9600-034 Section 4 Test Rules Submission

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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.

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Signature:

ES/William Brigman
Contact Person:

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William K. Brigman

Official Title:

consultant
Email Address:

[email protected]

Date Signed:

Contact Information

Submission
Information

Submission Type:

N

PART 1

TestRules
Federal Register Notice:

53 FR 22300
Submitter
Information

Company Name:

CDX Test Org
Contact Person:

William K. Brigman
EPA Form 9600-034

Form Alias:

TestRules-20230105-14:41:45 EST
Chemical Docket:

EPA-HQ-OPTS-42088D
Address:

123 Main St
Virginia Beach, VA, 23462
United States

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.

SEC4 Submission Page 2

Phone Number:

Email Address:

8289191634
Technical Contact
Information

[email protected]

CBI

Yes: ✔ No:
Company Name:

Address:

CDX Test Org

123 Main St
Virginia Beach, VA, 23462
United States

Contact Person:

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Mr William K. Brigman
Phone Number:

Email Address:

[email protected]

PART 2

Letter Of Intent

Chemical
Identification

CASRN:

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8289191634

640-19-7
Chemical Name:

Sponsoring Firms

CBI

No:

Company Name:

CGI Federal

Phone Number:

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8281111234

Additional
Information

✔

✔

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Yes:

No:

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Chemical Test Name:

E1

Yes:

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2-Fluoroacetamide

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CBI

Address:

12601 Fairlakes Cir.
Fairfax, VA, 22033
United States

Document Type:

Amendment to the Study Plan 40 CFR 790.50

File Name:

Attachment for Testing.docx

Attachment Date:

01/05/2023

Chemicals
PART 3

Chemical - 640-19-7 : Study Plan

Attached
Document(s)

File Name:

Attachment for Testing_1.docx
CBI

Yes: ✔ No:
Effects:

Health Effects
PART 4

Chemical - 640-19-7 - Test Results

Attachment Date:

01/05/2023
Sanitized Document Upload:

Attachment for Testing_2.docx
Endpoints:

Immunotoxicity

SEC4 Submission Page 3

File Name:

Attached
Document(s)

Attachment Date:

Attachment for Testing_4.docx

01/05/2023

CBI

Sanitized Document Upload:

Yes: ✔ No:

TEST ATTACHMENT-1.docx

Effects:

Endpoints:

Environmental Fate

Other Distribution Data

CBI Substantiations

Substantiation
Questions

Below are a list of Substantiation questions and the responses filled out in the
CBI Substantiation page.
Technical Contact Information

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Data Identifier:

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PART 5

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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.

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CBI: No
Response: Yes
Response Text: test

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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 nonconfidential (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.

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CBI: No
Response: Yes
Response Text: test

3A. Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If
yes, please explain.

CBI: No
Response: Yes
Response Text: 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.

CBI: No
Response: Yes
Response Text: test

SEC4 Submission Page 4

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.

CBI: No
Response: Yes
Response Text: 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.

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CBI: No
Response: Yes
Response Text: test

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Data Identifier:

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CBI: No
Response: Yes
Response Text: test

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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.

Chemical Attachments - Attachment for Testing_1.docx

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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.

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CBI: No
Response: Yes
Response Text: 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 nonconfidential (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: No
Response: Yes
Response Text: test
3A. Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If
yes, please explain.

CBI: No
Response: Yes
Response Text: test

SEC4 Submission Page 5

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.

CBI: No
Response: Yes
Response Text: test

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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.

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CBI: No
Response: Yes
Response Text: test

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CBI: No
Response: Yes
Response Text: test

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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.

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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.

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CBI: No
Response: Yes
Response Text: test

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Data Identifier:

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Chemical Attachments - Attachment for Testing_4.docx

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.

CBI: No
Response: Yes
Response Text: test

SEC4 Submission Page 6

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 nonconfidential (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: No
Response: Yes
Response Text: test

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3A. Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If
yes, please explain.

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CBI: No
Response: Yes
Response Text: test

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CBI: No
Response: Yes
Response Text: test

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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.

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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.

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CBI: No
Response: Yes
Response Text: test

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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.

CBI: No
Response: Yes
Response Text: 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.

CBI: No
Response: Yes
Response Text: test
Data Identifier:

Submitting Official Information

SEC4 Submission Page 7

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.

CBI: No
Response: Yes
Response Text: test

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CBI: No
Response: Yes
Response Text: test

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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 nonconfidential (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.

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3A. Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If
yes, please explain.

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CBI: No
Response: Yes
Response Text: test

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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.

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ot

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CBI: No
Response: Yes
Response Text: 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.

CBI: No
Response: Yes
Response Text: 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.

CBI: No
Response: Yes
Response Text: test

SEC4 Submission Page 8

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.

CBI: No
Response: Yes
Response Text: test
Paperwork Reduction Act: The Government Paperwork Elimination Act (GPEA) (44 U.S.C. 3501) 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), published in the Federal Register on October 13,
2005 (70 FR 59848) (FRL-7977-1)(Ref. 2), provides that any requirement in title 40 of the Code of Federal Regulations (CFR) to submit a report directly to EPA can be satisfied with an electronic

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submission that meets certain conditions once the Agency published a notice in the Federal Register announcing that EPA is prepared to receive certain documents in electronic form. For more

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information about CROMERR, go to http://www.epa.gov/cromerr/.