Part
VI - SUBSTANTIATION FOR SPECIFIC CHEMICAL IDENTITY CBI CLAIM –
Supplemental Filing
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This
substantiation contains CBI: Yes ☐
No
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Exemption
1. I completed the voluntary substantiation process for my
specific chemical identity CBI claim by submitting responses to
all substantiation questions in my original Notice of Activity
Form A submission. I am now supplementing my substantiation by
only addressing Questions 7 and 8.
If
you check this box, skip Questions 1-6 and provide responses to
Questions 7 and 8.
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☐
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Exemption 2. I
previously substantiated my specific chemical identity CBI claim
in another submission to EPA and wish to rely on that previous
submission to fulfill my substantiation requirement.
Note
that to qualify for this exemption, the previous substantiation
must have been submitted to EPA not more than five years before
the deadline for completing this form.
If
you check this box, enter the submission date; submission type;
and case number, transaction ID, or equivalent identifier for the
previous submission that contained the substantiation. Answer no
other substantiation questions on this form.
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or tap here to enter text.
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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.
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☐ Yes
☐ No
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To the extent your
business has disclosed the information to others (both internally
and externally), 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.
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☐ Yes
☐ No
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(A) Is any of the
information claimed as confidential required to be publicly
disclosed under any other Federal law? If yes, please explain.
(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.
(C) Does any of the information
claimed as confidential appear in one or more patents or patent
applications? If yes, please provide the associated patent number
or patent application number (or numbers) and explain why the
information should be treated as confidential.
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☐ Yes ☐
No
☐ Yes
☐
No
☐ Yes
☐
No
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Is the claim of confidentiality intended to
last less than 10 years? If yes, 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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☐ Yes
☐ No
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or tap here to enter text.
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Has EPA, another federal agency, or court
made any confidentiality determination regarding information
associated with this chemical substance? 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.
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☐ Yes
☐ No
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Is the confidential chemical substance
publicly known (including by your competitors) to have ever been
offered for commercial distribution in the United States? If yes,
please explain why the specific chemical identity should still be
afforded confidential status (e.g., the chemical substance 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 chemical substance in the
United States is publicly available).
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☐ Yes
☐ No
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or tap here to enter text.
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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.
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☐ Yes
☐ No
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or tap here to enter text.
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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.
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☐ Yes
☐ No
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Click
or tap here to enter text.
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CERTIFICATION
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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.
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Signature
of authorized official
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Date
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OA
Form A: Additional Substantiation Questions Mockup
– February 18, 2020