What to Include in CBI Substantiations
In order for EPA to make a determination regarding the validity of a confidential business information (CBI) claim in a particular Toxic Substances Control Act (TSCA) submission, information regarding the basis for the CBI claim (i.e. substantiation) must be provided. Submitters may provide to EPA any information they believe supports the validity of their CBI claims.
When reviewing and making a CBI determination, EPA considers each CBI claim and corresponding substantiation, the provisions of TSCA and applicable regulations, any previously-issued determinations which are pertinent, and other relevant materials as appropriate. Learn more about EPA’s review and determination of CBI claims under TSCA, including prior confidentiality determinations.
Note that while each information element claimed as CBI and not exempt from substantiation must be substantiated, 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. For example, information that identifies a company, including the company name, address, official and technical contact names and telephone numbers, and other identifying data could be grouped together and a single set of substantiation responses provided in support of CBI claims for all those information elements.
- General substantiation questions
- Sample substantiation templates
- Information exempt from substantiation
- Guidance on completing Chemical Data Reporting Form U and Pre-manufacture Notices
- Information Not Protected From Disclosure
- EPA Contacts
General substantiation questions
EPA has found that an effective means for providing information to support the validity of a CBI claim is in the form of responses to the following substantiation questions found in 40 CFR section 2.204(e)(4). These questions are intended to generate responses providing the factual basis for the assertion that the particular data element is CBI. While these specific questions are not dictated by the self-executing substantiation requirement in TSCA section 14(c)(3), EPA suggests that companies look to these questions for guidance as to how to fulfill the TSCA section 14(c)(3) substantiation requirement for information that is not currently subject to an existing regulatory up-front substantiation requirement.
EPA is in the process of developing TSCA-specific substantiation questions that submitters could elect to use in support of CBI claims. Please continue to check this website for new updates.
- The portions of the information which are alleged to be entitled to confidential treatment;
- The period of time for which confidential treatment is desired by the business (e.g., until a certain date, until the occurrence of a specified event, or permanently);
- The purpose for which the information was furnished to EPA and the approximate date of submission, if known;
- Whether a business confidentiality claim accompanied the information when it was received by EPA;
- Measures taken by the business to guard against undesired disclosure of the information to others;
- The extent to which the information has been disclosed to others, and the precautions taken in connection therewith;
- Pertinent confidentiality determinations, if any, by EPA or other Federal agencies, and a copy of any such determination, or reference to it, if available;
- Whether the business asserts that disclosure of the information would be likely to result in substantial harmful effects on the business' competitive position, and if so, what those harmful effects would be, why they should be viewed as substantial, and an explanation of the causal relationship between disclosure and such harmful effects; and
- Whether the business asserts that the information is voluntarily submitted information as defined in [40 CFR] § 2.201(i), and if so, whether and why disclosure of the information would tend to lessen the availability to EPA of similar information in the future.
View a PDF version of the general substantiation questions.
Sample substantiation templates
In order to assist submitters in substantiating their CBI claims, EPA has developed substantiation templates that may be used as a starting point in preparing their CBI substantiations for uploading into CDX electronic reporting applications or for inclusion with submissions made via paper. Submitters are encouraged to use these substantiation template documents, but are not required to do so.
Please note that the Section 5 substantiation template was updated in June of 2020. This template is for use when making submissions under TSCA section 5, including Premanufacture Notices (PMNs), Low Volume Exemptions (LVEs), and Significant New Use Notices (SNUNs). The updates to the Section 5 template are intended to assist submitters with appropriately addressing CBI claims in attachments, including assuring that all non-exempt redacted information includes required substantiation. The template has also been updated to break up previously combined claims in Part II section A.2, to allow for independent substantiation of each claim.
- Section 5 (PMN/LVE/SNUN) substantiation template(13 pp, 221 K) (Updated June 2020)
- Notice of Commencement substantiation template (for claims other than chemical identity)(3 pp, 66 K)
- Bona Fide submission substantiation template(3 pp, 67 K)
- Polymer exemption report substantiation template(3 pp, 71 K)
- Section 8(e) notice of substantial risk substantiation template(4 pp, 111 K)
- Section 12(b) export notice substantiation template (5 pp, 91 K)
- Chemical Data Reporting (CDR) substantiation template(5 pp, 104 K)
- General substantiation template(5 pp, 105 K)
Information exempt from substantiation
TSCA section 14(c)(2) identifies certain information that is generally not subject to substantiation requirements. This information includes:
- Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article;
- Marketing and sales information;
- Information identifying a supplier or customer;
- In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents;
- Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article;
- Specific production or import volumes of the manufacturer or processor; and
- 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 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 TSCA 5.
Guidance on completing Chemical Data Reporting Form U and Pre-manufacture Notices
Two of the most common TSCA submissions EPA receives are Chemical Data Reporting (CDR) Form U submissions under TSCA section 8(a) of TSCA and 40 CFR part 711, and Pre-manufacture Notices (PMNs) under TSCA section 5 (15 U.S.C. § 2604) and 40 CFR part 720. In order to assist companies with substantiating CBI claims, the tables below provide a list of fields used on the forms corresponding to these submission types that EPA believes are exempt from substantiation.
The tables also provide the principal statutory basis for each exemption. However, note that one or more of the exemptions under TSCA section 14(c)(2) may apply to information submitted under other fields in some circumstances. If you believe that any TSCA section 14(c)(2) exemption applies to information submitted under a field that is not listed here, you may note this in your substantiation response, citing the exemption and the reason you believe it applies, and not substantiate at that time.
CDR- EPA Form U
|Field #||Information Type||Basis for Exemption|
|2.A.7||Secondary Company Name||§ 14(c)(2)(C)|
|2.A.8||Secondary Company Address||§ 14(c)(2)(C)|
|2.A.10||State or Province||§ 14(c)(2)(C)|
|2.A.11||Zip Code||§ 14(c)(2)(C)|
|2.B.5||Production Volume – Domestically Manufactured||§ 14(c)(2)(F)|
|2.B.6||Production Volume – Imported||§ 14(c)(2)(F)|
|2.B.20.a||Past Production Volume – CY 2014||§ 14(c)(2)(F)|
|2.B.20.b||Past Production Volume – CY 2013||§ 14(c)(2)(F)|
|2.B.20.c||Past Production Volume – CY 2012||§ 14(c)(2)(F)|
|2.B.20.d||Past Production Volume – CY 2011||§ 14(c)(2)(F)
|Field #||Information Type||Basis for Exemption|
|Part I, B.1.b||Chemical Name||§ 14(c)(2)(G)*|
|Part I, B.1.d||Molecular formula||§ 14(c)(2)(G)*|
|Part I, B.1.e||Chemical Structure Diagram||§ 14(c)(2)(G)*|
|Part I, B.1.e.(1)||Class 2 Substance Precursors||§ 14(c)(2)(A)|
|Part I, B.1.e.(2)||Class 2 nature of reaction or process||§ 14(c)(2)(A)|
|Part I, B.1.e.(3)||Class 2 range of composition||§ 14(c)(2)(A)|
|Part I, B.2.a.(i)||Lowest number average molecular weight||§ 14(c)(2)(G)*|
|Part I, B.2.a.(ii)||Max weight % below 500 molecular weight||§ 14(c)(2)(G)*|
|Part I, B.2.a.(iii)||Max weight % below 1000 molecular weight||§ 14(c)(2)(G)*|
|Part I, B.2.b.(1)||Monomer or other reactant specific chemical name||§ 14(c)(2)(A)|
|Part I, B.2.b.(4)||Include in identity||§ 14(c)(2)(A)|
|Part I, B.2.d||The currently correct Chemical Abstracts (CA) name for the polymer||§ 14(c)(2)(G)*|
|Part I, B.2.e||Chemical structure diagram||§ 14(c)(2)(G)*|
|Part I, C.1||Max first 12-month production||§ 14(c)(2)(F)|
|Part I, C.1||Max 12-month production||§ 14(c)(2)(F)|
|Part I, C.2||Use information||§ 14(c)(2)(E)|
|Part II, A.1.c||Amount and duration||§ 14(c)(2)(F)|
|Part II, A.1.d||Process description||§ 14(c)(2)(A)|
|Part II, B.1(a)||Operation Description||§ 14(c)(2)(A)|
|Part II, B.1(b)||Optional description of operation description diagram||§ 14(c)(2)(A)|
|Physical and Chemical Properties Worksheet - Spectra||Spectra||§ 14(c)(2)(G)*|
* An exemption from substantiation under TSCA section 14(c)(2)(G) only applies prior to the date on which a chemical substance is first offered for commercial distribution
Information Not Protected From Disclosure
EPA is evaluating which information provided under various sections of TSCA may not be CBI under section 14(b)(3). EPA expects to publish guidance regarding this in the near future.
For more information on what information to include in CBI substantiations, please contact:
- Scott Sherlock, 202-564-8257, firstname.lastname@example.org
- Jessica Barkas, 202-250-8880, email@example.com