Form B Form B 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)

Mailing Address (number and street)

CBI*

(last)
Company Name

City

Name
(first)

State

Zip Code

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 – Activity Information**
Domestic Manufacture:

Import:

Processing:

Date:
** Check the appropriate activity box(es) and provide date of the anticipated activity. Date is the actual date when the inactive chemical substance is
to be domestically manufactured, imported, and/or processed commercially for non-exempt purpose. Mark (X) in the CBI box(es) if the activity and/or
date information is to be held confidential.

Part III – 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)***

*** Mark (X) in the CBI box if the confidentiality of the specific chemical substance identity as listed on the TSCA Inventory is to be maintained.

Part IV – 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 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 there are significant penalties for submitting incomplete, false and/or
misleading information, including the possibility of fine and imprisonment for knowing violations.
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 30 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]

A person requesting to maintain an existing CBI claim for specific chemical identity must submit detailed written
answers to the following questions not later than 30 days after submitting a Form B. Although substantiation for
a request to maintain a CBI claim for specific chemical identity is not required at the time a Form B is submitted,
persons submitting a Form B may find it more efficient to simply provide the substantiation at the time of filing.
1.

What harmful effects to your competitive position, if any, or to your supplier's competitive position, do you think would
result from the identity of the chemical substance being disclosed in connection with reporting under this part? How
could a competitor use such information? Would the effects of disclosure be substantial? What is the causal
relationship between the disclosure and the harmful effects?
2. How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or
permanently? Why?
3. Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it
applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the
patent, why should it be treated as confidential?
4. Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is
being manufactured for a commercial purpose by anyone?
5. Is the fact that the chemical substance is being manufactured for a commercial purpose available to the public, for
example in technical journals, libraries, or State, local, or Federal agency public files?
6. What measures have been taken to prevent undesired disclosure of the fact that the chemical substance is being
manufactured for a commercial purpose?
7. To what extent has the fact that this chemical substance is manufactured for commercial purposes been revealed to
others? What precautions have been taken regarding these disclosures? Have there been public disclosures or
disclosures to competitors?
8. Does this particular chemical substance leave the site of manufacture in any form, e.g., as product, effluent,
emission? If so, what measures have been taken to guard against the discovery of its identity?
9. If the chemical substance leaves the site in a product that is available to the public or your competitors, can the
chemical substance be identified by analysis of the product?
10. For what purpose do you manufacture the chemical substance?
11. Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding
this chemical substance? If so, please attach copies of such determinations.
A person asserting a claim of confidentiality for any data element other than specific chemical identity must
submit detailed written answers to the following questions at the time a Form B is submitted.
1. For what period of time do you request that the information be maintained as confidential, e.g., until a certain date,
until the occurrence of a specified event, or permanently? If the occurrence of a specific event will eliminate the need
for confidentiality, please specify that event.
2. Information submitted to the EPA becomes stale over time. Why should the information you claim as confidential be
protected for the time period specified in your answer to question #1?
3. What measures have you taken to protect the information claimed as confidential? Have you disclosed the information
to anyone other than a governmental body or someone who is bound by an agreement not to disclose the information
further? If so, why should the information be considered confidential?
4. Is the information contained in any publicly available material such as the Internet, publicly available databases,
promotional publications, annual reports, or articles? If so, specify which.
5. Is there any means by which a member of the public could obtain access to the information? Is the information of a
kind that you would customarily not release to the public?
6. Has any governmental body made a determination as to the confidentiality of the information? If so, please attach a
copy of the determination.
7. For each item or category of information claimed as confidential, explain with specificity why release of the information
is likely to cause substantial harm to your competitive position. Explain the specific nature of those harmful effects,
why they should be viewed as substantial, and the causal relationship between disclosure and such harmful effects.
How could your competitors make use of this information to your detriment?
8. Do you assert that the information is submitted on a voluntary or a mandatory basis? Please explain the reason for
your assertion. If you assert that the information is voluntarily submitted information, please explain whether the
information is the kind that would customarily not be released to the public.
9. Whether you assert the information as voluntary or involuntary, please address why disclosure of the information
would tend to lessen the availability to the EPA of similar information in the future.
10. If you believe any information to be (a) trade secret(s), please so state and explain the reason for your belief. Please
attach copies of those pages containing such information with brackets around the text that you claim to be (a) trade
secret(s).
11. Explain any other issue you deem relevant.