9600-034 Section 4 Final Study Plan

CBI SUBMISSION

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

SECTION 4 TEST ORDER - FINAL STUDY PLAN

Submission Date:

Part I - Submitter Information
Submitter
Information

Name of Authorized Official

Mailing Address

CBI

Mr William Brigman

123 Main St

X

Company Name EPA Form 9600-034

City, State, Zip

CDX Test Org

Virginia Beach, VA 23462

Phone Number

Email Address

8289191634

william.brigman@cgifederal.com
Job Title
consultant

Part II - Order Information
Order Number: TO2022-1973-11650001-A

Title of Action: TSCA-10973-2

Docket Number: EPA-HQ-OPPT-2022-1973

Part III - Chemical Information
Chemical Substance Name (Regulatory Name):
test

Chemical Substance
Identifier: 50-00-000
Chemical Group:

Chemical Category:

Part IV - Test Response Information
OECD 416: 2-Generation Reproduction Toxicity
Study Report Deadline: 12-29-2023
File Name

Document Type

Attachment Date

CBI

Attachment for Testing_1.docx

Study Plan

01-05-2023

X

OECD 424: Subchronic Neurotoxicity Study in Rodents
Study Report Deadline: 12-29-2023
File Name

Document Type

Attachment Date

CBI

Attachment for Testing_1.docx

Study Plan

01-05-2023

X
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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.

CBI SUBMISSION

Part V - Technical Contact Information
Contact

Contact

Address

CBI

Mr William K Brigman

123 Main St

X

Company Name

City, State, Zip, Country

CDX Test Org

Virginia Beach, VA 23462, US

Telephone Number

Email Address

8289191634

william.brigman@cgifederal.com

Part VI - CBI Substantiations
Claim: Attached Document - Attachment for Testing_1.docx (Study Plan)
Applicable Only to General CBI Claims

Yes

No

CBI

A person may assert a claim of confidentiality for the specific chemical identity of a chemical substance as described in § 711.15(b)(3) of this part only if the identity of
that chemical substance is treated as confidential in the Master Inventory File as of the time the report is submitted for that chemical substance. Generic chemical
identities and accession numbers may not be claimed as confidential. To assert a claim of confidentiality for the identity of a reportable chemical substance, you must
submit with the report detailed written answers to the questions from subsection (b) and to the following questions.
1. Please specifically explain what harm to the competitive position of your business would be likely to result from the release of the information
claimed as confidential. How would that harm be substantial? Why is the substantial harm to your competitive position likely (i.e., probable) to be
caused by release of the information rather than just possible? If you claimed multiple types of information to be confidential (e.g. site
information, exposure information, environmental release information, etc.), explain how disclosure of each type of information would be likely to
cause substantial harm to the competitive position of your business.
test
2. 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.
test
3A. Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.
test
3B. 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.
test
3C. Has a patent been published for the chemical identity you claim confidential? What chemical identity information is not revealed by the
patent? How is release of that specific information likely to cause substantial competitive harm? And failure to explain this harm may lead to
denial of your confidentiality claim.
test
4. 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.
test
5. 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.
test

X

X

X

X

X

X

X

Claim: Technical Contact Information
Applicable Only to General CBI Claims
EPA Form 9600-034

Yes

No

CBI

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CBI SUBMISSION

A person may assert a claim of confidentiality for the specific chemical identity of a chemical substance as described in § 711.15(b)(3) of this part only if the identity of
that chemical substance is treated as confidential in the Master Inventory File as of the time the report is submitted for that chemical substance. Generic chemical
identities and accession numbers may not be claimed as confidential. To assert a claim of confidentiality for the identity of a reportable chemical substance, you must
submit with the report detailed written answers to the questions from subsection (b) and to the following questions.
1. Please specifically explain what harm to the competitive position of your business would be likely to result from the release of the information
claimed as confidential. How would that harm be substantial? Why is the substantial harm to your competitive position likely (i.e., probable) to be
caused by release of the information rather than just possible? If you claimed multiple types of information to be confidential (e.g. site
information, exposure information, environmental release information, etc.), explain how disclosure of each type of information would be likely to
cause substantial harm to the competitive position of your business.
test
2. 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.
test
3A. Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.
test
3B. 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.
test
3C. Has a patent been published for the chemical identity you claim confidential? What chemical identity information is not revealed by the
patent? How is release of that specific information likely to cause substantial competitive harm? And failure to explain this harm may lead to
denial of your confidentiality claim.
test
4. 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.
test
5. 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.
test

X

X

X

X

X

X

X

Claim: Submitting Official Information
Applicable Only to General CBI Claims

Yes

No

CBI

A person may assert a claim of confidentiality for the specific chemical identity of a chemical substance as described in § 711.15(b)(3) of this part only if the identity of
that chemical substance is treated as confidential in the Master Inventory File as of the time the report is submitted for that chemical substance. Generic chemical
identities and accession numbers may not be claimed as confidential. To assert a claim of confidentiality for the identity of a reportable chemical substance, you must
submit with the report detailed written answers to the questions from subsection (b) and to the following questions.
1. Please specifically explain what harm to the competitive position of your business would be likely to result from the release of the information
claimed as confidential. How would that harm be substantial? Why is the substantial harm to your competitive position likely (i.e., probable) to be
caused by release of the information rather than just possible? If you claimed multiple types of information to be confidential (e.g. site
information, exposure information, environmental release information, etc.), explain how disclosure of each type of information would be likely to
cause substantial harm to the competitive position of your business.
test
2. 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.
test
3A. Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.
test
3B. 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.
test

X

X

X

X

3C. Has a patent been published for the chemical identity you claim confidential? What chemical identity information is not revealed by the
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CBI SUBMISSION
patent? How is release of that specific information likely to cause substantial competitive harm? And failure to explain this harm may lead to
denial of your confidentiality claim.
test
4. 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.
test
5. 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.
test

X

X

X

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:

Date:

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