST
Chemical Docket:

EPA-HQ-OPPT-2009-0112
Address:

XXX

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SEC4 Submission Page 2

Phone Number:

Email Address:

XXX
Technical Contact
Information

XXX

CBI

Yes:

No:

Company Name:

Address:

XXX

XXX

Contact Person:

on

XXX
Phone Number:

Email Address:

XXX
Consortium Name:

si

Submitting on Behalf
of Consortium

XXX

XXX
No:

Company Name:

XXX
XXX

ub

Contact Person:

Phone Number:

rS

XXX

m

Yes:

is

CBI

Address:

XXX

Email Address:

XXX

CBI

Yes:

No:

fo

Company Name:

XXX

Address:

XXX

N

ot

Contact Person:

XXX
Phone Number:

XXX

XXX

PART 2

Letter Of Intent

Chemical
Identification

CASRN:

CBI

Yes:

XXX
Chemical Name:

XXX
Chemical Test Name:

XXX
Sponsoring Firms

CBI

Yes:
EPA Form Number 9600-034

Email Address:

No:

No:

SEC4 Submission Page 3

Company Name:

OMB Control No. 2070-0033
Expires 12/31/2023

Address:

XXX

XXX

Phone Number:

XXX
Additional
Information

Document Type:

Amendment to the Study Plan 40 CFR 790.50
File Name:

Attachment Date:

Test doc 1 - Copy (2).docx
Additional
Information

11/17/2021

Document Type:

XXX
File Name:

Attachment Date:

XXX

XXX

Explanation and rationale for the modification:

XXX
Chemicals
Chemical - XXX : Study Plan

Attached
Document(s)

File Name:

b

PART 3

XXX
CBI

Yes:

No:

XXX
Endpoints:

XXX

XXX

File Name:

Attachment Date:

XXX

XXX

CBI

Sanitized Document Upload:

No:

Effects:

XXX
Additional
Information

XXX
Sanitized Document Upload:

Effects:

Yes:

Attachment Date:

XXX
Endpoints:

XXX

Document Type:

Amendment to the Study Plan 40 CFR 790.50
File Name:

Test doc 1.docx

EPA Form Number 9600-034

Attachment Date:

11/17/2021

SEC4 Submission Page 4
PART 4

Chemical - XXX - Test Results

Attached
Document(s)

File Name:

Attachment Date:

XXX

XXX
Sanitized Document Upload:

No:

Effects:

XXX
PART 5

Optional Substantiation

Attached
Document(s)

File Name:

Test doc 1 - Copy (5).docx
Effects:

Health Effects

XXX
Endpoints:

XXX

Attachment Date:

11/17/2021

o

CBI

Yes:

OMB Control No. 2070-0033
Expires 12/31/2023

Endpoints:

Eye irritation

Paperwork Reduction Act: This collection of information is approved by the United States Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
(OMB Control No. 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), 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.

EPA Form Number 9600-034

OMB Control No. 2070-0033
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CBI SUBMISSION

Substantiation - Applicable to Any Claim
(i) Will disclosure of the information claimed as confidential likely cause substantial harm to your business's competitive position? If
you answered yes, describe the substantial harmful effects that would likely result to your competitive position if the information is
disclosed, including but not limited to how a competitor could use such information, and the causal relationship between the
disclosure and the harmful effects.

CBI:

Yes
:No

✔

Test
(ii) Has your business taken precautions to protect the confidentiality of the disclosed information? If yes, please explain and identify
the specific measures, including but not limited to internal controls, that your business has taken to protect the information
claimed as confidential. If the same or similar information was previously reported to EPA as non-confidential (such as in an
earlier version of this submission), please explain the circumstances of that prior submission and reasons for believing the
information is nonetheless still confidential.

CBI:

Yes
:No

✔

Test
(ii) A. Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please
explain

CBI:

Yes
:No

✔

Test
(iii) B. Does any of the information claimed as confidential otherwise appear in any public documents, including (but not limited to)
safety data sheets; advertising or promotional material; professional or trade publications; state, local, or Federal agency files;
or any other media or publications available to the general public? If yes, please explain why the information should be treated
as confidential.

CBI:

Yes
:No

✔

Test
(iii) C. Does any of the information claimed as confidential appear in one or more patents or patent applications? If yes, provide the
associated patent number or patent application number (or numbers) and explain why the information should be
treated as confidential.

CBI:

Yes
:No

✔

Test
(iv) Is the claim of confidentiality intended to last less than 10 years (see TSCA section 14(e)(1)(B))? If yes, please indicate the
number of years (between 1-10 years) or the specific date after which the claim is withdrawn.

CBI:

Yes
:No

✔

Test
(v). Has EPA, another federal agency, or court made any confidentiality determination regarding information associated with
this chemical substance? If yes, please provide the circumstances associated with the prior determination, whether the
information was found to be entitled to confidential treatment, the entity that made the decision, and the date of the
determination.

CBI:

Yes
:No

✔

Test

Substantiation - Chemical Identity Claim
(i)

Is this chemical substance publicly known (including by your competitors) to be in U.S. commerce? If yes, please explain why
the specific chemical identity should still be afforded confidential status (e.g., the chemical substance is publicly known only as
being distributed in commerce for research and development purposes, but no other information about the current commercial
distribution of the chemical substance in the United States is publicly available). If no, please complete the certification
statement:

CBI:

Yes
:No

✔

I certify that on the date referenced I searched the internet for the chemical substance identity (i.e., by both chemical substance
name and CASRN). I did not find a reference to this chemical substance that would indicate that the chemical is being
manufactured or imported by anyone for a commercial purpose in the United States. [provide date].
Test
(ii) Does this specific chemical substance leave the site of manufacture (including import) in any form, e.g., as a product, effluent,
emission? If yes, please explain what measures have been taken to guard against the discovery of its identity.

CBI:

Yes
:No

✔

Test

Page 2

EPA Form Number 9600-034

OMB Control No. 2070-0033
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CBI SUBMISSION

(ii) If the chemical substance leaves the site in a form that is available to the public or your competitors, can the chemical identity
be readily discovered by analysis of the substance (e.g., product, effluent, emission), in light of existing technologies and any
costs, difficulties, or limitations associated with such technologies? Please explain why or why not.

CBI:

Yes
:No

✔

Test
(iv) Would disclosure of the specific chemical identity release confidential process information? If yes, please explain.

CBI:

Yes
:No

✔

Test

Part VII - 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 of 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 I have:
(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.
Signature of authorized official: William Brigman

Date: 2021-08-24

Page 3

EPA Form Number 9600-034


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File Modified2021-12-03
File Created2021-11-17

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