Tbd Notice Of Activity Of Manufacture, Import, Or Processing

EPA

U.S. Environmental Protection Agency
NOTICE OF ACTIVITY OF MANUFACTURE,
IMPORT, OR PROCESSING – FORM B

Submission Date:
Revised Date:

Part I – Submitter Identification
Name of Authorized Official
Manufacturer,
Importer,
Processor (in U.S.)

Technical Contact
(in U.S.)

(first)

(first)

Mailing Address (street, city, zip code)

CBI*

(last)
Company Name

Mailing Address (street, city, zip code)

Name

Telephone Number

(last)

* CBI refers to the term “Confidential Business Information.” Mark (X) in the CBI box(es) if the submitter information is to be held confidential.

Part II – Chemical Substance Identity
CASRN

TSCA Inventory Chemical Name (if specific chemical identity is not CBI)

Accession
Number

Generic Chemical Name (if specific chemical identity is CBI)

Part III – Status of Confidential Chemical Substance Identity
I am seeking to maintain an existing claim of confidentiality for the specific chemical identity, as listed on the TSCA Inventory.
I am not seeking to maintain an existing claim of confidentiality for the specific chemical identity, as listed on the TSCA Inventory.

Part IV – Anticipated Date of Reintroduction of Chemical Substance in U.S. Commerce**
Date:
** Mark (X) in the CBI box if the date is to be held confidential.

Part V – Certification
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 it is unlawful to knowingly submit incomplete, false and/or misleading
information, and there are significant criminal penalties for such unlawful conduct, including the possibility of fine and imprisonment.
Signature of authorized official

Date

Domestic manufacturers, importers, and processors must submit a completed notice prior to the date that the inactive substance is domestically
manufactured, imported, and/or processed, but not more than 90 calendar days prior. Requests to maintain an existing CBI claim for specific chemical
identity must be substantiated not later than 30 calendar days after submitting this notice, but may be substantiated at the time this notice is submitted.
Assertions of CBI claims for data elements other than specific chemical identity must be substantiated at the time this notice is submitted.
The public reporting and recordkeeping burden for this collection of information is estimated to average [insert] 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, including through the use of automated collection techniques to the Director, Collection Strategies Division, U.S. Environmental Protection
Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the
completed EPA Form [insert] to this address.

EPA Form [insert]

Part VI - CBI SUBSTANTIATION
This substantiation contains CBI:

Yes ☐

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-time-initial-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 not later than 30 days after providing this notice.
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.,
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:
☐ Name of Authorized Official/Mailing address (Part I)
☐ Company Name/Mailing address (Part I)
☐ Technical Contact/Telephone Number (in U.S.) (Part I)
☐ Specific Confidential Chemical Identity (as listed on the TSCA Inventory) (Part II/III)
☐ Anticipated Date of Reintroduction of Chemical Substance in U.S. Commerce (Part IV)
A. APPLICABLE TO ANY CBI CLAIM
1. Do you believe that the information is exempt from substantiation pursuant to TSCA section
14(c)(2)i?

Yes
No

If you answered yes, you must individually identify the specific information claimed as confidential
and specify the applicable exemption(s).
If the Agency disagrees with this assertion, you may be asked to provide additional information to
support your claim
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2. Will disclosure of the information likely result in substantial harm to your business’s competitive
position?

Yes
No

If you answered yes, please describe with specificity the substantial harmful effects that would likely
result to your competitive position if the information is made available to the public.
If, for example, it is not publicly known that the submitter manufactures, imports or processes the
reported chemical, describe with specificity the harmful effects that would result if this information
were made available to the public. If you are claiming technical contact name or name of authorized
official as CBI, describe with specificity the harmful effects that would result if this information were
made available to the public.
If you are claiming multiple information elements as CBI, please provide information for EACH
element you identified above.
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3. To the extent your business has disclosed the information to others (both internally and externally), what precautions
has your business taken? Please identify the measures or internal controls your business has taken to protect the
information claimed as confidential.
1. Non-disclosure agreement required prior to access.

Yes

No

2. Access is limited to individuals with a need-to-know

Yes

No

3. Information is physically secured (e.g. locked in room or cabinet) or electronically
secured (encrypted, password protected, etc.).

Yes

No

4. Other internal control measure(s). If yes, please explain below.

Yes

No

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4. Does the information appear in any public documents, including (but not limited to) safety data
sheets, advertising or promotional material, professional or trade publication, or any other media or
publications available to the general public?

Yes
No

If you answered yes, please explain why the information should be treated as confidential.
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5. Is the claim of confidentiality intended to last less than 10 years (see TSCA section 14(e)(1)(B) ii)? If so, please
indicate the number of years (between 1-10 years) or the specific date/occurrence after which the claim is withdrawn.
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6. Has EPA, another federal agency, or court made any confidentiality determination regarding
information associated with this substance?

Yes
No

If you answered yes, please explain the outcome of that determination and provide a copy of the
previous confidentiality determination or any other information that will assist in identifying the prior
determination.
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Additional comments:
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B. APPLICABLE ONLY TO A CHEMICAL IDENTITY CBI CLAIM
1. Are you providing a substantiation at this time to maintain a specific confidential chemical identity as
CBI?

Yes
No

If you answered yes, please respond to questions below and in Section A.
If you answered no, please leave all questions below blank. You must substantiate not later than 30
days after providing this notice in accordance with TSCA section 8(b)(5)(B)(ii)(II).
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2. Is the confidential chemical substance publicly known to have ever been offered for commercial
distribution in the United States?

Yes
No

If you answered yes, please explain why the information should be treated as confidential.
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Additional comments:
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C. CERTIFICATION
I certify that, for all claims for confidentiality made with this submission, all information submitted to substantiate such
claims is true and correct, and 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.
[Electronic signature]

i

TSCA Section 14(c)(2) states:
Information generally not subject to substantiation requirements
Subject to subsection (f), the following information shall not be subject to substantiation requirements under paragraph (3):
(A) Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or
article.
(B) Marketing and sales information.
(C) Information identifying a supplier or customer.
(D) In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents.
(E) Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or
article.
(F) Specific production or import volumes of the manufacturer or processor.
(G) Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of
the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service Registry number,
and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as
confidential at the time it was submitted in a notice under section 2604 of this title.

ii

TSCA section 14(e)(1)(B) states
(B) in the case of information other than information described in subsection (c)(2)—
(i) for a period of 10 years from the date on which the person asserts the claim with respect to the information submitted to
the Administrator; or
(ii) if applicable before the expiration of such 10-year period, until such time as—
(I) the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case
the information shall not be protected from disclosure under this section; or
(II) the Administrator becomes aware that the information does not qualify for protection from disclosure under this
section, in which case the Administrator shall take any actions required under subsections (f) and (g).