7710-25 EPA Biotech Form

CBI SUBMISSION

Cover Letter

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This is an Optional Cover Letter Test.

CBI SUBMISSION
BIO2021P1

Form Approved. O.M.B. No. 2070-0012. Approval Expires 12/31/2022

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

Brooke

(Number & Street)

e-mail

State

Virginia Beach
[email protected]

Plaisance

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
3375231765

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)

N

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

City
e-mail

Company

CBI
Plaisance
CDX Test Org

123 Main St

[email protected]

EPA Form 7710-25 (12-19)

Last Name

Brooke

Virginia Beach

X

State

Postal Code
Telephone

23462

(include area code)

3333333333

VA

X

CBI SUBMISSION
BIO2021P2

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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123456

IV. TEXT / COMMENTS

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Testing Submission

CBI

X

CBI SUBMISSION
BIO2021P3

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

X

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).

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The Company named in Part I will remit the fee as specified in 40 CFR 700.45(c).
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/Brooke E Plaisance

Confidential

Date

08/24/2021

X

N

This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0012).
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
BIO2021P4

LIST OF ATTACHMENTS

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

CBI

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Attachment Description Test

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1

Associated
Section
Number

Number
of Pages

Attachment Filename

Attachment Name

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#

X

CBI SUBMISSION
BIO2021P5

Part IV -- CBI Substantiation
This substantiation contains CBI:

Yes

X

No

Pursuant to TSCA section 14(c)(3), you must substantiate any CBI claims for information elements other than specific chemical identity at the time this notice is
submitted. EPA guidance for complying with TSCA section 14(c)(3) may be found at https://www.epa.gov/tsca-cbi/substantiating-cbi-claims-under-tsca-timeinitial-submission. You may also substantiate a request to maintain an existing CBI claim for a specific chemical identity at the time this notice is submitted,
but this is not required. Rather, you must substantiate the existing CBI claim for the specific chemical identity by the deadline established in a forthcoming
Review Plan, to be promulgated at a later date in accordance with TSCA section 8(b)(4)(C).
If you do not assert a CBI claim at time of submission of this form, or otherwise fail to assert a proper CBI claim (i.e., by failing to substantiate your CBI claim or
not providing a certification statement), the information shall be treated as not subject to a CBI claim, and may be made public without further notice. If a single
substantiation response applies for all or a class of information claimed as CBI, you should indicate this in your substantiation response. If different
substantiation responses are necessary to support CBI claims for different information types, you should provide separate substantiation responses for each
information type, clearly identifying the information for which each substantiation applies in the free text boxes (e.g. Question A.1. or 2) or in the additional
information box at the end of this form.
Information element(s) that you identified as CBI in previous parts:
X

Name of Authorized Official/Mailing address (Part I)

X

Technical Contact/Telephone Number (in U.S.) (Part I)

X

Specific Confidential Chemical Identity (as listed on the TSCA Inventory)

A. APPLICABLE TO ANY CBI CLAIM (Submitter Identification Information)
(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.

Yes
X No

(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
(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
(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
(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

CBI SUBMISSION
BIO2021P5
(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 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
X No

test
Additional comments:

B. APPLICABLE ONLY TO A SPECIFIC CHEMICAL (Microorganism) IDENTITY CBI CLAIM
(i) 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 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 microorganism in the United
States is publicly available).

X Yes
No

test
(ii) 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?

X Yes
No

test
Additional comments:

C. CERTIFICATION
I certify that all claims for confidentiality made or sought to be maintained with this submission are true and correct, and all information submitted herein to
substantiate such claims is true and correct. I further certify that it is true and correct that:
i. My company has taken reasonable measures to protect the confidentiality of the information;
ii. I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
iii. I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and
iv. I have 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