Confidentiality Rules

SAMPLE LETTER A: Generic Substantiation, FOIA

Approved OMB 2020-003
Approval expires 09/30/2023

By Certified U.S. Mail; Return Receipt Requested
(Name, title, and address of the [designated] representative of the affected business)
Re: Freedom of Information Act (FOIA) Request [INSERT FOIA #]
Dear [Addressee]:
The U.S. Environmental Protection Agency (“EPA” or “Agency”) has received a request
under the FOIA for certain records [if submitted by the business whose information it is: that you
submitted to the EPA] [if submitted by an entity other than the business whose information it is:
in EPA’s possession] pertaining to [a detailed description of the information or specific list of
documents that is/are the subject of the advance or final confidentiality determination]. [If
information has been claimed as CBI: You have claimed (all or part) of this information as
confidential business information (“CBI”).] [If no claim has been made: In accordance with
applicable EPA regulations, 40 C.F.R. Part 2, Subpart B, the EPA has determined that you might
be expected to assert a claim that some or all of [if submitted by the business whose information
it is: the information you submitted to the EPA] [if submitted by an entity other than the business
whose information it is: this information in EPA’s possession] is confidential business
information (“CBI”).] Under the EPA regulations at 40 C.F.R. Part 2, Subpart B, the FOIA
request has been initially denied to afford you an opportunity to provide comments to [If no
claim has been made: claim this information as CBI and] substantiate your claim(s) as described
below.
The purpose of this letter is to notify you that the EPA (appropriate legal office) will be
making a(n) (advance or final) confidentiality determination concerning the information you
have claimed as CBI. If you feel that some or all of the information is entitled to confidential
treatment, you must make the showings below with specific reference to those portions of the
information you consider confidential.
Please be specific by page (including Bates Stamp, if applicable), paragraph, and
sentence when identifying and substantiating the information subject to your claim. Where your
claim, as originally made or as modified by your response to this letter, does not include all
information on a page, please attach a copy of each such page with brackets around the text that
you claim to be CBI. Please note that if a page, document, group, or class of documents claimed
by you to be CBI contains a significant amount of information which (appropriate legal office)
determines is not CBI, your CBI claim regarding that page, document, group, or class of
documents may be denied. Please be advised that any information not specifically identified as

subject to a confidentiality claim and substantiated as such in your response to this letter may be
disclosed to the requester without further notice to you.
In making its final confidentiality determination, the EPA will consider the relevant
substantive criteria in its CBI regulations, under 40 C.F.R. § 2.208(a)-(d), as well as the U.S.
Supreme Court’s decision in Food Marketing Institute v. Argus Leader Media (Argus), 139 S. Ct.
2356, 204 L.Ed.2d 742 (2019), which evaluated the definition of “confidential” as used in
Exemption 4. In the Argus decision, the Court held that at least where “[1] commercial or
financial information is both customarily and actually treated as private by its owner and [2]
provided to the government under an assurance of privacy, the information is ‘confidential’
within the meaning of Exemption 4.” Argus, 139 S. Ct. at 2366.
Thus, for each item or class of information that you claim as CBI, please answer the
following questions, giving as much detail as possible. EPA will use your responses to these
questions to determine whether the information has been shown to be entitled to confidential
treatment:
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.

Has EPA, another federal agency, or court made any determination as to the
confidentiality of the information? If so, please attach a copy of the determination.

3.

Is the information claimed as confidential contained in any publicly available
material such as patents or patent applications, publicly available databases
(including state databases), promotional publications, annual reports, or articles?
Yes/No
If you answered “yes”, please identify the publicly available information and its
location (e.g., patent number or website address).

4.

Has your company taken reasonable measures to protect the information claimed as
CBI? If so, please identify the measure or internal controls your business has taken
to protect the information claimed as confidential:
a. Non-disclosure agreement required prior to access. Yes/No
b. Access is limited to individuals with a need-to-know. Yes/No
c. Information is physically secured (e.g. locked in a room or cabinet) or
electronically secured (encrypted, password protected, etc.). Yes/No
d. Other internal control measures(s). Yes/No. (If yes, please explain.)

5.

Does your company customarily keep the information private or closely-held? If so,
please explain the basis for your response. Your response must also explain any
reasonably foreseeable harm to an interest protected by Exemption 4 that would
result from disclosure of the information claimed as confidential.

6.

At the time you submitted the information you claimed as CBI, did EPA provide any
express or implied assurance of confidentiality? If so, please provide the specific
assurance(s) you received. For example, express assurances indicating that
information will not be publicly disclosed could include legal authorities (regulation
or statute), direct communications, class determinations, etc. Examples of implicit
assurances could include a description of the specific context in which the
information was received.

7.

Did the Agency provide any express or implied indications at the time the
information was submitted that EPA would publicly disclose the information?

8.

If you believe any submitted information to be a trade secret, please 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.

9.

[Potential Question based on circumstance: Are there any means by which a
member of the public could obtain access to the information or readily discover the
information claimed as confidential through reverse engineering?]

10. [Potential Question based on the type of CBI claim: Please explain why the
information claimed as confidential is not emissions data under the Clean Air Act,
effluent data under the Clean Water Act, health and safety data under the Toxics
Substances Control Act, or any other information that is prohibited from protection
under regulation or statute.]
11. Explain any other issue or additional information you deem relevant to EPA’s
determination.
Please note that you bear the burden of substantiating your CBI and trade secret
claim(s). Generalized or conclusory statements will be given little or no weight in EPA’s
determination on the confidentiality of the information you claim to be CBI.
Your comments must be postmarked or hand delivered to this office, or emailed to [email
address], by the 15th working day after your receipt of this letter. You may seek an extension of
time to submit your comments to this office, but your request must be made before the end of the
15-day period. Except in extraordinary circumstances, no extension will be approved without the
consent of the FOIA requester. Failure to submit your comments within that time will be
regarded as a waiver of your confidentiality claim(s), and the EPA may release the information.
If you wish to claim any information that you provide in your response to this letter to be
claimed as CBI, you must mark the response with “CONFIDENTIAL BUSINESS
INFORMATION” or with a similar designation, and you must bracket all text in the response
that you so claim. Information so designated will be disclosed by the EPA only to the extent
allowed by, and by means of the procedures set forth in, 40 C.F.R. Part 2, Subpart B. If you fail
to claim the information provided in your response as confidential, it may be made available to
the public without further notice to you.

Should you have any questions concerning this matter, please call me at [telephone
number].
Sincerely,

[Signature and Title; Office Name and Address]
[Enclosure]

SAMPLE LETTER B: Generic Substantiation, Non-FOIA

Approved OMB 2020-003
Approval expires 09/30/2023

Request for Substantiation From an Affected Business

By Certified U.S. Mail; Return Receipt Requested
[Name, title, and address of the [designated] representative of the affected business]
Re: _________
Dear [Addressee]:
The U.S. Environmental Protection Agency (“EPA” or “Agency”) is seeking to
determine the entitlement to confidentiality of [description of the information that is the subject
of the advance or final confidentiality determination] [if submitted by the business whose
information it is: that you submitted to the EPA] [if submitted by an entity other than the
business whose information it is: in EPA’s possession.] [If information has been claimed as CBI:
You have claimed (all or part) of this information as confidential business information (“CBI”).]
[If no claim has been made: In accordance with applicable EPA regulations, 40 C.F.R. Part 2,
Subpart B, the EPA has determined that you might be expected to assert a claim that some or all
of [if submitted by the business whose information it is: the information you submitted to the
EPA] [if submitted by an entity other than the business whose information it is: this information
in EPA’s possession] is confidential business information (“CBI”).]
The purpose of this letter is to notify you that the EPA [appropriate legal office] will be
making a(n) [advance or final] confidentiality determination concerning the information you
have claimed as CBI. If you feel that some or all of the information is entitled to confidential
treatment, you must make the showings below with specific reference to those portions of the
information you consider confidential.
Please be specific by page (including Bates Stamp, if applicable), paragraph, and
sentence when identifying and substantiating the information subject to your claim. Where your
claim, as originally made or as modified by your response to this letter, does not include all
information on a page, please attach a copy of each such page with brackets around the text that
you claim to be CBI. Please note that if a page, document, group or class of documents claimed
by you to be CBI contains a significant amount of information that our [appropriate legal office]
determines is not CBI, your CBI claim regarding that page, document, group, or class of
documents may be denied. Any information not specifically identified as subject to a
confidentiality claim and substantiated as such in your response to this letter may be disclosed
without further notice to you.

In making its final confidentiality determination, the EPA will consider the relevant
substantive criteria in its CBI regulations, under 40 C.F.R. § 2.208(a)-(d), as well as the U.S.
Supreme Court’s decision in Food Marketing Institute v. Argus Leader Media (Argus), 139 S. Ct.
2356, 204 L.Ed.2d 742 (2019), which evaluated the definition of “confidential” as used in
Exemption 4. In the Argus decision, the Court held that at least where “[1] commercial or
financial information is both customarily and actually treated as private by its owner and [2]
provided to the government under an assurance of privacy, the information is ‘confidential’
within the meaning of Exemption 4.” Argus, 139 S. Ct. at 2366.
Thus, for each item or class of information that you claim as CBI, please answer the
following questions, giving as much detail as possible. EPA will use your responses to these
questions to determine whether the information has been shown to be entitled to confidential
treatment:
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.

Has EPA, another federal agency, or court made any determination as to the
confidentiality of the information? If so, please attach a copy of the determination.

3.

Is the information contained in any publicly available material such as patents or
patent applications, publicly available databases (including state databases),
promotional publications, annual reports, or articles? Yes/No
If you answered “yes”, please identify the publicly available information and its
location (e.g., patent number or website address).

4.

Has your company taken reasonable measures to protect the information claimed as
CBI? If so, please identify the measure or internal controls your business has taken
to protect the information claimed as confidential:
a. Non-disclosure agreement required prior to access. Yes/No
b. Access is limited to individuals with a need-to-know. Yes/No
c. Information is physically secured (e.g. locked in a room or cabinet) or
electronically secured (encrypted, password protected, etc.). Yes/No
d. Other internal control measures(s). Yes/No. (If yes, please explain.)

5.

Does your company customarily keep the information private or closely-held? If so,
please explain the basis for your response.

6.

At the time you submitted the information you claimed as CBI, did EPA provide any
express or implied assurance of confidentiality? If so, please explain the specific
assurance(s) you received. For example, express assurances indicating that
information will not be publicly disclosed could include legal authorities (regulation
or statute), direct communications, class determinations, etc. Examples of implicit

assurances could include a description of the specific context in which the
information was received.
7.

Did the Agency provide any express or implied indications at the time the
information was submitted that EPA would publicly disclose the information?

8.

If you believe any submitted information to be a trade secret, please 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.

9.

[Optional Question for Program to include if applicable: Are there any means by
which a member of the public could obtain access to the information or readily
discover the information claimed as confidential through reverse engineering?]

10. [Optional Question for Program to include if applicable: Please explain why the
information claimed as confidential is not emissions data under the Clean Air Act,
effluent data under the Clean Water Act, health and safety data under the Toxics
Substances Control Act, or any other information that is prohibited from protection
under regulation or statute.]
11. Explain any other issue or additional information you deem relevant to EPA’s
determination.
[If applicable to a EPA class determination: Enclosed is the EPA Class Determination
[class determination number] entitled, [name of the class determination], which addresses the
treatment of [description of class determination]. You may consider reviewing Class
Determination [#] as you develop your response.]
Please note that you bear the burden of substantiating your confidentiality and trade
secret claim(s). Generalized or conclusory statements will be given little or no weight in EPA’s
determination on the confidentiality of the information you claim to be CBI.
Your comments must be postmarked or hand delivered to this office, or emailed to [email
address], by the 15th working day after your receipt of this letter. You may seek an extension of
time to submit your comments to this office, but the request must be made before the end of the
15-day period. Except in extraordinary circumstances, no extension will be approved. Failure to
submit your comments within that time will be regarded as a waiver of your confidentiality claim
or claims, and the EPA may release the information.
If you wish to claim any information that you provide in your response to this letter to
itself be confidential, you must mark the response with “CONFIDENTIAL BUSINESS
INFORMATION” or with a similar designation, and you must bracket all text in the response
that you so claim. Information so designated will be disclosed by the EPA only to the extent
allowed by, and by means of the procedures set forth in, 40 C.F.R. Part 2, Subpart B. If you fail
to claim the information provided in your response as confidential, it may be made available to
the public without further notice to you.

Should you have any questions concerning this matter, please call me at [telephone
number].
Sincerely,
[Signature and Title; Office Name and Address]
[Enclosure]

SAMPLE LETTER C: FIFRA, FOIA
Approved OMB 2020-003
Approval expires 09/30/2023
Inert Ingredients

Request for Substantiation From an Affected Business

By Certified U.S. Mail; Return Receipt Requested
[Name, title, and address of the [designated] representative of the affected business]
RE: Confidential Business Information Determination
Dear [ADDRESSEE]:
The U.S. Environmental Protection Agency (“EPA”) Office of Pesticide Programs has
received a request under the FOIA for certain records [if submitted by the business whose
information it is: that you submitted to the EPA] [if submitted by an entity other than the
business whose information it is: in EPA’s possession] pertaining to [a detailed description of
the information or specific list of documents that is/are the subject of the advance or final
confidentiality determination]. [If information has been claimed as CBI: You have claimed (all
or part) of this information as confidential business information (“CBI”).] [If no claim has been
made: In accordance with applicable EPA regulations, 40 C.F.R. Part 2, Subpart B, the EPA has
determined that you might be expected to assert a claim that some or all of [if submitted by the
business whose information it is: the information you submitted to the EPA] [if submitted by an
entity other than the business whose information it is: this information in EPA’s possession] is
confidential business information (“CBI”).] Under the EPA regulations at 40 C.F.R. Part 2,
Subpart B, the FOIA request has been initially denied to afford you an opportunity to provide
comments to [If no claim has been made: claim this information as CBI and] substantiate your
claim(s) as described below.
The purpose of this letter is to notify you that the EPA Office of General Counsel will be
making a(n) [advance or final] confidentiality determination concerning the information you
have claimed as CBI. If you feel that some or all of the information is entitled to confidential
treatment, you must make the showings below with specific reference to those portions of the
information you consider confidential.
Please be specific by page (including Bates Stamp, if applicable), paragraph, and
sentence when identifying and substantiating the information subject to your claim. Where your

claim, as originally made or as modified by your response to this letter, does not include all
information on a page, please attach a copy of each such page with brackets around the text that
you claim to be CBI. Please note that if a page, document, group, or class of documents claimed
by you to be CBI contains a significant amount of information which the Office of General
Counsel determines is not CBI, your CBI claim regarding that page, document, group, or class of
documents may be denied. Any information not specifically identified as subject to a
confidentiality claim and substantiated as such in your response to this letter may be disclosed to
the requester without further notice to you.
In making its final confidentiality determination, the EPA will consider the relevant
substantive criteria in its CBI regulations, under 40 C.F.R. § 2.208(a)-(d), as well as the U.S.
Supreme Court’s decision in Food Marketing Institute v. Argus Leader Media (Argus), 139 S. Ct.
2356, 204 L.Ed.2d 742 (2019), which evaluated the definition of “confidential” as used in
Exemption 4. In the Argus decision, the Court held that at least where “[1] commercial or
financial information is both customarily and actually treated as private by its owner and [2]
provided to the government under an assurance of privacy, the information is ‘confidential’
within the meaning of Exemption 4.” Argus, 139 S. Ct. at 2366.
Thus, for each item or class of information that you claim as CBI, please answer the
following questions, giving as much detail as possible. EPA will use your responses to these
questions to determine whether the information has been shown to be entitled to confidential
treatment:
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.

Has EPA, another federal agency, or court made any determination as to the
confidentiality of the information? If so, please attach a copy of the determination.

3.

Is the information contained in any publicly available material such as patents or
patent applications, publicly available databases (including state databases),
promotional publications, annual reports, or articles? Yes/No
If you answered “yes”, please identify the publicly available information and its
location (e.g., patent number or website address).

4.

Has your company taken reasonable measures to protect the information claimed as
CBI? If so, please identify the measure or internal controls your business has taken
to protect the information claimed as confidential:
a. Non-disclosure agreement required prior to access. Yes/No
b. Access is limited to individuals with a need-to-know. Yes/No
c. Information is physically secured (e.g. locked in a room or cabinet) or
electronically secured (encrypted, password protected, etc.). Yes/No
d. Other internal control measures(s). Yes/No. (If yes, please explain.)

5.

Does your company customarily keep the information private or closely-held? If so,
please explain the basis for your response. Your response must also explain any
reasonably foreseeable harm to an interest protected by Exemption 4 that would
result from disclosure of the information claimed as confidential.

6.

At the time you submitted the information you claimed as CBI, did EPA provide any
express or implied assurance of confidentiality? If so, please explain the specific
assurance(s) you received. For example, express assurances indicating that
information will not be publicly disclosed could include legal authorities (regulation
or statute), direct communications, class determinations, etc. Examples of implicit
assurances could include a description of the specific context in which the
information was received.

7.

Did the Agency provide any express or implied indications at the time the
information was submitted that EPA would publicly disclose the information?

8.

If you believe any submitted information to be a trade secret, please 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.

9.

[Optional Question for Program to include if applicable: Are there any means by
which a member of the public could obtain access to the information or readily
discover the information claimed as confidential through reverse engineering?]

10. Explain any other issue or additional information you deem relevant to EPA’s
determination.
Please note that you bear the burden of substantiating your confidentiality and trade
secret claim(s). Generalized or conclusory statements will be given little or no weight in EPA’s
determination on the confidentiality of the information you claim to be CBI.
Your comments must be postmarked or hand delivered to this office, or emailed to [email
address], by the 15th working day after your receipt of this letter. You may seek an extension of
time to submit your comments to this office, but the request must be made before the end of the
15-day period. Except in extraordinary circumstances, no extension will be approved. Failure to
submit your comments within that time will be regarded as a waiver of your confidentiality claim
or claims, and the EPA may release the information.
If you wish to claim any information that you provide in your response to this letter to
itself be confidential, you must mark the response with “CONFIDENTIAL BUSINESS
INFORMATION” or with a similar designation, and you must bracket all text in the response
that you so claim. Information so designated will be disclosed by the EPA only to the extent
allowed by, and by means of the procedures set forth in, 40 C.F.R. Part 2, Subpart B. If you fail
to claim the information provided in your response as confidential, it may be made available to
the public without further notice to you.

Should you have any questions concerning this matter, please call me at [telephone
number].
Sincerely,
[Signature and Title; Office Name and Address]
[Enclosure]

SAMPLE LETTER D: FIFRA; Non-FOIA

Approved OMB 2020-003
Approval expires 09/30/2023
Request for Substantiation From an Affected Business

By Certified U.S. Mail; Return Receipt Requested
[Name, title, and address of the [designated] representative of the affected business]
Re: Freedom of Information Act Request [INSERT NUMBER]
Dear [INSERT NAME]:
The U.S. Environmental Protection Agency (“EPA”) Office of Pesticide Programs is
seeking to determine the entitlement to confidentiality of [description of the information that is
the subject of the advance or final confidentiality determination] [if submitted by the business
whose information it is: that you submitted to the EPA] [if submitted by an entity other than the
business whose information it is: in EPA’s possession.] [If information has been claimed as CBI:
You have claimed (all or part) of this information as confidential business information (“CBI”).]
[If no claim has been made: In accordance with applicable EPA regulations, 40 C.F.R. Part 2,
Subpart B, the EPA has determined that you might be expected to assert a claim that some or all
of [if submitted by the business whose information it is: the information you submitted to the
EPA] [if submitted by an entity other than the business whose information it is: this information
in EPA’s possession] is confidential business information (“CBI”).]
The purpose of this letter is to notify you that the EPA Office of General Counsel will be
making a(n) [advance or final] confidentiality determination concerning the information you
have claimed as CBI. If you feel that some or all of the information is entitled to confidential
treatment, you must make the showings below with specific reference to those portions of the
information you consider confidential.
Please be specific by page (including Bates Stamp, if applicable), paragraph, and
sentence when identifying and substantiating the information subject to your claim. Where your
claim, as originally made or as modified by your response to this letter, does not include all
information on a page, please attach a copy of each such page with brackets around the text that
you claim to be CBI. Please note that if a page, document, group, or class of documents claimed
by you to be CBI contains a significant amount of information which the Office of General
Counsel determines is not CBI, your CBI claim regarding that page, document, group, or class of
documents may be denied. Any information not specifically identified as subject to a

confidentiality claim and substantiated as such in your response to this letter may be disclosed to
the requester without further notice to you.
In making its final confidentiality determination, the EPA will consider the relevant
substantive criteria in its CBI regulations, under 40 C.F.R. § 2.208(a)-(d), as well as the U.S.
Supreme Court’s decision in Food Marketing Institute v. Argus Leader Media (Argus), 139 S. Ct.
2356, 204 L.Ed.2d 742 (2019), which evaluated the definition of “confidential” as used in
Exemption 4. In the Argus decision, the Court held that at least where “[1] commercial or
financial information is both customarily and actually treated as private by its owner and [2]
provided to the government under an assurance of privacy, the information is ‘confidential’
within the meaning of Exemption 4.” Argus, 139 S. Ct. at 2366.
Thus, for each item or class of information that you claim as CBI, please answer the
following questions, giving as much detail as possible. EPA will use your responses to these
questions to determine whether the information has been shown to be entitled to confidential
treatment:
Questions 1-7 must be answered with respect to any confidentiality claims pertaining to
the enclosed product chemistry information.
1. What value can your competitors derive from knowing the identity, percent by weight,
certified limits, or parent process of each impurity? Is this impurity unique to your
manufacturing process? Why would your competitors find this impurity preferable over
whatever impurity results from their equivalent process?
2. Does published analytical methodology exist that could identify and quantify this
impurity? If so, why do you believe that your competitors have not already performed
such analysis?
3. What value can your competitors derive from knowing the description of materials used
to produce the product, the description of the production process, or the preliminary
production analysis? Why would your competitors find these processes preferable over
their equivalent processes?
Questions 4-7 must be answered with respect to any confidentiality claims pertaining to
the inert ingredients. Each question must be answered separately with respect to each inert
ingredient:
4. What is the value that this inert ingredient brings to the product formulation? What
characteristics of this ingredient are unique such that competitors might prefer it over
whatever ingredients perform the equivalent function in their formulations? Is the use of
this ingredient limited to your product, or does it have broader applications?
5. Why is it unlikely that your competitors have not already discovered the value of this
ingredient? Are you aware of the use of this ingredient as an inert by your competitors?

6. To your knowledge, has the use of this inert ingredient in a pesticide been disclosed in a
patent? If so, how would disclosure of the identity of the ingredient assist your
competitors beyond what is already available through a patent?
7. Can the identity of this inert ingredient be determined by product sample analysis? If so,
why do you believe that your competitors have not already performed such analysis?
Questions 8 through 17 must be answered for each type of information that you claimed as
confidential:
8.

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.

9.

Has EPA, another federal agency, or court made any determination as to the
confidentiality of the information? If so, please attach a copy of the determination.

10. Is the information contained in any publicly available material such as patents or
patent applications, publicly available databases (including state databases),
promotional publications, annual reports, or articles? Yes/No
If you answered “yes”, please identify the publicly available information and its
location (e.g., patent number or website address).
11. Has your company taken reasonable measures to protect the information claimed as
CBI? If so, please identify the measure or internal controls your business has taken
to protect the information claimed as confidential:
a. Non-disclosure agreement required prior to access. Yes/No
b. Access is limited to individuals with a need-to-know. Yes/No
c. Information is physically secured (e.g. locked in a room or cabinet) or
electronically secured (encrypted, password protected, etc.). Yes/No
d. Other internal control measures(s). Yes/No. (If yes, please explain.)
12. Does your company customarily keep the information private or closely-held? If so,
please explain the basis for your response.
13. At the time you submitted the information you claimed as CBI, did EPA provide any
express or implied assurance of confidentiality? If so, please explain the specific
assurance(s) you received. For example, express assurances indicating that
information will not be publicly disclosed could include legal authorities (regulation
or statute), direct communications, class determinations, etc. Examples of implicit
assurances could include a description of the specific context in which the
information was received.
14. Did the Agency provide any express or implied indications at the time the
information was submitted that EPA would publicly disclose the information?

15. If you believe any submitted information to be a trade secret, please 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.
16. Explain any other issue or additional information you deem relevant to EPA’s
determination.
Please note that you bear the burden of substantiating your CBI and trade secret
claim(s). Generalized or conclusory statements will be given little or no weight in EPA’s
determination on the confidentiality of the information you claim to be CBI. Be advised that
information described by Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) section
10(d)(l)(A), (B), and (C) is not automatically entitled to confidential treatment. Disclosure of
such information would only be prohibited, by FIFRA section (b), if the information is eligible
for confidential treatment as described by 40 CFR 2.208(a)-(d).
Your comments must be postmarked or hand delivered to this office, or emailed to [email
address], by the 15th working day after your receipt of this letter. You may seek an extension of
time to submit your comments to this office, but your request must be made before the end of the
15-day period. Except in extraordinary circumstances, no extension will be approved without the
consent of the FOIA requester. Failure to submit your comments within that time will be
regarded as a waiver of your confidentiality claim(s), and the EPA may release the information.
If you wish to claim any information that you provide in your response to this letter to be
claimed as CBI, you must mark the response with “CONFIDENTIAL BUSINESS
INFORMATION” or with a similar designation, and you must bracket all text in the response
that you so claim. Information so designated will be disclosed by the EPA only to the extent
allowed by, and by means of the procedures set forth in, 40 C.F.R. Part 2, Subpart B. If you fail
to claim the information provided in your response as confidential, it may be made available to
the public without further notice to you.
Should you have any questions concerning this matter, please call me at [telephone
number].
Sincerely,

[SIGNATORY AND TITLE]

Enclosures

SAMPLE LETTER E: TSCA

Approved OMB 2020-003
Approval expires 09/30/2023

By Certified U.S. Mail; Return Receipt Requested
MAY CONTAIN CONFIDENTIAL BUSINESS INFORMATION
[Technical Contact Name, title, Company, and Address]
Re: Notice of Review and Request for Substantiation of Confidential Business Information
Claim(s)
Document Type:
Document Identifying Number:
Date of Submission:
Type of claim(s) to be reviewed:

 specific chemical identity
 all other CBI claims

Dear [Addressee]:
Under section 14(f) of the Toxic Substances Control Act (TSCA), EPA shall require any person
to “reassert and substantiate or resubstantiate the [CBI] claim” under certain circumstances.
EPA will review such CBI claim (1) to determine whether the information qualifies for
protection under Exemption 4 when requested to be disclosed under a Freedom of Information
request; (2) if the Administrator has a reasonable basis to believe the information does not
qualify for protection under TSCA; or (3) for any chemical substance that EPA determines under
TSCA section 5(b)(4)(A) presents an unreasonable risk of injury to health or the environment.
15 U.S.C. § 2613(f).
This letter is to notify you that the U.S. Environmental Protection Agency (EPA) Office of
General Counsel will be making a final confidentiality determination concerning information
you have claimed as CBI, as identified above. All CBI claims must be substantiated.
If you feel that some or all of the information checked above is entitled to confidential treatment,
you must substantiate as described below with specific reference to those portions of the
information you consider confidential.

Substantiating a CBI Claim.
There are two different sets of substantiation questions for CBI claims: (I) questions for all CBI
claims in the submission; and (II) questions for chemical identity CBI claims. If you are
claiming a specific chemical identity as CBI, you must answer the questions in both sets of
substantiation questions. EPA has identified the appropriate question set(s) via the checkboxes
at the top of this letter. In some instances, for example TSCA section 8(a) Chemical Data
Reporting (CDR) Rule submissions, you may have already provided up-front substantiations for
some or all of the CBI claims. If you have already substantiated your CBI claim at the time of
submission and believe that your previously submitted substantiation remains accurate and up to
date, you may choose to rely on that substantiation by referring to or preferably physically
attaching your substantiation to your response to this letter.
I. REQUIRED FOR ALL CBI CLAIMS.
If you are asserting ANY information in the submission as CBI, please answer the
following questions.
In supporting your CBI claim(s), please be specific by page, paragraph, sentence, or by data
element when identifying and substantiating the information subject to your claim. Where your
claim, as originally made or as modified by your response to this letter, does not include all
information on a page, please attach a copy of each such page with brackets around the text that
you claim to be CBI.
In some cases, it may be appropriate to group the information into a class of information rather
than responding to each item claimed as CBI. See EPA webpage [INSERT WEBPAGE] for
suggested approaches to providing substantiations of materials grouped. For any information
that is not specifically identified as subject to a confidentiality claim and substantiated as such in
your response to this letter, it shall be determined that you have waived your CBI claim, pursuant
to 40 C.F.R. § 2.205(d).
For each item or class of information that you continue to claim as CBI, please answer the
following questions, giving as much detail as possible. Your substantiation response to these
questions will be used by the EPA to determine whether the information has been shown to be
entitled to confidential treatment:
1. Please specifically explain what harm to the competitive position of your business would
be likely to result from the release of the information claimed as confidential. How would
that harm be substantial? Why is the substantial harm to your competitive position likely
(i.e., probable) to be caused by release of the information rather than just possible? If you
claimed multiple types of information to be confidential (e.g., site information, exposure
information, environmental release information, etc.), explain how disclosure of each
type of information would be likely to cause substantial harm to the competitive position
of your business.

2. 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.
3. Is any of the information claimed as confidential required to be publicly disclosed under
any other Federal law? If yes, please explain.
4. 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. If this chemical is patented and the patent
reveals the information you are claiming confidential, please explain your reasons for
believing the information is nonetheless still confidential.
5. 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 and 10 years) or the
specific date after which the claim is withdrawn.
6. 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 or not the information
was found to be entitled to confidential treatment, the entity that made the decision, and
the date of the determination.
II. REQUIRED FOR ONLY CHEMICAL IDENTITY CBI CLAIMS.
If you are claiming a specific chemical identity as CBI, please answer the additional
following questions. If you are not substantiating a chemical identity CBI claim, then you do
not need to respond to the questions below.
1. Is this chemical substance publicly known (including by your competitors) to be in U.S.
commerce? If yes, please explain why the specific chemical identity should still be
afforded confidential status. If no, please complete the certification statement:
I certify that on the date referenced I searched the internet for the chemical substance
identity (i.e., by both chemical substance name and CASRN). I did not find a
reference to this chemical substance and have no knowledge of public information
that would indicate that the chemical is being manufactured or imported by anyone
for a commercial purpose in the United States. [provide date].

2. Does this specific chemical substance leave the site of manufacture (including import) in
any form, e.g., as a product, effluent, emission? If yes, please explain what measures
have been taken to guard against the discovery of its identity.
3. 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, emission), in light of existing technologies and any costs,
difficulties, or limitations associated with such technologies? Please explain why or why
not.
4. Would disclosure of the specific chemical identity release confidential process
information? If yes, please explain.
Asserting a CBI claim in your substantiation response.
Businesses may claim their substantiation response as CBI. Information claimed as confidential
should be clearly marked by bracketing, circling, or underlining. All pages containing such
information must also be stamped "CONFIDENTIAL BUSINESS INFORMATION" or with
similar designation in order to assert a confidentiality claim. Care should be taken to ensure that
these markings do not obscure the text.
Certification
You must include the following statement in the submission.
I hereby certify to the best of my knowledge and belief that all information provided in
this submission is complete and accurate.
I further certify that, pursuant to 15 U.S.C. § 2613(c), 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.

Timely Responses and Postal Requirements
Your substantiation response must be postmarked or hand delivered to this office by the 15th
working day after your receipt of this letter. While it is anticipated that there will be a means
for sending these to the Agency electronically in the future, at this point substantiations should
be sent via US Mail or courier.
Filings should be directed to the below address.
TSCA Confidential Business Information Center (7407M)
WJC East; Room 6428; Attn: TSCA CBI Substantiations
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001
Courier Deliveries:
U.S. EPA
Office of Pollution Prevention and Toxics
Confidential Business Information Center (CBIC)
Attn: TSCA CBI Substantiations
1201 Constitution Avenue, NW
WJC East; Room 6428
Washington, DC 20004-3302
(202) 564-8930
You may seek an extension of time to submit your substantiation response to this office, but the
request must be made before the end of the 15-day period. Requests for an extension may be
directed to Ms. Quoc Nguyen, Office of General Counsel, [email protected].
Failure to timely submit your substantiation response will be regarded as a waiver of your
confidentiality claim or claims, and the EPA may release the information.
Should you have any questions concerning this matter, please contact Ms. Jessica Barkas, (202)
250-8880 and [email protected].
Sincerely,
[Signature and Title; Office Name and Address]