2594.03 Attachment E

N OA Form B: Additional Substantiation Questions Mockup – February 18, 2020

EPA	U.S. Environmental Protection Agency NOTICE OF ACTIVITY OF MANUFACTURE, IMPORT, OR PROCESSING – FORM B			Submission Date:
				Revised Date:
Part I – Submitter Identification
Manufacturer, Importer, Processor (in U.S.)	Name of Authorized Official		Mailing Address (street, city, zip code)				CBI*
	(first)	last)
	Company Name		Mailing Address (street, city, zip code)
Technical Contact (in U.S.)	Name		Telephone Number
	(first)	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:
** If the notice is filed prior to the effective date of the chemical substance’s inactive designation, the most recent date of manufacture or processing may be provided in lieu of an anticipated 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 also certify that I have intent to manufacture, import, or process the above chemical within 90 days of submission. 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
Paperwork Reduction Action Notice: The public reporting and record keeping burden for this collection is estimated to average about 11.398 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. This is a mandatory collection pursuant to 40 CFR 710.  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number. The OMB Control Number of this collection is 2070-0210. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to Director, Collection Strategies Division (Mail Code 2822T), U.S. Environmental Protection Agency, Washington, DC 20460. Include the OMS control number in any correspondence, but do not submit the form or report to this address. The form should be submitted in accordance with the instructions for the form.

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EPA Form 9600-06

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., 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:
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) (Parts 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? 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.	Yes No
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2. Will disclosure of the information likely result in substantial harm to your business’s competitive position? 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.	Yes No
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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. Non-disclosure agreement required prior to access.
	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 Click or tap here to enter text.	Yes	No
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? If you answered yes, please explain why the information should be treated as confidential.			Yes No
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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 chemical substance? 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.			Yes No
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Additional comments:
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B. APPLICABLE ONLY TO A SPECIFIC CHEMICAL IDENTITY CBI CLAIM
1. Are you providing a substantiation at this time to maintain a specific confidential chemical identity as CBI? 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).			Yes No
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2. Is the confidential chemical substance publicly known to have ever been offered for commercial distribution in the United States? If you answered yes, explain why the information should be treated as confidential.			Yes No
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3. Does this particular chemical substance leave the site of manufacture (including import) or processing in any form, e.g., as a product, effluent, or emission? If yes, please explain what measures have been taken, if any, to guard against the discovery of its identity.			Yes No
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4. If the chemical substance leaves the site in a form that is available to the public or your competitors, can the chemical identity be readily discovered by analysis of the substance (e.g., product, effluent, or emission), in light of existing technologies and any costs, difficulties, or limitations associated with such technologies? Please explain why or why not.				Yes No
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Additional comments:
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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: My company has taken reasonable measures to protect the confidentiality of the information; I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; 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 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

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):

1. Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article.

2. Marketing and sales information.

3. Information identifying a supplier or customer.

4. In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents.

5. Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article.

6. Specific production or import volumes of the manufacturer or processor.

7. 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

2. in the case of information other than information described in subsection (c)(2)—

   1. 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

   2. if applicable before the expiration of such 10-year period, until such time as—

      1. 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

      2. 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).