9600-036 Risk Evaluation

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

8223-01_ICR_SupportingStmtRiskEvalMRRESubmission

Rule Famiilarization

OMB: 2070-0223

Document [pdf]
Download: pdf | pdf
OMB Control No.: 2070-0202
Expires 11/30/2024
CBI SUBMISSION

Submission Date:

2021-08-24

RISK EVALUATION
Revised Date:

Part I - Submitter Information
Submitter
Information

Name of Authorized Official

Company Name

CBI

Brooke E. Plaisance

CDX Test Org

X

Telephone Number

Email Address

3375555555

brooke.plaisance@cgifederal.com

Mailing Address

City, State, Zip, Country

123 Main St

Virginia Beach, VA 23462 US

Contact
Technical Contact

Submission Alias

Contact

CBI

MRRE Mockup

Brooke Plaisance

X

Position

Company Name
CDX Test Org

United States Agent

Address

City, State, Zip, Country

123 Main St

Virginia Beach, VA 23462, United States

Telephone Number

Email Address

3375555555

brooke.plaisance@cgifederal.com

Contact

Address

Company Name

City, State, Zip

Telephone Number

Email Address

CBI

Position

This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0202). Respondents are not obligated to respond or report to EPA.
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 83.3 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.

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EPA Form Number 9600-036

OMB Control No.: 2070-0202
Expires 11/30/2024
CBI SUBMISSION

Part II - Chemical Substance or Category
Unique Identifier

X CASRN

PMN No.

Accession No.

ID Number

Chemical Name

2687-91-4

Test Chemical

Generic Name

Trade Name

Molecular
Structure

Test Name

Test Structure

CBI

Part III - Documents
Document Name

Document Type

Document Subtype

Document Description

Page Count

cgi-logo.png

Fate

Hydrolysis

Test

1

cgi-logo.pdf

Condition of Use Rationale

Test

1

Conditions Of Use

CBI

CBI

Test

X

Hazard Studies / Information

CBI

Testing

X

Additional Information

CBI

More Tests

X

Information Submitted

CBI

Test

X

Submission of Referenced Information
Upon request, I commit to provide to EPA any referenced information contained in this request.
I certify that to the best of my knowledge and belief:

(i) The company (or companies) named in this request manufactures the chemical substance identified for risk evaluation.
(ii) All information provided in the notice is complete and accurate as of the date of the request.
(iii) I have either identified or am submitting all information in my possession, control, and a description of all other data known to or reasonably ascertainable by me as required for this request
under this part. I am aware it is unlawful to knowingly submit incomplete, false and/or misleading information in this request and there are significant criminal penalties for such unlawful
conduct, including the possibility of fine and imprisonment.

Substantiating CBI Claims
Document Name

Page Count

EPA-Logo.pdf

1

CBI

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.

X 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.

X Yes
No

Test

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EPA Form Number 9600-036

OMB Control No.: 2070-0202
Expires 11/30/2024
CBI SUBMISSION

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

X 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.

X 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.

X 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.

X 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.

X 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:

X 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.

X Yes
No

Test
(iii) 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.

X Yes
No

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

X Yes
No

Test

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EPA Form Number 9600-036

OMB Control No.: 2070-0202
Expires 11/30/2024
CBI SUBMISSION

Part IV - 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 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.

Risk Evaluation Certification
Page
3
I certify under penalty of law that this document and all attachments were prepared under my direction or supervision and the information contained therein, to the best of my knowledge is,
true,
accurate, and complete. I am aware there are significant penalties for submitting incomplete, false and/or misleading information, including the possibility of fine and imprisonment for knowing
violations.

Signature of authorized official:

Brooke Plaisance

Date:

2021-08-24

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EPA Form Number 9600-036


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File Modified2022-04-04
File Created2021-08-24

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