7710-25 Biotech MCAN

Paperwork Reduction Act: This collection of information is approved by OMB under the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0038). Responses to this collection of information are
mandatory for certain persons, as specified at 40 CFR 721 and 725. 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
between 16.97 to 525.85 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

Cover Letter

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CBI SUBMISSION
BIO2022P1

OMB No. 2070-0038Expires 12/31/2025

EPA Biotech Form
Biotech Form Report Number

Mark (X) if anything is CBI

X

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:

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(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.

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

First Name
Position
Mailing Address

William

(Number & Street)

e-mail

State

Virginia Beach
william.brigman@cgifederal.com

Brigman

Company

CDX Test Org

Postal Code
Telephone
VA

(include area code)

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City

123 Main St

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Not Applicable

CBI

Last Name

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I. SUBMITTER IDENTIFICATION INFORMATION

23462
8289191634

CBI

(Number & Street)

Last Name
Company

State

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City

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Ia. JOINT SUBMITTER -- If you are submitting this notice as part of a joint submission, mark (X)

First Name
Position
Mailing Address

e-mail

Postal Code
Telephone
(include area code)

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II. TECHNICAL CONTACT IDENTIFICATION INFORMATION
First Name
Position
Mailing Address
(Number & Street)

City
e-mail

Company

CBI
Brigman
CDX Test Org

123 Main St

william.brigman@cgifederal.com

EPA Form 7710-25 (12-19)

Last Name

William

Virginia Beach

X

State

Postal Code
Telephone

23462

(include area code)

8289191634

VA

X

CBI SUBMISSION
BIO2022P2

III. TYPE OF SUBMISSION (Check One)
X

MCAN (Microbial Commercial Activity Notice)
TERA (TSCA Experimental Release Application)
Tier I Exemption
Tier II Exemption
Biotech TME (Test Market Exemption)

IIIa. TS Number

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214513

IV. TEXT / COMMENTS

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CBI

X

CBI SUBMISSION
BIO2022P3

V. FEES CERTIFICATION
If you are submitting a MCAN, Tier II Exemption, TERA, or Biotechnology TME, check the
following Fees Certification statement that applies:

The Company named in Part I is a “small business concern” as defined under 40 CFR 700.43 and will remit the fee as
specified in 40 CFR 700.45(c).
The Company named in Part I will remit the fee as specified in 40 CFR 700.45(c).

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X

This joint submission includes at least one Company which is a “small business concern” and at least one Company which is
not a “small business concern,” as defined under 40 CFR 700.43. The fee will be remitted with the joint submission. Any
remaining balance due for this joint submission is to be paid by the secondary submitter(s).

I certify that to the best of my knowledge and belief:

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The company named in Part I is submitting a sustainable futures TME. The company has graduated from EPA's
Sustainable Futures program and is therefore exempt from fees for this sustainable futures TME.

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The company named in this submission intends to manufacture, import, or process for a commercial purpose,
other than in small quantities solely for research and development, the microorganism identified in this
submission. All information provided in this submission is complete and truthful as of the date of submission. I
am including with this submission all test data in my possession or control and a description of all other data
known to or reasonably ascertainable by me as required by 40 CFR 725.160 or 725.260.

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Signature and title of
the Authorized Official
(Original Signature
Required)

ES/William K Brigman

Confidential

Date

12/19/2022

X

CBI SUBMISSION
BIO2022P4

LIST OF ATTACHMENTS

#

Number
of Pages

Attachment for Testing_1.docx

1

Associated
Section
Number

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Attachment Filename

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1

Attachment Name

Mark (X) this box if the data continues on the next page.

CBI

CBI SUBMISSION
BIO2022P5

Continuation Sheet
Field

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ID

CBI SUBMISSION
BIO2022P5

CBI Substantiation
Selected Chemical Identifier: N/A
Selected Chemical Claim: Chemical ID
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

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substantial harm to the competitive position of your business.
Yes/No: Yes
Cbi: No

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Selected Chemical Identifier: N/A
Selected Chemical Claim: Chemical ID

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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

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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.

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Yes/No: Yes
Cbi: Yes
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Selected Chemical Identifier: N/A

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Selected Chemical Claim: Chemical ID

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

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If yes, please explain.
Yes/No: Yes
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Cbi: Yes

Selected Chemical Identifier: N/A
Selected Chemical Claim: Chemical ID
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. If this chemical is patented and the patent reveals the
information you are claiming confidential, please explain your reasons for believing the information is nonetheless
still confidential.
Yes/No: Yes
Cbi: No
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CBI SUBMISSION
BIO2022P5

Selected Chemical Identifier: N/A
Selected Chemical Claim: Chemical ID
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 and 10 years) or the specific date after which the claim is
withdrawn.
Yes/No: Yes

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Cbi: No
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Selected Chemical Identifier: N/A

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Selected Chemical Claim: Chemical ID

5. Has EPA, another federal agency, or court made any confidentiality determination regarding information

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associated with this microorganism? 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

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decision, and the date of the determination.
Cbi: No
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Selected Chemical Identifier: N/A

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Yes/No: Yes

Selected Chemical Claim: Chemical ID

1. Has the identity of the microorganism been kept confidential to the extent that competitors do not know it is
being manufactured or imported into US commerce? If not, explain why the microorganism identity should still be

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afforded confidential status (e.g., the microorganism 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
Yes/No: Yes
Cbi: No

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microorganism in the United States is publicly available).

Selected Chemical Identifier: N/A
Selected Chemical Claim: Chemical ID
2. Does the microorganism leave the site of production or testing in a form which is accessible to the public or to
competitors? If yes, please explain what measures have been taken to guard against the discovery of its identity.
Further, what is the cost to a competitor, in time and money, to develop appropriate use conditions? What factors
facilitate or impede product analysis?
Yes/No: Yes
Cbi: No
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CBI SUBMISSION
BIO2022P5

CBI Substantiation
Selected Chemical Identifier: N/A
Selected Chemical Claim: Submitting Official Information
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

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substantial harm to the competitive position of your business.
Yes/No: Yes
Cbi: No

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Selected Chemical Identifier: N/A Selected Chemical
Claim: Submitting Official Information

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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

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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.

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Yes/No: Yes
Cbi: Yes
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Selected Chemical Identifier: N/A Selected

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Chemical Claim: Submitting Official Information

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

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If yes, please explain.
Yes/No: Yes
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Cbi: Yes

Selected Chemical Identifier: N/A
Selected Chemical Claim: Submitting Official Information
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. If this chemical is patented and the patent reveals the
information you are claiming confidential, please explain your reasons for believing the information is nonetheless
still confidential.
Yes/No: Yes
Cbi: No
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Selected Chemical Identifier: N/A

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CBI SUBMISSION
BIO2022P5

Selected Chemical Claim: Submitting Official Information

4. Is the claim of confidentiality intended to last less than 10 years (see TSCA section 14(e)(1)(B))? If yes,
withdrawn.
Yes/No: Yes
Cbi: No
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please indicate the number of years (between 1 and 10 years) or the specific date after which the claim is

Selected Chemical Identifier: N/A Selected

Chemical Claim: Submitting Official Information

5. Has EPA, another federal agency, or court made any confidentiality determination regarding information

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associated with this microorganism? 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.
Yes/No: Yes

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Cbi: No

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